Multi-Center Clean Air Randomized Controlled Trial in COPD

Phase 3

Recruiting

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)

• Registration Number: NCT06376994
• Lead Sponsor: JHSPH Center for Clinical Trials

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.

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 Timeline

• Study First Submitted: 2024-04-16
• Study First Submitted QC: 2024-04-16
• Study First Posted: 2024-04-22
• Study Start: 2024-05-24
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-01
• Last Update Posted: 2025-08-06
• Primary Completion: 2029-08-31
• Study Completion: 2029-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 770

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
St. George's Respiratory Questionnaire (SGRQ)	baseline and 3, 6, 9, and 12 months after baseline	The St. George's Respiratory Questionnaire (SGRQ) is a widely used measure of disease impact as an indicator of disease-specific quality of life. The SGRQ is a disease specific instrument containing 50 items in three subscales (symptoms, activity, and impact). Scores range from 0 to 100, with higher scores indicating more limitations.

Trial Locations

Locations (8)

University of Alabama, Lung Health Center; 🇺🇸 Birmingham, Alabama, United States

University of California, Los Angeles; 🇺🇸 Los Angeles, California, United States

University of Iowa; 🇺🇸 Iowa City, Iowa, United States

University of Maryland; 🇺🇸 Baltimore, Maryland, United States

Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States

Tidal Health; 🇺🇸 Salisbury, Maryland, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Reading Hospital; 🇺🇸 West Reading, Pennsylvania, United States