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Multi-Center Clean Air Randomized Controlled Trial in COPD
NCT06376994 · JHSPH Center for Clinical Trials
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
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
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
Enrollment target: 770 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2024-05-24
Estimated completion: 2029-11-30
Last updated: 2025-10-10
Interventions
Device: Air cleanerDevice: Sham air cleaner
Primary outcomes
- • St. George's Respiratory Questionnaire (SGRQ) (baseline and 3, 6, 9, and 12 months after baseline)
Sponsor
JHSPH Center for Clinical Trials · other
With: National Heart, Lung, and Blood Institute (NHLBI)
Contacts & investigators
ContactStephan Ehrhardt, MD, PhD · contact · sehrhar6@jhu.edu · (410) 502-3872
All locations (11)
University of Alabama, Lung Health CenterRecruiting
Birmingham, Alabama, United States
University of California, Los AngelesRecruiting
Los Angeles, California, United States
University of IowaRecruiting
Iowa City, Iowa, United States
University of MarylandRecruiting
Baltimore, Maryland, United States
Johns HopkinsRecruiting
Baltimore, Maryland, United States
Tidal HealthRecruiting
Salisbury, Maryland, United States
Beth Israel Deaconess Medical CenterNot Yet Recruiting
Boston, Massachusetts, United States
University of MichiganRecruiting
Ann Arbor, Michigan, United States
Dartmouth HitchcockNot Yet Recruiting
Lebanon, New Hampshire, United States
Cleveland ClinicNot Yet Recruiting
Cleveland, Ohio, United States
Reading HospitalRecruiting
West Reading, Pennsylvania, United States