Recruiting
Phase 3

Clean Air

Sponsor:

JHSPH Center for Clinical Trials

Code:

NCT06376994

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Air cleaner

Sham air cleaner

Study Details

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Study ID

NCT06376994

Start date

May 24, 2024

Status verified date

Jul, 2026

Completion date

Aug 31, 2029

Anticipated

Primary completion date

Aug 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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

770 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Active air cleaner

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.

sham comparator: Sham air cleaner

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.

Interventions

Air cleaner

The intervention is two active air cleaners with high efficiency particulate air (HEPA) filters which remove PM, as well as activated carbon filters to remove NO2 (and other trace gases). These will be run for a year in a participant's house.

Sham air cleaner

The sham intervention is 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. These will be run for a year in a participant's house.

Primary outcome measure

  • St. George's Respiratory Questionnaire (SGRQ) [ Time Frame: baseline and 3, 6, 9, and 12 months after baseline ]

Central Contacts and Locations

Central contacts

Stephan Ehrhardt, MD, PhD

(410) 502-3872sehrhar6@jhu.edu

Locations

University of Alabama, Lung Health Center

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Principal Investigator:

James Michael Wells, MD

University of California, Los Angeles

Recruiting

Los Angeles, California, United States, 90095

Contacts

Principal Investigator:

Igor Barjaktarevic, MD

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Principal Investigator:

Alejandro Comellas, MD

University of Maryland

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Principal Investigator:

William Grier, MD

Johns Hopkins

Recruiting

Baltimore, Maryland, United States, 21224

Contacts

Tidal Health

Recruiting

Salisbury, Maryland, United States, 21801

Contacts

Principal Investigator:

Robert Chasse, MD

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Principal Investigator:

Mary Rice, MD

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Principal Investigator:

Meilan Han, MD

Dartmouth Hitchcock

Recruiting

Lebanon, New Hampshire, United States, 03756

Contacts

Principal Investigator:

Laura Paulin, MD

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Principal Investigator:

Russel Bowler, MD

Reading Hospital

Recruiting

West Reading, Pennsylvania, United States, 19611

Contacts

Principal Investigator:

Luis Murillo, MD

More Information

Sponsor

JHSPH Center for Clinical Trials

Last update posted

Jul 31, 2026

Last verified

Jul, 2026

Keywords

  • air cleaner
  • indoor air quality
  • quality of life
  • rescue medication use

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by JHSPH Center for Clinical Trials on 2026-07-31.