Clinical trial NCT03324607: Effects of Bevespi on Ventilation and Gas Exchange Abnormalities in COPD Assessed by 129Xe MRI
Official title: Effects of Glycopyrrolate/Formoterol (Bevespi) on Ventilation and Gas Exchange Abnormalities in COPD Assessed by 129Xe MRI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: COPD
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2017-10-27
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Detailed description: The study will characterize ventilation and gas transfer distributions in GOLD II and III COPD patients and assess the potential for these physiological parameters as a novel phenotyping method using Magnetic resonance imaging (MRI) using inhaled hyperpolarized 129Xe gas.

The study will additionally quantify regional ventilation and gas transfer response to glycopyrrolate/formoterol in GOLD II and III COPD patients.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of COPD confirmed by post-bronchodilator spirometry demonstrating (forced expiratory volume at 1 second(FEV1)/forced vital capacity (FVC) \< 0.70 and forced expiratory volume at 1 second (FEV1) in GOLD 2 or 3 stage (30%≤ (forced expiratory volume at 1 second \[FEV1\] \< 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

Primary outcomes:
measure: Ventilation Distribution as Measured by Ventilation Defect+Low Percent
timeFrame: Week 2
measure: Barrier Uptake.
timeFrame: 2 weeks
measure: Red Blood Cell (RBC) Uptake
timeFrame: 2 weeks
Secondary outcomes:
measure: Pulmonary Function Test - Forced Vital Capacity (FVC)
timeFrame: 2 weeks
measure: Pulmonary Function Test - Forced Expiratory Volume-one Second (FEV1)
timeFrame: 2 weeks
measure: Pulmonary Function Test - Total Lung Capacity (TLC)
timeFrame: 2 weeks
measure: Pulmonary Function Test - Residual Volume (RV)
timeFrame: 2 weeks
measure: Pulmonary Function Test - Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)
timeFrame: 2 weeks
measure: 6-minute Walk Test (6MWT)
timeFrame: 2 weeks
measure: St. George's Respiratory Questionnaire (SGRQ) Score
timeFrame: 2 weeks
measure: Rating of Perceived Dyspnea (RPD) Scale
timeFrame: 2 weeks
measure: COPD Assessment Test (CAT) Score
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Asthma, Allergy, and Airway Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Yuh Chin Huang, MD
role: PRINCIPAL_INVESTIGATOR
References: