Multi-Center Clean Air Randomized Controlled Trial in COPD

JHSPH Center for Clinical Trials

Status and phase: Enrolling; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Device: Air cleaner; Device: Sham air cleaner

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06376994

1U24HL169566-01 (U.S. NIH Grant/Contract)

IRB00407311

Details and patient eligibility

About

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.

Full 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.

Enrollment: 770 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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770 participants in 2 patient groups

Active air cleaner

Experimental group

Description:

The active arm will receive two active air cleaners with high efficiency particulate air (HEPA) filters which remove particulate matter (PM), as well as activated carbon filters to remove Nitrogen Dioxide (NO2) and other trace gases.

Treatment:

Device: Air cleaner

Sham air cleaner

Sham Comparator group

Description:

The sham control treatment arm will receive two sham air cleaners that have the internal HEPA and carbon filters removed, but which will run normally, including similar noise, airflow, and overall appearance compared to active air cleaners, thus blinding participants to filter status.

Treatment:

Device: Sham air cleaner