<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/NCT01703624</url>
  </required_header>
  <id_info>
    <org_study_id>PSX100201</org_study_id>
    <secondary_id>2012-003791-40</secondary_id>
    <nct_id>NCT01703624</nct_id>
  </id_info>
  <brief_title>Dose Ranging Study of Glycopyrronium Bromide in Patients With Moderate or Severe Chronic Obstructive Pulmonary Disease</brief_title>
  <official_title>An Investigation of the Efficacy, Tolerability and Safety of a Range of Doses of Orally Inhaled Glycopyrronium Bromide (PSX1002-GB pMDI) in Male and Female Patients With Moderate or Severe Chronic Obstructive Pulmonary Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prosonix Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Prosonix Limited</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an investigation of the beneficial effects, tolerability and safety of a range of&#xD;
      single doses of orally inhaled glycopyrronium bromide (PSX1002GB pMDI) in male and female&#xD;
      patients with moderate or severe chronic obstructive pulmonary disease (COPD). COPD is a long&#xD;
      term and progressive disease of the lungs, generally caused by cigarette smoking, but other&#xD;
      factors may be involved. Glycopyrronium bromide (GB) appears to be particularly useful in&#xD;
      dilating the constricted airways of such patients, with a duration of action variously&#xD;
      described as being between 12 and 24 hours.&#xD;
&#xD;
      This study will investigate how well tolerated and safe this medication is at a range of&#xD;
      doses. It will also help in the selection of a suitable dose for larger and repeat dose&#xD;
      studies, based on measures of lung response. It will also help to determine how often the&#xD;
      medication should be given; twice daily, or once daily.&#xD;
&#xD;
      Up to 40 patients will be enrolled into the study, ranging in age from 40 to 75 years of age.&#xD;
      Patients will be medically assessed before participation to ensure their suitability. The&#xD;
      study will take place in one centre in the UK over five sessions; at each session one dose (2&#xD;
      puffs) of GB or one dose (2 puffs) of placebo will be administered from a simple inhaler&#xD;
      device. Neither staff nor patients will know which dose, or if placebo, is being taken. Lung&#xD;
      function will be measured for up to 26 hours after the administration of each dose using&#xD;
      standard spirometry equipment. Blood samples will be taken over a 24-hour period to check the&#xD;
      blood levels of GB. There will be a period of about a week between each dosing session.&#xD;
      Patients will be medically reviewed after the study to confirm that no untoward effects are&#xD;
      present.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2013</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">August 2013</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Forced Expiratory Volume in one second (FEV1) Area Under the Curve (AUC)</measure>
    <time_frame>From time zero to 24-hours</time_frame>
    <description>FEV1 time-adjusted AUC(0-24 hours)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Forced Expiratory Volume in one second (FEV1) Area Under the Curve (AUC)</measure>
    <time_frame>From time zero to 12-hours</time_frame>
    <description>FEV1 time-adjusted AUC(0-12 hours)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Forced Expiratory Volume in one second (FEV1) Area Under the Curve (AUC)</measure>
    <time_frame>From 12 to 24-hours</time_frame>
    <description>FEV1 time-adjusted AUC(12-24 hours)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Forced Expiratory Volume in one second (FEV1)</measure>
    <time_frame>From time zero to 24-hours</time_frame>
    <description>Serial FEV1 time-point assessments</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Forced Vital Capacity (FVC) Area Under the Curve (AUC)</measure>
    <time_frame>From time zero to 24-hours</time_frame>
    <description>FVC time-adjusted AUC(0-24 hours), AUC(0-12 hours), AUC(12-24 hours), serial time-point assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Forced Expiratory Volume in one second (FEV1) / Forced Vital Capacity (FVC) ratio</measure>
    <time_frame>From time zero to 24-hours</time_frame>
    <description>Serial FEV1/FVC time-point assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects reporting adverse events after each treatment as a measure of safety and tolerability</measure>
    <time_frame>An average of 9 weeks</time_frame>
    <description>Adverse event monitoring will begin once a subject provides informed consent and will continue until study participation is concluded; incidence rates will be summarised by system organ class, preferred term, severity and by reported relationship to study drug for each treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systolic blood pressure</measure>
    <time_frame>From time zero to 24-hours</time_frame>
    <description>Descriptive statistics will be presented for the serial measurements by treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diastolic blood pressure</measure>
    <time_frame>From time zero to 24-hours</time_frame>
    <description>Descriptive statistics will be presented for the serial measurements by treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peripheral pulse rate</measure>
    <time_frame>From time zero to 24-hours</time_frame>
    <description>Descriptive statistics will be presented for the serial measurements by treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Electrocardiography (ECG)</measure>
    <time_frame>From time zero to 24-hours</time_frame>
    <description>Descriptive statistics will be presented for the serial measurements of each of the standard electrocardiographic (12-lead) parameters by treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical hematology</measure>
    <time_frame>An average of 9 weeks</time_frame>
    <description>Clinical hematology measures will be taken at the Screening Visit and at the Safety Follow-up Visit and will consist of: red blood cell count, hemoglobin, hematocrit, mean cell hemoglobin, mean cell hemoglobin concentration, mean cell volume, white blood cell count, differential white blood cell count and platelet count. Data will be summarised using descriptive statistics</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical chemistry</measure>
    <time_frame>An average of 9 weeks</time_frame>
    <description>Clinical chemistry measures will be taken at the Screening Visit and at the Safety Follow-up Visit and will consist of: sodium, potassium, urea, creatinine, uric acid, glucose, calcium, inorganic phosphorus, total bilirubin, alkaline phosphatase, alanine transaminase, aspartate transminase, gamma glutamyl transferase, creatine kinase, total protein, albumin, cholesterol and triglycerides. Data will be summarised using descriptive statistics</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma glycopyrronium bromide concentration-time Area Under the Curve (AUC)</measure>
    <time_frame>From time zero to 24-hours</time_frame>
    <description>AUC (0-infinity) will be extrapolated from serial measures taken over time zero to 24-hours. The descriptive statistics presented by treatment will be: minimum, median, maximum, geometric mean, arithmetic mean and arithmetic standard deviation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma glycopyrronium bromide peak concentration (Cmax)</measure>
    <time_frame>From time zero to 24-hours</time_frame>
    <description>Cmax will be obtained from serial measures taken over time zero to 24-hours. The descriptive statistics presented by treatment will be: minimum, median, maximum, geometric mean, arithmetic mean and arithmetic standard deviation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma glycopyrronium bromide time to maximum concentration (tmax)</measure>
    <time_frame>From time zero to 24-hours</time_frame>
    <description>tmax will be calculated from serial measures taken over time zero to 24-hours. The descriptive statistics presented by treatment will be: minimum, median, maximum, geometric mean, arithmetic mean and arithmetic standard deviation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma glycopyrronium bromide concentration elimination half-life (t1/2)</measure>
    <time_frame>From time zero to 24-hours</time_frame>
    <description>t1/2 will be calculated from serial measures taken over time zero to 24-hours. The descriptive statistics presented by treatment will be: minimum, median, maximum, geometric mean, arithmetic mean and arithmetic standard deviation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycopyrronium bromide total plasma clearance following extravascular administration (CL/F)</measure>
    <time_frame>From time zero to 24-hours</time_frame>
    <description>CL/F will be calculated from serial plasma concentration measures taken over time zero to 24-hours. The descriptive statistics presented by treatment will be: minimum, median, maximum, geometric mean, arithmetic mean and arithmetic standard deviation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycopyrronium bromide apparent volume of distribution following extravascular administration (Vz/F)</measure>
    <time_frame>From time zero to 24-hours</time_frame>
    <description>Vz/F will be calculated from serial plasma concentration measures taken over time zero to 24-hours. The descriptive statistics presented by treatment will be: minimum, median, maximum, geometric mean, arithmetic mean and arithmetic standard deviation</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <arm_group>
    <arm_group_label>glycopyrronium bromide 12.5mcg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>glycopyrronium bromide 12.5mcg single dose via pressurised metered dose inhaler (pMDI)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>glycopyrronium bromide 25mcg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>glycopyrronium bromide 25mcg single dose via pressurised metered dose inhaler (pMDI)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>glycopyrronium bromide 50mcg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>glycopyrronium bromide 50mcg single dose via pressurised metered dose inhaler (pMDI)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>glycopyrronium bromide 100mcg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>glycopyrronium bromide 100mcg single dose via pressurised metered dose inhaler (pMDI)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>placebo single dose via pressurised metered dose inhaler (pMDI)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>glycopyrronium bromide</intervention_name>
    <description>glycopyrronium bromide suspension in HFA</description>
    <arm_group_label>glycopyrronium bromide 100mcg</arm_group_label>
    <arm_group_label>glycopyrronium bromide 12.5mcg</arm_group_label>
    <arm_group_label>glycopyrronium bromide 25mcg</arm_group_label>
    <arm_group_label>glycopyrronium bromide 50mcg</arm_group_label>
    <arm_group_label>placebo</arm_group_label>
    <other_name>PSX1002-GB</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female age 40-75 years, inclusive&#xD;
&#xD;
          -  A clinical diagnosis of moderate to severe COPD (GOLD guidelines)&#xD;
&#xD;
          -  Current smokers or ex-smokers with at least 10-pack year smoking history&#xD;
&#xD;
          -  Post-bronchodilator FEV1/FVC ratio &lt; 70 % at Screen&#xD;
&#xD;
          -  Post-bronchodilator FEV1 ≥ 40 % to &lt; 80 % of predicted at Screen&#xD;
&#xD;
          -  Demonstrated to be responsive to ipratropium (defined as at least an 100ml increase in&#xD;
             FEV1 following ipratropium 80 µg)&#xD;
&#xD;
          -  Ability to perform acceptable spirometry (ATS/ERS guidelines)&#xD;
&#xD;
          -  Willing and able to provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Females who are pregnant or lactating at the Screening Visit, or if of childbearing&#xD;
             potential not using an acceptable means of birth control throughout the study (defined&#xD;
             in protocol)&#xD;
&#xD;
          -  Current evidence or recent history of any clinically significant disease (other than&#xD;
             COPD) or abnormality in the opinion of the Investigator that would put the subject at&#xD;
             risk or which would compromise the quality of the study data (defined in protocol)&#xD;
&#xD;
          -  Recent history of hospitalisation due to an exacerbation of airway disease within&#xD;
             three months prior to the Screening Visit or randomisation&#xD;
&#xD;
          -  Need for increased treatments of COPD within six weeks prior to the Screening Visit or&#xD;
             randomisation&#xD;
&#xD;
          -  Primary diagnosis of asthma&#xD;
&#xD;
          -  Prior lung volume reductions surgery or history of chest/lung irradiation&#xD;
&#xD;
          -  Regular use of daily oxygen therapy&#xD;
&#xD;
          -  Use of systemic steroids within three months prior to the Screening Visit or during&#xD;
             the run-in period&#xD;
&#xD;
          -  Respiratory tract infection within six weeks prior to the Screening Visit.&#xD;
&#xD;
          -  History of tuberculosis, bronchiectasis or other non-specific pulmonary disease&#xD;
&#xD;
          -  History of urinary retention or bladder neck obstructive type symptoms&#xD;
&#xD;
          -  History of narrow-angle glaucoma&#xD;
&#xD;
          -  Clinically significant abnormal ECG&#xD;
&#xD;
          -  Positive Hepatitis B antigen or positive Hepatitis C antibody&#xD;
&#xD;
          -  Positive screening test for HIV antibodies&#xD;
&#xD;
          -  Current evidence or history of excessive use or abuse of alcohol in the opinion of the&#xD;
             Investigator&#xD;
&#xD;
          -  Current evidence or history of abusing legal drugs or use of illegal drugs or&#xD;
             substances in the opinion of the Investigator&#xD;
&#xD;
          -  Donation of 450 ml or more of blood within eight weeks of the Screening Visit&#xD;
&#xD;
          -  History of hypersensitivity or intolerance to aerosol medications&#xD;
&#xD;
          -  Participation in another investigational drug study where drug was received within 30&#xD;
             days prior to the Screening Visit.&#xD;
&#xD;
          -  Inability to comply with study procedures or with study treatment intake, including&#xD;
             inability to be trained and/or inability to demonstrate good inhaler technique with&#xD;
             Vitalograph AIM&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Geoff Down, MB BS FFPM</last_name>
    <role>Study Director</role>
    <affiliation>Prosonix Limited, Oxford, UK</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dave Singh, MA MD MRCP</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medicines Evaluation Unit, Manchester, UK</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medicines Evaluation Unit</name>
      <address>
        <city>Manchester</city>
        <zip>M23 9QZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>October 4, 2012</study_first_submitted>
  <study_first_submitted_qc>October 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2012</study_first_posted>
  <last_update_submitted>March 29, 2016</last_update_submitted>
  <last_update_submitted_qc>March 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 30, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>glycopyrronium bromide</keyword>
  <keyword>glycopyrrolate</keyword>
  <keyword>oral inhalation</keyword>
  <keyword>COPD</keyword>
  <keyword>chronic obstructive pulmonary disease</keyword>
  <keyword>lung function</keyword>
  <keyword>pharmacokinetics</keyword>
  <keyword>tolerability</keyword>
  <keyword>safety</keyword>
  <keyword>cross-over</keyword>
  <keyword>single-dose</keyword>
  <keyword>dose-ranging</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glycopyrrolate</mesh_term>
    <mesh_term>Bromides</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT01703624
org study id: PSX100201
secondary id: 2012-003791-40
nct id: NCT01703624
lead sponsor: 
has dmc: No
This is an investigation of the beneficial effects, tolerability and safety of a range of
      single doses of orally inhaled glycopyrronium bromide (PSX1002GB pMDI) in male and female
      patients with moderate or severe chronic obstructive pulmonary disease (COPD). COPD is a long
      term and progressive disease of the lungs, generally caused by cigarette smoking, but other
      factors may be involved. Glycopyrronium bromide (GB) appears to be particularly useful in
      dilating the constricted airways of such patients, with a duration of action variously
      described as being between 12 and 24 hours.

      This study will investigate how well tolerated and safe this medication is at a range of
      doses. It will also help in the selection of a suitable dose for larger and repeat dose
      studies, based on measures of lung response. It will also help to determine how often the
      medication should be given; twice daily, or once daily.

      Up to 40 patients will be enrolled into the study, ranging in age from 40 to 75 years of age.
      Patients will be medically assessed before participation to ensure their suitability. The
      study will take place in one centre in the UK over five sessions; at each session one dose (2
      puffs) of GB or one dose (2 puffs) of placebo will be administered from a simple inhaler
      device. Neither staff nor patients will know which dose, or if placebo, is being taken. Lung
      function will be measured for up to 26 hours after the administration of each dose using
      standard spirometry equipment. Blood samples will be taken over a 24-hour period to check the
      blood levels of GB. There will be a period of about a week between each dosing session.
      Patients will be medically reviewed after the study to confirm that no untoward effects are
      present.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Forced Expiratory Volume in one second (FEV1) Area Under the Curve (AUC)
time frame: From time zero to 24-hours
description: FEV1 time-adjusted AUC(0-24 hours)
measure: Forced Expiratory Volume in one second (FEV1) Area Under the Curve (AUC)
time frame: From time zero to 12-hours
description: FEV1 time-adjusted AUC(0-12 hours)
measure: Forced Expiratory Volume in one second (FEV1) Area Under the Curve (AUC)
time frame: From 12 to 24-hours
description: FEV1 time-adjusted AUC(12-24 hours)
measure: Forced Expiratory Volume in one second (FEV1)
time frame: From time zero to 24-hours
description: Serial FEV1 time-point assessments
measure: Forced Vital Capacity (FVC) Area Under the Curve (AUC)
time frame: From time zero to 24-hours
description: FVC time-adjusted AUC(0-24 hours), AUC(0-12 hours), AUC(12-24 hours), serial time-point assessment
measure: Forced Expiratory Volume in one second (FEV1) / Forced Vital Capacity (FVC) ratio
time frame: From time zero to 24-hours
description: Serial FEV1/FVC time-point assessment
measure: Number of subjects reporting adverse events after each treatment as a measure of safety and tolerability
time frame: An average of 9 weeks
description: Adverse event monitoring will begin once a subject provides informed consent and will continue until study participation is concluded; incidence rates will be summarised by system organ class, preferred term, severity and by reported relationship to study drug for each treatment
measure: Systolic blood pressure
time frame: From time zero to 24-hours
description: Descriptive statistics will be presented for the serial measurements by treatment
measure: Diastolic blood pressure
time frame: From time zero to 24-hours
description: Descriptive statistics will be presented for the serial measurements by treatment
measure: Peripheral pulse rate
time frame: From time zero to 24-hours
description: Descriptive statistics will be presented for the serial measurements by treatment
measure: Electrocardiography (ECG)
time frame: From time zero to 24-hours
description: Descriptive statistics will be presented for the serial measurements of each of the standard electrocardiographic (12-lead) parameters by treatment
measure: Clinical hematology
time frame: An average of 9 weeks
description: Clinical hematology measures will be taken at the Screening Visit and at the Safety Follow-up Visit and will consist of: red blood cell count, hemoglobin, hematocrit, mean cell hemoglobin, mean cell hemoglobin concentration, mean cell volume, white blood cell count, differential white blood cell count and platelet count. Data will be summarised using descriptive statistics
measure: Clinical chemistry
time frame: An average of 9 weeks
description: Clinical chemistry measures will be taken at the Screening Visit and at the Safety Follow-up Visit and will consist of: sodium, potassium, urea, creatinine, uric acid, glucose, calcium, inorganic phosphorus, total bilirubin, alkaline phosphatase, alanine transaminase, aspartate transminase, gamma glutamyl transferase, creatine kinase, total protein, albumin, cholesterol and triglycerides. Data will be summarised using descriptive statistics
measure: Plasma glycopyrronium bromide concentration-time Area Under the Curve (AUC)
time frame: From time zero to 24-hours
description: AUC (0-infinity) will be extrapolated from serial measures taken over time zero to 24-hours. The descriptive statistics presented by treatment will be: minimum, median, maximum, geometric mean, arithmetic mean and arithmetic standard deviation
measure: Plasma glycopyrronium bromide peak concentration (Cmax)
time frame: From time zero to 24-hours
description: Cmax will be obtained from serial measures taken over time zero to 24-hours. The descriptive statistics presented by treatment will be: minimum, median, maximum, geometric mean, arithmetic mean and arithmetic standard deviation
measure: Plasma glycopyrronium bromide time to maximum concentration (tmax)
time frame: From time zero to 24-hours
description: tmax will be calculated from serial measures taken over time zero to 24-hours. The descriptive statistics presented by treatment will be: minimum, median, maximum, geometric mean, arithmetic mean and arithmetic standard deviation
measure: Plasma glycopyrronium bromide concentration elimination half-life (t1/2)
time frame: From time zero to 24-hours
description: t1/2 will be calculated from serial measures taken over time zero to 24-hours. The descriptive statistics presented by treatment will be: minimum, median, maximum, geometric mean, arithmetic mean and arithmetic standard deviation
measure: Glycopyrronium bromide total plasma clearance following extravascular administration (CL/F)
time frame: From time zero to 24-hours
description: CL/F will be calculated from serial plasma concentration measures taken over time zero to 24-hours. The descriptive statistics presented by treatment will be: minimum, median, maximum, geometric mean, arithmetic mean and arithmetic standard deviation
measure: Glycopyrronium bromide apparent volume of distribution following extravascular administration (Vz/F)
time frame: From time zero to 24-hours
description: Vz/F will be calculated from serial plasma concentration measures taken over time zero to 24-hours. The descriptive statistics presented by treatment will be: minimum, median, maximum, geometric mean, arithmetic mean and arithmetic standard deviation
arm group label: glycopyrronium bromide 12.5mcg
arm group type: Experimental
description: glycopyrronium bromide 12.5mcg single dose via pressurised metered dose inhaler (pMDI)
arm group label: glycopyrronium bromide 25mcg
arm group type: Experimental
description: glycopyrronium bromide 25mcg single dose via pressurised metered dose inhaler (pMDI)
arm group label: glycopyrronium bromide 50mcg
arm group type: Experimental
description: glycopyrronium bromide 50mcg single dose via pressurised metered dose inhaler (pMDI)
arm group label: glycopyrronium bromide 100mcg
arm group type: Experimental
description: glycopyrronium bromide 100mcg single dose via pressurised metered dose inhaler (pMDI)
arm group label: placebo
arm group type: Placebo Comparator
description: placebo single dose via pressurised metered dose inhaler (pMDI)
intervention type: Drug
intervention name: glycopyrronium bromide
description: glycopyrronium bromide suspension in HFA
arm group label: glycopyrronium bromide 100mcg
arm group label: glycopyrronium bromide 12.5mcg
arm group label: glycopyrronium bromide 25mcg
arm group label: glycopyrronium bromide 50mcg
arm group label: placebo
other name: PSX1002-GB
criteria: 
gender: All
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: No
last name: Geoff Down, MB BS FFPM
role: Study Director
affiliation: Prosonix Limited, Oxford, UK
last name: Dave Singh, MA MD MRCP
role: Principal Investigator
affiliation: Medicines Evaluation Unit, Manchester, UK
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Glycopyrrolate
mesh term: Bromides