Multi-Center Clean Air Randomized Controlled Trial in COPD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Air cleaner, Sham air cleaner.
- Who it may be relevant to
- Registry conditions: Chronic Obstructive Pulmonary Disease (COPD). Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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. - 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.
Primary outcome measures
- St. George's Respiratory Questionnaire (SGRQ) [Time frame: baseline and 3, 6, 9, and 12 months after baseline]
Eligibility 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 (\*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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
United States · 11 centers
- University of Alabama, Lung Health Center — Birmingham
- University of California, Los Angeles — Los Angeles
- University of Iowa — Iowa City
- University of Maryland — Baltimore
- Johns Hopkins — Baltimore
- Tidal Health — Salisbury
- Beth Israel Deaconess Medical Center — Boston
- University of Michigan — Ann Arbor
- … and 3 more centers
Identifiers
NCT: NCT06376994 · IRB00407311 · 1U24HL169566-01