Status:
COMPLETED
Effects of Bevespi on Ventilation and Gas Exchange Abnormalities in COPD Assessed by 129Xe MRI
Lead Sponsor:
Bastiaan Driehuys
Conditions:
COPD
Eligibility:
All Genders
40+ years
Phase:
PHASE2
PHASE3
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 imag...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 12 2019
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03324607
Start Date
April 20 2018
End Date
November 12 2019
Last Update
January 19 2021
Active Locations (1)
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1
Duke Asthma, Allergy, and Airway Center
Durham, North Carolina, United States, 27705