NCT06376994 Multi-Center Clean Air Randomized Controlled Trial in COPD
| NCT ID | NCT06376994 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | JHSPH Center for Clinical Trials |
| Condition | Chronic Obstructive Pulmonary Disease (COPD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 770 participants |
| Start Date | 2024-05-24 |
| Primary Completion | 2029-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 770 participants in total. It began in 2024-05-24 with a primary completion date of 2029-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06376994 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Chronic Obstructive Pulmonary Disease (COPD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06376994 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 770 participants.
Is NCT06376994 currently recruiting?
Yes, NCT06376994 is actively recruiting participants. Contact the research team at sehrhar6@jhu.edu for enrollment information.
Where is the NCT06376994 trial being conducted?
This trial is being conducted at Birmingham, United States, Los Angeles, United States, Iowa City, United States, Baltimore, United States and 7 additional locations.
Who is sponsoring the NCT06376994 clinical trial?
NCT06376994 is sponsored by JHSPH Center for Clinical Trials. The trial plans to enroll 770 participants.
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