Air Filtration for COPD in VA Population of Veterans

NCT05913765 | Active Not Recruiting

• 3 other identifiers: irb-2022-92ILHHU0049-19IRB #1675992
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• COPD exacerbations

  Physician diagnosed exacerbation of acute COPD

  Through study completion, an average of 1 year

Secondary Outcomes (7)

• ED visits

  Through study completion, an average of 1 year

• Urgent care visits

  Through study completion, an average of 1 year

• Unscheduled clinic visits

  Through study completion, an average of 1 year

• 6MWD

  At the end of study completion, an average of 1 year

• O2 sat

  At the end of study completion, an average of 1 year

Study Arms (2)

Intervention

ACTIVE COMPARATOR

an air cleaner with HEPA and carbon filter installed

Device: Air cleaner

Placebo

PLACEBO COMPARATOR

an air cleaner with the primary filter removed

Device: Air cleaner

Interventions

Air cleaner DEVICE

Austin Air Healthmate air cleaner with or without standard filter

Intervention; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 - 90+ years.
• English speaking and writing.
• Able to provide consent.
• Resident of Chicago metropolitan area.
• Veteran receiving health care at JBVAMC with a documented diagnosis of COPD.
• Stable housing for at least 6 months prior to screening.
• Able to communicate regularly by telephone.

You may not qualify if:

• Home palliative care.
• Life expectancy \<6 months.
• Hazardous conditions and/or safety concerns in or around the veteran's household
• Screened patients that already have an air cleaner and alike in his/her current residence
• 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.

Sponsors & Collaborators

• Illinois Institute of Technology: lead
• Jesse Brown VA Medical Center: collaborator
• US Department of Housing and Urban Development: collaborator
• Elevate: collaborator

Study Sites (1)

Jesse Brown Veterans Affairs Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

• Stephens B, Kang I, Jagota K, Elfessi Z, Karpen N, Farhoodi S, Heidarinejad M, Rubinstein I. Study protocol for a 1-year, randomized, single-blind, parallel group trial of stand-alone indoor air filtration in the homes of US military Veterans with moderate to severe COPD in metropolitan Chicago. Trials. 2025 Jun 4;26(1):196. doi: 10.1186/s13063-025-08880-0.

  PMID: 40468409 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Kaveeta Jagota

  Jesse Brown VA Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Department Chair

Model Details: Randomized, single-blind, placebo-controlled case-control design

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: June 22, 2023
• Study Start: January 11, 2023
• Primary Completion: October 1, 2025
• Study Completion: December 31, 2025
• Last Updated: October 23, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)