RightFit
RecruitingPhase 3

Multi-Center Clean Air Randomized Controlled Trial in COPD

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 1 year

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether home air cleaners can reduce flare-ups of COPD, a long-term lung disease. It also looks at quality of life, ability to do daily activities, and use of quick-relief medicines. It is for adults age 40 or older with COPD who have stopped smoking cigarettes.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are age 40 or older.
  • You report that a doctor diagnosed you with COPD.
  • A breathing test after medicine to open your airways confirms blocked airflow, with an FEV1/FVC ratio below 0.7.
  • You have smoked cigarettes for at least 10 pack-years, such as 1 pack a day for 10 years.
  • You report quitting cigarettes at least 6 months ago. E-cigarette use does not count toward this rule.
  • You meet at least one of these: a COPD symptom score (CAT) of 10 or higher; a breathlessness score (mMRC) of 2 or higher; or a flare-up in the past 12 months that needed steroid medicine, antibiotics, an emergency room visit, or a hospital stay.

Who can't join

  • You live somewhere other than a home, such as a nursing home or long-term care center.
  • You have another long-term lung disease besides COPD. Asthma is allowed.
  • You have a condition expected to limit your life to less than 1 year, or you are in hospice care.
  • You spend more than 2 months a year away from home, or plan to move in the next 12 months.
  • You are pregnant or breastfeeding.
  • You use an air cleaner at home and are not willing to stop using it.
  • You cannot bring air cleaners weighing about 15 pounds each into your home, even with help from a friend or relative.
  • The study doctor thinks you cannot complete the study, including because you may lack internet access, or you are in another trial that tests a treatment or other health intervention.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion criteria To be eligible, subjects must meet all these criteria: 1. Age ≥ 40 years. 2. Self-report of physician diagnosis of COPD. 3. 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) 4. Tobacco exposure ≥ 10 pack-years. This refers to regular cigarette tobacco consumption. 5. Self-reported former smoker of at least 6 months' duration. This does not include e-cigarette use. 6. 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 To be eligible, subjects must not meet any one of these criteria: 1. Living in a location other than home (e.g., long-term care facility, nursing home) 2. Other chronic lung diseases, except asthma 3. Condition with less than a year of life expectancy (e.g., metastatic cancer) or in hospice 4. Spends \>2 months per year in location other than home; or plans to change residence in the next 12 months 5. Pregnant or breastfeeding 6. 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) 7. Inability to bring air cleaners (about 15 pounds each) into home, either by self, friend, or relative 8. Deemed by the study investigator to be unable to complete study protocol, including likely lack of internet connectivity 9. Participating in another interventional clinical trial

Study sites (11)

AL

CA

IA

MA

MD

MI

NH

OH

PA