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NCT06376994 | Not yet recruiting | Chronic Obstructive Pulmonary Disease (COPD)

Multi-Center Clean Air Randomized Controlled Trial in COPD
Sponsor:

JHSPH Center for Clinical Trials

Information provided by (Responsible Party):

Stephan Ehrhardt

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.

Condition or disease

Chronic Obstructive Pulmonary Disease (COPD)

Intervention/treatment

Air cleaner

Sham air cleaner

Phase

Phase 3

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
Estimated Enrollment : 770 participants
Masking : Quadruple
Primary Purpose : Prevention
Official Title : Multi-Center Clean Air Randomized Controlled Trial in COPD
Actual Study Start Date : September 2024
Estimated Primary Completion Date : September 2027
Estimated Study Completion Date : September 2028
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

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
Ages Eligible for Study: 40 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion criteria
  • 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.)
    • Exclusion criteria
    • 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
      • 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
    • Multi-Center Clean Air Randomized Controlled Trial in COPD

    Location Details

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    Multi-Center Clean Air Randomized Controlled Trial in COPD

    How to Participate

    Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

    Locations

    Not yet recruiting

    United States, Maryland

    Johns Hopkins

    Baltimore, Maryland, United States, 21224