Air Filtration for COPD in VA Population of Veterans

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Device: Air cleaner

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Jesse Brown Veterans Affairs Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention; an air cleaner with HEPA and carbon filter installed	Device: Air cleaner; Austin Air Healthmate air cleaner with or without standard filter
Placebo Comparator: Placebo; an air cleaner with the primary filter removed	Device: Air cleaner; Austin Air Healthmate air cleaner with or without standard filter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
COPD exacerbations	Physician diagnosed exacerbation of acute COPD	Through study completion, an average of 1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Illinois Institute of Technology
• Collaborators: US Department of Housing and Urban Development; Jesse Brown VA Medical Center; Elevate
• Investigators: Principal Investigator: Israel Rubinstein, MD, Jesse Brown VA Medical Center; Principal Investigator: Mohammad Heidarinejad, PhD, Illinois Institute of Technology; Principal Investigator: Zane Elfessi, PharmD, Jesse Brown VA Medical Center; Study Director: Kaveeta Jagota, Jesse Brown VA Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2023
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: June 5, 2023
• First Submitted That Met QC Criteria: June 13, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): October 23, 2024
• Last Update Submitted That Met QC Criteria: October 21, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: irb-2022-92; ILHHU0049-19 (Other Grant/Funding Number: US Department of Housing and Urban Development); IRB #1675992 (Other Identifier: JBVAMC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No