Multi-Center Clean Air Randomized Controlled Trial in COPD (Clean Air)

October 8, 2025 updated by: Stephan Ehrhardt, JHSPH Center for Clinical Trials
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

770

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Stephan Ehrhardt, MD, PhD
  • Phone Number: (410) 502-3872
  • Email: sehrhar6@jhu.edu

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • University of Alabama, Lung Health Center
        • Principal Investigator:
          • James Michael Wells, MD
        • Contact:
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • University of California, Los Angeles
        • Principal Investigator:
          • Igor Barjaktarevic, MD
        • Contact:
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa
        • Principal Investigator:
          • Alejandro Comellas, MD
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland
        • Contact:
        • Principal Investigator:
          • William Grier, MD
      • Baltimore, Maryland, United States, 21224
        • Recruiting
        • Johns Hopkins
        • Contact:
        • Contact:
      • Salisbury, Maryland, United States, 21801
        • Recruiting
        • Tidal Health
        • Contact:
        • Principal Investigator:
          • Robert Chasse, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Not yet recruiting
        • Beth Israel Deaconess Medical Center
        • Contact:
        • Principal Investigator:
          • Mary Rice, MD
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
        • Principal Investigator:
          • MeiLan Han, MD
        • Contact:
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Not yet recruiting
        • Dartmouth Hitchcock
        • Contact:
        • Principal Investigator:
          • Laura Paulin, MD
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Not yet recruiting
        • Cleveland Clinic
        • Contact:
        • Principal Investigator:
          • Russel Bowler, MD
    • Pennsylvania
      • West Reading, Pennsylvania, United States, 19611
        • Recruiting
        • Reading Hospital
        • Principal Investigator:
          • Luis Murillo, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: 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 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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
St. George's Respiratory Questionnaire (SGRQ)
Time Frame: baseline and 3, 6, 9, and 12 months after baseline
The St. George's Respiratory Questionnaire (SGRQ) is a widely used measure of disease impact as an indicator of disease-specific quality of life. The SGRQ is a disease specific instrument containing 50 items in three subscales (symptoms, activity, and impact). Scores range from 0 to 100, with higher scores indicating more limitations.
baseline and 3, 6, 9, and 12 months after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

JHSPH Center for Clinical Trials

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 24, 2024

Primary Completion (Estimated)

August 31, 2029

Study Completion (Estimated)

November 30, 2029

Study Registration Dates

First Submitted

April 16, 2024

First Submitted That Met QC Criteria

April 16, 2024

First Posted (Actual)

April 22, 2024

Study Record Updates

Last Update Posted (Estimated)

October 10, 2025

Last Update Submitted That Met QC Criteria

October 8, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00407311
  • 1U24HL169566-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Obstructive Pulmonary Disease (COPD)

Clinical Trials on Air cleaner

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Armenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe