Multi-Center Clean Air Randomized Controlled Trial in COPD
Clean Air
2 other identifiers
interventional
770
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2024
Longer than P75 for phase_3
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2024
CompletedFirst Posted
Study publicly available on registry
April 22, 2024
CompletedStudy Start
First participant enrolled
May 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 30, 2029
October 10, 2025
August 1, 2025
5.3 years
April 16, 2024
October 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
St. George's Respiratory Questionnaire (SGRQ)
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
Study Arms (2)
Active air cleaner
EXPERIMENTALThe 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 air cleaner
SHAM COMPARATORThe 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
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.
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.
Eligibility Criteria
You may qualify if:
- To be eligible, subjects must meet all these criteria:
- Age ≥ 40 years.
- Self-report of physician diagnosis of COPD.
- 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)
- Tobacco exposure ≥ 10 pack-years. This refers to regular cigarette tobacco consumption.
- Self-reported former smoker of at least 6 months' duration. This does not include e-cigarette use.
- 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.)
You may not qualify if:
- To be eligible, subjects must not meet any one of these criteria:
- Living in a location other than home (e.g., long-term care facility, nursing home)
- Other chronic lung diseases, except asthma
- Condition with less than a year of life expectancy (e.g., metastatic cancer) or in hospice
- Spends \>2 months per year in location other than home; or plans to change residence in the next 12 months
- Pregnant or breastfeeding
- 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)
- Inability to bring air cleaners (about 15 pounds each) into home, either by self, friend, or relative
- Deemed by the study investigator to be unable to complete study protocol, including likely lack of internet connectivity
- Participating in another interventional clinical trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
University of Alabama, Lung Health Center
Birmingham, Alabama, 35233, United States
University of California, Los Angeles
Los Angeles, California, 90095, United States
University of Iowa
Iowa City, Iowa, 52242, United States
University of Maryland
Baltimore, Maryland, 21201, United States
Johns Hopkins
Baltimore, Maryland, 21224, United States
Tidal Health
Salisbury, Maryland, 21801, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Dartmouth Hitchcock
Lebanon, New Hampshire, 03756, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Reading Hospital
West Reading, Pennsylvania, 19611, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
April 16, 2024
First Posted
April 22, 2024
Study Start
May 24, 2024
Primary Completion (Estimated)
August 31, 2029
Study Completion (Estimated)
November 30, 2029
Last Updated
October 10, 2025
Record last verified: 2025-08