Multi-Center Clean Air Randomized Controlled Trial in COPD
JHSPH Center for Clinical Trials
770 participants
May 24, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- To be eligible, subjects must meet all these criteria:
- Age ≥ 40 years.
- Self-report of physician diagnosis of COPD.
- 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)
- Tobacco exposure ≥ 10 pack-years. This refers to regular cigarette tobacco consumption.
- Self-reported former smoker of at least 6 months' duration. This does not include e-cigarette use.
- COPD Assessment Test (CAT) score ≥ 10, Modified Medical Research Council dyspnea scale (mMRC) ≥ 2, or history of moderate or severe exacerbation in the past 12 months (as defined by history of receiving a course of systemic corticosteroids or antibiotics for respiratory problems; or visiting an emergency department or being hospitalized for a COPD exacerbation within the past 12 months.)
Exclusion Criteria10
- To be eligible, subjects must not meet any one of these criteria:
- Living in a location other than home (e.g., long-term care facility, nursing home)
- Other chronic lung diseases, except asthma
- Condition with less than a year of life expectancy (e.g., metastatic cancer) or in hospice
- Spends \>2 months per year in location other than home; or plans to change residence in the next 12 months
- Pregnant or breastfeeding
- Current air cleaner use in the home (\*If the individual is willing to discontinue use of the personal air cleaner, this person can be eligible if all other eligibility has been met)
- Inability to bring air cleaners (about 15 pounds each) into home, either by self, friend, or relative
- Deemed by the study investigator to be unable to complete study protocol, including likely lack of internet connectivity
- Participating in another interventional clinical trial
Interventions
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.
Locations(11)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06376994