<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03235726</url>
  </required_header>
  <id_info>
    <org_study_id>205822</org_study_id>
    <secondary_id>2017-001070-42</secondary_id>
    <nct_id>NCT03235726</nct_id>
  </id_info>
  <brief_title>Study of Safety and Drug Levels of CCI15106 Inhalation Powder in Healthy Adults and Adults With Moderate Chronic Obstructive Pulmonary Disease. Study of CCI15106 Levels in People Standing Near the Person Inhaling the Drug</brief_title>
  <official_title>A Double-blind (Sponsor Unblind), Randomized, Placebo-controlled, Single and Repeat Escalating Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of CCI15106 Inhalation Powder in Healthy Participants and Participants With Moderate Chronic Obstructive Pulmonary Disease (COPD) Including Evaluation of Environmental and Healthy By-stander Exposure Levels During Dosing</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This single and repeat increasing dose study will collect information on safety, tolerability&#xD;
      and drug levels in the body of the CCI15106 inhalation powder. The study will also look at&#xD;
      the level of CCI15106 that will be released into the air and may be found in the blood of the&#xD;
      people standing around the person inhaling it (bystanders). This is a two-part study in which&#xD;
      Part 1 will enroll healthy subjects and look at environmental and bystander exposure and Part&#xD;
      2 will enroll subjects with moderate COPD. Approximately 36 healthy subjects and&#xD;
      approximately 22 subjects with COPD will be randomized in this study for dosing. The total&#xD;
      study duration will be 82 days for Cohort A Part 1; 75 days for Cohort B Part 1 and Cohort C&#xD;
      Part 1; 77 days for Cohort A Part 2; and 90 days for Cohort B Part 2.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 13, 2017</start_date>
  <completion_date type="Actual">June 19, 2018</completion_date>
  <primary_completion_date type="Actual">June 19, 2018</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>In this study, subjects will be randomized to receive either study drug or placebo in a parallel manner.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>This is a double blind, randomized study and subject and investigator will be blinded.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Part 1 Cohort A: Number of Participants With Non-serious Adverse Events (NSAEs) and Serious Adverse Events (SAEs) in CCI15106</measure>
    <time_frame>Up to 51 days</time_frame>
    <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician. Safety population comprised of all participants who received at least one dose of study treatment during the study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1 Cohort B: Number of Participants With NSAEs and SAEs in CCI15106</measure>
    <time_frame>Up to 46 days</time_frame>
    <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1 Cohort C: Number of Participants With NSAEs and SAEs in Bystanders</measure>
    <time_frame>Up to 46 days</time_frame>
    <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2 Cohort A: Number of Participants With NSAEs and SAEs</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2 Cohort B: Number of Participants With NSAEs and SAEs</measure>
    <time_frame>Up to 46 days</time_frame>
    <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: Number of Participants With Hematology Values of Potential Clinical Importance (PCI) in CCI15106</measure>
    <time_frame>Up to 51 days</time_frame>
    <description>PCI ranges for the hematology parameters were as follows: hematocrit (high: &gt;0.54 proportion of red blood cell [RBC] in blood for male, &gt;0.54 proportion of RBC in blood for female), hemoglobin (high: &gt;180 grams [g]/L in male, &gt;180 g/L in female), lymphocytes (low: &lt;0.8 10^9/L), neutrophil count (low: &lt;1.5 10^9/L) and platelet count (low: &lt;100 10^9/L and high: 550 10^9/L). Data for the participants with high and low values has been reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: Number of Participants With Hematology Values of PCI in Bystanders</measure>
    <time_frame>Up to 46 days</time_frame>
    <description>PCI ranges for the hematology parameters were as follows: hematocrit (high: &gt;0.54 proportion of RBC in blood for male, &gt;0.54 proportion of RBC in blood for female), hemoglobin (high: &gt;180 g/L in male, &gt;180 g/L in female), lymphocytes (low: &lt;0.8 10^9/L), neutrophil count (low: &lt;1.5 10^9/L) and platelet count (low: &lt;100 10^9/L and high: 550 10^9/L). Data for the participants with high and low values has been reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: Number of Participants With Hematology Values of PCI</measure>
    <time_frame>Up to 46 days</time_frame>
    <description>PCI ranges for the hematology parameters were as follows: hematocrit (high: &gt;0.54 proportion of RBC in blood for male, &gt;0.54 proportion of RBC in blood for female), hemoglobin (high: &gt;180 g/L in male, &gt;180 g/L in female), lymphocytes (low: &lt;0.8 10^9/L), neutrophil count (low: &lt;1.5 10^9/L) and platelet count (low: &lt;100 10^9/L and high: 550 10^9/L). Data for the participants with high and low values has been reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106</measure>
    <time_frame>Up to 51 days</time_frame>
    <description>PCI ranges for the clinical chemistry parameters were as follows: albumin (low: &lt;30 millimole per liter [mmol/L]), calcium (low: &lt;2 mmol/L and high: &gt;2.75 mmol/L), glucose (low: &lt;3 mmol/L and high: &gt;9 mmol/L), potassium (low: &lt;3 mmol/L and high: &gt;5.5 mmol/L) and sodium (low: &lt;130 mmol/L and high: &gt;150 mmol/L). Data for the participants with high and low values has been reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: Number of Participants With Clinical Chemistry Values of PCI in Bystanders</measure>
    <time_frame>Up to 46 days</time_frame>
    <description>PCI ranges for the clinical chemistry parameters were as follows: albumin (low: &lt;30 mmol/L), calcium (low: &lt;2 mmol/L and high: &gt;2.75 mmol/L), glucose (low: &lt;3 mmol/L and high: &gt;9 mmol/L), potassium (low: &lt;3 mmol/L and high: &gt;5.5 mmol/L) and sodium (low: &lt;130 mmol/L and high: &gt;150 mmol/L). Data for the participants with high and low values has been reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: Number of Participants With Clinical Chemistry Values of PCI</measure>
    <time_frame>Up to 46 days</time_frame>
    <description>PCI ranges for the clinical chemistry parameters were as follows: albumin (low: &lt;30 mmol/L), calcium (low: &lt;2 mmol/L and high: &gt;2.75 mmol/L), glucose (low: &lt;3 mmol/L and high: &gt;9 mmol/L), potassium (low: &lt;3 mmol/L and high: &gt;5.5 mmol/L) and sodium (low: &lt;130 mmol/L and high: &gt;150 mmol/L). Data for the participants with high and low values has been reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1 Cohort A: Potential of Hydrogen (pH) Value by Visit- CCI15106 60 mg SD</measure>
    <time_frame>Baseline (Day -1) and Day 2</time_frame>
    <description>Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1 Cohort A: pH Value by Visit- CCI15106 120 mg SD</measure>
    <time_frame>Day 5</time_frame>
    <description>Urine sample was collected from participants at indicated time point for analysis of pH.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1 Cohort A: pH Value by Visit- CCI15106 30 mg BID</measure>
    <time_frame>Days 12 and 22</time_frame>
    <description>Urine samples were collected from participants at indicated time points for analysis of pH.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1 Cohort B: pH Value by Visit- CCI15106 60 mg BID</measure>
    <time_frame>Baseline (Day -1), Days 7 and 15</time_frame>
    <description>Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: pH Value by Visit- Placebo</measure>
    <time_frame>Baseline (Day -1), Days 2, 5, 7, 12, 15 and 22</time_frame>
    <description>Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1 Cohort C: pH Value by Visit- CCI15106 in Bystanders</measure>
    <time_frame>Baseline (Day -1), Days 7 and 15</time_frame>
    <description>Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2 Cohort A: pH Value by Visit- CCI15106</measure>
    <time_frame>Baseline (Day -1) and Day 2</time_frame>
    <description>Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2 Cohort B: pH Value by Visit- CCI15106 60 mg BID</measure>
    <time_frame>Baseline (Day -1), Days 7 and 15</time_frame>
    <description>Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1 Cohort A: Specific Gravity Value by Visit- CCI15106 60 mg SD</measure>
    <time_frame>Baseline (Day -1) and Day 2</time_frame>
    <description>Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1 Cohort A: Specific Gravity Value by Visit- CCI15106 120 mg SD</measure>
    <time_frame>Day 5</time_frame>
    <description>Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine sample was collected from participants at indicated time point for analysis of specific gravity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1 Cohort A: Specific Gravity Value by Visit- CCI15106 30 mg BID</measure>
    <time_frame>Days 12 and 22</time_frame>
    <description>Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1 Cohort B: Specific Gravity Value by Visit- CCI15106 60 mg BID</measure>
    <time_frame>Baseline (Day -1), Days 7 and 15</time_frame>
    <description>Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of Specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: Specific Gravity Value by Visit- Placebo</measure>
    <time_frame>Baseline (Day -1), Days 2, 5, 7, 12, 15 and 22</time_frame>
    <description>Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of Specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1 Cohort C: Specific Gravity Value by Visit- CCI15106 in Bystanders</measure>
    <time_frame>Baseline (Day -1), Days 7 and 15</time_frame>
    <description>Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2 Cohort A: Specific Gravity Value by Visit- CCI15106</measure>
    <time_frame>Baseline (Day -1) and Day 2</time_frame>
    <description>Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2 Cohort B: Specific Gravity Value by Visit- CCI15106 60 mg BID</measure>
    <time_frame>Baseline (Day -1), Days 7 and 15</time_frame>
    <description>Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106</measure>
    <time_frame>Up to 51 days</time_frame>
    <description>PCI ranges for the ECG parameters were as follows: absolute QTc interval &gt;450 and &lt;480, &gt;=480 and &lt;500, &gt;=500 milliseconds (msec), absolute PR interval &lt;110 and &gt;220 msec and absolute QRS interval &lt;75 and &gt;110 msec. QTcF=Frederica's QT interval corrected for heart rate; QTcB=Bazett's QT interval corrected for heart rate. Data for worst case post-Baseline has been reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI in Bystander</measure>
    <time_frame>Up to 46 days</time_frame>
    <description>PCI ranges for the ECG parameters were as follows: absolute QTc interval &gt;450 and &lt;480, &gt;=480 and &lt;500, &gt;=500 msec, absolute PR interval &lt;110 and &gt;220 msec and absolute QRS interval &lt;75 and &gt;110 msec. Data for worst case post-Baseline has been reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI</measure>
    <time_frame>Up to 46 days</time_frame>
    <description>PCI ranges for the ECG parameters were as follows: absolute QTc interval &gt;450 and &lt;480, &gt;=480 and &lt;500, &gt;=500 msec, absolute PR interval &lt;110 and &gt;220 msec and absolute QRS interval &lt;75 and &gt;110 msec. Data for worst case post-Baseline has been reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: Number of Participants With Abnormal Telemetry Findings</measure>
    <time_frame>Days 1, 3, 6, 7, 12 and 18: 0.5 hour (pre-dose) to 4 hours post-dose</time_frame>
    <description>Continuous cardiac telemetry was performed from approximately 0.5 hour (pre-dose) to 4 hours post-dose. Abnormal findings were categorized as clinically significant (CS) and not clinically significant (NCS). Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: Number of Participants With Abnormal Telemetry Findings</measure>
    <time_frame>Days 1, 7, 12 and 13: 0.5 hour (pre-dose) to 4 hours post-dose</time_frame>
    <description>Continuous cardiac telemetry was performed from approximately 0.5 hour (pre-dose) to 4 hours post-dose. Abnormal findings were categorized as CS and NCS. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points</measure>
    <time_frame>Days 1, 3, 6 and 19: pre-dose, 0.25, 0.5, 1 and 4 hours post-dose; Days 8, 11 and 16: pre-dose and 4 hours post-dose; Day 14: pre-dose, 0.5, 1 and 4 hours post-dose</time_frame>
    <description>FEV1 is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using standard spirometry. Percent predicted FEV1 was calculated as: Percent predicted FEV1=(maximum FEV1 divided by predicted normal FEV1)*100.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points</measure>
    <time_frame>Days 1, 3, 6 and 19: pre-dose, 0.25, 0.5, 1 and 4 hours post-dose; Days 8, 11 and 16: pre-dose and 4 hours post-dose; Day 14: pre-dose, 0.5, 1 and 4 hours post-dose</time_frame>
    <description>FVC is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FVC was measured using standard spirometry. Percent predicted FVC was calculated as: Percent predicted FVC=(maximum FVC divided by predicted normal FVC)*100.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: Percent Predicted FEV1 at Indicated Time Points</measure>
    <time_frame>Day 1 and 14: pre-dose, 0.25, 0.5, 1 and 4 hours post-dose; Days 3, 6 and 11: pre-dose and 4 hours post-dose</time_frame>
    <description>FEV1 is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using standard spirometry. Percent predicted FEV1 was calculated as: Percent predicted FEV1=(maximum FEV1 divided by predicted normal FEV1)*100.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: Percent Predicted FVC at Indicated Time Points</measure>
    <time_frame>Day 1 and 14: pre-dose, 0.25, 0.5, 1 and 4 hours post-dose; Days 3, 6 and 11: pre-dose and 4 hours post-dose</time_frame>
    <description>FVC is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FVC was measured using standard spirometry. Percent predicted FVC was calculated as: Percent predicted FVC=(maximum FVC divided by predicted normal FVC)*100.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: Number of Participants With Vital Signs Values of PCI</measure>
    <time_frame>Up to 51 days</time_frame>
    <description>PCI ranges for the vital signs parameters were as follows: systolic blood pressure (SBP) &lt;85 and &gt;160 millimeters of mercury (mmHg), diastolic blood pressure (DBP) &lt;45 and &gt;100 mmHg and heart rate &lt;40 and &gt;110 beats per minute (bpm). Data for the participants with high and low values has been reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: Number of Participants With Vital Signs Values of PCI in Bystanders</measure>
    <time_frame>Up to 46 days</time_frame>
    <description>PCI ranges for the vital signs parameters were as follows: SBP &lt;85 and &gt;160 mmHg, DBP &lt;45 and &gt;100 mmHg and heart rate &lt;40 and &gt;110 bpm. Data for the participants with high and low values has been reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: Number of Participants With Vital Signs Values of PCI</measure>
    <time_frame>Up to 46 days</time_frame>
    <description>PCI ranges for the vital signs parameters were as follows: SBP &lt;85 and &gt;160 mmHg, DBP &lt;45 and &gt;100 mmHg and heart rate &lt;40 and &gt;110 bpm. Data for the participants with high and low values has been reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1 Cohort A: Area Under the Curve (AUC) From Time Zero to the Time of Last Quantifiable Concentration (AUC[0-t]) After Single Dose Administration of CCI15106 60 mg on Day 1</measure>
    <time_frame>Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dose</time_frame>
    <description>Blood samples were collected to evaluate the pharmacokinetics (PKs) of CCI15106 at the indicated time points on Day 1 for the analysis of AUC(0-t) data. PK population consisted of participants who received at least one dose of study treatment and who undergo plasma PK sampling and had at least one post-dose concentration result.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1 Cohort A: AUC(0-t) After Single Dose Administration of CCI15106 120 mg on Day 3</measure>
    <time_frame>Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose</time_frame>
    <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of AUC(0-t) data.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2 Cohort A: AUC(0-t) After Single Dose Administration of CCI15106 60 mg on Day 1</measure>
    <time_frame>Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose</time_frame>
    <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of AUC(0-t) data.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1 Cohort A: Maximum Observed Plasma Concentration (Cmax) After Single Dose Administration of CCI15106 60 mg on Day 1</measure>
    <time_frame>Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dose</time_frame>
    <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of Cmax data.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1 Cohort A: Cmax After Single Dose Administration of CCI15106 120 mg on Day 3</measure>
    <time_frame>Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose</time_frame>
    <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of Cmax data.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2 Cohort A: Cmax After Single Dose Administration of CCI15106 60 mg on Day 1</measure>
    <time_frame>Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose</time_frame>
    <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of Cmax data.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1 Cohort A: Time of Maximum Concentration (Tmax) After Single Dose Administration of CCI15106 60 mg on Day 1</measure>
    <time_frame>Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dose</time_frame>
    <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of tmax data.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1 Cohort A: Tmax After Single Dose Administration of CCI15106 120 mg on Day 3</measure>
    <time_frame>Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose</time_frame>
    <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of tmax data.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2 Cohort A: Tmax After Single Dose Administration of CCI15106 60 mg on Day 1</measure>
    <time_frame>Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose</time_frame>
    <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of tmax data.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1 Cohort A: AUC From Time Zero to Infinity (AUC[0-infinity]) After Single Dose Administration of CCI15106 60 mg on Day 1</measure>
    <time_frame>Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dose</time_frame>
    <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of AUC(0-infinity) data.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1 Cohort A: AUC(0-infinity) After Single Dose Administration of CCI15106 120 mg on Day 3</measure>
    <time_frame>Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose</time_frame>
    <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of AUC(0-infinity) data.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2 Cohort A: AUC(0-infinity) After Single Dose Administration of CCI15106 60 mg on Day 1</measure>
    <time_frame>Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose</time_frame>
    <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of AUC(0-infinity) data.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1 Cohort A: Elimination Half-life (t1/2) After Single Dose Administration of CCI15106 60 mg on Day 1</measure>
    <time_frame>Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dose</time_frame>
    <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of t1/2 data.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1 Cohort A: t1/2 After Single Dose Administration of CCI15106 120 mg on Day 3</measure>
    <time_frame>Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose</time_frame>
    <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of t1/2 data.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2 Cohort A: t1/2 After Single Dose Administration of CCI15106 60 mg on Day 1</measure>
    <time_frame>Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose</time_frame>
    <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of t1/2 data.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1 Cohort A: Clearance (CL/F) After Single Dose Administration of CCI15106 60 mg on Day 1</measure>
    <time_frame>Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dose</time_frame>
    <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of CL/F data.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1 Cohort A: CL/F After Single Dose Administration of CCI15106 120 mg on Day 3</measure>
    <time_frame>Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose</time_frame>
    <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of CL/F data.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2 Cohort A: CL/F After Single Dose Administration of CCI15106 60 mg on Day 1</measure>
    <time_frame>Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose</time_frame>
    <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of CL/F data.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1 Cohort A: AUC From Time Zero to End of Dosing Interval (AUC[0-tau]) After Repeated Dose Administration of CCI15106 30 mg</measure>
    <time_frame>Day 6: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 19: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose</time_frame>
    <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 6 and 19 for the analysis of AUC(0-tau) data.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1 Cohort B: AUC(0-tau) After Repeated Dose Administration of CCI15106 60 mg</measure>
    <time_frame>Days 1 and 14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose</time_frame>
    <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of AUC(0-tau) data.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2 Cohort B: AUC(0-tau) After Repeated Dose Administration of CCI15106 60 mg</measure>
    <time_frame>Days 1 and 14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose</time_frame>
    <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of AUC(0-tau) data.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1 Cohort A: Cmax After Repeated Dose Administration of CCI15106 30 mg</measure>
    <time_frame>Day 6: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 19: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose</time_frame>
    <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 6 and 19 for the analysis of Cmax data.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1 Cohort B: Cmax After Repeated Dose Administration of CCI15106 60 mg</measure>
    <time_frame>Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose</time_frame>
    <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of Cmax data.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2 Cohort B: Cmax After Repeated Dose Administration of CCI15106 60 mg</measure>
    <time_frame>Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose</time_frame>
    <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of Cmax data.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1 Cohort A: Tmax After Repeated Dose Administration of CCI15106 30 mg</measure>
    <time_frame>Day 6: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 19: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose</time_frame>
    <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 6 and 19 for the analysis of tmax data.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1 Cohort B: Tmax After Repeated Dose Administration of CCI15106 60 mg</measure>
    <time_frame>Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose</time_frame>
    <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of tmax data.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2 Cohort B: Tmax After Repeated Dose Administration of CCI15106 60 mg</measure>
    <time_frame>Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose</time_frame>
    <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of tmax data.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1 Cohort A: t1/2 After Repeated Dose Administration of CCI15106 30 mg</measure>
    <time_frame>Day 6: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 19: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose</time_frame>
    <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 6 and 19 for the analysis of t1/2 data.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1 Cohort B: t1/2 After Repeated Dose Administration of CCI15106 60 mg</measure>
    <time_frame>Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose</time_frame>
    <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of t1/2 data.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2 Cohort B: t1/2 After Repeated Dose Administration of CCI15106 60 mg</measure>
    <time_frame>Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose</time_frame>
    <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of t1/2 data.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: Concentration of CCI15106 in Plasma of Bystanders: Cohort C</measure>
    <time_frame>Days 1, 7 and 14: pre-dose, 15 minutes post-dose</time_frame>
    <description>Blood samples were collected from bystanders 15 minutes after dosing at indicated time points. Bystander PK population consisted of participants who were present at least once in the room with the participant receiving the dose, undergo plasma PK sampling and had post-dose concentration result.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C</measure>
    <time_frame>Days 1, 7 and 14: 15 minutes post-dose</time_frame>
    <description>Personal exposure air samples were collected on filters placed on each bystander after the first daily dose at indicated time points. The filters were used to measure CCI15106 concentration in the person's breathing zone. Fixed location concentrations were measured near window, near door, back to wall and facing wall in the dosing room over 15 minutes post-dose. Each bystander had a filter attached to their study clothing. The filters were measured for CCI15106. This was a single measurement from the filter for each bystsander. The locations (near window, near door, back to wall and facing wall) were just to record where the bystander was located in the room.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C</measure>
    <time_frame>Days 1, 7 and 14: 20 and 60 minutes post-dose</time_frame>
    <description>Static air samples were collected on filters within air pumps positioned in two locations (bench and corner) in the room. Sampling devices attached to sampling pumps were used to measure CCI15106 concentration. Fixed location concentrations were measured in corner of room and on bench at back of room over 20 minutes and 60 minutes post-dosing.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Part 1: Concentration of CCI15106 in Lung Epithelial Lining Fluid (ELF) in Repeated Dose of Cohort B 60 mg</measure>
    <time_frame>Up to Day 13</time_frame>
    <description>Bronchoalveolar lavage samples for ELF concentration analysis of CCI15106 were collected up to Day 13. Participants who received at least one dose of study treatment and who underwent bronchoalveolar lavage (BAL) sampling and had post-dose lung ELF CCI15106 and urea concentration result were included in BAL PK Population.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2: Concentration of CCI15106 in ELF in Repeated Dose of Cohort B 60 mg</measure>
    <time_frame>Up to Day 13</time_frame>
    <description>BAL samples for ELF concentration analysis of CCI15106 were collected up to Day 13.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 1: Number of Participants With Medical Device Incidents in CCI15106</measure>
    <time_frame>Up to Day 19</time_frame>
    <description>A medical device incident is any malfunction or deterioration in the characteristics and/or performance of a device as well as any inadequacy in the labeling or the instructions for use which, directly or indirectly, might lead to or might have led to the death of a participant/user/other person or to a serious deterioration in his/her state of health.</description>
  </secondary_outcome>
  <number_of_arms>9</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Pulmonary Disease, Chronic Obstructive</condition>
  <arm_group>
    <arm_group_label>Cohort A, Part 1: Active</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>60 milligrams (mg) single dose of CCI15106 will be administered by inhalation route on Day 1; 120 mg single dose will be administered on Day 3; and then 30 mg dose will be administered twice daily (BID) on Days 6-19 to healthy subjects.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort A, Part 1: Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>60 mg single dose of placebo will be administered by inhalation route on Day 1; 120 mg single dose will be administered on Day 3; and then 30 mg dose will be administered BID on Days 6-19 to healthy subjects.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort B, Part 1: Active</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>60 mg of CCI15106 BID will be administered by inhalation route for 14 days to healthy subjects.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort B, Part 1: Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>60 mg of placebo BID will be administered by inhalation route for 14 days to healthy subjects.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort C, Part 1: bystanders</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Healthy subjects will be enrolled to follow bystander exposure and will be studied concomitantly with Cohort B.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort A, Part 2: Active</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>60 mg single dose of CCI15106 will be administered by inhalation route to subjects with COPD.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort A, Part 2: Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>60 mg single dose of placebo will be administered by inhalation route to subjects with COPD.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort B, Part 2: Active</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>60 mg BID dose of CCI15106 will be administered by inhalation route for 14 days to subjects with COPD.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort B, Part 2: Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>60 mg BID dose of placebo will be administered by inhalation route for 14 days to subjects with COPD.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CCI15106</intervention_name>
    <description>One capsule (single dose or repeat dose) of 30 mg of CCI15106 will be administered to healthy subjects and subjects with COPD via inhalation route using Monodose RS01 device. The morning dose will be taken in fasting state and for repeat dose; the evening dose will be taken at least 2 hours after food.</description>
    <arm_group_label>Cohort A, Part 1: Active</arm_group_label>
    <arm_group_label>Cohort A, Part 2: Active</arm_group_label>
    <arm_group_label>Cohort B, Part 1: Active</arm_group_label>
    <arm_group_label>Cohort B, Part 2: Active</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>One capsule of placebo will be administered to healthy subjects and subjects with COPD via inhalation route using Monodose RS01 device. The morning dose will be taken in fasting state and for repeat dose; the evening dose will be taken at least 2 hours after food.</description>
    <arm_group_label>Cohort A, Part 1: Placebo</arm_group_label>
    <arm_group_label>Cohort A, Part 2: Placebo</arm_group_label>
    <arm_group_label>Cohort B, Part 1: Placebo</arm_group_label>
    <arm_group_label>Cohort B, Part 2: Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Some important Inclusion Criteria:&#xD;
&#xD;
        For healthy subjects and bystanders:&#xD;
&#xD;
          -  18 to 65 years of age.&#xD;
&#xD;
          -  Healthy as determined by a doctor.&#xD;
&#xD;
          -  Men who agree to use contraception during the treatment period and for at least 7&#xD;
             months after the last dose of study medicine and agree not to donate sperm during this&#xD;
             period.&#xD;
&#xD;
          -  Women who are not pregnant or breastfeeding, and not of childbearing potential.&#xD;
&#xD;
        For subjects with COPD:&#xD;
&#xD;
          -  40 to 75 years of age.&#xD;
&#xD;
          -  Diagnosed with moderate COPD by a doctor.&#xD;
&#xD;
          -  Have breathing test results that are consistent with moderate COPD as defined in the&#xD;
             study protocol.&#xD;
&#xD;
          -  A smoker or an ex-smoker.&#xD;
&#xD;
          -  Men who agree to use contraception during the treatment period and for at least 7&#xD;
             months after the last dose of study medicine and agree not to donate sperm during this&#xD;
             period.&#xD;
&#xD;
          -  Women who are not pregnant or breastfeeding, and not of childbearing potential.&#xD;
&#xD;
        Some Important Exclusion Criteria:&#xD;
&#xD;
        For healthy subjects and bystanders:&#xD;
&#xD;
          -  History of liver disease.&#xD;
&#xD;
          -  Use of over-the-counter or prescription drugs (including vitamins) 7 days before the&#xD;
             study until completion of the follow-up visit.&#xD;
&#xD;
          -  Participation in the study would result in loss of more than 500 milliliter (mL) of&#xD;
             blood within 3 months.&#xD;
&#xD;
          -  Participation in another clinical trial with an investigational product within about 3&#xD;
             months before this study.&#xD;
&#xD;
          -  Positive drug/alcohol screen.&#xD;
&#xD;
          -  Regular use of known drugs of abuse.&#xD;
&#xD;
          -  Regular alcohol consumption within 3 months before the study.&#xD;
&#xD;
          -  Breath test indicative of smoking at study start.&#xD;
&#xD;
          -  Documented lactose allergy/intolerance.&#xD;
&#xD;
          -  Men whose partner is pregnant or breastfeeding cannot participate.&#xD;
&#xD;
          -  Certain blood test results may not allow subjects to participate, as described in the&#xD;
             study protocol.&#xD;
&#xD;
        For subjects with COPD:&#xD;
&#xD;
          -  History of liver disease.&#xD;
&#xD;
          -  Poorly controlled COPD disease as, for example, more than 2 exacerbations of COPD per&#xD;
             year.&#xD;
&#xD;
          -  Some respiratory conditions, like for example active tuberculosis, lung cancer or any&#xD;
             other respiratory condition. Subjects with other respiratory conditions (for example,&#xD;
             clinically significant: asthma, pulmonary fibrosis, bronchiectasis) are excluded if&#xD;
             these conditions are the primary cause of their respiratory symptoms.&#xD;
&#xD;
          -  Unstable or uncontrolled cardiac disease.&#xD;
&#xD;
          -  Problems with kidney function as defined in the study protocol.&#xD;
&#xD;
          -  Past or current medical conditions or diseases that are not well controlled.&#xD;
&#xD;
          -  Subjects are not allowed to take oral corticosteroids from 4 weeks prior to screening&#xD;
             and for the duration of the study.&#xD;
&#xD;
          -  Subjects taking medications for any chronic conditions have to be on stable doses for&#xD;
             4 weeks before screening and until after study treatment is finished.&#xD;
&#xD;
          -  Use of short-acting inhaled bronchodilators is allowed, but subjects must be able to&#xD;
             stop their medications several times during the study.&#xD;
&#xD;
          -  Use of long-acting bronchodilators is allowed, but subjects must be able to change the&#xD;
             schedule of their medications twice during the study.&#xD;
&#xD;
          -  Participation in the study would result in loss of more than 500 mL within 3 months.&#xD;
&#xD;
          -  Participation in another clinical trial with an investigational product within about 3&#xD;
             months before this study.&#xD;
&#xD;
          -  Positive drug/alcohol screen.&#xD;
&#xD;
          -  Regular use of known drugs of abuse.&#xD;
&#xD;
          -  Regular alcohol consumption within 3 months before the study.&#xD;
&#xD;
          -  Unable to refrain from smoking for certain periods during the study (maximum about 6&#xD;
             hours).&#xD;
&#xD;
          -  Documented lactose allergy/intolerance.&#xD;
&#xD;
          -  Men whose partner is pregnant or breastfeeding cannot participate.&#xD;
&#xD;
          -  Certain blood test results may not allow subjects to participate, as described in the&#xD;
             study protocol.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Park Royal</city>
        <state>London</state>
        <zip>NE10 7EW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>July 11, 2017</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <results_first_submitted>June 18, 2019</results_first_submitted>
  <results_first_submitted_qc>August 30, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">September 27, 2019</results_first_posted>
  <last_update_submitted>June 26, 2020</last_update_submitted>
  <last_update_submitted_qc>June 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>bystander</keyword>
  <keyword>inhalation powder</keyword>
  <keyword>monodose device</keyword>
  <keyword>COPD</keyword>
  <keyword>pharmacokinetics</keyword>
  <keyword>safety</keyword>
  <keyword>Healthy</keyword>
  <keyword>CCI15106</keyword>
  <keyword>tolerability</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
    <mesh_term>Respiratory Aspiration</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>IPD for this study will be made available via the Clinical Study Data Request site.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>IPD is available via the Clinical Study Data Request site (click on the link provided below)</ipd_time_frame>
    <ipd_access_criteria>Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.</ipd_access_criteria>
    <ipd_url>https://clinicalstudydatarequest.com/Posting.aspx?ID=20373</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 20, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/26/NCT03235726/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 30, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/26/NCT03235726/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This was a two parts single and repeat dose escalation study. Part 1 was conducted in healthy volunteers and Part 2 was conducted in participants with moderate chronic obstructive pulmonary disease (COPD).</recruitment_details>
      <pre_assignment_details>A total of 52 participants (36 in Part 1 and 16 in Part 2) were enrolled in this study. This study was conducted at a single center in the United Kingdom from 13-July-2017 to 19-June-2018.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Part 1: Cohort A- CCI15106 60 mg SD</title>
          <description>Healthy participants were administered a single dose (SD) of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.</description>
        </group>
        <group group_id="P2">
          <title>Part 1: Cohort A- CCI15106 120 mg SD</title>
          <description>Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.</description>
        </group>
        <group group_id="P3">
          <title>Part 1: Cohort A- CCI15106 30 mg BID</title>
          <description>Healthy participants were administered a twice daily (BID) dose of CCI15106 30 mg by inhalation route on Days 6 to 19 via Monodose RS01.</description>
        </group>
        <group group_id="P4">
          <title>Part 1: Cohort A- Placebo</title>
          <description>Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; further followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A.</description>
        </group>
        <group group_id="P5">
          <title>Part 1: Cohort B- CCI15106 60 mg BID</title>
          <description>Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.</description>
        </group>
        <group group_id="P6">
          <title>Part 1: Cohort B- Placebo</title>
          <description>Healthy participants were administered with a BID dose of matching placebo 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.</description>
        </group>
        <group group_id="P7">
          <title>Part 1: Cohort C- Bystanders</title>
          <description>Healthy participants were enrolled to evaluate bystander exposure and evaluated concomitantly with Cohort B. Bystanders reported to the unit on Day -1 and remained for 14 days of dosing of Cohort B.</description>
        </group>
        <group group_id="P8">
          <title>Part 2: Cohort A- CCI15106 60 mg SD</title>
          <description>Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.</description>
        </group>
        <group group_id="P9">
          <title>Part 2: Cohort A- Placebo</title>
          <description>Participants with COPD received a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01 in Cohort A.</description>
        </group>
        <group group_id="P10">
          <title>Part 2: Cohort B- CCI15106 60 mg BID</title>
          <description>Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Part 1 (Cohort A 60 mg - Day 1)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Part 1 (Cohort A 120 mg - Day 3)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Part 1 (Cohort A 30mg BID-Days 6 to 19)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Part 1 (Cohort B and C- Days 1 to 14)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="12"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="14"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="10"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="14"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Drug was prematurely discontinued</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Part 2 (Cohort A - Day 1)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="6"/>
                <participants group_id="P9" count="2"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="6"/>
                <participants group_id="P9" count="2"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Part 2 (Cohort B - Days 1 to 14)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Part 1: Cohort A- CCI15106</title>
          <description>Healthy participants were administered a SD dose of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01, followed by a SD dose of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01, further followed by a BID dose of CCI15106 30 mg by inhalation route on Days 6 to 19 via Monodose RS01.</description>
        </group>
        <group group_id="B2">
          <title>Part 1: Cohort A- Placebo</title>
          <description>Healthy participants were administered a SD dose of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01, followed by a SD dose of matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01, further followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01.</description>
        </group>
        <group group_id="B3">
          <title>Part 1: Cohort B- CCI15106 60 mg BID</title>
          <description>Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.</description>
        </group>
        <group group_id="B4">
          <title>Part 1: Cohort B- Placebo</title>
          <description>Healthy participants were administered with a BID dose of matching placebo 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.</description>
        </group>
        <group group_id="B5">
          <title>Part 1: Cohort C- Bystanders</title>
          <description>Healthy participants were enrolled to evaluate bystander exposure and evaluated concomitantly with Cohort B. Bystanders reported to the unit on Day -1 and remained for 14 days of dosing of Cohort B.</description>
        </group>
        <group group_id="B6">
          <title>Part 2: Cohort A- CCI15106 60 mg SD</title>
          <description>Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.</description>
        </group>
        <group group_id="B7">
          <title>Part 2: Cohort A- Placebo</title>
          <description>Participants with COPD received a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01 in Cohort A.</description>
        </group>
        <group group_id="B8">
          <title>Part 2: Cohort B- CCI15106 60 mg BID</title>
          <description>Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.</description>
        </group>
        <group group_id="B9">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="6"/>
            <count group_id="B2" value="2"/>
            <count group_id="B3" value="12"/>
            <count group_id="B4" value="2"/>
            <count group_id="B5" value="14"/>
            <count group_id="B6" value="6"/>
            <count group_id="B7" value="2"/>
            <count group_id="B8" value="8"/>
            <count group_id="B9" value="52"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="14"/>
                    <measurement group_id="B6" value="4"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="4"/>
                    <measurement group_id="B9" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="4"/>
                    <measurement group_id="B9" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="2"/>
                    <measurement group_id="B9" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="13"/>
                    <measurement group_id="B6" value="4"/>
                    <measurement group_id="B7" value="2"/>
                    <measurement group_id="B8" value="6"/>
                    <measurement group_id="B9" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White-White/Caucasian/European</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="9"/>
                    <measurement group_id="B6" value="6"/>
                    <measurement group_id="B7" value="2"/>
                    <measurement group_id="B8" value="8"/>
                    <measurement group_id="B9" value="43"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American and White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American and Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Part 1 Cohort A: Number of Participants With Non-serious Adverse Events (NSAEs) and Serious Adverse Events (SAEs) in CCI15106</title>
        <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician. Safety population comprised of all participants who received at least one dose of study treatment during the study.</description>
        <time_frame>Up to 51 days</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Cohort A- CCI15106 60 mg SD</title>
            <description>Healthy participants were administered a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: Cohort A- CCI15106 120 mg SD</title>
            <description>Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.</description>
          </group>
          <group group_id="O3">
            <title>Part 1: Cohort A- CCI15106 30 mg BID</title>
            <description>Healthy participants were administered a BID dose of CCI15106 30 mg by inhalation route on Days 6 to 19 via Monodose RS01.</description>
          </group>
          <group group_id="O4">
            <title>Part 1: Cohort A- Placebo</title>
            <description>Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; further followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1 Cohort A: Number of Participants With Non-serious Adverse Events (NSAEs) and Serious Adverse Events (SAEs) in CCI15106</title>
          <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician. Safety population comprised of all participants who received at least one dose of study treatment during the study.</description>
          <population>Safety Population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>NSAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1 Cohort B: Number of Participants With NSAEs and SAEs in CCI15106</title>
        <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician.</description>
        <time_frame>Up to 46 days</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Cohort B- CCI15106 60 mg BID</title>
            <description>Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: Cohort B- Placebo</title>
            <description>Healthy participants were administered with a BID dose of matching placebo 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1 Cohort B: Number of Participants With NSAEs and SAEs in CCI15106</title>
          <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician.</description>
          <population>Safety Population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>NSAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1 Cohort C: Number of Participants With NSAEs and SAEs in Bystanders</title>
        <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician.</description>
        <time_frame>Up to 46 days</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Cohort C- Bystanders</title>
            <description>Healthy participants were enrolled to evaluate bystander exposure and evaluated concomitantly with Cohort B. Bystanders reported to the unit on Day -1 and remained for 14 days of dosing of Cohort B.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1 Cohort C: Number of Participants With NSAEs and SAEs in Bystanders</title>
          <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician.</description>
          <population>Safety Population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>NSAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 2 Cohort A: Number of Participants With NSAEs and SAEs</title>
        <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician.</description>
        <time_frame>Up to 33 days</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Cohort A- CCI15106 60 mg SD</title>
            <description>Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.</description>
          </group>
          <group group_id="O2">
            <title>Part 2: Cohort A- Placebo</title>
            <description>Participants with COPD received a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01 in Cohort A.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2 Cohort A: Number of Participants With NSAEs and SAEs</title>
          <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician.</description>
          <population>Safety Population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>NSAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 2 Cohort B: Number of Participants With NSAEs and SAEs</title>
        <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician.</description>
        <time_frame>Up to 46 days</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Cohort B- CCI15106 60 mg BID</title>
            <description>Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2 Cohort B: Number of Participants With NSAEs and SAEs</title>
          <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician.</description>
          <population>Safety Population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>NSAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1: Number of Participants With Hematology Values of Potential Clinical Importance (PCI) in CCI15106</title>
        <description>PCI ranges for the hematology parameters were as follows: hematocrit (high: &gt;0.54 proportion of red blood cell [RBC] in blood for male, &gt;0.54 proportion of RBC in blood for female), hemoglobin (high: &gt;180 grams [g]/L in male, &gt;180 g/L in female), lymphocytes (low: &lt;0.8 10^9/L), neutrophil count (low: &lt;1.5 10^9/L) and platelet count (low: &lt;100 10^9/L and high: 550 10^9/L). Data for the participants with high and low values has been reported.</description>
        <time_frame>Up to 51 days</time_frame>
        <population>Safety Population. The primary aim was to compare the safety profiles of the different active doses; hence, placebo arms have been combined as pre-specified in reporting and analysis plan.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Cohort A- CCI15106 60 mg SD</title>
            <description>Healthy participants were administered a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: Cohort A- CCI15106 120 mg SD</title>
            <description>Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.</description>
          </group>
          <group group_id="O3">
            <title>Part 1: Cohort A- CCI15106 30 mg BID</title>
            <description>Healthy participants were administered a BID dose of CCI15106 30 mg by inhalation route on Days 6 to 19 via Monodose RS01.</description>
          </group>
          <group group_id="O4">
            <title>Part 1: Cohort B- CCI15106 60 mg BID</title>
            <description>Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.</description>
          </group>
          <group group_id="O5">
            <title>Part 1: Placebo</title>
            <description>Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Number of Participants With Hematology Values of Potential Clinical Importance (PCI) in CCI15106</title>
          <description>PCI ranges for the hematology parameters were as follows: hematocrit (high: &gt;0.54 proportion of red blood cell [RBC] in blood for male, &gt;0.54 proportion of RBC in blood for female), hemoglobin (high: &gt;180 grams [g]/L in male, &gt;180 g/L in female), lymphocytes (low: &lt;0.8 10^9/L), neutrophil count (low: &lt;1.5 10^9/L) and platelet count (low: &lt;100 10^9/L and high: 550 10^9/L). Data for the participants with high and low values has been reported.</description>
          <population>Safety Population. The primary aim was to compare the safety profiles of the different active doses; hence, placebo arms have been combined as pre-specified in reporting and analysis plan.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="12"/>
                <count group_id="O5" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hematocrit: high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin: high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes: low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophil count: low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelet count: low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelet count: high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1: Number of Participants With Hematology Values of PCI in Bystanders</title>
        <description>PCI ranges for the hematology parameters were as follows: hematocrit (high: &gt;0.54 proportion of RBC in blood for male, &gt;0.54 proportion of RBC in blood for female), hemoglobin (high: &gt;180 g/L in male, &gt;180 g/L in female), lymphocytes (low: &lt;0.8 10^9/L), neutrophil count (low: &lt;1.5 10^9/L) and platelet count (low: &lt;100 10^9/L and high: 550 10^9/L). Data for the participants with high and low values has been reported.</description>
        <time_frame>Up to 46 days</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Cohort C- Bystanders</title>
            <description>Healthy participants were enrolled to evaluate bystander exposure and evaluated concomitantly with Cohort B. Bystanders reported to the unit on Day -1 and remained for 14 days of dosing of Cohort B.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Number of Participants With Hematology Values of PCI in Bystanders</title>
          <description>PCI ranges for the hematology parameters were as follows: hematocrit (high: &gt;0.54 proportion of RBC in blood for male, &gt;0.54 proportion of RBC in blood for female), hemoglobin (high: &gt;180 g/L in male, &gt;180 g/L in female), lymphocytes (low: &lt;0.8 10^9/L), neutrophil count (low: &lt;1.5 10^9/L) and platelet count (low: &lt;100 10^9/L and high: 550 10^9/L). Data for the participants with high and low values has been reported.</description>
          <population>Safety Population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hematocrit: high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin: high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes: low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophil count: low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelet count: low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelet count: high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 2: Number of Participants With Hematology Values of PCI</title>
        <description>PCI ranges for the hematology parameters were as follows: hematocrit (high: &gt;0.54 proportion of RBC in blood for male, &gt;0.54 proportion of RBC in blood for female), hemoglobin (high: &gt;180 g/L in male, &gt;180 g/L in female), lymphocytes (low: &lt;0.8 10^9/L), neutrophil count (low: &lt;1.5 10^9/L) and platelet count (low: &lt;100 10^9/L and high: 550 10^9/L). Data for the participants with high and low values has been reported.</description>
        <time_frame>Up to 46 days</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Cohort A- CCI15106 60 mg SD</title>
            <description>Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.</description>
          </group>
          <group group_id="O2">
            <title>Part 2: Cohort A- Placebo</title>
            <description>Participants with COPD received a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01 in Cohort A.</description>
          </group>
          <group group_id="O3">
            <title>Part 2: Cohort B- CCI15106 60 mg BID</title>
            <description>Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2: Number of Participants With Hematology Values of PCI</title>
          <description>PCI ranges for the hematology parameters were as follows: hematocrit (high: &gt;0.54 proportion of RBC in blood for male, &gt;0.54 proportion of RBC in blood for female), hemoglobin (high: &gt;180 g/L in male, &gt;180 g/L in female), lymphocytes (low: &lt;0.8 10^9/L), neutrophil count (low: &lt;1.5 10^9/L) and platelet count (low: &lt;100 10^9/L and high: 550 10^9/L). Data for the participants with high and low values has been reported.</description>
          <population>Safety Population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="2"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hematocrit: high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin: high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes: low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophil count: low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelet count: low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelet count: high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106</title>
        <description>PCI ranges for the clinical chemistry parameters were as follows: albumin (low: &lt;30 millimole per liter [mmol/L]), calcium (low: &lt;2 mmol/L and high: &gt;2.75 mmol/L), glucose (low: &lt;3 mmol/L and high: &gt;9 mmol/L), potassium (low: &lt;3 mmol/L and high: &gt;5.5 mmol/L) and sodium (low: &lt;130 mmol/L and high: &gt;150 mmol/L). Data for the participants with high and low values has been reported.</description>
        <time_frame>Up to 51 days</time_frame>
        <population>Safety Population. The primary aim was to compare the safety profiles of the different active doses; hence, placebo arms have been combined as pre-specified in reporting and analysis plan.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Cohort A- CCI15106 60 mg SD</title>
            <description>Healthy participants were administered a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: Cohort A- CCI15106 120 mg SD</title>
            <description>Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.</description>
          </group>
          <group group_id="O3">
            <title>Part 1: Cohort A- CCI15106 30 mg BID</title>
            <description>Healthy participants were administered a BID dose of CCI15106 30 mg by inhalation route on Days 6 to 19 via Monodose RS01.</description>
          </group>
          <group group_id="O4">
            <title>Part 1: Cohort B- CCI15106 60 mg BID</title>
            <description>Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.</description>
          </group>
          <group group_id="O5">
            <title>Part 1: Placebo</title>
            <description>Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106</title>
          <description>PCI ranges for the clinical chemistry parameters were as follows: albumin (low: &lt;30 millimole per liter [mmol/L]), calcium (low: &lt;2 mmol/L and high: &gt;2.75 mmol/L), glucose (low: &lt;3 mmol/L and high: &gt;9 mmol/L), potassium (low: &lt;3 mmol/L and high: &gt;5.5 mmol/L) and sodium (low: &lt;130 mmol/L and high: &gt;150 mmol/L). Data for the participants with high and low values has been reported.</description>
          <population>Safety Population. The primary aim was to compare the safety profiles of the different active doses; hence, placebo arms have been combined as pre-specified in reporting and analysis plan.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="12"/>
                <count group_id="O5" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Albumin: low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium: low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium: high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose: low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose: high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium: low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium: high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium: low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium: high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1: Number of Participants With Clinical Chemistry Values of PCI in Bystanders</title>
        <description>PCI ranges for the clinical chemistry parameters were as follows: albumin (low: &lt;30 mmol/L), calcium (low: &lt;2 mmol/L and high: &gt;2.75 mmol/L), glucose (low: &lt;3 mmol/L and high: &gt;9 mmol/L), potassium (low: &lt;3 mmol/L and high: &gt;5.5 mmol/L) and sodium (low: &lt;130 mmol/L and high: &gt;150 mmol/L). Data for the participants with high and low values has been reported.</description>
        <time_frame>Up to 46 days</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Cohort C- Bystanders</title>
            <description>Healthy participants were enrolled to evaluate bystander exposure and evaluated concomitantly with Cohort B. Bystanders reported to the unit on Day -1 and remained for 14 days of dosing of Cohort B.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Number of Participants With Clinical Chemistry Values of PCI in Bystanders</title>
          <description>PCI ranges for the clinical chemistry parameters were as follows: albumin (low: &lt;30 mmol/L), calcium (low: &lt;2 mmol/L and high: &gt;2.75 mmol/L), glucose (low: &lt;3 mmol/L and high: &gt;9 mmol/L), potassium (low: &lt;3 mmol/L and high: &gt;5.5 mmol/L) and sodium (low: &lt;130 mmol/L and high: &gt;150 mmol/L). Data for the participants with high and low values has been reported.</description>
          <population>Safety Population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Albumin: low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium: low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium: high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose: low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose: high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium: low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium: high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium: low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium: high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 2: Number of Participants With Clinical Chemistry Values of PCI</title>
        <description>PCI ranges for the clinical chemistry parameters were as follows: albumin (low: &lt;30 mmol/L), calcium (low: &lt;2 mmol/L and high: &gt;2.75 mmol/L), glucose (low: &lt;3 mmol/L and high: &gt;9 mmol/L), potassium (low: &lt;3 mmol/L and high: &gt;5.5 mmol/L) and sodium (low: &lt;130 mmol/L and high: &gt;150 mmol/L). Data for the participants with high and low values has been reported.</description>
        <time_frame>Up to 46 days</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Cohort A- CCI15106 60 mg SD</title>
            <description>Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.</description>
          </group>
          <group group_id="O2">
            <title>Part 2: Cohort A- Placebo</title>
            <description>Participants with COPD received a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01 in Cohort A.</description>
          </group>
          <group group_id="O3">
            <title>Part 2: Cohort B- CCI15106 60 mg BID</title>
            <description>Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2: Number of Participants With Clinical Chemistry Values of PCI</title>
          <description>PCI ranges for the clinical chemistry parameters were as follows: albumin (low: &lt;30 mmol/L), calcium (low: &lt;2 mmol/L and high: &gt;2.75 mmol/L), glucose (low: &lt;3 mmol/L and high: &gt;9 mmol/L), potassium (low: &lt;3 mmol/L and high: &gt;5.5 mmol/L) and sodium (low: &lt;130 mmol/L and high: &gt;150 mmol/L). Data for the participants with high and low values has been reported.</description>
          <population>Safety Population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="2"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Albumin: low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium: low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium: high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose: low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose: high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium: low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium: high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium: low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium: high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1 Cohort A: Potential of Hydrogen (pH) Value by Visit- CCI15106 60 mg SD</title>
        <description>Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).</description>
        <time_frame>Baseline (Day -1) and Day 2</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Cohort A- CCI15106 60 mg SD</title>
            <description>Healthy participants were administered a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1 Cohort A: Potential of Hydrogen (pH) Value by Visit- CCI15106 60 mg SD</title>
          <description>Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).</description>
          <population>Safety Population.</population>
          <units>pH</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.00" spread="0.000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.33" spread="0.816"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1 Cohort A: pH Value by Visit- CCI15106 120 mg SD</title>
        <description>Urine sample was collected from participants at indicated time point for analysis of pH.</description>
        <time_frame>Day 5</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Cohort A- CCI15106 120 mg SD</title>
            <description>Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1 Cohort A: pH Value by Visit- CCI15106 120 mg SD</title>
          <description>Urine sample was collected from participants at indicated time point for analysis of pH.</description>
          <population>Safety Population.</population>
          <units>pH</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.58" spread="0.736"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1 Cohort A: pH Value by Visit- CCI15106 30 mg BID</title>
        <description>Urine samples were collected from participants at indicated time points for analysis of pH.</description>
        <time_frame>Days 12 and 22</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Cohort A- CCI15106 30 mg BID</title>
            <description>Healthy participants were administered a BID dose of CCI15106 30 mg by inhalation route on Days 6 to 19 via Monodose RS01.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1 Cohort A: pH Value by Visit- CCI15106 30 mg BID</title>
          <description>Urine samples were collected from participants at indicated time points for analysis of pH.</description>
          <population>Safety Population.</population>
          <units>pH</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.50" spread="0.949"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 22</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.92" spread="0.665"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1 Cohort B: pH Value by Visit- CCI15106 60 mg BID</title>
        <description>Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).</description>
        <time_frame>Baseline (Day -1), Days 7 and 15</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Cohort B- CCI15106 60 mg BID</title>
            <description>Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1 Cohort B: pH Value by Visit- CCI15106 60 mg BID</title>
          <description>Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).</description>
          <population>Safety Population.</population>
          <units>pH</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.21" spread="0.811"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.63" spread="0.882"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.21" spread="0.620"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1: pH Value by Visit- Placebo</title>
        <description>Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).</description>
        <time_frame>Baseline (Day -1), Days 2, 5, 7, 12, 15 and 22</time_frame>
        <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). The primary aim was to compare the safety profiles of the different active doses; hence, placebo arms have been combined as pre-specified in reporting and analysis plan.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Placebo</title>
            <description>Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: pH Value by Visit- Placebo</title>
          <description>Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).</description>
          <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). The primary aim was to compare the safety profiles of the different active doses; hence, placebo arms have been combined as pre-specified in reporting and analysis plan.</population>
          <units>pH</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline: n=4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.50" spread="0.707"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 2: n=2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.50" spread="0.707"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 5: n=2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.25" spread="0.354"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7: n=2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.00" spread="1.414"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 12: n=2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.75" spread="1.061"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15: n=2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.50" spread="0.707"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 22: n=2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.75" spread="1.061"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1 Cohort C: pH Value by Visit- CCI15106 in Bystanders</title>
        <description>Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).</description>
        <time_frame>Baseline (Day -1), Days 7 and 15</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Cohort C- Bystanders</title>
            <description>Healthy participants were enrolled to evaluate bystander exposure and evaluated concomitantly with Cohort B. Bystanders reported to the unit on Day -1 and remained for 14 days of dosing of Cohort B.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1 Cohort C: pH Value by Visit- CCI15106 in Bystanders</title>
          <description>Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).</description>
          <population>Safety Population.</population>
          <units>pH</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.36" spread="0.633"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.36" spread="0.719"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.96" spread="0.499"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 2 Cohort A: pH Value by Visit- CCI15106</title>
        <description>Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).</description>
        <time_frame>Baseline (Day -1) and Day 2</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Cohort A- CCI15106 60 mg SD</title>
            <description>Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.</description>
          </group>
          <group group_id="O2">
            <title>Part 2: Cohort A- Placebo</title>
            <description>Participants with COPD received a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01 in Cohort A.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2 Cohort A: pH Value by Visit- CCI15106</title>
          <description>Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).</description>
          <population>Safety Population.</population>
          <units>pH</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.25" spread="0.822"/>
                    <measurement group_id="O2" value="6.75" spread="1.061"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.58" spread="0.801"/>
                    <measurement group_id="O2" value="6.50" spread="0.707"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 2 Cohort B: pH Value by Visit- CCI15106 60 mg BID</title>
        <description>Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).</description>
        <time_frame>Baseline (Day -1), Days 7 and 15</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Cohort B- CCI15106 60 mg BID</title>
            <description>Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2 Cohort B: pH Value by Visit- CCI15106 60 mg BID</title>
          <description>Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).</description>
          <population>Safety Population.</population>
          <units>pH</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.13" spread="0.916"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.94" spread="0.863"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.81" spread="0.884"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1 Cohort A: Specific Gravity Value by Visit- CCI15106 60 mg SD</title>
        <description>Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).</description>
        <time_frame>Baseline (Day -1) and Day 2</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Cohort A- CCI15106 60 mg SD</title>
            <description>Healthy participants were administered a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1 Cohort A: Specific Gravity Value by Visit- CCI15106 60 mg SD</title>
          <description>Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).</description>
          <population>Safety Population.</population>
          <units>Ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0217" spread="0.01033"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0105" spread="0.00625"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1 Cohort A: Specific Gravity Value by Visit- CCI15106 120 mg SD</title>
        <description>Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine sample was collected from participants at indicated time point for analysis of specific gravity.</description>
        <time_frame>Day 5</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Cohort A- CCI15106 120 mg SD</title>
            <description>Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1 Cohort A: Specific Gravity Value by Visit- CCI15106 120 mg SD</title>
          <description>Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine sample was collected from participants at indicated time point for analysis of specific gravity.</description>
          <population>Safety Population.</population>
          <units>Ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0182" spread="0.00722"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1 Cohort A: Specific Gravity Value by Visit- CCI15106 30 mg BID</title>
        <description>Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity.</description>
        <time_frame>Days 12 and 22</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Cohort A- CCI15106 30 mg BID</title>
            <description>Healthy participants were administered a BID dose of CCI15106 30 mg by inhalation route on Days 6 to 19 via Monodose RS01.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1 Cohort A: Specific Gravity Value by Visit- CCI15106 30 mg BID</title>
          <description>Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity.</description>
          <population>Safety Population.</population>
          <units>Ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0115" spread="0.00442"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 22</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0115" spread="0.00442"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1 Cohort B: Specific Gravity Value by Visit- CCI15106 60 mg BID</title>
        <description>Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of Specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).</description>
        <time_frame>Baseline (Day -1), Days 7 and 15</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Cohort B- CCI15106 60 mg BID</title>
            <description>Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1 Cohort B: Specific Gravity Value by Visit- CCI15106 60 mg BID</title>
          <description>Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of Specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).</description>
          <population>Safety Population.</population>
          <units>Ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0136" spread="0.00734"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0152" spread="0.01039"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0167" spread="0.00444"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1: Specific Gravity Value by Visit- Placebo</title>
        <description>Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of Specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).</description>
        <time_frame>Baseline (Day -1), Days 2, 5, 7, 12, 15 and 22</time_frame>
        <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). The primary aim was to compare the safety profiles of the different active doses; hence, placebo arms have been combined as pre-specified in reporting and analysis plan.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Placebo</title>
            <description>Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Specific Gravity Value by Visit- Placebo</title>
          <description>Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of Specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).</description>
          <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). The primary aim was to compare the safety profiles of the different active doses; hence, placebo arms have been combined as pre-specified in reporting and analysis plan.</population>
          <units>Ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline: n=4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0148" spread="0.00858"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 2: n=2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0150" spread="0.00000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 5: n=2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0150" spread="0.00707"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7: n=2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0150" spread="0.00707"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 12: n=2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0120" spread="0.01131"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15: n=2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0150" spread="0.00707"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 22: n=2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0095" spread="0.00778"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1 Cohort C: Specific Gravity Value by Visit- CCI15106 in Bystanders</title>
        <description>Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).</description>
        <time_frame>Baseline (Day -1), Days 7 and 15</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Cohort C- Bystanders</title>
            <description>Healthy participants were enrolled to evaluate bystander exposure and evaluated concomitantly with Cohort B. Bystanders reported to the unit on Day -1 and remained for 14 days of dosing of Cohort B.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1 Cohort C: Specific Gravity Value by Visit- CCI15106 in Bystanders</title>
          <description>Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).</description>
          <population>Safety Population.</population>
          <units>Ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0191" spread="0.01339"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0163" spread="0.00907"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0182" spread="0.00750"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 2 Cohort A: Specific Gravity Value by Visit- CCI15106</title>
        <description>Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).</description>
        <time_frame>Baseline (Day -1) and Day 2</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Cohort A- CCI15106 60 mg SD</title>
            <description>Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.</description>
          </group>
          <group group_id="O2">
            <title>Part 2: Cohort A- Placebo</title>
            <description>Participants with COPD received a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01 in Cohort A.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2 Cohort A: Specific Gravity Value by Visit- CCI15106</title>
          <description>Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).</description>
          <population>Safety Population.</population>
          <units>Ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0205" spread="0.01694"/>
                    <measurement group_id="O2" value="1.0175" spread="0.01061"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0147" spread="0.00737"/>
                    <measurement group_id="O2" value="1.0275" spread="0.01768"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 2 Cohort B: Specific Gravity Value by Visit- CCI15106 60 mg BID</title>
        <description>Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).</description>
        <time_frame>Baseline (Day -1), Days 7 and 15</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Cohort B- CCI15106 60 mg BID</title>
            <description>Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2 Cohort B: Specific Gravity Value by Visit- CCI15106 60 mg BID</title>
          <description>Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).</description>
          <population>Safety Population.</population>
          <units>Ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0106" spread="0.00678"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0114" spread="0.00424"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0133" spread="0.00523"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106</title>
        <description>PCI ranges for the ECG parameters were as follows: absolute QTc interval &gt;450 and &lt;480, &gt;=480 and &lt;500, &gt;=500 milliseconds (msec), absolute PR interval &lt;110 and &gt;220 msec and absolute QRS interval &lt;75 and &gt;110 msec. QTcF=Frederica's QT interval corrected for heart rate; QTcB=Bazett's QT interval corrected for heart rate. Data for worst case post-Baseline has been reported.</description>
        <time_frame>Up to 51 days</time_frame>
        <population>Safety Population. The primary aim was to compare the safety profiles of the different active doses; hence, placebo arms have been combined as pre-specified in reporting and analysis plan.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Cohort A- CCI15106 60 mg SD</title>
            <description>Healthy participants were administered a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: Cohort A- CCI15106 120 mg SD</title>
            <description>Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.</description>
          </group>
          <group group_id="O3">
            <title>Part 1: Cohort A- CCI15106 30 mg BID</title>
            <description>Healthy participants were administered a BID dose of CCI15106 30 mg by inhalation route on Days 6 to 19 via Monodose RS01.</description>
          </group>
          <group group_id="O4">
            <title>Part 1: Cohort B- CCI15106 60 mg BID</title>
            <description>Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.</description>
          </group>
          <group group_id="O5">
            <title>Part 1: Placebo</title>
            <description>Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106</title>
          <description>PCI ranges for the ECG parameters were as follows: absolute QTc interval &gt;450 and &lt;480, &gt;=480 and &lt;500, &gt;=500 milliseconds (msec), absolute PR interval &lt;110 and &gt;220 msec and absolute QRS interval &lt;75 and &gt;110 msec. QTcF=Frederica's QT interval corrected for heart rate; QTcB=Bazett's QT interval corrected for heart rate. Data for worst case post-Baseline has been reported.</description>
          <population>Safety Population. The primary aim was to compare the safety profiles of the different active doses; hence, placebo arms have been combined as pre-specified in reporting and analysis plan.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="12"/>
                <count group_id="O5" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PR interval: Value&lt;110</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PR interval: 110&lt;=Value&lt;=220</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="12"/>
                    <measurement group_id="O5" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PR interval: Value&gt;220</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QRS duration: Value&lt;75</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QRS duration: 75&lt;=Value&lt;=110</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="9"/>
                    <measurement group_id="O5" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QRS duration: Value&gt;110</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QT interval: Value&lt;=450</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="11"/>
                    <measurement group_id="O5" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QT interval: 450&lt;Value&lt;480</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QT interval: 480&lt;=Value&lt;500</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QT interval: Value&gt;=500</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcB interval: Value&lt;=450</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="8"/>
                    <measurement group_id="O5" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcB interval: 450&lt;Value&lt;480</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcB interval: 480&lt;=Value&lt;500</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcB interval: Value&gt;=500</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcF interval: Value&lt;=450</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="11"/>
                    <measurement group_id="O5" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcF interval: 450&lt;Value&lt;480</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcF interval: 480&lt;=Value&lt;500</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcF interval: Value&gt;=500</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI in Bystander</title>
        <description>PCI ranges for the ECG parameters were as follows: absolute QTc interval &gt;450 and &lt;480, &gt;=480 and &lt;500, &gt;=500 msec, absolute PR interval &lt;110 and &gt;220 msec and absolute QRS interval &lt;75 and &gt;110 msec. Data for worst case post-Baseline has been reported.</description>
        <time_frame>Up to 46 days</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Cohort C- Bystanders</title>
            <description>Healthy participants were enrolled to evaluate bystander exposure and evaluated concomitantly with Cohort B. Bystanders reported to the unit on Day -1 and remained for 14 days of dosing of Cohort B.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI in Bystander</title>
          <description>PCI ranges for the ECG parameters were as follows: absolute QTc interval &gt;450 and &lt;480, &gt;=480 and &lt;500, &gt;=500 msec, absolute PR interval &lt;110 and &gt;220 msec and absolute QRS interval &lt;75 and &gt;110 msec. Data for worst case post-Baseline has been reported.</description>
          <population>Safety Population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PR interval: Value&lt;110</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PR interval: 110&lt;=Value&lt;=220</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PR interval: Value&gt;220</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QRS duration: Value&lt;75</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QRS duration: 75&lt;=Value&lt;=110</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QRS duration: Value&gt;110</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QT interval: Value&lt;=450</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QT interval: 450&lt;Value&lt;480</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QT interval: 480&lt;=Value&lt;500</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QT interval: Value&gt;=500</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcB interval: Value&lt;=450</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcB interval: 450&lt;Value&lt;480</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcB interval: 480&lt;=Value&lt;500</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcB interval: Value&gt;=500</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcF interval: Value&lt;=450</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcF interval: 450&lt;Value&lt;480</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcF interval: 480&lt;=Value&lt;500</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcF interval: Value&gt;=500</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI</title>
        <description>PCI ranges for the ECG parameters were as follows: absolute QTc interval &gt;450 and &lt;480, &gt;=480 and &lt;500, &gt;=500 msec, absolute PR interval &lt;110 and &gt;220 msec and absolute QRS interval &lt;75 and &gt;110 msec. Data for worst case post-Baseline has been reported.</description>
        <time_frame>Up to 46 days</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Cohort A- CCI15106 60 mg SD</title>
            <description>Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.</description>
          </group>
          <group group_id="O2">
            <title>Part 2: Cohort A- Placebo</title>
            <description>Participants with COPD received a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01 in Cohort A.</description>
          </group>
          <group group_id="O3">
            <title>Part 2: Cohort B- CCI15106 60 mg BID</title>
            <description>Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI</title>
          <description>PCI ranges for the ECG parameters were as follows: absolute QTc interval &gt;450 and &lt;480, &gt;=480 and &lt;500, &gt;=500 msec, absolute PR interval &lt;110 and &gt;220 msec and absolute QRS interval &lt;75 and &gt;110 msec. Data for worst case post-Baseline has been reported.</description>
          <population>Safety Population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="2"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PR interval: Value&lt;110</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PR interval: 110&lt;=Value&lt;=220</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PR interval: Value&gt;220</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QRS duration: Value&lt;75</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QRS duration: 75&lt;=Value&lt;=110</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QRS duration: Value&gt;110</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QT interval: Value&lt;=450</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QT interval: 450&lt;Value&lt;480</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QT interval: 480&lt;=Value&lt;500</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QT interval: Value&gt;=500</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcB interval: Value&lt;=450</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcB interval: 450&lt;Value&lt;480</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcB interval: 480&lt;=Value&lt;500</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcB interval: Value&gt;=500</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcF interval: Value&lt;=450</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcF interval: 450&lt;Value&lt;480</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcF interval: 480&lt;=Value&lt;500</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcF interval: Value&gt;=500</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1: Number of Participants With Abnormal Telemetry Findings</title>
        <description>Continuous cardiac telemetry was performed from approximately 0.5 hour (pre-dose) to 4 hours post-dose. Abnormal findings were categorized as clinically significant (CS) and not clinically significant (NCS). Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.</description>
        <time_frame>Days 1, 3, 6, 7, 12 and 18: 0.5 hour (pre-dose) to 4 hours post-dose</time_frame>
        <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). The primary aim was to compare the safety profiles of the different active doses; hence, placebo arms have been combined as pre-specified in reporting and analysis plan.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Cohort A- CCI15106 60 mg SD</title>
            <description>Healthy participants were administered a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: Cohort A- CCI15106 120 mg SD</title>
            <description>Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.</description>
          </group>
          <group group_id="O3">
            <title>Part 1: Cohort A- CCI15106 30 mg BID</title>
            <description>Healthy participants were administered a BID dose of CCI15106 30 mg by inhalation route on Days 6 to 19 via Monodose RS01.</description>
          </group>
          <group group_id="O4">
            <title>Part 1: Cohort B- CCI15106 60 mg BID</title>
            <description>Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.</description>
          </group>
          <group group_id="O5">
            <title>Part 1: Placebo</title>
            <description>Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Number of Participants With Abnormal Telemetry Findings</title>
          <description>Continuous cardiac telemetry was performed from approximately 0.5 hour (pre-dose) to 4 hours post-dose. Abnormal findings were categorized as clinically significant (CS) and not clinically significant (NCS). Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.</description>
          <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). The primary aim was to compare the safety profiles of the different active doses; hence, placebo arms have been combined as pre-specified in reporting and analysis plan.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="12"/>
                <count group_id="O5" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1: 0.5 to 4 hours post-dose-CS;n=6,0,0,12,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: 0.5 to 4 hours post-dose-NCS;n=6,0,0,12,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3: 0.5 to 4 hours post-dose-CS;n=0,6,0,0,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3: 0.5 to 4 hours post-dose-NCS;n=0,6,0,0,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 6: 0.5 to 4 hours post-dose-CS;n=0,0,6,0,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 6: 0.5 to 4 hours post-dose-NCS;n=0,0,6,0,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7: 0.5 to 4 hours post-dose-CS;n=0,0,0,12,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7: 0.5 to 4 hours post-dose-NCS;n=0,0,0,12,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 12: 0.5 to 4 hours post-dose-CS;n=0,0,6,12,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 12: 0.5 to 4 hours post-dose-NCS;n=0,0,6,12,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 18: 0.5 to 4 hours post-dose-CS;n=0,0,6,0,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 18: 0.5 to 4 hours post-dose-NCS;n=0,0,6,0,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 2: Number of Participants With Abnormal Telemetry Findings</title>
        <description>Continuous cardiac telemetry was performed from approximately 0.5 hour (pre-dose) to 4 hours post-dose. Abnormal findings were categorized as CS and NCS. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.</description>
        <time_frame>Days 1, 7, 12 and 13: 0.5 hour (pre-dose) to 4 hours post-dose</time_frame>
        <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Cohort A- CCI15106 60 mg SD</title>
            <description>Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.</description>
          </group>
          <group group_id="O2">
            <title>Part 2: Cohort A- Placebo</title>
            <description>Participants with COPD received a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01 in Cohort A.</description>
          </group>
          <group group_id="O3">
            <title>Part 2: Cohort B- CCI15106 60 mg BID</title>
            <description>Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2: Number of Participants With Abnormal Telemetry Findings</title>
          <description>Continuous cardiac telemetry was performed from approximately 0.5 hour (pre-dose) to 4 hours post-dose. Abnormal findings were categorized as CS and NCS. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.</description>
          <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="2"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1: 0.5 to 4 hours post-dose-CS; n=6,2,8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: 0.5 to 4 hours post-dose-NCS; n=6,2,8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7: 0.5 to 4 hours post-dose-CS; n=0,0,8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7: 0.5 to 4 hours post-dose-NCS; n=0,0,8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 12: 0.5 to 4 hours post-dose-CS; n=0,0,5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 12: 0.5 to 4 hours post-dose-NCS; n=0,0,5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 13: 0.5 to 4 hours post-dose-CS; n=0,0,3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 13: 0.5 to 4 hours post-dose-NCS; n=0,0,3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points</title>
        <description>FEV1 is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using standard spirometry. Percent predicted FEV1 was calculated as: Percent predicted FEV1=(maximum FEV1 divided by predicted normal FEV1)*100.</description>
        <time_frame>Days 1, 3, 6 and 19: pre-dose, 0.25, 0.5, 1 and 4 hours post-dose; Days 8, 11 and 16: pre-dose and 4 hours post-dose; Day 14: pre-dose, 0.5, 1 and 4 hours post-dose</time_frame>
        <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). The primary aim was to compare the safety profiles of the different active doses; hence, placebo arms have been combined as pre-specified in reporting and analysis plan.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Cohort A- CCI15106 60 mg SD</title>
            <description>Healthy participants were administered a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: Cohort A- CCI15106 120 mg SD</title>
            <description>Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.</description>
          </group>
          <group group_id="O3">
            <title>Part 1: Cohort A- CCI15106 30 mg BID</title>
            <description>Healthy participants were administered a BID dose of CCI15106 30 mg by inhalation route on Days 6 to 19 via Monodose RS01.</description>
          </group>
          <group group_id="O4">
            <title>Part 1: Cohort B- CCI15106 60 mg BID</title>
            <description>Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.</description>
          </group>
          <group group_id="O5">
            <title>Part 1: Placebo</title>
            <description>Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points</title>
          <description>FEV1 is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using standard spirometry. Percent predicted FEV1 was calculated as: Percent predicted FEV1=(maximum FEV1 divided by predicted normal FEV1)*100.</description>
          <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). The primary aim was to compare the safety profiles of the different active doses; hence, placebo arms have been combined as pre-specified in reporting and analysis plan.</population>
          <units>Percent predicted FEV1</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="12"/>
                <count group_id="O5" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1: pre-dose, n=6,0,0,12,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="101.0" spread="8.49"/>
                    <measurement group_id="O4" value="101.1" spread="15.31"/>
                    <measurement group_id="O5" value="102.0" spread="9.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: 0.25 hour, n=6,0,0,0,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="101.5" spread="7.87"/>
                    <measurement group_id="O5" value="99.0" spread="14.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: 0.5 hour, n=6,0,0,12,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="104.3" spread="7.17"/>
                    <measurement group_id="O4" value="100.3" spread="13.94"/>
                    <measurement group_id="O5" value="102.5" spread="12.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: 1 hour, n=6,0,0,12,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="105.2" spread="6.62"/>
                    <measurement group_id="O4" value="102.2" spread="14.86"/>
                    <measurement group_id="O5" value="103.8" spread="11.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: 4 hours, n=6,0,0,12,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="104.5" spread="8.04"/>
                    <measurement group_id="O4" value="101.4" spread="16.20"/>
                    <measurement group_id="O5" value="104.3" spread="11.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3: pre-dose, n=0,6,0,12,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="103.2" spread="5.71"/>
                    <measurement group_id="O4" value="101.5" spread="14.47"/>
                    <measurement group_id="O5" value="105.3" spread="12.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3: 0.25 hour, n=0,6,0,0,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="103.2" spread="6.49"/>
                    <measurement group_id="O5" value="102.5" spread="19.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3: 0.5 hour, n=0,6,0,0,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="103.0" spread="5.97"/>
                    <measurement group_id="O5" value="100.0" spread="18.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3: 1 hour, n=0,6,0,0,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="104.3" spread="6.68"/>
                    <measurement group_id="O5" value="101.0" spread="16.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3: 4 hours, n=0,6,0,12,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="106.7" spread="7.00"/>
                    <measurement group_id="O4" value="103.1" spread="15.64"/>
                    <measurement group_id="O5" value="106.8" spread="12.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 6: pre-dose, n=0,0,6,12,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="104.5" spread="5.61"/>
                    <measurement group_id="O4" value="101.3" spread="15.69"/>
                    <measurement group_id="O5" value="102.8" spread="10.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 6: 0.25 hour, n=0,0,6,0,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="102.3" spread="6.80"/>
                    <measurement group_id="O5" value="101.5" spread="17.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 6: 0.5 hour, n=0,0,6,0,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="103.5" spread="7.31"/>
                    <measurement group_id="O5" value="101.0" spread="18.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 6: 1 hour, n=0,0,6,0,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="104.0" spread="6.26"/>
                    <measurement group_id="O5" value="99.0" spread="18.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 6: 4 hours, n=0,0,6,12,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="106.3" spread="3.93"/>
                    <measurement group_id="O4" value="104.0" spread="15.50"/>
                    <measurement group_id="O5" value="105.5" spread="10.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8: pre-dose, n=0,0,6,0,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="105.0" spread="5.73"/>
                    <measurement group_id="O5" value="103.0" spread="16.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8: 4 hours, n=0,0,6,0,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="104.7" spread="4.50"/>
                    <measurement group_id="O5" value="103.5" spread="17.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 11: pre-dose, n=0,0,6,12,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="103.3" spread="3.88"/>
                    <measurement group_id="O4" value="101.6" spread="16.76"/>
                    <measurement group_id="O5" value="106.0" spread="11.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 11: 4 hours, n=0,0,6,12,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="105.0" spread="6.69"/>
                    <measurement group_id="O4" value="103.6" spread="15.84"/>
                    <measurement group_id="O5" value="107.0" spread="10.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14: pre-dose, n=0,0,0,11,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="11"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O4" value="101.0" spread="16.84"/>
                    <measurement group_id="O5" value="105.5" spread="6.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14: 0.5 hour, n=0,0,0,11,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="11"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O4" value="100.7" spread="15.88"/>
                    <measurement group_id="O5" value="104.0" spread="8.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14: 1 hour, n=0,0,0,12,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O4" value="99.1" spread="16.09"/>
                    <measurement group_id="O5" value="107.5" spread="6.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14: 4 hours, n=0,0,0,12,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O4" value="97.3" spread="16.23"/>
                    <measurement group_id="O5" value="112.5" spread="9.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 16: pre-dose, n=0,0,6,0,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="102.5" spread="5.32"/>
                    <measurement group_id="O5" value="104.5" spread="17.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 16: 4 hours, n=0,0,6,0,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="105.3" spread="6.38"/>
                    <measurement group_id="O5" value="104.0" spread="19.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 19: pre-dose, n=0,0,6,0,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="101.7" spread="7.47"/>
                    <measurement group_id="O5" value="104.0" spread="18.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 19: 0.25 hour, n=0,0,6,0,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="102.5" spread="6.72"/>
                    <measurement group_id="O5" value="99.5" spread="20.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 19: 0.5 hour, n=0,0,6,0,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="102.7" spread="10.09"/>
                    <measurement group_id="O5" value="103.0" spread="18.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 19: 1 hour, n=0,0,6,0,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="99.3" spread="9.29"/>
                    <measurement group_id="O5" value="103.5" spread="16.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 19: 4 hours, n=0,0,6,0,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="104.0" spread="6.78"/>
                    <measurement group_id="O5" value="103.0" spread="15.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points</title>
        <description>FVC is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FVC was measured using standard spirometry. Percent predicted FVC was calculated as: Percent predicted FVC=(maximum FVC divided by predicted normal FVC)*100.</description>
        <time_frame>Days 1, 3, 6 and 19: pre-dose, 0.25, 0.5, 1 and 4 hours post-dose; Days 8, 11 and 16: pre-dose and 4 hours post-dose; Day 14: pre-dose, 0.5, 1 and 4 hours post-dose</time_frame>
        <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). The primary aim was to compare the safety profiles of the different active doses; hence, placebo arms have been combined as pre-specified in reporting and analysis plan.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Cohort A- CCI15106 60 mg SD</title>
            <description>Healthy participants were administered a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: Cohort A- CCI15106 120 mg SD</title>
            <description>Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.</description>
          </group>
          <group group_id="O3">
            <title>Part 1: Cohort A- CCI15106 30 mg BID</title>
            <description>Healthy participants were administered a BID dose of CCI15106 30 mg by inhalation route on Days 6 to 19 via Monodose RS01.</description>
          </group>
          <group group_id="O4">
            <title>Part 1: Cohort B- CCI15106 60 mg BID</title>
            <description>Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.</description>
          </group>
          <group group_id="O5">
            <title>Part 1: Placebo</title>
            <description>Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points</title>
          <description>FVC is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FVC was measured using standard spirometry. Percent predicted FVC was calculated as: Percent predicted FVC=(maximum FVC divided by predicted normal FVC)*100.</description>
          <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). The primary aim was to compare the safety profiles of the different active doses; hence, placebo arms have been combined as pre-specified in reporting and analysis plan.</population>
          <units>Percent predicted FVC</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="12"/>
                <count group_id="O5" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1: pre-dose, n=6,0,0,12,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="101.2" spread="7.14"/>
                    <measurement group_id="O4" value="104.1" spread="14.19"/>
                    <measurement group_id="O5" value="102.0" spread="2.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: 0.25 hour, n=6,0,0,0,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="101.5" spread="8.41"/>
                    <measurement group_id="O5" value="102.0" spread="5.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: 0.5 hour, n=6,0,0,12,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="108.3" spread="7.31"/>
                    <measurement group_id="O4" value="102.4" spread="13.28"/>
                    <measurement group_id="O5" value="103.8" spread="2.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: 1 hour, n=6,0,0,12,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="109.8" spread="7.96"/>
                    <measurement group_id="O4" value="103.7" spread="13.66"/>
                    <measurement group_id="O5" value="105.3" spread="2.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: 4 hours, n=6,0,0,12,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="106.7" spread="8.94"/>
                    <measurement group_id="O4" value="103.4" spread="14.74"/>
                    <measurement group_id="O5" value="104.5" spread="4.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3: pre-dose, n=0,6,0,12,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="104.3" spread="6.92"/>
                    <measurement group_id="O4" value="105.0" spread="14.68"/>
                    <measurement group_id="O5" value="105.8" spread="2.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3: 0.25 hour, n=0,6,0,0,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="105.7" spread="8.50"/>
                    <measurement group_id="O5" value="106.5" spread="3.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3: 0.5 hour, n=0,6,0,0,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="105.0" spread="8.00"/>
                    <measurement group_id="O5" value="104.5" spread="3.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3: 1 hour, n=0,6,0,0,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="105.8" spread="8.01"/>
                    <measurement group_id="O5" value="105.0" spread="1.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3: 4 hours, n=0,6,0,12,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="106.5" spread="6.72"/>
                    <measurement group_id="O4" value="105.3" spread="14.91"/>
                    <measurement group_id="O5" value="105.0" spread="2.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 6: pre-dose, n=0,0,6,12,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="107.8" spread="7.08"/>
                    <measurement group_id="O4" value="103.7" spread="14.77"/>
                    <measurement group_id="O5" value="103.3" spread="2.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 6: 0.25 hour, n=0,0,6,0,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="104.7" spread="8.33"/>
                    <measurement group_id="O5" value="104.5" spread="2.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 6: 0.5 hour, n=0,0,6,0,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="105.7" spread="9.81"/>
                    <measurement group_id="O5" value="103.5" spread="2.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 6: 1 hour, n=0,0,6,0,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="106.0" spread="9.14"/>
                    <measurement group_id="O5" value="99.5" spread="10.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 6: 4 hours, n=0,0,6,12,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="110.2" spread="7.08"/>
                    <measurement group_id="O4" value="105.4" spread="14.85"/>
                    <measurement group_id="O5" value="104.8" spread="3.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8: pre-dose, n=0,0,6,0,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="108.8" spread="8.47"/>
                    <measurement group_id="O5" value="108.0" spread="1.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8: 4 hours, n=0,0,6,0,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="108.2" spread="8.47"/>
                    <measurement group_id="O5" value="108.0" spread="2.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 11: pre-dose, n=0,0,6,12,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="107.2" spread="7.41"/>
                    <measurement group_id="O4" value="104.3" spread="17.05"/>
                    <measurement group_id="O5" value="106.8" spread="6.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 11: 4 hours, n=0,0,6,12,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="107.8" spread="8.86"/>
                    <measurement group_id="O4" value="106.3" spread="17.43"/>
                    <measurement group_id="O5" value="107.0" spread="5.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14: pre-dose, n=0,0,0,11,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="11"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O4" value="104.7" spread="16.01"/>
                    <measurement group_id="O5" value="102.5" spread="3.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14: 0.5 hour, n=0,0,0,11,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="11"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O4" value="103.6" spread="14.52"/>
                    <measurement group_id="O5" value="100.5" spread="0.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14: 1 hour, n=0,0,0,12,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O4" value="100.8" spread="14.91"/>
                    <measurement group_id="O5" value="104.0" spread="1.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14: 4 hours, n=0,0,0,11,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="11"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O4" value="99.0" spread="16.81"/>
                    <measurement group_id="O5" value="106.0" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 16: pre-dose, n=0,0,6,0,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="107.7" spread="8.04"/>
                    <measurement group_id="O5" value="111.0" spread="4.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 16: 4 hours, n=0,0,6,0,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="108.5" spread="8.38"/>
                    <measurement group_id="O5" value="110.5" spread="6.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 19: pre-dose, n=0,0,6,0,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="104.0" spread="10.32"/>
                    <measurement group_id="O5" value="110.0" spread="4.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 19: 0.25 hour, n=0,0,6,0,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="105.7" spread="10.07"/>
                    <measurement group_id="O5" value="107.0" spread="7.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 19: 0.5 hour, n=0,0,6,0,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="104.3" spread="10.73"/>
                    <measurement group_id="O5" value="106.5" spread="7.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 19: 1 hour, n=0,0,6,0,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="100.8" spread="11.84"/>
                    <measurement group_id="O5" value="103.5" spread="6.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 19: 4 hours, n=0,0,6,0,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="101.0" spread="8.88"/>
                    <measurement group_id="O5" value="101.5" spread="6.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 2: Percent Predicted FEV1 at Indicated Time Points</title>
        <description>FEV1 is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using standard spirometry. Percent predicted FEV1 was calculated as: Percent predicted FEV1=(maximum FEV1 divided by predicted normal FEV1)*100.</description>
        <time_frame>Day 1 and 14: pre-dose, 0.25, 0.5, 1 and 4 hours post-dose; Days 3, 6 and 11: pre-dose and 4 hours post-dose</time_frame>
        <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Cohort A- CCI15106 60 mg SD</title>
            <description>Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.</description>
          </group>
          <group group_id="O2">
            <title>Part 2: Cohort A- Placebo</title>
            <description>Participants with COPD received a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01 in Cohort A.</description>
          </group>
          <group group_id="O3">
            <title>Part 2: Cohort B- CCI15106 60 mg BID</title>
            <description>Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2: Percent Predicted FEV1 at Indicated Time Points</title>
          <description>FEV1 is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using standard spirometry. Percent predicted FEV1 was calculated as: Percent predicted FEV1=(maximum FEV1 divided by predicted normal FEV1)*100.</description>
          <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
          <units>Percent predicted FEV1</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="2"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1: pre-dose, n=6,2,8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.3" spread="13.88"/>
                    <measurement group_id="O2" value="51.5" spread="20.51"/>
                    <measurement group_id="O3" value="52.4" spread="5.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: 0.25 hour, n=6,2,8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.3" spread="10.93"/>
                    <measurement group_id="O2" value="41.0" spread="24.04"/>
                    <measurement group_id="O3" value="44.8" spread="4.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: 0.5 hour, n=6,2,8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.8" spread="12.45"/>
                    <measurement group_id="O2" value="43.0" spread="24.04"/>
                    <measurement group_id="O3" value="47.8" spread="4.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: 1 hour, n=6,2,8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.5" spread="13.88"/>
                    <measurement group_id="O2" value="45.0" spread="21.21"/>
                    <measurement group_id="O3" value="50.8" spread="2.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: 4 hours, n=6,2,8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.5" spread="12.05"/>
                    <measurement group_id="O2" value="50.5" spread="17.68"/>
                    <measurement group_id="O3" value="59.0" spread="6.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3: pre-dose, n=0,0,8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="54.9" spread="6.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3: 4 hours, n=0,0,8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="55.5" spread="6.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 6: pre-dose, n=0,0,8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="54.1" spread="5.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 6: 4 hours, n=0,0,8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="57.1" spread="7.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 11: pre-dose, n=0,0,8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="52.4" spread="9.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 11: 4 hours, n=0,0,8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="54.9" spread="8.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14: pre-dose, n=0,0,8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="51.6" spread="8.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14: 0.25 hour, n=0,0,8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="46.0" spread="9.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14: 0.5 hour, n=0,0,8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="48.1" spread="8.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14: 1 hour, n=0,0,8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="50.3" spread="8.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14: 4 hours, n=0,0,8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="55.6" spread="6.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 2: Percent Predicted FVC at Indicated Time Points</title>
        <description>FVC is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FVC was measured using standard spirometry. Percent predicted FVC was calculated as: Percent predicted FVC=(maximum FVC divided by predicted normal FVC)*100.</description>
        <time_frame>Day 1 and 14: pre-dose, 0.25, 0.5, 1 and 4 hours post-dose; Days 3, 6 and 11: pre-dose and 4 hours post-dose</time_frame>
        <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Cohort A- CCI15106 60 mg SD</title>
            <description>Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.</description>
          </group>
          <group group_id="O2">
            <title>Part 2: Cohort A- Placebo</title>
            <description>Participants with COPD received a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01 in Cohort A.</description>
          </group>
          <group group_id="O3">
            <title>Part 2: Cohort B- CCI15106 60 mg BID</title>
            <description>Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2: Percent Predicted FVC at Indicated Time Points</title>
          <description>FVC is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FVC was measured using standard spirometry. Percent predicted FVC was calculated as: Percent predicted FVC=(maximum FVC divided by predicted normal FVC)*100.</description>
          <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
          <units>Percent predicted FVC</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="2"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1: pre-dose, n=6,2,8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.5" spread="19.07"/>
                    <measurement group_id="O2" value="89.0" spread="2.83"/>
                    <measurement group_id="O3" value="82.8" spread="15.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: 0.25 hour, n=6,2,8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.5" spread="20.03"/>
                    <measurement group_id="O2" value="70.5" spread="10.61"/>
                    <measurement group_id="O3" value="76.6" spread="11.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: 0.5 hour, n=6,2,8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.7" spread="18.48"/>
                    <measurement group_id="O2" value="76.0" spread="9.90"/>
                    <measurement group_id="O3" value="80.8" spread="13.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: 1 hour, n=6,2,8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.7" spread="20.49"/>
                    <measurement group_id="O2" value="77.5" spread="3.54"/>
                    <measurement group_id="O3" value="81.6" spread="10.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: 4 hours, n=6,2,8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.0" spread="15.59"/>
                    <measurement group_id="O2" value="91.5" spread="2.12"/>
                    <measurement group_id="O3" value="92.4" spread="13.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3: pre-dose, n=0,0,8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="86.8" spread="12.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3: 4 hours, n=0,0,8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="90.0" spread="15.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 6: pre-dose, n=0,0,8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="79.6" spread="8.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 6: 4 hours, n=0,0,8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="84.8" spread="13.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 11: pre-dose, n=0,0,8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="79.3" spread="15.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 11: 4 hours, n=0,0,8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="86.0" spread="16.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14: pre-dose, n=0,0,8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="84.6" spread="19.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14: 0.25 hour, n=0,0,8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="76.8" spread="24.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14: 0.5 hour, n=0,0,8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="80.3" spread="24.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14: 1 hour, n=0,0,8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="82.9" spread="25.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14: 4 hours, n=0,0,8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="89.1" spread="17.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1: Number of Participants With Vital Signs Values of PCI</title>
        <description>PCI ranges for the vital signs parameters were as follows: systolic blood pressure (SBP) &lt;85 and &gt;160 millimeters of mercury (mmHg), diastolic blood pressure (DBP) &lt;45 and &gt;100 mmHg and heart rate &lt;40 and &gt;110 beats per minute (bpm). Data for the participants with high and low values has been reported.</description>
        <time_frame>Up to 51 days</time_frame>
        <population>Safety Population. The primary aim was to compare the safety profiles of the different active doses; hence, placebo arms have been combined as pre-specified in reporting and analysis plan.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Cohort A- CCI15106 60 mg SD</title>
            <description>Healthy participants were administered a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: Cohort A- CCI15106 120 mg SD</title>
            <description>Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.</description>
          </group>
          <group group_id="O3">
            <title>Part 1: Cohort A- CCI15106 30 mg BID</title>
            <description>Healthy participants were administered a BID dose of CCI15106 30 mg by inhalation route on Days 6 to 19 via Monodose RS01.</description>
          </group>
          <group group_id="O4">
            <title>Part 1: Cohort B- CCI15106 60 mg BID</title>
            <description>Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.</description>
          </group>
          <group group_id="O5">
            <title>Part 1: Placebo</title>
            <description>Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Number of Participants With Vital Signs Values of PCI</title>
          <description>PCI ranges for the vital signs parameters were as follows: systolic blood pressure (SBP) &lt;85 and &gt;160 millimeters of mercury (mmHg), diastolic blood pressure (DBP) &lt;45 and &gt;100 mmHg and heart rate &lt;40 and &gt;110 beats per minute (bpm). Data for the participants with high and low values has been reported.</description>
          <population>Safety Population. The primary aim was to compare the safety profiles of the different active doses; hence, placebo arms have been combined as pre-specified in reporting and analysis plan.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="12"/>
                <count group_id="O5" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>DBP: low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP: high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SBP: low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SBP: high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Heart rate: low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Heart rate: high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1: Number of Participants With Vital Signs Values of PCI in Bystanders</title>
        <description>PCI ranges for the vital signs parameters were as follows: SBP &lt;85 and &gt;160 mmHg, DBP &lt;45 and &gt;100 mmHg and heart rate &lt;40 and &gt;110 bpm. Data for the participants with high and low values has been reported.</description>
        <time_frame>Up to 46 days</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Cohort C- Bystanders</title>
            <description>Healthy participants were enrolled to evaluate bystander exposure and evaluated concomitantly with Cohort B. Bystanders reported to the unit on Day -1 and remained for 14 days of dosing of Cohort B.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Number of Participants With Vital Signs Values of PCI in Bystanders</title>
          <description>PCI ranges for the vital signs parameters were as follows: SBP &lt;85 and &gt;160 mmHg, DBP &lt;45 and &gt;100 mmHg and heart rate &lt;40 and &gt;110 bpm. Data for the participants with high and low values has been reported.</description>
          <population>Safety Population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>DBP: low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP: high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SBP: low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SBP: high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Heart rate: low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Heart rate: high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 2: Number of Participants With Vital Signs Values of PCI</title>
        <description>PCI ranges for the vital signs parameters were as follows: SBP &lt;85 and &gt;160 mmHg, DBP &lt;45 and &gt;100 mmHg and heart rate &lt;40 and &gt;110 bpm. Data for the participants with high and low values has been reported.</description>
        <time_frame>Up to 46 days</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Cohort A- CCI15106 60 mg SD</title>
            <description>Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.</description>
          </group>
          <group group_id="O2">
            <title>Part 2: Cohort A- Placebo</title>
            <description>Participants with COPD received a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01 in Cohort A.</description>
          </group>
          <group group_id="O3">
            <title>Part 2: Cohort B- CCI15106 60 mg BID</title>
            <description>Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2: Number of Participants With Vital Signs Values of PCI</title>
          <description>PCI ranges for the vital signs parameters were as follows: SBP &lt;85 and &gt;160 mmHg, DBP &lt;45 and &gt;100 mmHg and heart rate &lt;40 and &gt;110 bpm. Data for the participants with high and low values has been reported.</description>
          <population>Safety Population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="2"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>DBP: low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP: high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SBP: low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SBP: high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Heart rate: low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Heart rate: high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1 Cohort A: Area Under the Curve (AUC) From Time Zero to the Time of Last Quantifiable Concentration (AUC[0-t]) After Single Dose Administration of CCI15106 60 mg on Day 1</title>
        <description>Blood samples were collected to evaluate the pharmacokinetics (PKs) of CCI15106 at the indicated time points on Day 1 for the analysis of AUC(0-t) data. PK population consisted of participants who received at least one dose of study treatment and who undergo plasma PK sampling and had at least one post-dose concentration result.</description>
        <time_frame>Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dose</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Cohort A- CCI15106 60 mg SD</title>
            <description>Healthy participants were administered a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1 Cohort A: Area Under the Curve (AUC) From Time Zero to the Time of Last Quantifiable Concentration (AUC[0-t]) After Single Dose Administration of CCI15106 60 mg on Day 1</title>
          <description>Blood samples were collected to evaluate the pharmacokinetics (PKs) of CCI15106 at the indicated time points on Day 1 for the analysis of AUC(0-t) data. PK population consisted of participants who received at least one dose of study treatment and who undergo plasma PK sampling and had at least one post-dose concentration result.</description>
          <population>PK Population.</population>
          <units>Hours*nanogram per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1255.3711" spread="19.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1 Cohort A: AUC(0-t) After Single Dose Administration of CCI15106 120 mg on Day 3</title>
        <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of AUC(0-t) data.</description>
        <time_frame>Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Cohort A- CCI15106 120 mg SD</title>
            <description>Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1 Cohort A: AUC(0-t) After Single Dose Administration of CCI15106 120 mg on Day 3</title>
          <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of AUC(0-t) data.</description>
          <population>PK Population.</population>
          <units>Hours*nanogram per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3256.6746" spread="29.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 2 Cohort A: AUC(0-t) After Single Dose Administration of CCI15106 60 mg on Day 1</title>
        <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of AUC(0-t) data.</description>
        <time_frame>Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Cohort A- CCI15106 60 mg SD</title>
            <description>Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2 Cohort A: AUC(0-t) After Single Dose Administration of CCI15106 60 mg on Day 1</title>
          <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of AUC(0-t) data.</description>
          <population>PK Population.</population>
          <units>Hours*nanogram per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="862.7642" spread="59.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1 Cohort A: Maximum Observed Plasma Concentration (Cmax) After Single Dose Administration of CCI15106 60 mg on Day 1</title>
        <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of Cmax data.</description>
        <time_frame>Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dose</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Cohort A- CCI15106 60 mg SD</title>
            <description>Healthy participants were administered a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1 Cohort A: Maximum Observed Plasma Concentration (Cmax) After Single Dose Administration of CCI15106 60 mg on Day 1</title>
          <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of Cmax data.</description>
          <population>PK Population.</population>
          <units>Nanogram per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="232.2" spread="20.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1 Cohort A: Cmax After Single Dose Administration of CCI15106 120 mg on Day 3</title>
        <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of Cmax data.</description>
        <time_frame>Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Cohort A- CCI15106 120 mg SD</title>
            <description>Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1 Cohort A: Cmax After Single Dose Administration of CCI15106 120 mg on Day 3</title>
          <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of Cmax data.</description>
          <population>PK Population.</population>
          <units>Nanogram per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="507.6" spread="27.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 2 Cohort A: Cmax After Single Dose Administration of CCI15106 60 mg on Day 1</title>
        <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of Cmax data.</description>
        <time_frame>Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Cohort A- CCI15106 60 mg SD</title>
            <description>Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2 Cohort A: Cmax After Single Dose Administration of CCI15106 60 mg on Day 1</title>
          <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of Cmax data.</description>
          <population>PK Population.</population>
          <units>Nanogram per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="179.3" spread="81.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1 Cohort A: Time of Maximum Concentration (Tmax) After Single Dose Administration of CCI15106 60 mg on Day 1</title>
        <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of tmax data.</description>
        <time_frame>Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dose</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Cohort A- CCI15106 60 mg SD</title>
            <description>Healthy participants were administered a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1 Cohort A: Time of Maximum Concentration (Tmax) After Single Dose Administration of CCI15106 60 mg on Day 1</title>
          <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of tmax data.</description>
          <population>PK Population.</population>
          <units>Hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.500" lower_limit="0.25" upper_limit="1.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1 Cohort A: Tmax After Single Dose Administration of CCI15106 120 mg on Day 3</title>
        <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of tmax data.</description>
        <time_frame>Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Cohort A- CCI15106 120 mg SD</title>
            <description>Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1 Cohort A: Tmax After Single Dose Administration of CCI15106 120 mg on Day 3</title>
          <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of tmax data.</description>
          <population>PK Population.</population>
          <units>Hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.625" lower_limit="0.25" upper_limit="0.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 2 Cohort A: Tmax After Single Dose Administration of CCI15106 60 mg on Day 1</title>
        <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of tmax data.</description>
        <time_frame>Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Cohort A- CCI15106 60 mg SD</title>
            <description>Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2 Cohort A: Tmax After Single Dose Administration of CCI15106 60 mg on Day 1</title>
          <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of tmax data.</description>
          <population>PK Population.</population>
          <units>Hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.500" lower_limit="0.27" upper_limit="0.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1 Cohort A: AUC From Time Zero to Infinity (AUC[0-infinity]) After Single Dose Administration of CCI15106 60 mg on Day 1</title>
        <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of AUC(0-infinity) data.</description>
        <time_frame>Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dose</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Cohort A- CCI15106 60 mg SD</title>
            <description>Healthy participants were administered a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1 Cohort A: AUC From Time Zero to Infinity (AUC[0-infinity]) After Single Dose Administration of CCI15106 60 mg on Day 1</title>
          <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of AUC(0-infinity) data.</description>
          <population>PK Population.</population>
          <units>Hours*nanogram per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1618.4216" spread="20.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1 Cohort A: AUC(0-infinity) After Single Dose Administration of CCI15106 120 mg on Day 3</title>
        <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of AUC(0-infinity) data.</description>
        <time_frame>Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Cohort A- CCI15106 120 mg SD</title>
            <description>Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1 Cohort A: AUC(0-infinity) After Single Dose Administration of CCI15106 120 mg on Day 3</title>
          <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of AUC(0-infinity) data.</description>
          <population>PK Population.</population>
          <units>Hours*nanogram per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4418.9437" spread="37.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 2 Cohort A: AUC(0-infinity) After Single Dose Administration of CCI15106 60 mg on Day 1</title>
        <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of AUC(0-infinity) data.</description>
        <time_frame>Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose</time_frame>
        <population>PK Population. Only those participants with data available at the indicated time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Cohort A- CCI15106 60 mg SD</title>
            <description>Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2 Cohort A: AUC(0-infinity) After Single Dose Administration of CCI15106 60 mg on Day 1</title>
          <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of AUC(0-infinity) data.</description>
          <population>PK Population. Only those participants with data available at the indicated time points were analyzed.</population>
          <units>Hours*nanogram per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="968.8838" spread="49.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1 Cohort A: Elimination Half-life (t1/2) After Single Dose Administration of CCI15106 60 mg on Day 1</title>
        <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of t1/2 data.</description>
        <time_frame>Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dose</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Cohort A- CCI15106 60 mg SD</title>
            <description>Healthy participants were administered a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1 Cohort A: Elimination Half-life (t1/2) After Single Dose Administration of CCI15106 60 mg on Day 1</title>
          <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of t1/2 data.</description>
          <population>PK Population.</population>
          <units>Hours</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.8346" spread="5.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1 Cohort A: t1/2 After Single Dose Administration of CCI15106 120 mg on Day 3</title>
        <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of t1/2 data.</description>
        <time_frame>Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Cohort A- CCI15106 120 mg SD</title>
            <description>Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1 Cohort A: t1/2 After Single Dose Administration of CCI15106 120 mg on Day 3</title>
          <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of t1/2 data.</description>
          <population>PK Population.</population>
          <units>Hours</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.2596" spread="32.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 2 Cohort A: t1/2 After Single Dose Administration of CCI15106 60 mg on Day 1</title>
        <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of t1/2 data.</description>
        <time_frame>Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose</time_frame>
        <population>PK Population. Only those participants with data available at the indicated time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Cohort A- CCI15106 60 mg SD</title>
            <description>Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2 Cohort A: t1/2 After Single Dose Administration of CCI15106 60 mg on Day 1</title>
          <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of t1/2 data.</description>
          <population>PK Population. Only those participants with data available at the indicated time points were analyzed.</population>
          <units>Hours</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.4000" spread="8.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1 Cohort A: Clearance (CL/F) After Single Dose Administration of CCI15106 60 mg on Day 1</title>
        <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of CL/F data.</description>
        <time_frame>Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dose</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Cohort A- CCI15106 60 mg SD</title>
            <description>Healthy participants were administered a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1 Cohort A: Clearance (CL/F) After Single Dose Administration of CCI15106 60 mg on Day 1</title>
          <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of CL/F data.</description>
          <population>PK Population.</population>
          <units>Liters per hour</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.0732" spread="20.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1 Cohort A: CL/F After Single Dose Administration of CCI15106 120 mg on Day 3</title>
        <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of CL/F data.</description>
        <time_frame>Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Cohort A- CCI15106 120 mg SD</title>
            <description>Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1 Cohort A: CL/F After Single Dose Administration of CCI15106 120 mg on Day 3</title>
          <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of CL/F data.</description>
          <population>PK Population.</population>
          <units>Liters per hour</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.1558" spread="37.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 2 Cohort A: CL/F After Single Dose Administration of CCI15106 60 mg on Day 1</title>
        <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of CL/F data.</description>
        <time_frame>Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose</time_frame>
        <population>PK Population. Only those participants with data available at the indicated time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Cohort A- CCI15106 60 mg SD</title>
            <description>Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2 Cohort A: CL/F After Single Dose Administration of CCI15106 60 mg on Day 1</title>
          <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of CL/F data.</description>
          <population>PK Population. Only those participants with data available at the indicated time points were analyzed.</population>
          <units>Liters per hour</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.9269" spread="49.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1 Cohort A: AUC From Time Zero to End of Dosing Interval (AUC[0-tau]) After Repeated Dose Administration of CCI15106 30 mg</title>
        <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 6 and 19 for the analysis of AUC(0-tau) data.</description>
        <time_frame>Day 6: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 19: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose</time_frame>
        <population>PK Population. NA indicates that, AUC(0-tau) could not be calculated because t1/2 considered unreliable as period over which they were calculated was less than twice resultant t1/2 in all cases. In addition, percent AUCextrapolated (%AUCex) was &gt;20% in most cases. This was largely due to short period of sampling times.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Cohort A- CCI15106 30 mg BID</title>
            <description>Healthy participants were administered a BID dose of CCI15106 30 mg by inhalation route on Days 6 to 19 via Monodose RS01.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1 Cohort A: AUC From Time Zero to End of Dosing Interval (AUC[0-tau]) After Repeated Dose Administration of CCI15106 30 mg</title>
          <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 6 and 19 for the analysis of AUC(0-tau) data.</description>
          <population>PK Population. NA indicates that, AUC(0-tau) could not be calculated because t1/2 considered unreliable as period over which they were calculated was less than twice resultant t1/2 in all cases. In addition, percent AUCextrapolated (%AUCex) was &gt;20% in most cases. This was largely due to short period of sampling times.</population>
          <units>Hours*nanogram per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">AUC(0-tau) could not be calculated because t1/2 considered unreliable as period over which they were calculated was &lt; twice resultant t1/2 in all cases.In addition,%AUCex was &gt;20% in most cases.This was largely due to short period of sampling times.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 19</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1214.2671" spread="21.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1 Cohort B: AUC(0-tau) After Repeated Dose Administration of CCI15106 60 mg</title>
        <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of AUC(0-tau) data.</description>
        <time_frame>Days 1 and 14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose</time_frame>
        <population>PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Cohort B- CCI15106 60 mg BID</title>
            <description>Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1 Cohort B: AUC(0-tau) After Repeated Dose Administration of CCI15106 60 mg</title>
          <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of AUC(0-tau) data.</description>
          <population>PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
          <units>Hours*nanogram per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1, n=12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="564.7314" spread="50.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, n=8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2059.8983" spread="15.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 2 Cohort B: AUC(0-tau) After Repeated Dose Administration of CCI15106 60 mg</title>
        <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of AUC(0-tau) data.</description>
        <time_frame>Days 1 and 14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose</time_frame>
        <population>PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Cohort B- CCI15106 60 mg BID</title>
            <description>Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2 Cohort B: AUC(0-tau) After Repeated Dose Administration of CCI15106 60 mg</title>
          <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of AUC(0-tau) data.</description>
          <population>PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
          <units>Hours*nanogram per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1, n=8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="687.0875" spread="39.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, n=7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3086.5172" spread="28.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1 Cohort A: Cmax After Repeated Dose Administration of CCI15106 30 mg</title>
        <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 6 and 19 for the analysis of Cmax data.</description>
        <time_frame>Day 6: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 19: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Cohort A- CCI15106 30 mg BID</title>
            <description>Healthy participants were administered a BID dose of CCI15106 30 mg by inhalation route on Days 6 to 19 via Monodose RS01.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1 Cohort A: Cmax After Repeated Dose Administration of CCI15106 30 mg</title>
          <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 6 and 19 for the analysis of Cmax data.</description>
          <population>PK Population.</population>
          <units>Nanogram per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="143.1" spread="23.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 19</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="193.9" spread="15.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1 Cohort B: Cmax After Repeated Dose Administration of CCI15106 60 mg</title>
        <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of Cmax data.</description>
        <time_frame>Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose</time_frame>
        <population>PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Cohort B- CCI15106 60 mg BID</title>
            <description>Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1 Cohort B: Cmax After Repeated Dose Administration of CCI15106 60 mg</title>
          <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of Cmax data.</description>
          <population>PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
          <units>Nanogram per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1, n=12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="188.7" spread="63.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, n=11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="285.0" spread="39.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 2 Cohort B: Cmax After Repeated Dose Administration of CCI15106 60 mg</title>
        <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of Cmax data.</description>
        <time_frame>Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose</time_frame>
        <population>PK Population. Only those participants with data available at the indicated time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Cohort B- CCI15106 60 mg BID</title>
            <description>Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2 Cohort B: Cmax After Repeated Dose Administration of CCI15106 60 mg</title>
          <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of Cmax data.</description>
          <population>PK Population. Only those participants with data available at the indicated time points were analyzed.</population>
          <units>Nanogram per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="178.2" spread="51.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="423.0" spread="31.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1 Cohort A: Tmax After Repeated Dose Administration of CCI15106 30 mg</title>
        <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 6 and 19 for the analysis of tmax data.</description>
        <time_frame>Day 6: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 19: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Cohort A- CCI15106 30 mg BID</title>
            <description>Healthy participants were administered a BID dose of CCI15106 30 mg by inhalation route on Days 6 to 19 via Monodose RS01.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1 Cohort A: Tmax After Repeated Dose Administration of CCI15106 30 mg</title>
          <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 6 and 19 for the analysis of tmax data.</description>
          <population>PK Population.</population>
          <units>Hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.500" lower_limit="0.50" upper_limit="0.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 19</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.500" lower_limit="0.25" upper_limit="0.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1 Cohort B: Tmax After Repeated Dose Administration of CCI15106 60 mg</title>
        <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of tmax data.</description>
        <time_frame>Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose</time_frame>
        <population>PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Cohort B- CCI15106 60 mg BID</title>
            <description>Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1 Cohort B: Tmax After Repeated Dose Administration of CCI15106 60 mg</title>
          <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of tmax data.</description>
          <population>PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
          <units>Hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1, n=12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.633" lower_limit="0.50" upper_limit="1.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, n=11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.500" lower_limit="0.30" upper_limit="1.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 2 Cohort B: Tmax After Repeated Dose Administration of CCI15106 60 mg</title>
        <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of tmax data.</description>
        <time_frame>Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Cohort B- CCI15106 60 mg BID</title>
            <description>Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2 Cohort B: Tmax After Repeated Dose Administration of CCI15106 60 mg</title>
          <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of tmax data.</description>
          <population>PK Population.</population>
          <units>Hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.633" lower_limit="0.25" upper_limit="1.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.500" lower_limit="0.25" upper_limit="1.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1 Cohort A: t1/2 After Repeated Dose Administration of CCI15106 30 mg</title>
        <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 6 and 19 for the analysis of t1/2 data.</description>
        <time_frame>Day 6: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 19: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose</time_frame>
        <population>PK Population. NA indicates that, t1/2 of CCI15106 plasma concentration in healthy participant was estimated but considered unreliable as period over which they were calculated was less than twice resultant t1/2 in all cases. In addition, %AUCex was &gt;20% in most cases. This was largely due to short period of sampling times.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Cohort A- CCI15106 30 mg BID</title>
            <description>Healthy participants were administered a BID dose of CCI15106 30 mg by inhalation route on Days 6 to 19 via Monodose RS01.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1 Cohort A: t1/2 After Repeated Dose Administration of CCI15106 30 mg</title>
          <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 6 and 19 for the analysis of t1/2 data.</description>
          <population>PK Population. NA indicates that, t1/2 of CCI15106 plasma concentration in healthy participant was estimated but considered unreliable as period over which they were calculated was less than twice resultant t1/2 in all cases. In addition, %AUCex was &gt;20% in most cases. This was largely due to short period of sampling times.</population>
          <units>Hours</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">t1/2 of CCI15106 plasma concentration was estimated but considered unreliable as period over which they were calculated was &lt; twice resultant t1/2 in all cases.%AUCex was &gt;20% in most cases.This was largely due to short period of sampling times.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 19</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.1484" spread="10.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1 Cohort B: t1/2 After Repeated Dose Administration of CCI15106 60 mg</title>
        <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of t1/2 data.</description>
        <time_frame>Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose</time_frame>
        <population>PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Cohort B- CCI15106 60 mg BID</title>
            <description>Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1 Cohort B: t1/2 After Repeated Dose Administration of CCI15106 60 mg</title>
          <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of t1/2 data.</description>
          <population>PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
          <units>Hours</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1, n=12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.3719" spread="14.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, n=8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.0497" spread="42.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 2 Cohort B: t1/2 After Repeated Dose Administration of CCI15106 60 mg</title>
        <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of t1/2 data.</description>
        <time_frame>Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose</time_frame>
        <population>PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Cohort B- CCI15106 60 mg BID</title>
            <description>Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2 Cohort B: t1/2 After Repeated Dose Administration of CCI15106 60 mg</title>
          <description>Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of t1/2 data.</description>
          <population>PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
          <units>Hours</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1, n=8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.1572" spread="18.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, n=7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.5034" spread="39.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1: Concentration of CCI15106 in Plasma of Bystanders: Cohort C</title>
        <description>Blood samples were collected from bystanders 15 minutes after dosing at indicated time points. Bystander PK population consisted of participants who were present at least once in the room with the participant receiving the dose, undergo plasma PK sampling and had post-dose concentration result.</description>
        <time_frame>Days 1, 7 and 14: pre-dose, 15 minutes post-dose</time_frame>
        <population>Bystander PK Population. NA indicates that, data could not be analyzed because data was below level of quantification.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Cohort C- Bystanders</title>
            <description>Healthy participants were enrolled to evaluate bystander exposure and evaluated concomitantly with Cohort B. Bystanders reported to the unit on Day -1 and remained for 14 days of dosing of Cohort B.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Concentration of CCI15106 in Plasma of Bystanders: Cohort C</title>
          <description>Blood samples were collected from bystanders 15 minutes after dosing at indicated time points. Bystander PK population consisted of participants who were present at least once in the room with the participant receiving the dose, undergo plasma PK sampling and had post-dose concentration result.</description>
          <population>Bystander PK Population. NA indicates that, data could not be analyzed because data was below level of quantification.</population>
          <units>Nanogram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Data could not be analyzed because data was below level of quantification.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C</title>
        <description>Personal exposure air samples were collected on filters placed on each bystander after the first daily dose at indicated time points. The filters were used to measure CCI15106 concentration in the person's breathing zone. Fixed location concentrations were measured near window, near door, back to wall and facing wall in the dosing room over 15 minutes post-dose. Each bystander had a filter attached to their study clothing. The filters were measured for CCI15106. This was a single measurement from the filter for each bystsander. The locations (near window, near door, back to wall and facing wall) were just to record where the bystander was located in the room.</description>
        <time_frame>Days 1, 7 and 14: 15 minutes post-dose</time_frame>
        <population>Bystander PK Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Bystander Group 1- Session 1</title>
            <description>Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: Bystander Group 1- Session 2</title>
            <description>Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.</description>
          </group>
          <group group_id="O3">
            <title>Part 1: Bystander Group 2- Session 1</title>
            <description>Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.</description>
          </group>
          <group group_id="O4">
            <title>Part 1: Bystander Group 2- Session 2</title>
            <description>Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.</description>
          </group>
          <group group_id="O5">
            <title>Part 1: Bystander Group 3- Session 1</title>
            <description>Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in a single session on Days 1, 7 and 14.</description>
          </group>
          <group group_id="O6">
            <title>Part 1: Bystander Group 4- Session 1</title>
            <description>Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.</description>
          </group>
          <group group_id="O7">
            <title>Part 1: Bystander Group 4- Session 2</title>
            <description>Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C</title>
          <description>Personal exposure air samples were collected on filters placed on each bystander after the first daily dose at indicated time points. The filters were used to measure CCI15106 concentration in the person's breathing zone. Fixed location concentrations were measured near window, near door, back to wall and facing wall in the dosing room over 15 minutes post-dose. Each bystander had a filter attached to their study clothing. The filters were measured for CCI15106. This was a single measurement from the filter for each bystsander. The locations (near window, near door, back to wall and facing wall) were just to record where the bystander was located in the room.</description>
          <population>Bystander PK Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).</population>
          <units>Microgram per cubic meter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="2"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="2"/>
                <count group_id="O5" value="2"/>
                <count group_id="O6" value="2"/>
                <count group_id="O7" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1: Near door,n=1,1,1,1,0,0,0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="1"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.53" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O2" value="0.39" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O3" value="1.81" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O4" value="8.99" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: Near window,n=1,1,1,1,0,0,0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="1"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.10" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O2" value="0.10" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O3" value="2.46" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O4" value="4.84" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: Back to wall,n=0,0,0,0,1,1,1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="1"/>
                    <count group_id="O7" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O5" value="5.27" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O6" value="0.10" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O7" value="0.10" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: Facing wall,n=0,0,0,0,1,1,1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="1"/>
                    <count group_id="O7" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O5" value="5.84" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O6" value="0.10" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O7" value="0.10" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7: Near door,n=1,1,1,1,0,0,0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="1"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.81" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O2" value="2.62" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O3" value="2.13" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O4" value="0.49" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7: Near window,n=1,1,1,1,0,0,0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="1"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.86" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O2" value="2.74" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O3" value="3.14" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O4" value="0.41" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7: Back to wall,n=0,0,0,0,1,1,1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="1"/>
                    <count group_id="O7" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O5" value="0.76" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O6" value="0.47" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O7" value="0.80" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7: Facing wall,n=0,0,0,0,1,1,1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="1"/>
                    <count group_id="O7" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O5" value="0.86" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O6" value="0.10" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O7" value="1.00" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14: Near door,n=1,1,1,1,0,0,0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="1"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.10" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O2" value="1.97" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O3" value="9.22" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O4" value="0.10" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14: Near window,n=1,1,1,1,0,0,0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="1"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.10" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O2" value="1.73" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O3" value="8.09" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O4" value="0.45" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14: Back to wall,n=0,0,0,0,1,1,1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="1"/>
                    <count group_id="O7" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O5" value="0.38" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O6" value="0.35" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O7" value="0.10" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14: Facing wall,n=0,0,0,0,1,1,1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="1"/>
                    <count group_id="O7" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O5" value="0.10" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O6" value="0.10" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O7" value="0.10" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C</title>
        <description>Static air samples were collected on filters within air pumps positioned in two locations (bench and corner) in the room. Sampling devices attached to sampling pumps were used to measure CCI15106 concentration. Fixed location concentrations were measured in corner of room and on bench at back of room over 20 minutes and 60 minutes post-dosing.</description>
        <time_frame>Days 1, 7 and 14: 20 and 60 minutes post-dose</time_frame>
        <population>Bystander PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Bystander Group 1- Session 1</title>
            <description>Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: Bystander Group 1- Session 2</title>
            <description>Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.</description>
          </group>
          <group group_id="O3">
            <title>Part 1: Bystander Group 2- Session 1</title>
            <description>Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.</description>
          </group>
          <group group_id="O4">
            <title>Part 1: Bystander Group 2- Session 2</title>
            <description>Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.</description>
          </group>
          <group group_id="O5">
            <title>Part 1: Bystander Group 3- Session 1</title>
            <description>Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in a single session on Days 1, 7 and 14.</description>
          </group>
          <group group_id="O6">
            <title>Part 1: Bystander Group 4- Session 1</title>
            <description>Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.</description>
          </group>
          <group group_id="O7">
            <title>Part 1: Bystander Group 4- Session 2</title>
            <description>Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C</title>
          <description>Static air samples were collected on filters within air pumps positioned in two locations (bench and corner) in the room. Sampling devices attached to sampling pumps were used to measure CCI15106 concentration. Fixed location concentrations were measured in corner of room and on bench at back of room over 20 minutes and 60 minutes post-dosing.</description>
          <population>Bystander PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
          <units>Microgram per cubic meter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="2"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="2"/>
                <count group_id="O5" value="2"/>
                <count group_id="O6" value="2"/>
                <count group_id="O7" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1: 20 minutes- Corner,n=1,1,1,1,1,1,1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="1"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="1"/>
                    <count group_id="O7" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.79" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O2" value="0.50" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O3" value="2.09" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O4" value="4.12" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O5" value="5.80" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O6" value="0.50" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O7" value="0.50" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: 20 minutes- Bench,n=1,1,1,1,1,1,1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="1"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="1"/>
                    <count group_id="O7" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.46" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O2" value="0.50" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O3" value="1.58" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O4" value="3.74" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O5" value="4.98" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O6" value="0.50" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O7" value="0.50" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7: 20 minutes- Corner,n=1,1,1,1,1,1,1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="1"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="1"/>
                    <count group_id="O7" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.52" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O2" value="2.53" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O3" value="2.64" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O4" value="0.30" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O5" value="0.30" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O6" value="0.28" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O7" value="1.01" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7: 20 minutes- Bench,n=1,1,1,1,1,1,1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="1"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="1"/>
                    <count group_id="O7" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.39" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O2" value="3.32" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O3" value="2.34" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O4" value="0.46" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O5" value="0.65" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O6" value="0.50" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O7" value="1.13" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14: 20 minutes- Corner,n=1,1,1,1,1,1,1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="1"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="1"/>
                    <count group_id="O7" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.50" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O2" value="1.87" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O3" value="8.54" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O4" value="0.36" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O5" value="0.30" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O6" value="0.50" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O7" value="0.50" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14: 20 minutes- Bench,n=1,1,1,1,1,1,1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="1"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="1"/>
                    <count group_id="O7" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.50" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O2" value="1.39" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O3" value="6.47" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O4" value="0.27" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O5" value="0.50" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O6" value="0.50" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O7" value="0.50" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: 60 minutes- Corner,n=1,1,1,1,1,1,1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="1"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="1"/>
                    <count group_id="O7" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.89" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O2" value="0.13" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O3" value="0.99" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O4" value="2.03" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O5" value="2.34" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O6" value="0.10" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O7" value="0.10" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: 60 minutes- Bench,n=1,1,1,1,1,1,1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="1"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="1"/>
                    <count group_id="O7" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.75" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O2" value="0.15" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O3" value="0.90" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O4" value="2.09" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O5" value="2.17" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O6" value="0.10" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O7" value="0.10" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7: 60 minutes- Corner,n=1,1,1,1,1,1,1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="1"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="1"/>
                    <count group_id="O7" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.22" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O2" value="1.72" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O3" value="1.19" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O4" value="0.19" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O5" value="0.34" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O6" value="0.10" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O7" value="0.46" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7: 60 minutes- Bench,n=1,1,1,1,1,1,1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="1"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="1"/>
                    <count group_id="O7" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.22" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O2" value="1.40" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O3" value="1.00" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O4" value="0.18" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O5" value="0.28" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O6" value="0.10" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O7" value="0.52" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14: 60 minutes- Corner,n=1,1,1,1,1,1,1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="1"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="1"/>
                    <count group_id="O7" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.10" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O2" value="0.70" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O3" value="3.58" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O4" value="0.10" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O5" value="0.14" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O6" value="0.10" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O7" value="0.10" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14: 60 minutes- Bench,n=1,1,1,1,1,1,1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="1"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="1"/>
                    <count group_id="O7" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.10" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O2" value="0.62" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O3" value="3.20" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O4" value="0.14" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O5" value="0.11" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O6" value="0.10" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                    <measurement group_id="O7" value="0.10" spread="NA">Standard deviation could not be calculated for one participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part 1: Concentration of CCI15106 in Lung Epithelial Lining Fluid (ELF) in Repeated Dose of Cohort B 60 mg</title>
        <description>Bronchoalveolar lavage samples for ELF concentration analysis of CCI15106 were collected up to Day 13. Participants who received at least one dose of study treatment and who underwent bronchoalveolar lavage (BAL) sampling and had post-dose lung ELF CCI15106 and urea concentration result were included in BAL PK Population.</description>
        <time_frame>Up to Day 13</time_frame>
        <population>BAL PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Cohort B- CCI15106 60 mg BID</title>
            <description>Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Concentration of CCI15106 in Lung Epithelial Lining Fluid (ELF) in Repeated Dose of Cohort B 60 mg</title>
          <description>Bronchoalveolar lavage samples for ELF concentration analysis of CCI15106 were collected up to Day 13. Participants who received at least one dose of study treatment and who underwent bronchoalveolar lavage (BAL) sampling and had post-dose lung ELF CCI15106 and urea concentration result were included in BAL PK Population.</description>
          <population>BAL PK Population.</population>
          <units>Nanogram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47306.383" spread="25231.0613"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part 2: Concentration of CCI15106 in ELF in Repeated Dose of Cohort B 60 mg</title>
        <description>BAL samples for ELF concentration analysis of CCI15106 were collected up to Day 13.</description>
        <time_frame>Up to Day 13</time_frame>
        <population>BAL PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Cohort B- CCI15106 60 mg BID</title>
            <description>Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2: Concentration of CCI15106 in ELF in Repeated Dose of Cohort B 60 mg</title>
          <description>BAL samples for ELF concentration analysis of CCI15106 were collected up to Day 13.</description>
          <population>BAL PK Population.</population>
          <units>Nanogram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="247290.327" spread="427471.7407"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part 1: Number of Participants With Medical Device Incidents in CCI15106</title>
        <description>A medical device incident is any malfunction or deterioration in the characteristics and/or performance of a device as well as any inadequacy in the labeling or the instructions for use which, directly or indirectly, might lead to or might have led to the death of a participant/user/other person or to a serious deterioration in his/her state of health.</description>
        <time_frame>Up to Day 19</time_frame>
        <population>Safety Population. The primary aim was to compare the safety profiles of the different active doses; hence, placebo arms have been combined as pre-specified in reporting and analysis plan.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Cohort A- CCI15106 60 mg SD</title>
            <description>Healthy participants were administered a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: Cohort A- CCI15106 120 mg SD</title>
            <description>Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.</description>
          </group>
          <group group_id="O3">
            <title>Part 1: Cohort A- CCI15106 30 mg BID</title>
            <description>Healthy participants were administered a BID dose of CCI15106 30 mg by inhalation route on Days 6 to 19 via Monodose RS01.</description>
          </group>
          <group group_id="O4">
            <title>Part 1: Cohort B- CCI15106 60 mg BID</title>
            <description>Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.</description>
          </group>
          <group group_id="O5">
            <title>Part 1: Placebo</title>
            <description>Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Number of Participants With Medical Device Incidents in CCI15106</title>
          <description>A medical device incident is any malfunction or deterioration in the characteristics and/or performance of a device as well as any inadequacy in the labeling or the instructions for use which, directly or indirectly, might lead to or might have led to the death of a participant/user/other person or to a serious deterioration in his/her state of health.</description>
          <population>Safety Population. The primary aim was to compare the safety profiles of the different active doses; hence, placebo arms have been combined as pre-specified in reporting and analysis plan.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="12"/>
                <count group_id="O5" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2</time_frame>
      <desc>Safety population was used to assess NSAEs and SAEs.</desc>
      <group_list>
        <group group_id="E1">
          <title>Part 1: Cohort A- CCI15106 60 mg SD</title>
          <description>Healthy participants were administered a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.</description>
        </group>
        <group group_id="E2">
          <title>Part 1: Cohort A- CCI15106 120 mg SD</title>
          <description>Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.</description>
        </group>
        <group group_id="E3">
          <title>Part 1: Cohort A- CCI15106 30 mg BID</title>
          <description>Healthy participants were administered a BID dose of CCI15106 30 mg by inhalation route on Days 6 to 19 via Monodose RS01.</description>
        </group>
        <group group_id="E4">
          <title>Part 1: Cohort A- Placebo</title>
          <description>Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; further followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A.</description>
        </group>
        <group group_id="E5">
          <title>Part 1: Cohort B- CCI15106 60 mg BID</title>
          <description>Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.</description>
        </group>
        <group group_id="E6">
          <title>Part 1: Cohort B- Placebo</title>
          <description>Healthy participants were administered with a BID dose of matching placebo 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.</description>
        </group>
        <group group_id="E7">
          <title>Part 1: Cohort C- Bystanders</title>
          <description>Healthy participants were enrolled to evaluate bystander exposure and evaluated concomitantly with Cohort B. Bystanders reported to the unit on Day -1 and remained for 14 days of dosing of Cohort B.</description>
        </group>
        <group group_id="E8">
          <title>Part 2: Cohort A- CCI15106 60 mg SD</title>
          <description>Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.</description>
        </group>
        <group group_id="E9">
          <title>Part 2: Cohort A- Placebo</title>
          <description>Participants with COPD received a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01 in Cohort A.</description>
        </group>
        <group group_id="E10">
          <title>Part 2: Cohort B- CCI15106 60 mg BID</title>
          <description>Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 21.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="6" subjects_at_risk="14"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="7" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Feeling hot</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Folliculitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Plantar fasciitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="4" subjects_affected="4" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Wheezing</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Rash macular</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>GSK Response Center</name_or_title>
      <organization>GlaxoSmithKline</organization>
      <phone>866-435-7343</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03235726
org study id: 205822
secondary id: 2017-001070-42
nct id: NCT03235726
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This single and repeat increasing dose study will collect information on safety, tolerability
      and drug levels in the body of the CCI15106 inhalation powder. The study will also look at
      the level of CCI15106 that will be released into the air and may be found in the blood of the
      people standing around the person inhaling it (bystanders). This is a two-part study in which
      Part 1 will enroll healthy subjects and look at environmental and bystander exposure and Part
      2 will enroll subjects with moderate COPD. Approximately 36 healthy subjects and
      approximately 22 subjects with COPD will be randomized in this study for dosing. The total
      study duration will be 82 days for Cohort A Part 1; 75 days for Cohort B Part 1 and Cohort C
      Part 1; 77 days for Cohort A Part 2; and 90 days for Cohort B Part 2.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: In this study, subjects will be randomized to receive either study drug or placebo in a parallel manner.
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: This is a double blind, randomized study and subject and investigator will be blinded.
measure: Part 1 Cohort A: Number of Participants With Non-serious Adverse Events (NSAEs) and Serious Adverse Events (SAEs) in CCI15106
time frame: Up to 51 days
description: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician. Safety population comprised of all participants who received at least one dose of study treatment during the study.
measure: Part 1 Cohort B: Number of Participants With NSAEs and SAEs in CCI15106
time frame: Up to 46 days
description: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician.
measure: Part 1 Cohort C: Number of Participants With NSAEs and SAEs in Bystanders
time frame: Up to 46 days
description: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician.
measure: Part 2 Cohort A: Number of Participants With NSAEs and SAEs
time frame: Up to 33 days
description: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician.
measure: Part 2 Cohort B: Number of Participants With NSAEs and SAEs
time frame: Up to 46 days
description: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician.
measure: Part 1: Number of Participants With Hematology Values of Potential Clinical Importance (PCI) in CCI15106
time frame: Up to 51 days
description: PCI ranges for the hematology parameters were as follows: hematocrit (high: >0.54 proportion of red blood cell [RBC] in blood for male, >0.54 proportion of RBC in blood for female), hemoglobin (high: >180 grams [g]/L in male, >180 g/L in female), lymphocytes (low: <0.8 10^9/L), neutrophil count (low: <1.5 10^9/L) and platelet count (low: <100 10^9/L and high: 550 10^9/L). Data for the participants with high and low values has been reported.
measure: Part 1: Number of Participants With Hematology Values of PCI in Bystanders
time frame: Up to 46 days
description: PCI ranges for the hematology parameters were as follows: hematocrit (high: >0.54 proportion of RBC in blood for male, >0.54 proportion of RBC in blood for female), hemoglobin (high: >180 g/L in male, >180 g/L in female), lymphocytes (low: <0.8 10^9/L), neutrophil count (low: <1.5 10^9/L) and platelet count (low: <100 10^9/L and high: 550 10^9/L). Data for the participants with high and low values has been reported.
measure: Part 2: Number of Participants With Hematology Values of PCI
time frame: Up to 46 days
description: PCI ranges for the hematology parameters were as follows: hematocrit (high: >0.54 proportion of RBC in blood for male, >0.54 proportion of RBC in blood for female), hemoglobin (high: >180 g/L in male, >180 g/L in female), lymphocytes (low: <0.8 10^9/L), neutrophil count (low: <1.5 10^9/L) and platelet count (low: <100 10^9/L and high: 550 10^9/L). Data for the participants with high and low values has been reported.
measure: Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106
time frame: Up to 51 days
description: PCI ranges for the clinical chemistry parameters were as follows: albumin (low: <30 millimole per liter [mmol/L]), calcium (low: <2 mmol/L and high: >2.75 mmol/L), glucose (low: <3 mmol/L and high: >9 mmol/L), potassium (low: <3 mmol/L and high: >5.5 mmol/L) and sodium (low: <130 mmol/L and high: >150 mmol/L). Data for the participants with high and low values has been reported.
measure: Part 1: Number of Participants With Clinical Chemistry Values of PCI in Bystanders
time frame: Up to 46 days
description: PCI ranges for the clinical chemistry parameters were as follows: albumin (low: <30 mmol/L), calcium (low: <2 mmol/L and high: >2.75 mmol/L), glucose (low: <3 mmol/L and high: >9 mmol/L), potassium (low: <3 mmol/L and high: >5.5 mmol/L) and sodium (low: <130 mmol/L and high: >150 mmol/L). Data for the participants with high and low values has been reported.
measure: Part 2: Number of Participants With Clinical Chemistry Values of PCI
time frame: Up to 46 days
description: PCI ranges for the clinical chemistry parameters were as follows: albumin (low: <30 mmol/L), calcium (low: <2 mmol/L and high: >2.75 mmol/L), glucose (low: <3 mmol/L and high: >9 mmol/L), potassium (low: <3 mmol/L and high: >5.5 mmol/L) and sodium (low: <130 mmol/L and high: >150 mmol/L). Data for the participants with high and low values has been reported.
measure: Part 1 Cohort A: Potential of Hydrogen (pH) Value by Visit- CCI15106 60 mg SD
time frame: Baseline (Day -1) and Day 2
description: Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).
measure: Part 1 Cohort A: pH Value by Visit- CCI15106 120 mg SD
time frame: Day 5
description: Urine sample was collected from participants at indicated time point for analysis of pH.
measure: Part 1 Cohort A: pH Value by Visit- CCI15106 30 mg BID
time frame: Days 12 and 22
description: Urine samples were collected from participants at indicated time points for analysis of pH.
measure: Part 1 Cohort B: pH Value by Visit- CCI15106 60 mg BID
time frame: Baseline (Day -1), Days 7 and 15
description: Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).
measure: Part 1: pH Value by Visit- Placebo
time frame: Baseline (Day -1), Days 2, 5, 7, 12, 15 and 22
description: Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).
measure: Part 1 Cohort C: pH Value by Visit- CCI15106 in Bystanders
time frame: Baseline (Day -1), Days 7 and 15
description: Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).
measure: Part 2 Cohort A: pH Value by Visit- CCI15106
time frame: Baseline (Day -1) and Day 2
description: Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).
measure: Part 2 Cohort B: pH Value by Visit- CCI15106 60 mg BID
time frame: Baseline (Day -1), Days 7 and 15
description: Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).
measure: Part 1 Cohort A: Specific Gravity Value by Visit- CCI15106 60 mg SD
time frame: Baseline (Day -1) and Day 2
description: Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).
measure: Part 1 Cohort A: Specific Gravity Value by Visit- CCI15106 120 mg SD
time frame: Day 5
description: Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine sample was collected from participants at indicated time point for analysis of specific gravity.
measure: Part 1 Cohort A: Specific Gravity Value by Visit- CCI15106 30 mg BID
time frame: Days 12 and 22
description: Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity.
measure: Part 1 Cohort B: Specific Gravity Value by Visit- CCI15106 60 mg BID
time frame: Baseline (Day -1), Days 7 and 15
description: Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of Specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).
measure: Part 1: Specific Gravity Value by Visit- Placebo
time frame: Baseline (Day -1), Days 2, 5, 7, 12, 15 and 22
description: Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of Specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).
measure: Part 1 Cohort C: Specific Gravity Value by Visit- CCI15106 in Bystanders
time frame: Baseline (Day -1), Days 7 and 15
description: Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).
measure: Part 2 Cohort A: Specific Gravity Value by Visit- CCI15106
time frame: Baseline (Day -1) and Day 2
description: Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).
measure: Part 2 Cohort B: Specific Gravity Value by Visit- CCI15106 60 mg BID
time frame: Baseline (Day -1), Days 7 and 15
description: Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).
measure: Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106
time frame: Up to 51 days
description: PCI ranges for the ECG parameters were as follows: absolute QTc interval >450 and <480, >=480 and <500, >=500 milliseconds (msec), absolute PR interval <110 and >220 msec and absolute QRS interval <75 and >110 msec. QTcF=Frederica's QT interval corrected for heart rate; QTcB=Bazett's QT interval corrected for heart rate. Data for worst case post-Baseline has been reported.
measure: Part 1: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI in Bystander
time frame: Up to 46 days
description: PCI ranges for the ECG parameters were as follows: absolute QTc interval >450 and <480, >=480 and <500, >=500 msec, absolute PR interval <110 and >220 msec and absolute QRS interval <75 and >110 msec. Data for worst case post-Baseline has been reported.
measure: Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI
time frame: Up to 46 days
description: PCI ranges for the ECG parameters were as follows: absolute QTc interval >450 and <480, >=480 and <500, >=500 msec, absolute PR interval <110 and >220 msec and absolute QRS interval <75 and >110 msec. Data for worst case post-Baseline has been reported.
measure: Part 1: Number of Participants With Abnormal Telemetry Findings
time frame: Days 1, 3, 6, 7, 12 and 18: 0.5 hour (pre-dose) to 4 hours post-dose
description: Continuous cardiac telemetry was performed from approximately 0.5 hour (pre-dose) to 4 hours post-dose. Abnormal findings were categorized as clinically significant (CS) and not clinically significant (NCS). Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
measure: Part 2: Number of Participants With Abnormal Telemetry Findings
time frame: Days 1, 7, 12 and 13: 0.5 hour (pre-dose) to 4 hours post-dose
description: Continuous cardiac telemetry was performed from approximately 0.5 hour (pre-dose) to 4 hours post-dose. Abnormal findings were categorized as CS and NCS. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
measure: Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points
time frame: Days 1, 3, 6 and 19: pre-dose, 0.25, 0.5, 1 and 4 hours post-dose; Days 8, 11 and 16: pre-dose and 4 hours post-dose; Day 14: pre-dose, 0.5, 1 and 4 hours post-dose
description: FEV1 is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using standard spirometry. Percent predicted FEV1 was calculated as: Percent predicted FEV1=(maximum FEV1 divided by predicted normal FEV1)*100.
measure: Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points
time frame: Days 1, 3, 6 and 19: pre-dose, 0.25, 0.5, 1 and 4 hours post-dose; Days 8, 11 and 16: pre-dose and 4 hours post-dose; Day 14: pre-dose, 0.5, 1 and 4 hours post-dose
description: FVC is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FVC was measured using standard spirometry. Percent predicted FVC was calculated as: Percent predicted FVC=(maximum FVC divided by predicted normal FVC)*100.
measure: Part 2: Percent Predicted FEV1 at Indicated Time Points
time frame: Day 1 and 14: pre-dose, 0.25, 0.5, 1 and 4 hours post-dose; Days 3, 6 and 11: pre-dose and 4 hours post-dose
description: FEV1 is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using standard spirometry. Percent predicted FEV1 was calculated as: Percent predicted FEV1=(maximum FEV1 divided by predicted normal FEV1)*100.
measure: Part 2: Percent Predicted FVC at Indicated Time Points
time frame: Day 1 and 14: pre-dose, 0.25, 0.5, 1 and 4 hours post-dose; Days 3, 6 and 11: pre-dose and 4 hours post-dose
description: FVC is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FVC was measured using standard spirometry. Percent predicted FVC was calculated as: Percent predicted FVC=(maximum FVC divided by predicted normal FVC)*100.
measure: Part 1: Number of Participants With Vital Signs Values of PCI
time frame: Up to 51 days
description: PCI ranges for the vital signs parameters were as follows: systolic blood pressure (SBP) <85 and >160 millimeters of mercury (mmHg), diastolic blood pressure (DBP) <45 and >100 mmHg and heart rate <40 and >110 beats per minute (bpm). Data for the participants with high and low values has been reported.
measure: Part 1: Number of Participants With Vital Signs Values of PCI in Bystanders
time frame: Up to 46 days
description: PCI ranges for the vital signs parameters were as follows: SBP <85 and >160 mmHg, DBP <45 and >100 mmHg and heart rate <40 and >110 bpm. Data for the participants with high and low values has been reported.
measure: Part 2: Number of Participants With Vital Signs Values of PCI
time frame: Up to 46 days
description: PCI ranges for the vital signs parameters were as follows: SBP <85 and >160 mmHg, DBP <45 and >100 mmHg and heart rate <40 and >110 bpm. Data for the participants with high and low values has been reported.
measure: Part 1 Cohort A: Area Under the Curve (AUC) From Time Zero to the Time of Last Quantifiable Concentration (AUC[0-t]) After Single Dose Administration of CCI15106 60 mg on Day 1
time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dose
description: Blood samples were collected to evaluate the pharmacokinetics (PKs) of CCI15106 at the indicated time points on Day 1 for the analysis of AUC(0-t) data. PK population consisted of participants who received at least one dose of study treatment and who undergo plasma PK sampling and had at least one post-dose concentration result.
measure: Part 1 Cohort A: AUC(0-t) After Single Dose Administration of CCI15106 120 mg on Day 3
time frame: Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose
description: Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of AUC(0-t) data.
measure: Part 2 Cohort A: AUC(0-t) After Single Dose Administration of CCI15106 60 mg on Day 1
time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose
description: Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of AUC(0-t) data.
measure: Part 1 Cohort A: Maximum Observed Plasma Concentration (Cmax) After Single Dose Administration of CCI15106 60 mg on Day 1
time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dose
description: Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of Cmax data.
measure: Part 1 Cohort A: Cmax After Single Dose Administration of CCI15106 120 mg on Day 3
time frame: Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose
description: Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of Cmax data.
measure: Part 2 Cohort A: Cmax After Single Dose Administration of CCI15106 60 mg on Day 1
time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose
description: Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of Cmax data.
measure: Part 1 Cohort A: Time of Maximum Concentration (Tmax) After Single Dose Administration of CCI15106 60 mg on Day 1
time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dose
description: Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of tmax data.
measure: Part 1 Cohort A: Tmax After Single Dose Administration of CCI15106 120 mg on Day 3
time frame: Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose
description: Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of tmax data.
measure: Part 2 Cohort A: Tmax After Single Dose Administration of CCI15106 60 mg on Day 1
time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose
description: Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of tmax data.
measure: Part 1 Cohort A: AUC From Time Zero to Infinity (AUC[0-infinity]) After Single Dose Administration of CCI15106 60 mg on Day 1
time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dose
description: Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of AUC(0-infinity) data.
measure: Part 1 Cohort A: AUC(0-infinity) After Single Dose Administration of CCI15106 120 mg on Day 3
time frame: Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose
description: Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of AUC(0-infinity) data.
measure: Part 2 Cohort A: AUC(0-infinity) After Single Dose Administration of CCI15106 60 mg on Day 1
time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose
description: Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of AUC(0-infinity) data.
measure: Part 1 Cohort A: Elimination Half-life (t1/2) After Single Dose Administration of CCI15106 60 mg on Day 1
time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dose
description: Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of t1/2 data.
measure: Part 1 Cohort A: t1/2 After Single Dose Administration of CCI15106 120 mg on Day 3
time frame: Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose
description: Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of t1/2 data.
measure: Part 2 Cohort A: t1/2 After Single Dose Administration of CCI15106 60 mg on Day 1
time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose
description: Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of t1/2 data.
measure: Part 1 Cohort A: Clearance (CL/F) After Single Dose Administration of CCI15106 60 mg on Day 1
time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dose
description: Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of CL/F data.
measure: Part 1 Cohort A: CL/F After Single Dose Administration of CCI15106 120 mg on Day 3
time frame: Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose
description: Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of CL/F data.
measure: Part 2 Cohort A: CL/F After Single Dose Administration of CCI15106 60 mg on Day 1
time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose
description: Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of CL/F data.
measure: Part 1 Cohort A: AUC From Time Zero to End of Dosing Interval (AUC[0-tau]) After Repeated Dose Administration of CCI15106 30 mg
time frame: Day 6: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 19: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose
description: Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 6 and 19 for the analysis of AUC(0-tau) data.
measure: Part 1 Cohort B: AUC(0-tau) After Repeated Dose Administration of CCI15106 60 mg
time frame: Days 1 and 14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose
description: Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of AUC(0-tau) data.
measure: Part 2 Cohort B: AUC(0-tau) After Repeated Dose Administration of CCI15106 60 mg
time frame: Days 1 and 14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose
description: Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of AUC(0-tau) data.
measure: Part 1 Cohort A: Cmax After Repeated Dose Administration of CCI15106 30 mg
time frame: Day 6: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 19: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose
description: Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 6 and 19 for the analysis of Cmax data.
measure: Part 1 Cohort B: Cmax After Repeated Dose Administration of CCI15106 60 mg
time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose
description: Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of Cmax data.
measure: Part 2 Cohort B: Cmax After Repeated Dose Administration of CCI15106 60 mg
time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose
description: Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of Cmax data.
measure: Part 1 Cohort A: Tmax After Repeated Dose Administration of CCI15106 30 mg
time frame: Day 6: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 19: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose
description: Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 6 and 19 for the analysis of tmax data.
measure: Part 1 Cohort B: Tmax After Repeated Dose Administration of CCI15106 60 mg
time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose
description: Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of tmax data.
measure: Part 2 Cohort B: Tmax After Repeated Dose Administration of CCI15106 60 mg
time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose
description: Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of tmax data.
measure: Part 1 Cohort A: t1/2 After Repeated Dose Administration of CCI15106 30 mg
time frame: Day 6: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 19: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose
description: Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 6 and 19 for the analysis of t1/2 data.
measure: Part 1 Cohort B: t1/2 After Repeated Dose Administration of CCI15106 60 mg
time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose
description: Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of t1/2 data.
measure: Part 2 Cohort B: t1/2 After Repeated Dose Administration of CCI15106 60 mg
time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose
description: Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of t1/2 data.
measure: Part 1: Concentration of CCI15106 in Plasma of Bystanders: Cohort C
time frame: Days 1, 7 and 14: pre-dose, 15 minutes post-dose
description: Blood samples were collected from bystanders 15 minutes after dosing at indicated time points. Bystander PK population consisted of participants who were present at least once in the room with the participant receiving the dose, undergo plasma PK sampling and had post-dose concentration result.
measure: Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C
time frame: Days 1, 7 and 14: 15 minutes post-dose
description: Personal exposure air samples were collected on filters placed on each bystander after the first daily dose at indicated time points. The filters were used to measure CCI15106 concentration in the person's breathing zone. Fixed location concentrations were measured near window, near door, back to wall and facing wall in the dosing room over 15 minutes post-dose. Each bystander had a filter attached to their study clothing. The filters were measured for CCI15106. This was a single measurement from the filter for each bystsander. The locations (near window, near door, back to wall and facing wall) were just to record where the bystander was located in the room.
measure: Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C
time frame: Days 1, 7 and 14: 20 and 60 minutes post-dose
description: Static air samples were collected on filters within air pumps positioned in two locations (bench and corner) in the room. Sampling devices attached to sampling pumps were used to measure CCI15106 concentration. Fixed location concentrations were measured in corner of room and on bench at back of room over 20 minutes and 60 minutes post-dosing.
measure: Part 1: Concentration of CCI15106 in Lung Epithelial Lining Fluid (ELF) in Repeated Dose of Cohort B 60 mg
time frame: Up to Day 13
description: Bronchoalveolar lavage samples for ELF concentration analysis of CCI15106 were collected up to Day 13. Participants who received at least one dose of study treatment and who underwent bronchoalveolar lavage (BAL) sampling and had post-dose lung ELF CCI15106 and urea concentration result were included in BAL PK Population.
measure: Part 2: Concentration of CCI15106 in ELF in Repeated Dose of Cohort B 60 mg
time frame: Up to Day 13
description: BAL samples for ELF concentration analysis of CCI15106 were collected up to Day 13.
measure: Part 1: Number of Participants With Medical Device Incidents in CCI15106
time frame: Up to Day 19
description: A medical device incident is any malfunction or deterioration in the characteristics and/or performance of a device as well as any inadequacy in the labeling or the instructions for use which, directly or indirectly, might lead to or might have led to the death of a participant/user/other person or to a serious deterioration in his/her state of health.
arm group label: Cohort A, Part 1: Active
arm group type: Experimental
description: 60 milligrams (mg) single dose of CCI15106 will be administered by inhalation route on Day 1; 120 mg single dose will be administered on Day 3; and then 30 mg dose will be administered twice daily (BID) on Days 6-19 to healthy subjects.
arm group label: Cohort A, Part 1: Placebo
arm group type: Placebo Comparator
description: 60 mg single dose of placebo will be administered by inhalation route on Day 1; 120 mg single dose will be administered on Day 3; and then 30 mg dose will be administered BID on Days 6-19 to healthy subjects.
arm group label: Cohort B, Part 1: Active
arm group type: Experimental
description: 60 mg of CCI15106 BID will be administered by inhalation route for 14 days to healthy subjects.
arm group label: Cohort B, Part 1: Placebo
arm group type: Placebo Comparator
description: 60 mg of placebo BID will be administered by inhalation route for 14 days to healthy subjects.
arm group label: Cohort C, Part 1: bystanders
arm group type: No Intervention
description: Healthy subjects will be enrolled to follow bystander exposure and will be studied concomitantly with Cohort B.
arm group label: Cohort A, Part 2: Active
arm group type: Experimental
description: 60 mg single dose of CCI15106 will be administered by inhalation route to subjects with COPD.
arm group label: Cohort A, Part 2: Placebo
arm group type: Placebo Comparator
description: 60 mg single dose of placebo will be administered by inhalation route to subjects with COPD.
arm group label: Cohort B, Part 2: Active
arm group type: Experimental
description: 60 mg BID dose of CCI15106 will be administered by inhalation route for 14 days to subjects with COPD.
arm group label: Cohort B, Part 2: Placebo
arm group type: Placebo Comparator
description: 60 mg BID dose of placebo will be administered by inhalation route for 14 days to subjects with COPD.
intervention type: Drug
intervention name: CCI15106
description: One capsule (single dose or repeat dose) of 30 mg of CCI15106 will be administered to healthy subjects and subjects with COPD via inhalation route using Monodose RS01 device. The morning dose will be taken in fasting state and for repeat dose; the evening dose will be taken at least 2 hours after food.
arm group label: Cohort A, Part 1: Active
arm group label: Cohort A, Part 2: Active
arm group label: Cohort B, Part 1: Active
arm group label: Cohort B, Part 2: Active
intervention type: Drug
intervention name: Placebo
description: One capsule of placebo will be administered to healthy subjects and subjects with COPD via inhalation route using Monodose RS01 device. The morning dose will be taken in fasting state and for repeat dose; the evening dose will be taken at least 2 hours after food.
arm group label: Cohort A, Part 1: Placebo
arm group label: Cohort A, Part 2: Placebo
arm group label: Cohort B, Part 1: Placebo
arm group label: Cohort B, Part 2: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Respiratory Aspiration
sharing ipd: Yes
ipd description: IPD for this study will be made available via the Clinical Study Data Request site.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
ipd access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
ipd url: https://clinicalstudydatarequest.com/Posting.aspx?ID=20373
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 