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Air Filtration for COPD in VA Population of Veterans

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Air cleaner
Sponsored by
Illinois Institute of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age: 18 - 90+ years. English speaking and writing. Able to provide consent. Chicago resident. 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. Documentation of full COVID-19 vaccination. 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.

Sites / Locations

  • Jesse Brown Veterans Affairs Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Intervention

Placebo

Arm Description

an air cleaner with HEPA and carbon filter installed

an air cleaner with the primary filter removed

Outcomes

Primary Outcome Measures

COPD exacerbations
Physician diagnosed exacerbation of acute COPD

Secondary Outcome Measures

ED visits
Number of emergency room visits
Urgent care visits
Number of urgent care visits
Unscheduled clinic visits
Number of unscheduled clinic visits
6MWD
6-minute walk distance
O2 sat
Transcutaneous oxygen saturation at rest and during 6MWD
Health related quality of life
Veterans Rand 36 Item Healthy Survey (VR 36)
St. George's
St. George's Respiratory Questionnaire (SGRQ) score

Full Information

First Posted
June 5, 2023
Last Updated
June 13, 2023
Sponsor
Illinois Institute of Technology
Collaborators
Jesse Brown VA Medical Center, US Department of Housing and Urban Development, Elevate
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1. Study Identification

Unique Protocol Identification Number
NCT05913765
Brief Title
Air Filtration for COPD in VA Population of Veterans
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 11, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Illinois Institute of Technology
Collaborators
Jesse Brown VA Medical Center, US Department of Housing and Urban Development, Elevate

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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. Additional 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.
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) 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 consumer-grade air quality sensors will be used to monitor for longer-term periods (i.e., in place 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, single-blind, placebo-controlled case-control design
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
an air cleaner with HEPA and carbon filter installed
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
an air cleaner with the primary filter removed
Intervention Type
Device
Intervention Name(s)
Air cleaner
Intervention Description
Austin Air Healthmate air cleaner with or without standard filter
Primary Outcome Measure Information:
Title
COPD exacerbations
Description
Physician diagnosed exacerbation of acute COPD
Time Frame
Through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
ED visits
Description
Number of emergency room visits
Time Frame
Through study completion, an average of 1 year
Title
Urgent care visits
Description
Number of urgent care visits
Time Frame
Through study completion, an average of 1 year
Title
Unscheduled clinic visits
Description
Number of unscheduled clinic visits
Time Frame
Through study completion, an average of 1 year
Title
6MWD
Description
6-minute walk distance
Time Frame
At the end of study completion, an average of 1 year
Title
O2 sat
Description
Transcutaneous oxygen saturation at rest and during 6MWD
Time Frame
At the end of study completion, an average of 1 year
Title
Health related quality of life
Description
Veterans Rand 36 Item Healthy Survey (VR 36)
Time Frame
At the end of study completion, an average of 1 year
Title
St. George's
Description
St. George's Respiratory Questionnaire (SGRQ) score
Time Frame
At the end of study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age: 18 - 90+ years. English speaking and writing. Able to provide consent. Chicago resident. 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. Documentation of full COVID-19 vaccination. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brent Stephens, PhD
Phone
312-567-3629
Email
brent@iit.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Insung Kang, PhD
Phone
312-342-5733
Email
ikang2@iit.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Israel Rubinstein, MD
Organizational Affiliation
Jesse Brown VA Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohammad Heidarinejad, PhD
Organizational Affiliation
Illinois Institute of Technology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zane Elfessi, PharmD
Organizational Affiliation
Jesse Brown VA Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kaveeta Jagota
Organizational Affiliation
Jesse Brown VA Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Jesse Brown Veterans Affairs Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaveeta Jagota
Email
Kaveeta.Jagota@va.gov
First Name & Middle Initial & Last Name & Degree
Israel Rubinstein
Phone
312-569-6166
Email
Israel.Rubinstein@va.gov

12. IPD Sharing Statement

Plan to Share IPD
No

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Air Filtration for COPD in VA Population of Veterans

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