Improving indoor air quality for patients with COPD

Multi-Center Clean Air Randomized Controlled Trial in COPD

This study is testing whether using an air cleaner can improve indoor air quality and help people with COPD feel better and have fewer breathing problems.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 770 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: JHSPH Center for Clinical Trials (other)
• Locations: 11 sites (Birmingham, Alabama and 10 other locations)
• Trial ID: NCT06376994 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of an air cleaner intervention in enhancing indoor air quality for individuals with Chronic Obstructive Pulmonary Disease (COPD). It is a multi-center, randomized, double-blind, sham-controlled trial that will enroll 770 former smokers diagnosed with COPD over a four-year period. Participants will be followed for one year, with the primary focus on respiratory-specific quality of life and secondary outcomes including the rate of acute exacerbations and rescue medication use.

Who should consider this trial

Good fit: Ideal candidates are former smokers aged 40 and older with a physician-confirmed diagnosis of COPD and specific spirometry results.

Not a fit: Patients who are current smokers or have not been diagnosed with COPD may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly reduce COPD exacerbations and improve the quality of life for patients.

How similar studies have performed: Previous studies have shown promising results in improving health outcomes through air quality interventions, suggesting potential success for this approach.

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

Where this trial is running

Birmingham, Alabama and 10 other locations

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

Study contacts

• Study coordinator: Stephan Ehrhardt, MD, PhD

Conditions: Chronic Obstructive Pulmonary Disease, air cleaner, indoor air quality, quality of life, rescue medication use