Summary

Eligibility
for people ages 40 years and up (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around

Description

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.

Details

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.

Keywords

Chronic Obstructive Pulmonary Disease (COPD), air cleaner, indoor air quality, quality of life, rescue medication use, Obstructive Lung Diseases, Chronic Obstructive Pulmonary Disease

Eligibility

You can join if…

Open to people ages 40 years and up

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.)

You CAN'T join if...

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
  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

Locations

  • University of California, Los Angeles accepting new patients
    Los Angeles California 90095 United States
  • University of Iowa accepting new patients
    Iowa City Iowa 52242 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
JHSPH Center for Clinical Trials
ID
NCT06376994
Phase
Phase 3 Chronic Obstructive Pulmonary Disease Research Study
Study Type
Interventional
Participants
Expecting 770 study participants
Last Updated