<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/NCT03012061</url>
  </required_header>
  <id_info>
    <org_study_id>205832</org_study_id>
    <secondary_id>2016-002843-40</secondary_id>
    <nct_id>NCT03012061</nct_id>
  </id_info>
  <brief_title>Phase IIb Study of Umeclidinium (UMEC) Bromide Versus Placebo in Subjects With Asthma</brief_title>
  <official_title>A Phase IIb, 24 Week, Randomized, Double-blind, 3 Arm Parallel Group Study, Comparing the Efficacy, Safety and Tolerability of Two Doses of Umeclidinium Bromide Administered Once-daily Via a Dry Powder Inhaler, Versus Placebo, in Participants With Asthma</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>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is conducted to evaluate the effects of UMEC 62.5 microgram (mcg) and UMEC 31.25&#xD;
      mcg on lung function versus placebo after 24 weeks of treatment. This study will provide&#xD;
      important information regarding the efficacy and safety of UMEC when administered in a&#xD;
      separate inhaler to subjects on a background of fluticasone furoate (FF). This is a Phase&#xD;
      IIb, randomized, double-blind, placebo controlled study that will compare the efficacy,&#xD;
      safety and tolerability of UMEC (62.5 mcg and 31.25 mcg) administered once-daily in subjects&#xD;
      with asthma that is not well controlled. Eligible subjects will be requested to participate&#xD;
      in the study for a maximum of approximately 31 weeks with 4 phases (pre screening,&#xD;
      screening/run-in, randomization/treatment and safety follow-up). The total number of&#xD;
      randomized subjects required is approximately 384, with 128 subjects randomized 1:1:1 to each&#xD;
      of the 3 double-blind treatment arms.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 25, 2017</start_date>
  <completion_date type="Actual">May 30, 2018</completion_date>
  <primary_completion_date type="Actual">May 30, 2018</primary_completion_date>
  <phase>Phase 2</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Change From Baseline in Clinic Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 24</measure>
    <time_frame>Baseline (Day 1 pre-dose) and Week 24</time_frame>
    <description>FEV1 is measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The highest of 3 technically acceptable measurements were recorded at each Visit. The Baseline value of clinic FEV1 was last acceptable/borderline acceptable (pre-dose) FEV1 value obtained prior to randomized treatment start date. Change from Baseline was calculated as FEV1 value at Week 24 minus FEV1 value at Baseline. Treatment policy estimand was assessed, including all on- and post-treatment data. Intent-to-Treat Population comprised all randomized participants, excluding those who were randomized in error, who did not receive the study drug. Least square (LS) mean and standard error (SE) data is presented. Different participants may have been analyzed at different time points; thus, overall number of participants analyzed reflects everyone in ITT Population without missing covariate information, with Baseline, at least one post-Baseline measurement.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Clinic FEV1 at 3 Hours Post Dose at Week 24</measure>
    <time_frame>Baseline (Day 1 pre-dose) and Week 24</time_frame>
    <description>FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The highest of 3 technically acceptable measurements were recorded at each Visit. The Baseline value of clinic FEV1 was the last acceptable/borderline acceptable (pre-dose) FEV1 value obtained prior to randomization (either from Visit 2 pre-dose or from Visit 1 pre-bronchodilator). Change from Baseline was calculated as FEV1 value at Week 24 (recorded at 3 hours post dose) minus FEV1 value at Baseline. The analysis only including data collected on-treatment. LS mean change and SE data is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With On-treatment Adverse Events (AE), Non-serious Adverse Events (Non-SAE)</measure>
    <time_frame>Up to Week 24</time_frame>
    <description>An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinemia were categorized as SAE. Number of participants with on-treatment AEs and SAEs and serious adverse events (SAE) and common (&gt;=3%)non-SAEs have been reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With On-treatment Abnormal Electrocardiograms (ECG) Findings</measure>
    <time_frame>Week 4 and Week 24</time_frame>
    <description>A single 12-lead ECG and rhythm strip was recorded after measurement of vital signs and spirometry at given time points. All ECG measurements were measured with participants in supine position after &gt;=5 minutes rest. All ECGs were electronically transmitted to an independent and treatment-blinded cardiologist for the measurement. ECG was obtained 15 minutes to 45 minutes after the administration of study treatment. Data for number of participants with abnormal ECG Findings have been reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in On-treatment Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)</measure>
    <time_frame>Baseline (Day 1 pre-dose), Weeks 4, 12 and 24</time_frame>
    <description>Blood pressure was measured at every clinic visit, starting at Visit 1, and prior to conducting spirometry. Blood pressure was measured with participant in sitting position after approximately 5 minutes rest. Baseline value was defined as the latest vital signs assessment prior to randomized treatment start, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the value at specified time point. LS mean and SE data is presented. Different participants may have data available at different time points; thus, the overall number of participants analyzed reflects everyone in the ITT Population without missing covariate information and with a Baseline and at least one post-Baseline measurement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in On-treatment Pulse Rate</measure>
    <time_frame>Baseline (Day 1 pre-dose), Weeks 4, 12 and 24</time_frame>
    <description>Pulse rate was measured at every clinic visit, starting at Visit 1, and prior to conducting spirometry. Pulse rate was measured with participant in sitting position after approximately 5 minutes rest. Baseline value was defined as the latest vital signs assessment prior to randomized treatment start, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the value at specified time point. LS mean and SE data is presented.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">425</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects will be administered placebo once daily via the ELLIPTA® dry powder inhaler (DPI) for 24 weeks. Subjects will also receive FF 100 mcg once daily, in the morning for 24 weeks. ELLIPTA is a registered trademark of the GSK group of companies.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>UMEC 62.5 mcg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will be administered UMEC 62.5 mcg once daily via the ELLIPTA dry powder inhaler (DPI) for 24 weeks. Subjects will also receive FF 100 mcg once daily, in the morning for 24 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>UMEC 31.25 mcg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will be administered UMEC 31.25 mcg once daily via the ELLIPTA dry powder inhaler (DPI) for 24 weeks. Subjects will also receive FF 100 mcg once daily, in the morning for 24 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo is a white powder to be administered using ELLIPTA DPI which hold two individual blister strips, both of which contains lactose monohydrate blended with magnesium stearate.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>UMEC</intervention_name>
    <description>UMEC is a white powder to be administered using ELLIPTA DPI which hold two individual blister strips, one of which contains GSK573719 blended with lactose blended with magnesium stearate and another one contains lactose monohydrate blended with magnesium stearate.</description>
    <arm_group_label>UMEC 31.25 mcg</arm_group_label>
    <arm_group_label>UMEC 62.5 mcg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fluticasone Furoate</intervention_name>
    <description>FF is a white powder to be administered using ELLIPTA DPI which hold two individual blister strips, one of which contains GW685698 blended with lactose monohydrate and another one contains lactose monohydrate with magnesium stearate.</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>UMEC 31.25 mcg</arm_group_label>
    <arm_group_label>UMEC 62.5 mcg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Albuterol/salbutamol</intervention_name>
    <description>Albuterol/salbutamol is to be administered via metered-dose inhaler as a rescue drug on need basis throughout the study.</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>UMEC 31.25 mcg</arm_group_label>
    <arm_group_label>UMEC 62.5 mcg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older at the time of signing the informed consent.&#xD;
&#xD;
          -  Subjects with a diagnosis of asthma as defined by the National Institutes of Health at&#xD;
             least 6 months prior to Visit 0.&#xD;
&#xD;
          -  Asthma Control Questionnaire (ACQ)-6 total score of &gt;0.75 at Visit 1.&#xD;
&#xD;
          -  Subjects are eligible if they have required daily Inhaled Corticosteroids (ICS)&#xD;
             therapy &gt;=100 milligram per day (mg/day) fluticasone propionate (FP) or equivalent&#xD;
             with or without Long-Acting Beta-2-Agonists (LABA) or Long-Acting Muscarinic&#xD;
             Antagonist (LAMA) for at least 12 weeks prior to Visit 0 and there have been no&#xD;
             changes in maintenance asthma medications during the 4 weeks immediately prior to&#xD;
             Visit 0. Dosing regimen (once or twice daily to equal the total daily dose) should be&#xD;
             restricted to the current local product labels.&#xD;
&#xD;
          -  A best pre-bronchodilator morning FEV1 &lt;=85% of the predicted normal value. Predicted&#xD;
             values will be based upon the European Respiratory Society (ERS) Global Lung Function&#xD;
             Initiative. A best post-bronchodilator FEV1/ forced vital capacity (FVC) &gt;=0.7 at&#xD;
             Visit 1.&#xD;
&#xD;
          -  Airway reversibility is defined as &gt;=12% and &gt;=200 mL increase in FEV1 between 20 and&#xD;
             60 minutes following 4 inhalations of albuterol/salbutamol aerosol at Visit 1. Note:&#xD;
             If the subject does not meet the above reversibility criteria at Visit 1 then the&#xD;
             reversibility assessment may be repeated once within 7 days of Visit 1 if either&#xD;
             criteria are met: The &gt;=9% increase in FEV1 between 20 and 60 minutes following 4&#xD;
             inhalations of albuterol/salbutamol aerosol at Visit 1; Documented evidence of a&#xD;
             reversibility assessment within 1 year prior to Visit 1 which demonstrated a&#xD;
             post-bronchodilator increase in FEV1 of &gt;=12% and &gt;=200 milliliter (mL). Should the&#xD;
             subject successfully demonstrate airway reversibility (defined as &gt;=12% and &gt;=200 mL&#xD;
             increase in FEV1 between 20 and 60 minutes following 4 inhalations of&#xD;
             albuterol/salbutamol aerosol) at the second attempt then, provided that all other&#xD;
             eligibility criteria assessed at Visit 1 are met, the subject may enter the 2-week&#xD;
             run-in period.&#xD;
&#xD;
          -  All subjects must be able to replace their current Short-Acting Beta-2-Agonists (SABA)&#xD;
             inhaler with albuterol/salbutamol aerosol inhaler at Visit 1 as needed for the&#xD;
             duration of the study. Subjects must be judged capable of withholding&#xD;
             albuterol/salbutamol for at least 6 hours prior to study visits.&#xD;
&#xD;
          -  Both male and female subjects are eligible to participate in the study. A female&#xD;
             subject is eligible to participate if she is not pregnant, not breastfeeding, and at&#xD;
             least one of the following conditions applies: Not a woman of childbearing potential&#xD;
             (WOCBP) or a WOCBP who agrees to follow the contraceptive guidance during the&#xD;
             treatment period and for at least 5 days after the last dose of study treatment.&#xD;
&#xD;
          -  Able to give written informed consent prior to participation in the study, which will&#xD;
             include the ability to comply with the requirements and restrictions listed in the&#xD;
             consent form and in this protocol. Subjects must be able to read, comprehend, and&#xD;
             write at a level sufficient to complete study related materials.&#xD;
&#xD;
        Inclusion Criteria (for randomization)&#xD;
&#xD;
          -  ACQ-6 total score of &gt;0.75 at Visit 2.&#xD;
&#xD;
          -  Spirometry: A best pre-bronchodilator morning FEV1 &lt;=85% of the predicted normal value&#xD;
             at Visit 2. Predicted values will be based upon the ERS Global Lung Function&#xD;
             Initiative.&#xD;
&#xD;
          -  Alanine aminotransferase (ALT) &lt;=2 x upper limit of normal (ULN). Alkaline phosphatase&#xD;
             &lt;=1.5 x ULN. Bilirubin &lt;=1.5 x ULN (isolated bilirubin &gt;1.5 x ULN is acceptable if&#xD;
             bilirubin is fractionated and direct bilirubin &lt;35%).&#xD;
&#xD;
          -  Compliance with completion of the Daily electronic diary (eDiary) reporting defined as&#xD;
             completion of all questions/assessments on &gt;=4 of the last 7 days during the run-in&#xD;
             period.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chest X-ray documented pneumonia in the 12 weeks prior to Visit 1.&#xD;
&#xD;
          -  Any severe asthma exacerbation, defined as deterioration of asthma requiring the use&#xD;
             of systemic corticosteroids (oral, parenteral or depot) within 12 weeks of Visit 1, or&#xD;
             an inpatient hospitalization or emergency department visit due to asthma that required&#xD;
             systemic corticosteroids within 12 weeks of Visit 1.&#xD;
&#xD;
          -  Current evidence of pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease,&#xD;
             bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive&#xD;
             pulmonary disease, lung cancer, or other respiratory abnormalities other than asthma.&#xD;
&#xD;
          -  Women who are pregnant or lactating or are planning to become pregnant during the&#xD;
             study.&#xD;
&#xD;
          -  Immune suppression (e.g., Human Immunodeficiency Virus [HIV], Lupus) or other risk&#xD;
             factors for pneumonia (e.g., neurological disorders affecting control of the upper&#xD;
             airway, such as Parkinson's disease, Myasthenia Gravis). Subjects at potentially high&#xD;
             risk (e.g., very low Body Mass Index [BMI], severely malnourished, or very low FEV1)&#xD;
             will only be included at the discretion of the Investigator&#xD;
&#xD;
          -  Subjects with historical or current evidence of clinically significant cardiovascular,&#xD;
             neurological, psychiatric, renal, hepatic, immunological, gastrointestinal,&#xD;
             urogenital, nervous system, musculoskeletal, skin, sensory, endocrine (including&#xD;
             uncontrolled diabetes or thyroid disease) or hematological abnormalities that are&#xD;
             uncontrolled. Significant is defined as any disease that, in the opinion of the&#xD;
             Investigator, would put the safety of the subject at risk through participation, or&#xD;
             which would affect the efficacy or safety analysis if the disease/condition&#xD;
             exacerbated during the study.&#xD;
&#xD;
          -  Unstable liver disease as defined by the presence of ascites, encephalopathy,&#xD;
             coagulopathy, hypoalbuminaemia, esophageal or gastric varices or persistent jaundice,&#xD;
             cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or&#xD;
             asymptomatic gallstones). Note: Chronic stable hepatitis B and C is acceptable if the&#xD;
             subject otherwise meets entry criteria.&#xD;
&#xD;
          -  Evidence of a clinically significant abnormality in the 12-lead ECG performed during&#xD;
             screening or run-in. The Principal Investigator will determine the clinical&#xD;
             significance of each abnormal ECG finding in relation to the subject's medical history&#xD;
             and exclude subjects who would be at undue risk by participating in the trial. An&#xD;
             abnormal and clinically significant finding is defined as a 12-lead tracing that is&#xD;
             interpreted as, but not limited to, any of the following: Atrial fibrillation (AF)&#xD;
             with rapid ventricular rate &gt;120 beats per minute (BPM); Sustained or nonsustained&#xD;
             ventricular tachycardia (VT); Second degree heart block Mobitz type II and third&#xD;
             degree heart block (unless pacemaker or defibrillator had been inserted); QT interval&#xD;
             corrected for heart rate by Fridericia's formula (QTcF) &gt;=500 millisecond (msec) in&#xD;
             subjects with QRS &lt;120 msec and QTcF &gt;=530 msec in subjects with QRS &gt;=120 msec.&#xD;
&#xD;
          -  Subjects with any of the following at Screening (Visit 1) would be excluded:&#xD;
             Myocardial infarction or unstable angina in the last 6 months; Unstable or life&#xD;
             threatening cardiac arrhythmia requiring intervention in the last 3 months; New York&#xD;
             Heart Association (NYHA) Class IV Heart failure.&#xD;
&#xD;
          -  Subjects with a medical condition such as narrow-angle glaucoma, urinary retention,&#xD;
             prostatic hypertrophy or bladder neck obstruction should only be included if in the&#xD;
             opinion of the Investigator the benefit outweighs the risk and that the condition&#xD;
             would not contraindicate study participation.&#xD;
&#xD;
          -  Subjects with carcinoma that has not been in complete remission for at least 5 years.&#xD;
             Subjects who have had carcinoma in situ of the cervix, squamous cell carcinoma and&#xD;
             basal cell carcinoma of the skin would not be excluded based on the 5 year waiting&#xD;
             period if the subject has been considered cured by treatment.&#xD;
&#xD;
          -  Subjects with a history of psychiatric disease, intellectual deficiency, poor&#xD;
             motivation or other conditions that will limit the validity of informed consent to&#xD;
             participate in the study.&#xD;
&#xD;
          -  Subjects who are medically unable to withhold their albuterol/salbutamol for the&#xD;
             6-hour period required prior to spirometry testing at each study visit.&#xD;
&#xD;
          -  Current smoker or a smoking history of &gt;=10 pack years (e.g., 20 cigarettes/day for 10&#xD;
             years). A subject may not have used inhaled tobacco products within the past 12 months&#xD;
             (i.e., cigarettes, e-cigarettes/vaping, cigars or pipe tobacco).&#xD;
&#xD;
          -  Subjects with a known or suspected history of alcohol or drug abuse within the last 2&#xD;
             years. This includes marijuana, which is considered an abused drug.&#xD;
&#xD;
          -  A history of allergy or hypersensitivity to any corticosteroid,&#xD;
             anticholinergic/muscarinic receptor antagonist, beta2-agonist, lactose/milk protein or&#xD;
             magnesium stearate.&#xD;
&#xD;
          -  Subjects at risk of non-compliance, or unable to comply with the study procedures. Any&#xD;
             infirmity, disability, or geographic location that would limit compliance for&#xD;
             scheduled visits.&#xD;
&#xD;
          -  Study investigators, sub-investigators, study coordinators, employees of a&#xD;
             participating investigator or study site, or immediate family members of the&#xD;
             aforementioned that is involved with this study.&#xD;
&#xD;
          -  In the opinion of the Investigator, any subject who is unable to read and/or would not&#xD;
             be able to complete study related materials.&#xD;
&#xD;
        Exclusion Criteria (for randomization)&#xD;
&#xD;
          -  Occurrence of a culture-documented or suspected bacterial or viral infection of the&#xD;
             upper or lower respiratory tract, sinus or middle ear during the run-in period that&#xD;
             led to a change in asthma management or, in the opinion of the Investigator, is&#xD;
             expected to affect the subject's asthma status or the subject's ability to participate&#xD;
             in the study.&#xD;
&#xD;
          -  Evidence of a moderate asthma exacerbation leading to a change in therapy or severe&#xD;
             exacerbation during screening or the run-in period, defined as deterioration of asthma&#xD;
             requiring the use of systemic corticosteroids (tablets, suspension, or injection) or&#xD;
             an in-patient hospitalization or emergency department visit due to asthma that&#xD;
             required systemic corticosteroids.&#xD;
&#xD;
          -  Changes in asthma medication (excluding changes after Visit 0 or run-in medication and&#xD;
             albuterol/salbutamol inhalation aerosol provided at Visit 1).&#xD;
&#xD;
          -  Evidence of clinically significant abnormal laboratory tests during screening or&#xD;
             run-in, which are still abnormal upon repeat analysis and are not believed to be due&#xD;
             to disease(s) present. Each Investigator will use his/her own discretion in&#xD;
             determining the clinical significance of the abnormality.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</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>Tempe</city>
        <state>Arizona</state>
        <zip>85283</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Rolling Hills Estates</city>
        <state>California</state>
        <zip>90274</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80907</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Topeka</city>
        <state>Kansas</state>
        <zip>66606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Natchitoches</city>
        <state>Louisiana</state>
        <zip>71457</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sunset</city>
        <state>Louisiana</state>
        <zip>70584</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>North Dartmouth</city>
        <state>Massachusetts</state>
        <zip>02747</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55402</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Monroe</city>
        <state>North Carolina</state>
        <zip>28112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Shelby</city>
        <state>North Carolina</state>
        <zip>28150</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Medford</city>
        <state>Oregon</state>
        <zip>97504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Indian Land</city>
        <state>South Carolina</state>
        <zip>29707</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Orangeburg</city>
        <state>South Carolina</state>
        <zip>29118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Spartanburg</city>
        <state>South Carolina</state>
        <zip>29303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Union</city>
        <state>South Carolina</state>
        <zip>29379</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75225</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2Y 2Z7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 4E1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Brampton</city>
        <state>Ontario</state>
        <zip>L6T 0G1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Burlington</city>
        <state>Ontario</state>
        <zip>L7N 3V2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Corunna</city>
        <state>Ontario</state>
        <zip>N0N 1G0</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Mississauga</city>
        <state>Ontario</state>
        <zip>L5A 3V4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M9V 4B4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Windsor</city>
        <state>Ontario</state>
        <zip>N8X 2G1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3G 1L5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Quebec</city>
        <zip>G3K 2P8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bialystok</city>
        <zip>15-044</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Elblag</city>
        <zip>82-300</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kielce</city>
        <zip>25-365</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Krakow</city>
        <zip>30-033</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Krakow</city>
        <zip>31-637</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Lodz</city>
        <zip>90-302</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Lublin</city>
        <zip>20-089</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Poznan</city>
        <zip>60-823</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Rzeszow</city>
        <zip>35-051</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sopot</city>
        <zip>81-741</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tarnow</city>
        <zip>33-100</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Warszawa</city>
        <zip>02-777</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Wroclaw</city>
        <zip>54-239</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Zgierz</city>
        <zip>95-100</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Brasov</city>
        <zip>500051</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bucharest</city>
        <zip>050159</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Cluj Napoca</city>
        <zip>400162</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Codlea</city>
        <zip>505100</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Deva</city>
        <zip>330084</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Iasi</city>
        <zip>700115</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Pitesti</city>
        <zip>110117</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ramnicu Valcea</city>
        <zip>240564</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sibiu</city>
        <zip>550196</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Timisoara</city>
        <zip>300310</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Arkhangelsk</city>
        <zip>163001</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Barnaul</city>
        <zip>656045</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ekaterinburg</city>
        <zip>620039</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Moscow</city>
        <zip>115478</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Moscow</city>
        <zip>119021</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Moscow</city>
        <zip>119121</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Odintsovo</city>
        <zip>143005</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Pyatigorsk</city>
        <zip>357538</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>196240</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Samara</city>
        <zip>443068</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Smolensk</city>
        <zip>214006</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>St'Petersburg</city>
        <zip>197706</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>St. Petersburg</city>
        <zip>194356</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tomsk</city>
        <zip>634 050</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Volgodonsk</city>
        <zip>347382</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Voronezh</city>
        <zip>394018</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Yaroslavl</city>
        <zip>150047</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Poland</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Kerwin E, Pascoe S, Bailes Z, Nathan R, Bernstein D, Dahl R, von Maltzahn R, Robbins K, Fowler A, Lee L. A phase IIb, randomised, parallel-group study: the efficacy, safety and tolerability of once-daily umeclidinium in patients with asthma receiving inhaled corticosteroids. Respir Res. 2020 Jun 12;21(1):148. doi: 10.1186/s12931-020-01400-5.</citation>
    <PMID>32532275</PMID>
  </reference>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <results_first_submitted>May 28, 2019</results_first_submitted>
  <results_first_submitted_qc>May 28, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">June 19, 2019</results_first_posted>
  <last_update_submitted>October 6, 2020</last_update_submitted>
  <last_update_submitted_qc>October 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Respiratory</keyword>
  <keyword>Efficacy</keyword>
  <keyword>Umeclidinium bromide</keyword>
  <keyword>Parallel</keyword>
  <keyword>Asthma</keyword>
  <keyword>Dry powder inhaler</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fluticasone</mesh_term>
    <mesh_term>Xhance</mesh_term>
    <mesh_term>Albuterol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>IPD for this study is 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 (copy the URL below to your browser)</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://www.clinicalstudydatarequest.com/Posting.aspx?ID=20592</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>July 6, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/61/NCT03012061/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>June 25, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/61/NCT03012061/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This study was conducted at different centers in Russia, United States, Canada, Poland and Romania to compare the efficacy, safety and tolerability of two doses of umeclidinium bromide (UMEC) administered once-daily (OD) via a dry powder inhaler, versus placebo.</recruitment_details>
      <pre_assignment_details>Total 421 participants were included in the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo QD</title>
          <description>Participants received placebo once daily (QD) via the ELLIPTA dry powder inhaler (DPI) for 24 weeks. Participants also received Fluticasone Furoate (FF) 100 micrograms (mcg) once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.</description>
        </group>
        <group group_id="P2">
          <title>UMEC 31.25 mcg QD</title>
          <description>Participants received UMEC 31.25 mcg once daily via the ELLIPTA DPI for 24 weeks. Participants also received FF 100 mcg once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.</description>
        </group>
        <group group_id="P3">
          <title>UMEC 62.5 mcg QD</title>
          <description>Participants received UMEC 62.5 mcg once daily via the ELLIPTA DPI for 24 weeks. Participants also received FF 100 mcg once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="143"/>
                <participants group_id="P2" count="139"/>
                <participants group_id="P3" count="139"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="137"/>
                <participants group_id="P2" count="130"/>
                <participants group_id="P3" count="131"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Investigator Site Closed</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study closed/ Terminated</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Met Protocol Withdrawal Criterion</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Placebo QD</title>
          <description>Participants received placebo once daily (QD) via the ELLIPTA dry powder inhaler (DPI) for 24 weeks. Participants also received Fluticasone Furoate (FF) 100 micrograms (mcg) once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.</description>
        </group>
        <group group_id="B2">
          <title>UMEC 31.25 mcg QD</title>
          <description>Participants received UMEC 31.25 mcg once daily via the ELLIPTA DPI for 24 weeks. Participants also received FF 100 mcg once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.</description>
        </group>
        <group group_id="B3">
          <title>UMEC 62.5 mcg QD</title>
          <description>Participants received UMEC 62.5 mcg once daily via the ELLIPTA DPI for 24 weeks. Participants also received FF 100 mcg once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.</description>
        </group>
        <group group_id="B4">
          <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="143"/>
            <count group_id="B2" value="139"/>
            <count group_id="B3" value="139"/>
            <count group_id="B4" value="421"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49.3" spread="13.93"/>
                    <measurement group_id="B2" value="48.7" spread="15.83"/>
                    <measurement group_id="B3" value="48.5" spread="14.21"/>
                    <measurement group_id="B4" value="48.8" spread="14.64"/>
                  </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="106"/>
                    <measurement group_id="B2" value="94"/>
                    <measurement group_id="B3" value="98"/>
                    <measurement group_id="B4" value="298"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="41"/>
                    <measurement group_id="B4" value="123"/>
                  </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="10"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian; Central/South Asian Heritage</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian; East Asian Heritage</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian; South East Asian Heritage</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White: Arabic/North African Heritage</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White: White/Caucasian/European Heritage</title>
                  <measurement_list>
                    <measurement group_id="B1" value="131"/>
                    <measurement group_id="B2" value="126"/>
                    <measurement group_id="B3" value="129"/>
                    <measurement group_id="B4" value="386"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American &amp; White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Change From Baseline in Clinic Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 24</title>
        <description>FEV1 is measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The highest of 3 technically acceptable measurements were recorded at each Visit. The Baseline value of clinic FEV1 was last acceptable/borderline acceptable (pre-dose) FEV1 value obtained prior to randomized treatment start date. Change from Baseline was calculated as FEV1 value at Week 24 minus FEV1 value at Baseline. Treatment policy estimand was assessed, including all on- and post-treatment data. Intent-to-Treat Population comprised all randomized participants, excluding those who were randomized in error, who did not receive the study drug. Least square (LS) mean and standard error (SE) data is presented. Different participants may have been analyzed at different time points; thus, overall number of participants analyzed reflects everyone in ITT Population without missing covariate information, with Baseline, at least one post-Baseline measurement.</description>
        <time_frame>Baseline (Day 1 pre-dose) and Week 24</time_frame>
        <population>Intent-to-Treat Population. Participants with available data at Baseline and at least one time point post-Baseline were analyzed. All on- and post-treatment data was included. Different participants may have been analyzed at different time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo QD</title>
            <description>Participants received placebo once daily (QD) via the ELLIPTA dry powder inhaler (DPI) for 24 weeks. Participants also received Fluticasone Furoate (FF) 100 micrograms (mcg) once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>UMEC 31.25 mcg QD</title>
            <description>Participants received UMEC 31.25 mcg once daily via the ELLIPTA DPI for 24 weeks. Participants also received FF 100 mcg once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>UMEC 62.5 mcg QD</title>
            <description>Participants received UMEC 62.5 mcg once daily via the ELLIPTA DPI for 24 weeks. Participants also received FF 100 mcg once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Clinic Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 24</title>
          <description>FEV1 is measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The highest of 3 technically acceptable measurements were recorded at each Visit. The Baseline value of clinic FEV1 was last acceptable/borderline acceptable (pre-dose) FEV1 value obtained prior to randomized treatment start date. Change from Baseline was calculated as FEV1 value at Week 24 minus FEV1 value at Baseline. Treatment policy estimand was assessed, including all on- and post-treatment data. Intent-to-Treat Population comprised all randomized participants, excluding those who were randomized in error, who did not receive the study drug. Least square (LS) mean and standard error (SE) data is presented. Different participants may have been analyzed at different time points; thus, overall number of participants analyzed reflects everyone in ITT Population without missing covariate information, with Baseline, at least one post-Baseline measurement.</description>
          <population>Intent-to-Treat Population. Participants with available data at Baseline and at least one time point post-Baseline were analyzed. All on- and post-treatment data was included. Different participants may have been analyzed at different time points.</population>
          <units>Liters</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="141"/>
                <count group_id="O2" value="136"/>
                <count group_id="O3" value="139"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1289" spread="0.0298"/>
                    <measurement group_id="O2" value="0.3046" spread="0.0304"/>
                    <measurement group_id="O3" value="0.3130" spread="0.0302"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed-model repeated measures (MMRM)</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.1758</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0426</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.0920</ci_lower_limit>
            <ci_upper_limit>0.2595</ci_upper_limit>
            <estimate_desc>UMEC 31.25 mcg versus placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>MMRM</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.1841</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0424</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1008</ci_lower_limit>
            <ci_upper_limit>0.2675</ci_upper_limit>
            <estimate_desc>UMEC 62.5 mcg versus placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Clinic FEV1 at 3 Hours Post Dose at Week 24</title>
        <description>FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The highest of 3 technically acceptable measurements were recorded at each Visit. The Baseline value of clinic FEV1 was the last acceptable/borderline acceptable (pre-dose) FEV1 value obtained prior to randomization (either from Visit 2 pre-dose or from Visit 1 pre-bronchodilator). Change from Baseline was calculated as FEV1 value at Week 24 (recorded at 3 hours post dose) minus FEV1 value at Baseline. The analysis only including data collected on-treatment. LS mean change and SE data is presented.</description>
        <time_frame>Baseline (Day 1 pre-dose) and Week 24</time_frame>
        <population>Intent-to-Treat Population. Only those participants with available on-treatment data at the specified time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo QD</title>
            <description>Participants received placebo once daily (QD) via the ELLIPTA dry powder inhaler (DPI) for 24 weeks. Participants also received Fluticasone Furoate (FF) 100 micrograms (mcg) once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>UMEC 31.25 mcg QD</title>
            <description>Participants received UMEC 31.25 mcg once daily via the ELLIPTA DPI for 24 weeks. Participants also received FF 100 mcg once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>UMEC 62.5 mcg QD</title>
            <description>Participants received UMEC 62.5 mcg once daily via the ELLIPTA DPI for 24 weeks. Participants also received FF 100 mcg once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Clinic FEV1 at 3 Hours Post Dose at Week 24</title>
          <description>FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The highest of 3 technically acceptable measurements were recorded at each Visit. The Baseline value of clinic FEV1 was the last acceptable/borderline acceptable (pre-dose) FEV1 value obtained prior to randomization (either from Visit 2 pre-dose or from Visit 1 pre-bronchodilator). Change from Baseline was calculated as FEV1 value at Week 24 (recorded at 3 hours post dose) minus FEV1 value at Baseline. The analysis only including data collected on-treatment. LS mean change and SE data is presented.</description>
          <population>Intent-to-Treat Population. Only those participants with available on-treatment data at the specified time points were analyzed.</population>
          <units>Liters</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="133"/>
                <count group_id="O2" value="127"/>
                <count group_id="O3" value="129"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1768" spread="0.0318"/>
                    <measurement group_id="O2" value="0.3663" spread="0.0325"/>
                    <measurement group_id="O3" value="0.3744" spread="0.0322"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Analysis of covariance (ANCOVA)</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.1895</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0455</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1000</ci_lower_limit>
            <ci_upper_limit>0.2789</ci_upper_limit>
            <estimate_desc>UMEC 31.25 mcg vs Placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.1976</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0453</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1086</ci_lower_limit>
            <ci_upper_limit>0.2866</ci_upper_limit>
            <estimate_desc>UMEC 62.5 mcg vs Placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With On-treatment Adverse Events (AE), Non-serious Adverse Events (Non-SAE)</title>
        <description>An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinemia were categorized as SAE. Number of participants with on-treatment AEs and SAEs and serious adverse events (SAE) and common (&gt;=3%)non-SAEs have been reported.</description>
        <time_frame>Up to Week 24</time_frame>
        <population>Intent-to-Treat Population</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo QD</title>
            <description>Participants received placebo once daily (QD) via the ELLIPTA dry powder inhaler (DPI) for 24 weeks. Participants also received Fluticasone Furoate (FF) 100 micrograms (mcg) once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>UMEC 31.25 mcg QD</title>
            <description>Participants received UMEC 31.25 mcg once daily via the ELLIPTA DPI for 24 weeks. Participants also received FF 100 mcg once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>UMEC 62.5 mcg QD</title>
            <description>Participants received UMEC 62.5 mcg once daily via the ELLIPTA DPI for 24 weeks. Participants also received FF 100 mcg once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With On-treatment Adverse Events (AE), Non-serious Adverse Events (Non-SAE)</title>
          <description>An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinemia were categorized as SAE. Number of participants with on-treatment AEs and SAEs and serious adverse events (SAE) and common (&gt;=3%)non-SAEs have been reported.</description>
          <population>Intent-to-Treat 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="143"/>
                <count group_id="O2" value="139"/>
                <count group_id="O3" value="139"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65"/>
                    <measurement group_id="O2" value="73"/>
                    <measurement group_id="O3" value="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any SAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any non-SAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                    <measurement group_id="O2" value="47"/>
                    <measurement group_id="O3" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With On-treatment Abnormal Electrocardiograms (ECG) Findings</title>
        <description>A single 12-lead ECG and rhythm strip was recorded after measurement of vital signs and spirometry at given time points. All ECG measurements were measured with participants in supine position after &gt;=5 minutes rest. All ECGs were electronically transmitted to an independent and treatment-blinded cardiologist for the measurement. ECG was obtained 15 minutes to 45 minutes after the administration of study treatment. Data for number of participants with abnormal ECG Findings have been reported.</description>
        <time_frame>Week 4 and Week 24</time_frame>
        <population>Intent-to-Treat 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>Placebo QD</title>
            <description>Participants received placebo once daily (QD) via the ELLIPTA dry powder inhaler (DPI) for 24 weeks. Participants also received Fluticasone Furoate (FF) 100 micrograms (mcg) once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>UMEC 31.25 mcg QD</title>
            <description>Participants received UMEC 31.25 mcg once daily via the ELLIPTA DPI for 24 weeks. Participants also received FF 100 mcg once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>UMEC 62.5 mcg QD</title>
            <description>Participants received UMEC 62.5 mcg once daily via the ELLIPTA DPI for 24 weeks. Participants also received FF 100 mcg once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With On-treatment Abnormal Electrocardiograms (ECG) Findings</title>
          <description>A single 12-lead ECG and rhythm strip was recorded after measurement of vital signs and spirometry at given time points. All ECG measurements were measured with participants in supine position after &gt;=5 minutes rest. All ECGs were electronically transmitted to an independent and treatment-blinded cardiologist for the measurement. ECG was obtained 15 minutes to 45 minutes after the administration of study treatment. Data for number of participants with abnormal ECG Findings have been reported.</description>
          <population>Intent-to-Treat 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="143"/>
                <count group_id="O2" value="139"/>
                <count group_id="O3" value="139"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4, n=139, 135, 138</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="139"/>
                    <count group_id="O2" value="135"/>
                    <count group_id="O3" value="138"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="26"/>
                    <measurement group_id="O3" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24, n=133, 129, 129</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="133"/>
                    <count group_id="O2" value="129"/>
                    <count group_id="O3" value="129"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="23"/>
                    <measurement group_id="O3" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in On-treatment Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)</title>
        <description>Blood pressure was measured at every clinic visit, starting at Visit 1, and prior to conducting spirometry. Blood pressure was measured with participant in sitting position after approximately 5 minutes rest. Baseline value was defined as the latest vital signs assessment prior to randomized treatment start, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the value at specified time point. LS mean and SE data is presented. Different participants may have data available at different time points; thus, the overall number of participants analyzed reflects everyone in the ITT Population without missing covariate information and with a Baseline and at least one post-Baseline measurement.</description>
        <time_frame>Baseline (Day 1 pre-dose), Weeks 4, 12 and 24</time_frame>
        <population>Intent-to-Treat Population. Participants with available data at Baseline and at least one time point post-Baseline were analyzed. 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>Placebo QD</title>
            <description>Participants received placebo once daily (QD) via the ELLIPTA dry powder inhaler (DPI) for 24 weeks. Participants also received Fluticasone Furoate (FF) 100 micrograms (mcg) once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>UMEC 31.25 mcg QD</title>
            <description>Participants received UMEC 31.25 mcg once daily via the ELLIPTA DPI for 24 weeks. Participants also received FF 100 mcg once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>UMEC 62.5 mcg QD</title>
            <description>Participants received UMEC 62.5 mcg once daily via the ELLIPTA DPI for 24 weeks. Participants also received FF 100 mcg once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in On-treatment Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)</title>
          <description>Blood pressure was measured at every clinic visit, starting at Visit 1, and prior to conducting spirometry. Blood pressure was measured with participant in sitting position after approximately 5 minutes rest. Baseline value was defined as the latest vital signs assessment prior to randomized treatment start, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the value at specified time point. LS mean and SE data is presented. Different participants may have data available at different time points; thus, the overall number of participants analyzed reflects everyone in the ITT Population without missing covariate information and with a Baseline and at least one post-Baseline measurement.</description>
          <population>Intent-to-Treat Population. Participants with available data at Baseline and at least one time point post-Baseline were analyzed. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).</population>
          <units>Millimeters of mercury</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="139"/>
                <count group_id="O2" value="137"/>
                <count group_id="O3" value="139"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SBP, Week 4, n=139, 137, 139</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="139"/>
                    <count group_id="O2" value="137"/>
                    <count group_id="O3" value="139"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.7" spread="0.70"/>
                    <measurement group_id="O2" value="1.1" spread="0.71"/>
                    <measurement group_id="O3" value="0.3" spread="0.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SBP, Week 12, n=139, 133, 135</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="139"/>
                    <count group_id="O2" value="133"/>
                    <count group_id="O3" value="135"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" spread="0.78"/>
                    <measurement group_id="O2" value="-0.2" spread="0.79"/>
                    <measurement group_id="O3" value="0.6" spread="0.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SBP, Week 24, n=135, 131, 130</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="131"/>
                    <count group_id="O3" value="130"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.6" spread="0.77"/>
                    <measurement group_id="O2" value="1.1" spread="0.78"/>
                    <measurement group_id="O3" value="-0.1" spread="0.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP, Week 4, n=139, 137, 139</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="139"/>
                    <count group_id="O2" value="137"/>
                    <count group_id="O3" value="139"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="0.55"/>
                    <measurement group_id="O2" value="1.2" spread="0.56"/>
                    <measurement group_id="O3" value="0.6" spread="0.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP, Week 12, n=139, 133, 135</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="139"/>
                    <count group_id="O2" value="133"/>
                    <count group_id="O3" value="135"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" spread="0.57"/>
                    <measurement group_id="O2" value="0.2" spread="0.59"/>
                    <measurement group_id="O3" value="1.8" spread="0.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP, Week 24, n=135, 131, 130</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="131"/>
                    <count group_id="O3" value="130"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" spread="0.57"/>
                    <measurement group_id="O2" value="1.6" spread="0.58"/>
                    <measurement group_id="O3" value="1.4" spread="0.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.083</p_value>
            <method>MMRM</method>
            <param_type>Median Difference (Net)</param_type>
            <param_value>1.7</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.00</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.2</ci_lower_limit>
            <ci_upper_limit>3.7</ci_upper_limit>
            <estimate_desc>UMEC 31.25 mcg vs Placebo, SBP, Week 4</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.636</p_value>
            <method>MMRM</method>
            <param_type>Median Difference (Net)</param_type>
            <param_value>-0.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.11</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.7</ci_lower_limit>
            <ci_upper_limit>1.7</ci_upper_limit>
            <estimate_desc>UMEC 31.25 mcg vs Placebo, SBP, Week 12</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.115</p_value>
            <method>MMRM</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>1.7</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.10</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.4</ci_lower_limit>
            <ci_upper_limit>3.9</ci_upper_limit>
            <estimate_desc>UMEC 31.25 mcg vs Placebo, SBP, Week 24</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.336</p_value>
            <method>MMRM</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>1.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.99</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.0</ci_lower_limit>
            <ci_upper_limit>2.9</ci_upper_limit>
            <estimate_desc>UMEC 62.5 mcg vs Placebo, SBP, Week 4</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.787</p_value>
            <method>MMRM</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.11</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.9</ci_lower_limit>
            <ci_upper_limit>2.5</ci_upper_limit>
            <estimate_desc>UMEC 62.5 mcg vs Placebo, SBP, Week 12</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.625</p_value>
            <method>MMRM</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.10</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.6</ci_lower_limit>
            <ci_upper_limit>2.7</ci_upper_limit>
            <estimate_desc>UMEC 62.5 mcg vs Placebo, SBP, Week 24</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.309</p_value>
            <method>MMRM</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.8</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.79</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.7</ci_lower_limit>
            <ci_upper_limit>2.3</ci_upper_limit>
            <estimate_desc>UMEC 31.25 mcg vs Placebo, DBP, Week 4</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.521</p_value>
            <method>MMRM</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.82</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.1</ci_lower_limit>
            <ci_upper_limit>1.1</ci_upper_limit>
            <estimate_desc>UMEC 31.25 mcg vs Placebo, DBP, Week 12</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.047</p_value>
            <method>MMRM</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>1.6</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.81</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.0</ci_lower_limit>
            <ci_upper_limit>3.2</ci_upper_limit>
            <estimate_desc>UMEC 31.25 mcg vs Placebo, DBP, Week 24</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.779</p_value>
            <method>MMRM</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.78</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.3</ci_lower_limit>
            <ci_upper_limit>1.8</ci_upper_limit>
            <estimate_desc>UMEC 62.5 mcg versus placebo, DBP, Week 4</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.204</p_value>
            <method>MMRM</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>1.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.82</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.6</ci_lower_limit>
            <ci_upper_limit>2.6</ci_upper_limit>
            <estimate_desc>UMEC 62.5 mcg versus placebo, DBP, Week 12</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.066</p_value>
            <method>MMRM</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>1.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.81</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.1</ci_lower_limit>
            <ci_upper_limit>3.1</ci_upper_limit>
            <estimate_desc>UMEC 62.5 mcg versus placebo, DBP, Week 24</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in On-treatment Pulse Rate</title>
        <description>Pulse rate was measured at every clinic visit, starting at Visit 1, and prior to conducting spirometry. Pulse rate was measured with participant in sitting position after approximately 5 minutes rest. Baseline value was defined as the latest vital signs assessment prior to randomized treatment start, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the value at specified time point. LS mean and SE data is presented.</description>
        <time_frame>Baseline (Day 1 pre-dose), Weeks 4, 12 and 24</time_frame>
        <population>Intent-to-Treat Population. Participants with available data at Baseline and at least one time point post-Baseline were analyzed. Participants with data available at the specified time points are represented by (n=X) in the category titles.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo QD</title>
            <description>Participants received placebo once daily (QD) via the ELLIPTA dry powder inhaler (DPI) for 24 weeks. Participants also received Fluticasone Furoate (FF) 100 micrograms (mcg) once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>UMEC 31.25 mcg QD</title>
            <description>Participants received UMEC 31.25 mcg once daily via the ELLIPTA DPI for 24 weeks. Participants also received FF 100 mcg once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>UMEC 62.5 mcg QD</title>
            <description>Participants received UMEC 62.5 mcg once daily via the ELLIPTA DPI for 24 weeks. Participants also received FF 100 mcg once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in On-treatment Pulse Rate</title>
          <description>Pulse rate was measured at every clinic visit, starting at Visit 1, and prior to conducting spirometry. Pulse rate was measured with participant in sitting position after approximately 5 minutes rest. Baseline value was defined as the latest vital signs assessment prior to randomized treatment start, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the value at specified time point. LS mean and SE data is presented.</description>
          <population>Intent-to-Treat Population. Participants with available data at Baseline and at least one time point post-Baseline were analyzed. Participants with data available at the specified time points are represented by (n=X) in the category titles.</population>
          <units>Beats per minute</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="139"/>
                <count group_id="O2" value="137"/>
                <count group_id="O3" value="139"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4, n=139, 137, 139</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="139"/>
                    <count group_id="O2" value="137"/>
                    <count group_id="O3" value="139"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.3" spread="0.69"/>
                    <measurement group_id="O2" value="-1.0" spread="0.69"/>
                    <measurement group_id="O3" value="-0.8" spread="0.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12, n=139, 133, 135</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="139"/>
                    <count group_id="O2" value="133"/>
                    <count group_id="O3" value="135"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.9" spread="0.59"/>
                    <measurement group_id="O2" value="-0.3" spread="0.60"/>
                    <measurement group_id="O3" value="0.8" spread="0.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24, n=135, 131, 130</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="131"/>
                    <count group_id="O3" value="130"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.8" spread="0.75"/>
                    <measurement group_id="O2" value="-0.7" spread="0.76"/>
                    <measurement group_id="O3" value="1.5" spread="0.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.195</p_value>
            <method>MMRM</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>1.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.97</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.7</ci_lower_limit>
            <ci_upper_limit>3.2</ci_upper_limit>
            <estimate_desc>UMEC 31.25 mcg vs Placebo, Week 4</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.457</p_value>
            <method>MMRM</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.6</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.84</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.0</ci_lower_limit>
            <ci_upper_limit>2.3</ci_upper_limit>
            <estimate_desc>UMEC 31.25 mcg versus Placebo, Week 12</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.300</p_value>
            <method>MMRM</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>1.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.07</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.0</ci_lower_limit>
            <ci_upper_limit>3.2</ci_upper_limit>
            <estimate_desc>UMEC 31.25 mcg versus Placebo, Week 24</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.140</p_value>
            <method>MMRM</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>1.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.97</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.5</ci_lower_limit>
            <ci_upper_limit>3.3</ci_upper_limit>
            <estimate_desc>UMEC 62.5 mcg versus Placebo, Week 4</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.045</p_value>
            <method>MMRM</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>1.7</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.84</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.0</ci_lower_limit>
            <ci_upper_limit>3.3</ci_upper_limit>
            <estimate_desc>UMEC 62.5 mcg versus Placebo, Week 12</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.002</p_value>
            <method>MMRM</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>3.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.07</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.3</ci_lower_limit>
            <ci_upper_limit>5.5</ci_upper_limit>
            <estimate_desc>UMEC 62.5 mcg versus Placebo, Week 24</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>On-treatment serious adverse events and non-serious adverse events were collected up to 25 weeks.</time_frame>
      <desc>Intent-to-Treat Population was used to collect adverse events.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo QD</title>
          <description>Participants received placebo once daily (QD) via the ELLIPTA dry powder inhaler (DPI) for 24 weeks. Participants also received Fluticasone Furoate (FF) 100 micrograms (mcg) once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.</description>
        </group>
        <group group_id="E2">
          <title>UMEC 31.25 mcg QD</title>
          <description>Participants received UMEC 31.25 mcg once daily via the ELLIPTA DPI for 24 weeks. Participants also received FF 100 mcg once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.</description>
        </group>
        <group group_id="E3">
          <title>UMEC 62.5 mcg QD</title>
          <description>Participants received UMEC 62.5 mcg once daily via the ELLIPTA DPI for 24 weeks. Participants also received FF 100 mcg once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <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, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="139"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="143"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="139"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="139"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="139"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaphylactic reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="139"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="139"/>
              </event>
              <event>
                <sub_title>Pneumonia bacterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="139"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Transient Ischemic attack</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="139"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="139"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="143"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="139"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="139"/>
              </event>
              <event>
                <sub_title>Pulmonary infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="139"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="143"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="139"/>
              </event>
              <event>
                <sub_title>Thrombophlebitis superficial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="139"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>3</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="39" subjects_at_risk="143"/>
                <counts group_id="E2" subjects_affected="47" subjects_at_risk="139"/>
                <counts group_id="E3" subjects_affected="33" subjects_at_risk="139"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="143"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="139"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="139"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="21" subjects_affected="17" subjects_at_risk="143"/>
                <counts group_id="E2" events="20" subjects_affected="14" subjects_at_risk="139"/>
                <counts group_id="E3" events="15" subjects_affected="13" subjects_at_risk="139"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="143"/>
                <counts group_id="E2" events="13" subjects_affected="8" subjects_at_risk="139"/>
                <counts group_id="E3" events="8" subjects_affected="6" subjects_at_risk="139"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection viral</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="143"/>
                <counts group_id="E2" events="9" subjects_affected="7" subjects_at_risk="139"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="139"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="143"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="139"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="139"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="139"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="139"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="22" subjects_affected="11" subjects_at_risk="143"/>
                <counts group_id="E2" events="14" subjects_affected="9" subjects_at_risk="139"/>
                <counts group_id="E3" events="17" subjects_affected="12" subjects_at_risk="139"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="143"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="139"/>
                <counts group_id="E3" events="6" subjects_affected="4" subjects_at_risk="139"/>
              </event>
              <event>
                <sub_title>Dysphonia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="143"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="139"/>
              </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/NCT03012061
org study id: 205832
secondary id: 2016-002843-40
nct id: NCT03012061
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This study is conducted to evaluate the effects of UMEC 62.5 microgram (mcg) and UMEC 31.25
      mcg on lung function versus placebo after 24 weeks of treatment. This study will provide
      important information regarding the efficacy and safety of UMEC when administered in a
      separate inhaler to subjects on a background of fluticasone furoate (FF). This is a Phase
      IIb, randomized, double-blind, placebo controlled study that will compare the efficacy,
      safety and tolerability of UMEC (62.5 mcg and 31.25 mcg) administered once-daily in subjects
      with asthma that is not well controlled. Eligible subjects will be requested to participate
      in the study for a maximum of approximately 31 weeks with 4 phases (pre screening,
      screening/run-in, randomization/treatment and safety follow-up). The total number of
      randomized subjects required is approximately 384, with 128 subjects randomized 1:1:1 to each
      of the 3 double-blind treatment arms.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Mean Change From Baseline in Clinic Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 24
time frame: Baseline (Day 1 pre-dose) and Week 24
description: FEV1 is measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The highest of 3 technically acceptable measurements were recorded at each Visit. The Baseline value of clinic FEV1 was last acceptable/borderline acceptable (pre-dose) FEV1 value obtained prior to randomized treatment start date. Change from Baseline was calculated as FEV1 value at Week 24 minus FEV1 value at Baseline. Treatment policy estimand was assessed, including all on- and post-treatment data. Intent-to-Treat Population comprised all randomized participants, excluding those who were randomized in error, who did not receive the study drug. Least square (LS) mean and standard error (SE) data is presented. Different participants may have been analyzed at different time points; thus, overall number of participants analyzed reflects everyone in ITT Population without missing covariate information, with Baseline, at least one post-Baseline measurement.
measure: Mean Change From Baseline in Clinic FEV1 at 3 Hours Post Dose at Week 24
time frame: Baseline (Day 1 pre-dose) and Week 24
description: FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The highest of 3 technically acceptable measurements were recorded at each Visit. The Baseline value of clinic FEV1 was the last acceptable/borderline acceptable (pre-dose) FEV1 value obtained prior to randomization (either from Visit 2 pre-dose or from Visit 1 pre-bronchodilator). Change from Baseline was calculated as FEV1 value at Week 24 (recorded at 3 hours post dose) minus FEV1 value at Baseline. The analysis only including data collected on-treatment. LS mean change and SE data is presented.
measure: Number of Participants With On-treatment Adverse Events (AE), Non-serious Adverse Events (Non-SAE)
time frame: Up to Week 24
description: An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinemia were categorized as SAE. Number of participants with on-treatment AEs and SAEs and serious adverse events (SAE) and common (>=3%)non-SAEs have been reported.
measure: Number of Participants With On-treatment Abnormal Electrocardiograms (ECG) Findings
time frame: Week 4 and Week 24
description: A single 12-lead ECG and rhythm strip was recorded after measurement of vital signs and spirometry at given time points. All ECG measurements were measured with participants in supine position after >=5 minutes rest. All ECGs were electronically transmitted to an independent and treatment-blinded cardiologist for the measurement. ECG was obtained 15 minutes to 45 minutes after the administration of study treatment. Data for number of participants with abnormal ECG Findings have been reported.
measure: Mean Change From Baseline in On-treatment Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
time frame: Baseline (Day 1 pre-dose), Weeks 4, 12 and 24
description: Blood pressure was measured at every clinic visit, starting at Visit 1, and prior to conducting spirometry. Blood pressure was measured with participant in sitting position after approximately 5 minutes rest. Baseline value was defined as the latest vital signs assessment prior to randomized treatment start, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the value at specified time point. LS mean and SE data is presented. Different participants may have data available at different time points; thus, the overall number of participants analyzed reflects everyone in the ITT Population without missing covariate information and with a Baseline and at least one post-Baseline measurement.
measure: Mean Change From Baseline in On-treatment Pulse Rate
time frame: Baseline (Day 1 pre-dose), Weeks 4, 12 and 24
description: Pulse rate was measured at every clinic visit, starting at Visit 1, and prior to conducting spirometry. Pulse rate was measured with participant in sitting position after approximately 5 minutes rest. Baseline value was defined as the latest vital signs assessment prior to randomized treatment start, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the value at specified time point. LS mean and SE data is presented.
arm group label: Placebo
arm group type: Placebo Comparator
description: Subjects will be administered placebo once daily via the ELLIPTA® dry powder inhaler (DPI) for 24 weeks. Subjects will also receive FF 100 mcg once daily, in the morning for 24 weeks. ELLIPTA is a registered trademark of the GSK group of companies.
arm group label: UMEC 62.5 mcg
arm group type: Experimental
description: Subjects will be administered UMEC 62.5 mcg once daily via the ELLIPTA dry powder inhaler (DPI) for 24 weeks. Subjects will also receive FF 100 mcg once daily, in the morning for 24 weeks.
arm group label: UMEC 31.25 mcg
arm group type: Experimental
description: Subjects will be administered UMEC 31.25 mcg once daily via the ELLIPTA dry powder inhaler (DPI) for 24 weeks. Subjects will also receive FF 100 mcg once daily, in the morning for 24 weeks.
intervention type: Drug
intervention name: Placebo
description: Placebo is a white powder to be administered using ELLIPTA DPI which hold two individual blister strips, both of which contains lactose monohydrate blended with magnesium stearate.
arm group label: Placebo
intervention type: Drug
intervention name: UMEC
description: UMEC is a white powder to be administered using ELLIPTA DPI which hold two individual blister strips, one of which contains GSK573719 blended with lactose blended with magnesium stearate and another one contains lactose monohydrate blended with magnesium stearate.
arm group label: UMEC 31.25 mcg
arm group label: UMEC 62.5 mcg
intervention type: Drug
intervention name: Fluticasone Furoate
description: FF is a white powder to be administered using ELLIPTA DPI which hold two individual blister strips, one of which contains GW685698 blended with lactose monohydrate and another one contains lactose monohydrate with magnesium stearate.
arm group label: Placebo
arm group label: UMEC 31.25 mcg
arm group label: UMEC 62.5 mcg
intervention type: Drug
intervention name: Albuterol/salbutamol
description: Albuterol/salbutamol is to be administered via metered-dose inhaler as a rescue drug on need basis throughout the study.
arm group label: Placebo
arm group label: UMEC 31.25 mcg
arm group label: UMEC 62.5 mcg
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
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country: Canada
country: Poland
country: Romania
country: Russian Federation
country: United States
citation: Kerwin E, Pascoe S, Bailes Z, Nathan R, Bernstein D, Dahl R, von Maltzahn R, Robbins K, Fowler A, Lee L. A phase IIb, randomised, parallel-group study: the efficacy, safety and tolerability of once-daily umeclidinium in patients with asthma receiving inhaled corticosteroids. Respir Res. 2020 Jun 12;21(1):148. doi: 10.1186/s12931-020-01400-5.
PMID: 32532275
responsible party type: Sponsor
mesh term: Asthma
mesh term: Fluticasone
mesh term: Xhance
mesh term: Albuterol
sharing ipd: Yes
ipd description: IPD for this study is 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 (copy the URL below to your browser)
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://www.clinicalstudydatarequest.com/Posting.aspx?ID=20592
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 