Multi-Center Clean Air Randomized Controlled Trial in COPD

Last updated: May 9, 2025
Sponsor: JHSPH Center for Clinical Trials
Overall Status: Active - Recruiting

Phase

3

Condition

Chronic Obstructive Pulmonary Disease (Copd)

Lung Disease

Chronic Bronchitis

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

  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:
September 30, 2028

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

  • Reading Hospital

    West Reading, Pennsylvania 19611
    United States

    Active - Recruiting

    33.39 miles

  • Johns Hopkins

    Baltimore, Maryland 21224
    United States

    Active - Recruiting

    99.18 miles

  • University of Maryland

    Baltimore, Maryland 21201
    United States

    Active - Recruiting

    101.49 miles

  • Tidal Health

    Salisbury, Maryland 21801
    United States

    Active - Recruiting

    138.06 miles

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

    456.18 miles

  • University of Alabama, Lung Health Center

    Birmingham, Alabama 35233
    United States

    Active - Recruiting

    790.71 miles

  • University of Iowa

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

    849.8 miles

  • University of California, Los Angeles

    Los Angeles, California 90095
    United States

    Active - Recruiting

    2,388.62 miles

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