Multi-Center Clean Air Randomized Controlled Trial in COPD

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary Disease (COPD)

In brief

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.

Key facts

Study ID

NCT06376994

Run by

JHSPH Center for Clinical Trials

People needed

770

Starts

2024-05-24

Expected to finish

2029-08-31

Last updated by the study team

2026-07-31

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.)

You may not qualify if…

• 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

Where it is running

• University of Alabama, Lung Health Center — Birmingham, Alabama, United States (enrolling)
• University of California, Los Angeles — Los Angeles, California, United States (enrolling)
• University of Iowa — Iowa City, Iowa, United States (enrolling)
• University of Maryland — Baltimore, Maryland, United States (enrolling)
• Johns Hopkins — Baltimore, Maryland, United States (enrolling)
• Tidal Health — Salisbury, Maryland, United States (enrolling)
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (enrolling)
• University of Michigan — Ann Arbor, Michigan, United States (enrolling)
• Dartmouth Hitchcock — Lebanon, New Hampshire, United States (enrolling)
• Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
• Reading Hospital — West Reading, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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