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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
770
The intervention is two active air cleaners with high efficiency particulate air (HEPA) filters which remove PM, as well as activated carbon filters to remove NO2 (and other trace gases). These will be run for a year in a participant's house.
The sham intervention is 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. These will be run for a year in a participant's house.
University of Alabama, Lung Health Center
Birmingham, Alabama, United States
RECRUITINGUniversity of California, Los Angeles
Los Angeles, California, United States
RECRUITINGSt. George's Respiratory Questionnaire (SGRQ)
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.
Time frame: baseline and 3, 6, 9, and 12 months after baseline
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University of Iowa
Iowa City, Iowa, United States
RECRUITINGUniversity of Maryland
Baltimore, Maryland, United States
RECRUITINGJohns Hopkins
Baltimore, Maryland, United States
RECRUITINGTidal Health
Salisbury, Maryland, United States
RECRUITINGBeth Israel Deaconess Medical Center
Boston, Massachusetts, United States
NOT_YET_RECRUITINGUniversity of Michigan
Ann Arbor, Michigan, United States
RECRUITINGDartmouth Hitchcock
Lebanon, New Hampshire, United States
NOT_YET_RECRUITINGCleveland Clinic
Cleveland, Ohio, United States
NOT_YET_RECRUITING...and 1 more locations