Multi-Center Clean Air Randomized Controlled Trial in COPD (NCT06376994) | Clinical Trial Compass
RecruitingPhase 3
Multi-Center Clean Air Randomized Controlled Trial in COPD
United States770 participantsStarted 2024-05-24
Plain-language 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.
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
St. George's Respiratory Questionnaire (SGRQ)
Timeframe: baseline and 3, 6, 9, and 12 months after baseline
. 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