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Effects of Bevespi on Ventilation and Gas Exchange Abnormalities in COPD Assessed by 129Xe MRI (COPD)

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ClinicalTrials.gov Identifier: NCT03324607
Recruitment Status : Recruiting
First Posted : October 27, 2017
Last Update Posted : July 4, 2018
Sponsor:
Information provided by (Responsible Party):
Bastiaan Driehuys, Duke University

Brief Summary:
The purpose of this study is to determine whether the new inhaler, Bevespi improves lung function. Magnetic resonance imaging (MRI) using inhaled hyperpolarized 129Xe gas, that can provide useful images of the functioning of the lung will be used as a new measure to determine change in function. The investigator anticipate these images will provide more specific information about lung disease than standard lung function tests in response to treatment.

Condition or disease Intervention/treatment Phase
Copd Drug: hyperpolarized 129Xe gas MRI Drug: Bevespi Aerosphere Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Effects of Glycopyrrolate/Formoterol (Bevespi) on Ventilation and Gas Exchange Abnormalities in COPD Assessed by 129Xe MRI
Actual Study Start Date : April 20, 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Intervention Details:
  • Drug: hyperpolarized 129Xe gas MRI
    There will be MRI imaging before the treatment with Bevespi and another one 2 weeks after use Bevespi. Images obtained using 129Xe MRI will be compared with standard lung function tests that are used routinely in the clinic, 6 minute walk test that assesses walking ability and several questionnaires that assess shortness of breath and life quality.
  • Drug: Bevespi Aerosphere
    There will be MRI imaging before the treatment with Bevespi and another one 2 weeks after use Bevespi.


Primary Outcome Measures :
  1. Change in ventilation distribution [ Time Frame: Baseline, Week 2 ]
    Assessment of ventilation distribution

  2. Change in dissuion distribution [ Time Frame: Baseline, Week 2 ]
    Assessment of dissuion distribution

  3. Change in perfusion distribution [ Time Frame: Baseline, Week 2 ]
    Assessment of perfusion distribution


Secondary Outcome Measures :
  1. pulmonary function test - forced vital capacity (FVC) [ Time Frame: Will be measured and compared baseline to 2 weeks ]
    FVC: lung airflow measure

  2. pulmonary function test - forced expiratory volume-one second (FEV1) [ Time Frame: Will be measured and compared baseline to 2 weeks ]
    FEV1: lung airflow measure

  3. pulmonary function test - forced expiratory flow at 25-75% (FEF25-75) [ Time Frame: Will be measured and compared baseline to 2 weeks ]
    FEF25-75: forced expiratory flow

  4. pulmonary function test - total lung capacity (TLC) [ Time Frame: Will be measured and compared baseline to 2 weeks ]
    TLC: the volume in the lungs at maximal inflation

  5. pulmonary function test - residual volume (RV) [ Time Frame: Will be measured and compared baseline to 2 weeks ]
    RV: the volume of air remaining in the lungs after a maximal exhalation

  6. pulmonary function test - residual volume expressed as percent of TLC (RV/TLC) [ Time Frame: Will be measured and compared baseline to 2 weeks ]
    RV/TLC: residual volume expressed as percent of TLC

  7. pulmonary function test - diffusing capacity of the lung for carbon monoxide (DLCO) [ Time Frame: Will be measured and compared baseline to 2 weeks ]
    DLCO: how much oxygen travels from the air sacs of the lungs to the blood stream

  8. 6-minute walk test [ Time Frame: Will be measured and compared baseline to 2 weeks ]
    a test that measures the distance you can walk at your natural pace for 6 minutes

  9. St. Georges's questionnaire [ Time Frame: Will be measured and compared baseline to 2 weeks ]
    patient reported outcome, to measure the quality of life

  10. Borg dyspnea scale [ Time Frame: Will be measured and compared baseline to 2 weeks ]
    patient reported outcome,to measure of perceived exertion during physical activity



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of COPD confirmed by post-bronchodilator spirometry demonstrating FEV1/FVC < 0.70 and FEV1 in GOLD 2 or 3 stage (30%≤ FEV1 < 80%)
  • Willing and able to give informed consent and adhere to visit/protocol schedules
  • Women of childbearing potential must have a negative urine pregnancy test

Exclusion Criteria:

  • Upper respiratory tract infection within 6 weeks
  • Chronic systemic corticosteroid use > 10 mg/day of prednisone

    • Chronic oxygen use (intermittent or continuous)
    • Previous lung resection surgery or decortication
    • Previous history of pneumothorax
    • Evidence of interstitial, occupational or chronic infectious lung disease by imaging studies
    • History of exposure to occupational or environmental hazards that are known to cause lung diseases
    • For women of child bearing potential, positive pregnancy test
    • Major chronic illnesses which in the judgement of the study physician would interfere with participation in the study
    • Patients who are not willing to withhold COPD inhalers for the run-in period.

      • MRI is contraindicated based on responses to MRI screening questionnaire
      • Subject is pregnant or lactating
      • Respiratory illness of a bacterial or viral etiology within 30 days of MRI
      • Subject has any form of known cardiac arrhythmia
      • Subject does not fit into 129Xe vest coil used for MRI
      • Subject cannot hold his/her breath for 15 seconds
      • Subject deemed unlikely to be able to comply with instructions during imaging

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03324607


Contacts
Contact: Heather Kuehn 919-479-0719 heather.kuehn@duke.edu

Locations
United States, North Carolina
Duke Asthma, Allergy, and Airway Center Recruiting
Durham, North Carolina, United States, 27705
Contact: Erika Coleman    919-479-0861      
Sponsors and Collaborators
Bastiaan Driehuys
Investigators
Principal Investigator: Yuh Chin Huang, MD Duke University

Responsible Party: Bastiaan Driehuys, Professor of Radiology, Duke University
ClinicalTrials.gov Identifier: NCT03324607     History of Changes
Other Study ID Numbers: Pro00086693
First Posted: October 27, 2017    Key Record Dates
Last Update Posted: July 4, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Glycopyrrolate
Formoterol Fumarate
Adjuvants, Anesthesia
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents