Multi-Center Clean Air Randomized Controlled Trial in COPD
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age40+
SponsorJHSPH Center for Clinical Trials
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Air cleaner
DeviceThe 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.
Sham air cleaner
DeviceThe 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.
Treatment groups
770 Participants
are divided into 2 treatment groupsGroup A: Active air cleanerExperimental treatment 1 intervention
Group B: Sham air cleanerSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
St. 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 baselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
JHSPH Center for Clinical Trials
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov