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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
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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