Multi-Center Clean Air Randomized Controlled Trial in COPD
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Interventions
- Device: Air cleanerDevice: Sham air cleaner
- Registration Number
- NCT06376994
- Lead Sponsor
- JHSPH Center for Clinical Trials
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 770
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active air cleaner Air cleaner The active arm will receive two active air cleaners with high efficiency particulate air (HEPA) filters which remove particulate matter (PM), as well as activated carbon filters to remove Nitrogen Dioxide (NO2) and other trace gases. Sham air cleaner Sham air cleaner The sham control treatment arm will receive two sham air cleaners that have the internal HEPA and carbon filters removed, but which will run normally, including similar noise, airflow, and overall appearance compared to active air cleaners, thus blinding participants to filter status.
- Primary Outcome Measures
Name Time Method St. George's Respiratory Questionnaire (SGRQ) baseline and 3, 6, 9, and 12 months after baseline The St. George's Respiratory Questionnaire (SGRQ) is a widely used measure of disease impact as an indicator of disease-specific quality of life. The SGRQ is a disease specific instrument containing 50 items in three subscales (symptoms, activity, and impact). Scores range from 0 to 100, with higher scores indicating more limitations.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (8)
University of Alabama, Lung Health Center
🇺🇸Birmingham, Alabama, United States
University of California, Los Angeles
🇺🇸Los Angeles, California, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Tidal Health
🇺🇸Salisbury, Maryland, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Reading Hospital
🇺🇸West Reading, Pennsylvania, United States