Back to Trials
NCT06376994PHASE3Recruiting

Multi-Center Clean Air Randomized Controlled Trial in COPD

JHSPH Center for Clinical Trials

Start Date

5/24/2024

Completion Date

8/31/2029

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.

Detailed 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.

Eligibility Criteria

Age Range: 40 years to No maximum

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

Interventions

DEVICE

Air cleaner

DEVICE

Sham air cleaner

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Locations

University of Alabama, Lung Health Center

Birmingham, Alabama 35233

United States

University of California, Los Angeles

Los Angeles, California 90095

United States

University of Iowa

Iowa City, Iowa 52242

United States

University of Maryland

Baltimore, Maryland 21201

United States

Johns Hopkins

Baltimore, Maryland 21224

United States

Tidal Health

Salisbury, Maryland 21801

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts 02215

United States

University of Michigan

Ann Arbor, Michigan 48109

United States

Dartmouth Hitchcock

Lebanon, New Hampshire 03756

United States

Cleveland Clinic

Cleveland, Ohio 44195

United States

Reading Hospital

West Reading, Pennsylvania 19611

United States