<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/NCT02207452</url>
  </required_header>
  <id_info>
    <org_study_id>111175</org_study_id>
    <nct_id>NCT02207452</nct_id>
  </id_info>
  <brief_title>Helium-3 MRI Imaging Study in COPD</brief_title>
  <official_title>A Randomized, Methodology Study to Investigate the Use of 3He-MRI Lung Ventilation and Proton MRI Perfusion Imaging to Detect Changes in Ventilation Perfusion Relationships in Chronic Obstructive Pulmonary Disease (COPD) Patients; a Proof of Concept Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <brief_summary>
    <textblock>
      This protocol describes the investigation of the use of hyperpolarised helium magnetic&#xD;
      resonance imaging (MRI) in reflecting the regional differences in lung function of moderate&#xD;
      to severe Chronic Obstructive Pulmonary Disease (COPD) patients.&#xD;
&#xD;
      Since finalisation of the original protocol, new medications for COPD have received Market&#xD;
      Authorisation Approvals. Protocol Amendment 02 has been prepared to include these medications&#xD;
      in the protocol eligibility criteria and restrictions for the study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic Obstructive Pulmonary Disease (COPD) is an important cause of morbidity, mortality,&#xD;
      and healthcare costs worldwide. COPD is characterized by progressive airflow limitation that&#xD;
      is not fully reversible and is associated with an abnormal inflammatory response of the lungs&#xD;
      to noxious particles or gases. It has become clear that simple measures of airflow&#xD;
      obstruction are inadequate to relate lung function to exercise capacity or symptoms, and that&#xD;
      complex expressions such as dynamic hyper-inflation need to be invoked in seeking to&#xD;
      understand overall physiology. In addition to abnormalities of air flow, gas exchange is also&#xD;
      deranged. Therefore in considering new treatment approaches, both abnormalities need to be&#xD;
      addressed.&#xD;
&#xD;
      Techniques to study ventilation variation and perfusion matching across the lung exist but&#xD;
      are invasive and exacting, and do not give an indication of the anatomical distribution of&#xD;
      changes. There is a clear need for techniques which can provide sensitive, useful and safe&#xD;
      repeated measures reflecting regional changes in ventilation and gas exchange in COPD. This&#xD;
      study investigates use of hyperpolarised helium magnetic resonance imaging (MRI) in&#xD;
      reflecting the regional differences in lung function of moderate to severe COPD patients. A&#xD;
      Beta2 bronchodilator - Salbutamol - and a anticholinergic - Ipratropium - will be used in&#xD;
      this study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 5, 2010</start_date>
  <completion_date type="Actual">July 4, 2011</completion_date>
  <primary_completion_date type="Actual">July 4, 2011</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in Oxygen Saturation</measure>
    <time_frame>Baseline measurement at screening visit (up to 30 days prior to first dose). Pre-treatment Day 1 (0.5-2 hours pre-dose) and post-dose Day 1 (1 hour post dose), for both treatment periods.</time_frame>
    <description>To correlate changes in oxygen saturation pre- and post- bronchodilator (as a reflection of ventilation/perfusion matching) with changes in distribution of regional ventilation/perfusion (V/Q) demonstrated by hyperpolarized helium ventilation MRI/spatially registered proton perfusion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in distribution of regional ventilation/perfusion assessed by spatially registered Helium-3 Magnetic Resonance Imaging (MRI) and proton perfusion MRI.</measure>
    <time_frame>Pre-treatment Day 1 (0.5-2 hours pre-dose) and post-dose Day 1 (1 hour post-dose), for both treatment periods.</time_frame>
    <description>To correlate changes in oxygen saturation pre- and post- bronchodilator (as a reflection of ventilation/perfusion matching) with changes in distribution of regional ventilation/perfusion (V/Q) demonstrated by hyperpolarized helium ventilation MRI/spatially registered proton perfusion.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in lung volumes.</measure>
    <time_frame>Pre-treatment Day 1 (0.5-2 hours pre-dose) and post-dose Day 1 (1 hour post-dose), for both treatment periods.</time_frame>
    <description>To compare lung volumes assessed by plethysmography with registered Helium-3 ventilation MRI and proton MRI.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in standard lung function parameters.</measure>
    <time_frame>Baseline measurement at screening visit (up to 30 days prior to first dose). Pre-treatment Day 1 (0.5-2 hours pre-dose) and post-dose Day 1 (1 hour post dose), for both treatment periods.</time_frame>
    <description>To compare changes in ventilatory parameters as assessed by pulmonary function tests (spirometry) and Helium-3 MRI.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of adverse events</measure>
    <time_frame>From screening (up to 30 days prior to Day 1) to follow-up (7-14 days after last dose).</time_frame>
    <description>To monitor the safety of Helium-3 MRI through adverse events and clinical lung function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reproducibility of Helium-3 MRI</measure>
    <time_frame>Pre-treatment Day 1 (0.5-2 hours pre-dose) for both treatment periods.</time_frame>
    <description>To evaluate reproducibility of Helium-3 MRI (pre-bronchodilator) over a 2 week period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptomatic effects of bronchodilators.</measure>
    <time_frame>Pre-treatment Day 1 (0.5-2 hours pre-dose) and post-dose Day 1 (1 hour post-dose), for both treatment periods.</time_frame>
    <description>To correlate the symptomatic effects of bronchodilators with measures of lung function derived from physiological measures and from 3He MRI and proton MRI.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Regional lung oxygen uptake (pO2)</measure>
    <time_frame>Pre-treatment Day 1 (0.5-2 hours pre-dose) and post-dose Day 1 (1 hour post-dose), for both treatment periods.</time_frame>
    <description>To compare regional oxygen uptake (direct V/Q) from 3He MRI pO2 mapping with regional V/Q derived from the ratio of 3He ventilation MRI (V) and spatially registered contrast enhanced proton perfusion MRI (Q).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in breathlessness</measure>
    <time_frame>From screening (up to 30 days prior to Day 1) to follow-up (7-14 days after last dose).</time_frame>
    <description>Change in breathlessness according to the Modified Borg Scale of breathlessness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Helium-3 apparent diffusion coefficient measurements</measure>
    <time_frame>Pre-treatment Day 1 (0.5-2 hours pre-dose) and post-dose Day 1 (1 hour post-dose), for both treatment periods.</time_frame>
    <description>Helium-3 apparent diffusion coefficient measurements (sensitivity to emphysematous alveolar destruction and minor airway size).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of flow velocities in major airways</measure>
    <time_frame>Pre-treatment Day 1 (0.5-2 hours pre-dose) and post-dose Day 1 (1 hour post-dose), for both treatment periods.</time_frame>
    <description>Distribution of flow velocities in major airways assessed by helium-3 MRI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in dyspnoea</measure>
    <time_frame>From screening (up to 30 days prior to first dose) to follow-up (7-14 days after last dose).</time_frame>
    <description>Changes in shortness of breath/air hunger monitored throughout the study.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Pulmonary Disease, Chronic Obstructive</condition>
  <arm_group>
    <arm_group_label>Salbutamol + Ipratropium</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Treatment period 1: Salbutamol 5mg nebulised, single Dose. Treatment period 2: Ipratropium 500mcg nebulised, single dose.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ipratropium + Salbutamol</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Treatment period 1: Ipratropium 500mcg nebulised, single dose. Treatment period 2: Salbutamol 5mg nebulised, single Dose.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>He-3 MRI</intervention_name>
    <description>Hyperpolarised helium-3 Magnetic Resonance Imaging (MRI) scan pre-bronchodilator and 1 hour post-bronchodilator (after 1 hour post-bronchodilator assessments/procedures completed).</description>
    <arm_group_label>Ipratropium + Salbutamol</arm_group_label>
    <arm_group_label>Salbutamol + Ipratropium</arm_group_label>
    <other_name>Hyperpolarised Helium-3 MRI</other_name>
    <other_name>He-3 Magnetic Resonance Imaging</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Salbutamol</intervention_name>
    <description>Salbutamol 5mg nebulised single dose</description>
    <arm_group_label>Ipratropium + Salbutamol</arm_group_label>
    <arm_group_label>Salbutamol + Ipratropium</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ipratropium</intervention_name>
    <description>Ipratropium 500mcg nebulised single dose</description>
    <arm_group_label>Ipratropium + Salbutamol</arm_group_label>
    <arm_group_label>Salbutamol + Ipratropium</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MRI</intervention_name>
    <description>Proton Magnetic Resonance Imaging (MRI) scan pre-bronchodilator and 1 hour post-bronchodilator (after 1 hour post-bronchodilator assessments/procedures completed).</description>
    <arm_group_label>Ipratropium + Salbutamol</arm_group_label>
    <arm_group_label>Salbutamol + Ipratropium</arm_group_label>
    <other_name>1H MRI</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) diagnosis: an established&#xD;
        clinical history of chronic pulmonary disorder in accordance with the following description&#xD;
        by the American Thoracic Society / European Respiratory Society [ATS / ETS, 2004]&#xD;
&#xD;
        Chronic obstructive pulmonary disease is a preventable and treatable disease characterised&#xD;
        by airflow limitation that is not fully reversible. The airflow limitation is usually&#xD;
        progressive and is associated with an abnormal inflammatory response of the lungs to&#xD;
        noxious particles or gases, primarily caused by cigarette smoking. Although COPD affects&#xD;
        the lungs, it also produces significant systemic consequences.&#xD;
&#xD;
          -  The patient is clinically stable with no change in symptoms or medication, no&#xD;
             admissions to hospital, and with neither antibiotic therapy nor systemic steroid use&#xD;
             for at least 6 weeks prior to screening. (Screening may be rescheduled after an&#xD;
             appropriate period of stability)&#xD;
&#xD;
          -  Male and female patients aged ≥50 years&#xD;
&#xD;
          -  A female patient is eligible to participate if she is of non-childbearing potential&#xD;
             defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or&#xD;
             postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a&#xD;
             blood sample with simultaneous follicle stimulating hormone (FSH) ≥40 M1U/mL and&#xD;
             estradiol ≤ 40 pg/mL (≤140 pmol/L) is confirmatory).&#xD;
&#xD;
          -  Subjects have refrained from short-acting bronchodilators for 8 hours, long-acting&#xD;
             β2-agonists (including any long-acting β2 agonist containing inhaler) and&#xD;
             theophyllines for 24 hours and Tiotropium, phosphodiesterase-4 (PDE4) inhibitors (e.g.&#xD;
             Roflumilast) and ultra long-acting beta-adrenoceptor agonists (e.g. Indacaterol) for&#xD;
             48 hours prior to admission to the unit on study days.&#xD;
&#xD;
          -  Subjects with a post-bronchodilator FEV1 to FVC ratio (FEV1/FVC) &lt; 0.7&#xD;
&#xD;
          -  Subjects with a post-bronchodilator FEV1 ≥ 30% and ≤ 80% of predicted normal for&#xD;
             height, age and sex at screening.&#xD;
&#xD;
          -  Subjects with a cigarette smoking history of ≥10 pack years (1 pack year = 20&#xD;
             cigarettes smoked per day for 1 year or the equivalent). Both current and former&#xD;
             smokers are eligible to be enrolled.&#xD;
&#xD;
          -  Resting SpO2 of &gt;90% on room air&#xD;
&#xD;
          -  QTcB or QTcF &lt; 450 msec; or QTc &lt; 480 msec in subjects with Bundle Branch Block (based&#xD;
             on a single ECG value).&#xD;
&#xD;
          -  The patient is able to understand and comply with protocol requirements, instructions&#xD;
             and protocol-stated restrictions, and to give informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unstable cardiac disease or history of clinically significant arrhythmia (including&#xD;
             established atrial fibrillation).&#xD;
&#xD;
          -  Patients with a primary diagnosis of α-1 antitrypsin deficiency.&#xD;
&#xD;
          -  Patients with other significant respiratory disorders.&#xD;
&#xD;
          -  Patients with any acute infection, exacerbation of COPD or other unstable medical&#xD;
             condition.&#xD;
&#xD;
          -  Patients in whom inhaled beta-2 agonists or anticholinergics are contraindicated.&#xD;
&#xD;
          -  Patients who have undergone thoracic surgery including lung volume reduction surgery&#xD;
             or have conditions that prevent them from performing spirometry and other&#xD;
             physiological testing.&#xD;
&#xD;
          -  Patients who are non Magnetic Resonance Imaging (MRI) compatible (ferro-magnetic&#xD;
             metallic implants, pacemakers) as per the MRI questionnaire.&#xD;
&#xD;
          -  Patients with renal complaints relating to potential adverse reactions to Gd-DTPA&#xD;
             intravascular MRI contrast agent.&#xD;
&#xD;
          -  Patients who suffer from claustrophobia.&#xD;
&#xD;
          -  The patient has participated in a clinical trial and has received an investigational&#xD;
             product within the following time period prior to the first study day in the current&#xD;
             study: 30 days, 5 half-lives or twice the duration of the biological effect of the&#xD;
             investigational product (whichever is longer) of that study.&#xD;
&#xD;
          -  Exposure to more than four new chemical entities within 12 months prior to the first&#xD;
             dosing day.&#xD;
&#xD;
          -  History of sensitivity to any of the study medications, or components thereof or a&#xD;
             history of drug or other allergy that, in the opinion of the investigator or GSK&#xD;
             Medical Monitor, contraindicates their participation.&#xD;
&#xD;
          -  Subjects must abstain from taking prescription (not related to their COPD) or&#xD;
             nonprescription drugs (including vitamins and dietary or herbal supplements), within 7&#xD;
             days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever&#xD;
             is longer) prior to the first study day until completion of the follow-up visit,&#xD;
             unless in the opinion of the Investigator and sponsor the medication will not&#xD;
             interfere with the study.&#xD;
&#xD;
          -  Unwillingness or inability to follow the procedures outlined in the protocol.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 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>Sheffield</city>
        <zip>S10 2JF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>January 12, 2012</study_first_submitted>
  <study_first_submitted_qc>July 31, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 4, 2014</study_first_posted>
  <last_update_submitted>June 26, 2017</last_update_submitted>
  <last_update_submitted_qc>June 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hyperpolarised helium-3</keyword>
  <keyword>Lung Imaging</keyword>
  <keyword>Magnetic Resonance Imaging</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</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>Albuterol</mesh_term>
    <mesh_term>Ipratropium</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/NCT02207452
org study id: 111175
nct id: NCT02207452
lead sponsor: 
This protocol describes the investigation of the use of hyperpolarised helium magnetic
      resonance imaging (MRI) in reflecting the regional differences in lung function of moderate
      to severe Chronic Obstructive Pulmonary Disease (COPD) patients.

      Since finalisation of the original protocol, new medications for COPD have received Market
      Authorisation Approvals. Protocol Amendment 02 has been prepared to include these medications
      in the protocol eligibility criteria and restrictions for the study.
Chronic Obstructive Pulmonary Disease (COPD) is an important cause of morbidity, mortality,
      and healthcare costs worldwide. COPD is characterized by progressive airflow limitation that
      is not fully reversible and is associated with an abnormal inflammatory response of the lungs
      to noxious particles or gases. It has become clear that simple measures of airflow
      obstruction are inadequate to relate lung function to exercise capacity or symptoms, and that
      complex expressions such as dynamic hyper-inflation need to be invoked in seeking to
      understand overall physiology. In addition to abnormalities of air flow, gas exchange is also
      deranged. Therefore in considering new treatment approaches, both abnormalities need to be
      addressed.

      Techniques to study ventilation variation and perfusion matching across the lung exist but
      are invasive and exacting, and do not give an indication of the anatomical distribution of
      changes. There is a clear need for techniques which can provide sensitive, useful and safe
      repeated measures reflecting regional changes in ventilation and gas exchange in COPD. This
      study investigates use of hyperpolarised helium magnetic resonance imaging (MRI) in
      reflecting the regional differences in lung function of moderate to severe COPD patients. A
      Beta2 bronchodilator - Salbutamol - and a anticholinergic - Ipratropium - will be used in
      this study.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Changes in Oxygen Saturation
time frame: Baseline measurement at screening visit (up to 30 days prior to first dose). Pre-treatment Day 1 (0.5-2 hours pre-dose) and post-dose Day 1 (1 hour post dose), for both treatment periods.
description: To correlate changes in oxygen saturation pre- and post- bronchodilator (as a reflection of ventilation/perfusion matching) with changes in distribution of regional ventilation/perfusion (V/Q) demonstrated by hyperpolarized helium ventilation MRI/spatially registered proton perfusion.
measure: Changes in distribution of regional ventilation/perfusion assessed by spatially registered Helium-3 Magnetic Resonance Imaging (MRI) and proton perfusion MRI.
time frame: Pre-treatment Day 1 (0.5-2 hours pre-dose) and post-dose Day 1 (1 hour post-dose), for both treatment periods.
description: To correlate changes in oxygen saturation pre- and post- bronchodilator (as a reflection of ventilation/perfusion matching) with changes in distribution of regional ventilation/perfusion (V/Q) demonstrated by hyperpolarized helium ventilation MRI/spatially registered proton perfusion.
measure: Changes in lung volumes.
time frame: Pre-treatment Day 1 (0.5-2 hours pre-dose) and post-dose Day 1 (1 hour post-dose), for both treatment periods.
description: To compare lung volumes assessed by plethysmography with registered Helium-3 ventilation MRI and proton MRI.
measure: Changes in standard lung function parameters.
time frame: Baseline measurement at screening visit (up to 30 days prior to first dose). Pre-treatment Day 1 (0.5-2 hours pre-dose) and post-dose Day 1 (1 hour post dose), for both treatment periods.
description: To compare changes in ventilatory parameters as assessed by pulmonary function tests (spirometry) and Helium-3 MRI.
measure: Number of adverse events
time frame: From screening (up to 30 days prior to Day 1) to follow-up (7-14 days after last dose).
description: To monitor the safety of Helium-3 MRI through adverse events and clinical lung function.
measure: Reproducibility of Helium-3 MRI
time frame: Pre-treatment Day 1 (0.5-2 hours pre-dose) for both treatment periods.
description: To evaluate reproducibility of Helium-3 MRI (pre-bronchodilator) over a 2 week period.
measure: Symptomatic effects of bronchodilators.
time frame: Pre-treatment Day 1 (0.5-2 hours pre-dose) and post-dose Day 1 (1 hour post-dose), for both treatment periods.
description: To correlate the symptomatic effects of bronchodilators with measures of lung function derived from physiological measures and from 3He MRI and proton MRI.
measure: Regional lung oxygen uptake (pO2)
time frame: Pre-treatment Day 1 (0.5-2 hours pre-dose) and post-dose Day 1 (1 hour post-dose), for both treatment periods.
description: To compare regional oxygen uptake (direct V/Q) from 3He MRI pO2 mapping with regional V/Q derived from the ratio of 3He ventilation MRI (V) and spatially registered contrast enhanced proton perfusion MRI (Q).
measure: Change in breathlessness
time frame: From screening (up to 30 days prior to Day 1) to follow-up (7-14 days after last dose).
description: Change in breathlessness according to the Modified Borg Scale of breathlessness.
measure: Helium-3 apparent diffusion coefficient measurements
time frame: Pre-treatment Day 1 (0.5-2 hours pre-dose) and post-dose Day 1 (1 hour post-dose), for both treatment periods.
description: Helium-3 apparent diffusion coefficient measurements (sensitivity to emphysematous alveolar destruction and minor airway size).
measure: Distribution of flow velocities in major airways
time frame: Pre-treatment Day 1 (0.5-2 hours pre-dose) and post-dose Day 1 (1 hour post-dose), for both treatment periods.
description: Distribution of flow velocities in major airways assessed by helium-3 MRI
measure: Changes in dyspnoea
time frame: From screening (up to 30 days prior to first dose) to follow-up (7-14 days after last dose).
description: Changes in shortness of breath/air hunger monitored throughout the study.
arm group label: Salbutamol + Ipratropium
arm group type: Other
description: Treatment period 1: Salbutamol 5mg nebulised, single Dose. Treatment period 2: Ipratropium 500mcg nebulised, single dose.
arm group label: Ipratropium + Salbutamol
arm group type: Other
description: Treatment period 1: Ipratropium 500mcg nebulised, single dose. Treatment period 2: Salbutamol 5mg nebulised, single Dose.
intervention type: Device
intervention name: He-3 MRI
description: Hyperpolarised helium-3 Magnetic Resonance Imaging (MRI) scan pre-bronchodilator and 1 hour post-bronchodilator (after 1 hour post-bronchodilator assessments/procedures completed).
arm group label: Ipratropium + Salbutamol
arm group label: Salbutamol + Ipratropium
other name: Hyperpolarised Helium-3 MRI
other name: He-3 Magnetic Resonance Imaging
intervention type: Drug
intervention name: Salbutamol
description: Salbutamol 5mg nebulised single dose
arm group label: Ipratropium + Salbutamol
arm group label: Salbutamol + Ipratropium
intervention type: Drug
intervention name: Ipratropium
description: Ipratropium 500mcg nebulised single dose
arm group label: Ipratropium + Salbutamol
arm group label: Salbutamol + Ipratropium
intervention type: Device
intervention name: MRI
description: Proton Magnetic Resonance Imaging (MRI) scan pre-bronchodilator and 1 hour post-bronchodilator (after 1 hour post-bronchodilator assessments/procedures completed).
arm group label: Ipratropium + Salbutamol
arm group label: Salbutamol + Ipratropium
other name: 1H MRI
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Albuterol
mesh term: Ipratropium