Air Filtration for COPD in VA Population of Veterans

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

Air Filtration to Improve Indoor Air Quality (IAQ) and Chronic Obstructive Pulmonary Disease (COPD) Outcomes in a High-risk Urban Population of U.S. Military Veterans

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05913765
• Other study ID #: irb-2022-92
• Secondary ID: ILHHU0049-19IRB
• Status: Recruiting
• Phase: N/A
• Start date: January 11, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: April 2024
• Source: Illinois Institute of Technology
• Contact: Brent Stephens, PhD
• Phone: 312-567-3629
• Email: brent[@]iit.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this study is to investigate the effectiveness of stand-alone air filtration for improving indoor air quality (IAQ) and chronic obstructive pulmonary disease (COPD) outcomes in a high-risk urban cohort of 80 U.S. military veterans with COPD. Secondary goals of the study are to (1) investigate housing-related factors that may contribute to COPD exacerbation, (2) investigate the utility of using low-cost sensors for indoor air pollution epidemiology studies and for providing actionable or useful information on the quality of their indoor air to patients and their physicians, and (3) evaluate the costs and benefits of using stand-alone air filtration to improve IAQ and COPD outcomes.

Description:

The study will utilize a randomized, single-blind, placebo-controlled case-control design in which stand-alone portable air cleaners will be introduced to the study population over a period of approximately 1 year. One-half of the study population (40 participants) will receive a normally functioning filtration unit (i.e., an air cleaner with HEPA filter installed) and one-half of the study population (40 participants) will receive a placebo filtration unit (i.e., an air cleaner with the primary filter removed). The participants will be blinded; they will not know the status of the filter. Stand-alone portable air cleaning units containing HEPA filters and high clean air delivery rates (CADRs) sufficiently sized for the spaces they will serve will be used. The study will also involve housing condition assessments conducted in each home to characterize housing-related factors that may contribute to COPD exacerbation at baseline, as well as measurements of indoor and outdoor air quality and environmental conditions, and records of clinical outcomes (e.g., COPD exacerbations, emergency room visits, 6-minute walk distance, oxygen saturation, etc. accessed through the subject's VA medical record) throughout the study duration. The validated and extensively used St. George's Respiratory Questionnaire (SGRQ-C) and Veterans RAND 36-Item Health Survey (VR-36) will be used to determine health-related quality of life (HR-QoL) of participants by the JBVAMC Study Personnel. Clinical outcomes will also be used to assess costs of care with and without filtration interventions in this population. Low-cost air quality sensors will be used to monitor IAQ for the duration of the study). The study will also evaluate the upfront costs and operational and maintenance costs of the air cleaners over the course of the intervention periods and will compare them to the expected impacts on costs of care both with and without filtration interventions in this population.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age: 18 - 90+ years.

2. English speaking and writing.

3. Able to provide consent.

4. Resident of Chicago metropolitan area.

5. Veteran receiving health care at JBVAMC with a documented diagnosis of COPD.

6. Stable housing for at least 6 months prior to screening.

7. Able to communicate regularly by telephone.

Exclusion Criteria:

1. Home palliative care.

2. Life expectancy <6 months.

3. Hazardous conditions and/or safety concerns in or around the veteran's household

4. Screened patients that already have an air cleaner and alike in his/her current residence

5. Concomitant operation of a non-study air cleaner and alike by a participant in his/her current residence at any time during the course of the trial constitutes protocol violation leading to disqualification of said participant from the study.

Related Conditions & MeSH terms

• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• Air cleaner
Austin Air Healthmate air cleaner with or without standard filter

Locations

Country	Name	City	State
United States	Jesse Brown Veterans Affairs Medical Center	Chicago	Illinois

Sponsors (4)

Lead Sponsor	Collaborator
Illinois Institute of Technology	Elevate, Jesse Brown VA Medical Center, US Department of Housing and Urban Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	COPD exacerbations	Physician diagnosed exacerbation of acute COPD	Through study completion, an average of 1 year
Secondary	ED visits	Number of emergency room visits	Through study completion, an average of 1 year
Secondary	Urgent care visits	Number of urgent care visits	Through study completion, an average of 1 year
Secondary	Unscheduled clinic visits	Number of unscheduled clinic visits	Through study completion, an average of 1 year
Secondary	6MWD	6-minute walk distance	At the end of study completion, an average of 1 year
Secondary	O2 sat	Transcutaneous oxygen saturation at rest and during 6MWD	At the end of study completion, an average of 1 year
Secondary	Health related quality of life	Veterans Rand 36 Item Healthy Survey (VR 36)	At the end of study completion, an average of 1 year
Secondary	St. George's	St. George's Respiratory Questionnaire (SGRQ) score	At the end of study completion, an average of 1 year