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OpenTrials
Active, Not Recruiting

NCT Number: NCT05913765

Air Filtration for COPD in VA Population of 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jesse Brown Veterans Affairs Medical Center

Chicago, Illinois, 60612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Air cleaner

Device

Austin Air Healthmate air cleaner with or without standard filter

Primary outcomes

  1. COPD exacerbations

    Time frame: Through study completion, an average of 1 year

    Physician diagnosed exacerbation of acute COPD

Secondary outcomes

  1. ED visits

    Time frame: Through study completion, an average of 1 year

    Number of emergency room visits

  2. Urgent care visits

    Time frame: Through study completion, an average of 1 year

    Number of urgent care visits

  3. Unscheduled clinic visits

    Time frame: Through study completion, an average of 1 year

    Number of unscheduled clinic visits

  4. 6MWD

    Time frame: At the end of study completion, an average of 1 year

    6-minute walk distance

  5. O2 sat

    Time frame: At the end of study completion, an average of 1 year

    Transcutaneous oxygen saturation at rest and during 6MWD

  6. Health related quality of life

    Time frame: At the end of study completion, an average of 1 year

    Veterans Rand 36 Item Healthy Survey (VR 36)

  7. St. George's

    Time frame: At the end of study completion, an average of 1 year

    St. George's Respiratory Questionnaire (SGRQ) score

Sponsors and collaborators

Lead sponsor

Illinois Institute of Technology

Other

Collaborators

  • Elevate
  • Jesse Brown VA Medical Center
  • US Department of Housing and Urban Development

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 22, 2023
Registry last updated
Oct 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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