Multi-Center Clean Air Randomized Controlled Trial in COPD

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

— Clean Air  

Official title:

Multi-Center Clean Air Randomized Controlled Trial in COPD

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06376994
• Other study ID #: IRB00407311
• Secondary ID: 1U24HL169566-01
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: September 2024
• Est. completion date: September 2028

Study information

• Verified date: April 2024
• Source: JHSPH Center for Clinical Trials
• Contact: Stephan Ehrhardt, MD, PhD
• Phone: (410) 502-3872
• Email: sehrhar6[@]jhu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 770
• Est. completion date: September 2028
• Est. primary completion date: September 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion criteria

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.)

Exclusion criteria

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Johns Hopkins	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
JHSPH Center for Clinical Trials	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	St. George's Respiratory Questionnaire (SGRQ)	The St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) 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).	baseline and 3, 6, 9, and 12 months after baseline