Chronic Obstructive Pulmonary Disease (COPD)Phase 3Clean AirNCT06376994
Multi-Center Clean Air Randomized Controlled Trial in COPD
A Phase 3 study testing Air cleaner in people with Chronic Obstructive Pulmonary Disease (COPD), run by JHSPH Center for Clinical Trials at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Air cleaner
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 770 participants
- Where
- 11 sitesUnited States
- Study dates
- 24 May 2024to 31 Aug 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.)
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
United States11 sites, 11 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Crystal Cutlip, 734-647-6399, ccutlip@med.umich.edu
Meilan Han, MD
- Recruiting
University of Maryland
Baltimore, Maryland, 21201
Valeriya Rodionova, 410-328-2835, vrodionova@som.umaryland.edu
William Grier, MD
- Recruiting
Johns Hopkins
Baltimore, Maryland, 21224
Wendy Lorizio, 410-510-2449, wlorizi1@jhmi.edu
Maggie Maly, 410-550-9527, mmaly1@jhmi.edu
- Recruiting
University of Alabama, Lung Health Center
Birmingham, Alabama, 35233
Geneva Avery, 205-934-5555, lunghealth@uabmc.edu
James Michael Wells, MD
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Alethea atadika, 781-964-8163, aatadika@bidmc.harvard.edu
Mary Rice, MD
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Elena Engel, 224-235-8363, engele2@ccf.org
Russel Bowler, MD
- Recruiting
University of Iowa
Iowa City, Iowa, 52242
Eric Garcia, 319-353-8863, eric-garcia@uiowa.edu
Alejandro Comellas, MD
- Recruiting
Dartmouth Hitchcock
Lebanon, New Hampshire, 03756
Athena Fowler, 603-650-0567, athena.r.fowler.shaw@hitchcock.org
Laura Paulin, MD
- Recruiting
University of California, Los Angeles
Los Angeles, California, 90095
Tiffany Bina, 310-206-1629, tbina@mednet.ucla.edu
Igor Barjaktarevic, MD
- Recruiting
Tidal Health
Salisbury, Maryland, 21801
Sandra Fetko, 410-912-6045, sandra.fetko@tidalhealth.org
Robert Chasse, MD
- Recruiting
Reading Hospital
West Reading, Pennsylvania, 19611
Pamela marrero, 484-628-8355, pamela.marrero@towerhealth.org
Luis Murillo, MD
About this study
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.
Read the 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.
- Being tested
- Air cleaner, Sham air cleaner
- Keywords
- air cleaner, indoor air quality, quality of life, rescue medication use
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air cleanerDevice
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 cleanerDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Active air cleaner | Experimental | 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. Receives: Device: Air cleaner |
| Sham air cleaner | Sham comparator | 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. Receives: Device: Sham air cleaner |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 3, 6, 9, and 12 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start24 May 2024
- Primary completion31 Aug 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 770 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JHSPH Center for Clinical Trials
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Stephan Ehrhardt, JHSPH Center for Clinical Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06376994
- Sponsor's protocol ID
- IRB00407311
- Other IDs
- 1U24HL169566-01
- Acronym
- Clean Air
- Status last verified
- Jul 2026
- First submitted
- 16 Apr 2024
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center Clean Air Randomized Controlled Trial in COPD
- ClinicalTrials.gov ID
- NCT06376994
- Acronym / sponsor ID
- Clean Air / IRB00407311
- Keywords
- air cleaner, indoor air quality, quality of life, rescue medication use
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 770 participants (estimated)
- Lead sponsor
- JHSPH Center for Clinical TrialsUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 24 May 2024 (actual)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 22 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active air cleaner | Experimental | Device: Air cleanerThe 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 comparator | Device: Sham air cleanerThe 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Air cleanerThe 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. | Device | Active air cleaner |
| Sham air cleanerThe 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. | Device | Sham air cleaner |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Air cleaner in people with Chronic Obstructive Pulmonary Disease (COPD), run by JHSPH Center for Clinical Trials at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephan Ehrhardt, MD, PhD ((410) 502-3872, sehrhar6@jhu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
St. George's Respiratory Questionnaire (SGRQ) (time frame: baseline and 3, 6, 9, and 12 months after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.