Multi-Center Clean Air Randomized Controlled Trial in COPD
JHSPH Center for Clinical Trials
Summary
This is a multi-center randomized, sham-controlled clinical trial to determine the effectiveness of an air cleaner intervention aimed at improving indoor air quality on reducing COPD exacerbation risk and improving quality of life, functional status, rescue medication use.
Description
The Multi-Center Clean Air Randomized Controlled Trial in COPD (Clean Air) is a multi-center, prospective, randomized, double-blind, sham-controlled trial that will enroll 770 former smokers with COPD over a 4-year period and follow participants at regular intervals for one year. The primary endpoint is respiratory specific quality of life. Secondary endpoints include rate of acute exacerbations, rescue medication use, quality of life, and cost-effectiveness.
Eligibility
- Age range
- 40+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion criteria To be eligible, subjects must meet all these criteria: 1. Age ≥ 40 years. 2. Self-report of physician diagnosis of COPD. 3. Spirometry confirmed airway obstruction (post-bronchodilator spirometry of forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) \< 0.7) as defined by the Global Initiative for Obstructive Lung Disease (GOLD) criteria (6, 11) 4. Tobacco exposure ≥ 10 pack-years. This refers to regular cigarette tobacco consumption. 5. Self-reported former smoker of at least 6 months' duration. This does not include e-cigarette use. 6. COPD Assessment…