Multi-Center Clean Air Randomized Controlled Trial in COPD

Last updated: October 8, 2025
Sponsor: JHSPH Center for Clinical Trials
Overall Status: Active - Recruiting

Phase

3

Condition

Chronic Bronchitis

Bronchiectasis

Emphysema

Treatment

Air cleaner

Sham air cleaner

Clinical Study ID

NCT06376994
IRB00407311
1U24HL169566-01
  • Ages > 40
  • All Genders

Study 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 Criteria

Inclusion

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 Design

Total Participants: 770
Treatment Group(s): 2
Primary Treatment: Air cleaner
Phase: 3
Study Start date:
May 24, 2024
Estimated Completion Date:
November 30, 2029

Study Description

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. The primary endpoint is respiratory specific quality of life. Secondary endpoints include rate of acute exacerbations, rescue medication use, quality of life, and cost-effectiveness.

Connect with a study center

  • University of Alabama, Lung Health Center

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • University of Alabama, Lung Health Center

    Birmingham 4049979, Alabama 4829764 35233
    United States

    Active - Recruiting

  • University of California, Los Angeles

    Los Angeles, California 90095
    United States

    Site Not Available

  • University of California, Los Angeles

    Los Angeles 5368361, California 5332921 90095
    United States

    Active - Recruiting

  • University of Iowa

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • University of Iowa

    Iowa City 4862034, Iowa 4862182 52242
    United States

    Active - Recruiting

  • Johns Hopkins

    Baltimore, Maryland 21224
    United States

    Active - Recruiting

  • University of Maryland

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Tidal Health

    Salisbury, Maryland 21801
    United States

    Site Not Available

  • Johns Hopkins

    Baltimore 4347778, Maryland 4361885 21224
    United States

    Active - Recruiting

  • University of Maryland

    Baltimore 4347778, Maryland 4361885 21201
    United States

    Active - Recruiting

  • Tidal Health

    Salisbury 4368711, Maryland 4361885 21801
    United States

    Active - Recruiting

  • Beth Israel Deaconess Medical Center

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor 4984247, Michigan 5001836 48109
    United States

    Active - Recruiting

  • Dartmouth Hitchcock

    Lebanon 5088597, New Hampshire 5090174 03756
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland 5150529, Ohio 5165418 44195
    United States

    Site Not Available

  • Reading Hospital

    West Reading, Pennsylvania 19611
    United States

    Site Not Available

  • Reading Hospital

    West Reading 5218867, Pennsylvania 6254927 19611
    United States

    Active - Recruiting

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