NCT06376994

Multi-Center Clean Air Randomized Controlled Trial in COPD

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 770 (estimated)
• Sponsor: JHSPH Center for Clinical Trials · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-05-24
• Primary completion: 2029-08-31
• Completion: 2029-11-30
• First posted: 2024-04-22
• Last updated: 2025-10-10

Locations

11 sites across 1 country: United States