Pulmonary Disease, Chronic ObstructiveNCT05913765
Air Filtration for COPD in VA Population of Veterans
A study testing Air cleaner in people with Pulmonary Disease, Chronic Obstructive, run by Illinois Institute of Technology at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Air cleaner
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Jesse Brown Veterans Affairs Medical Center
Chicago, Illinois, 60612
About this study
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
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.
Read the 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.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Air cleaner
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air cleanerDevice
Austin Air Healthmate air cleaner with or without standard filter
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | an air cleaner with HEPA and carbon filter installed Receives: Device: Air cleaner |
| Placebo | Placebo comparator | an air cleaner with the primary filter removed Receives: Device: Air cleaner |
What is being measured
The primary outcome is the main question the study is designed to answer.
COPD exacerbations
Physician diagnosed exacerbation of acute COPD
Measured: Through study completion, an average of 1 year
Secondary outcomes (7)
ED visits
Number of emergency room visits
Measured: Through study completion, an average of 1 year
Urgent care visits
Number of urgent care visits
Measured: Through study completion, an average of 1 year
Unscheduled clinic visits
Number of unscheduled clinic visits
Measured: Through study completion, an average of 1 year
6MWD
6-minute walk distance
Measured: At the end of study completion, an average of 1 year
O2 sat
Transcutaneous oxygen saturation at rest and during 6MWD
Measured: At the end of study completion, an average of 1 year
Health related quality of life
Veterans Rand 36 Item Healthy Survey (VR 36)
Measured: At the end of study completion, an average of 1 year
St. George's
St. George's Respiratory Questionnaire (SGRQ) score
Measured: At the end of study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start11 Jan 2023
- Primary completion1 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, single-blind, placebo-controlled case-control design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Illinois Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Jesse Brown VA Medical Center, US Department of Housing and Urban Development, Elevate
- Responsible party
- Principal investigator, Brent Stephens, Illinois Institute of Technology
- Investigators
- Israel Rubinstein, MD, Principal investigator, Jesse Brown VA Medical CenterMohammad Heidarinejad, PhD, Principal investigator, Illinois Institute of TechnologyZane Elfessi, PharmD, Principal investigator, Jesse Brown VA Medical CenterKaveeta Jagota, Study director, Jesse Brown VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05913765
- Sponsor's protocol ID
- irb-2022-92
- Other IDs
- ILHHU0049-19, IRB #1675992
- Status last verified
- Oct 2024
- First submitted
- 5 Jun 2023
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40468409
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05913765
- Acronym / sponsor ID
- irb-2022-92
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Illinois Institute of TechnologyUniversity, hospital or other
- Collaborators
- Jesse Brown VA Medical Center, US Department of Housing and Urban Development, Elevate
- Study start
- 11 Jan 2023 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized, single-blind, placebo-controlled case-control design
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Device: Air cleaneran air cleaner with HEPA and carbon filter installed |
| Placebo | Placebo comparator | Device: Air cleaneran air cleaner with the primary filter removed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Air cleanerAustin Air Healthmate air cleaner with or without standard filter | Device | Intervention, Placebo |
Primary outcome
COPD exacerbations
Time frame: Through study completion, an average of 1 year
Physician diagnosed exacerbation of acute COPD
7 secondary outcomes
ED visits
Time frame: Through study completion, an average of 1 year
Urgent care visits
Time frame: Through study completion, an average of 1 year
Unscheduled clinic visits
Time frame: Through study completion, an average of 1 year
6MWD
Time frame: At the end of study completion, an average of 1 year
O2 sat
Time frame: At the end of study completion, an average of 1 year
Health related quality of life
Time frame: At the end of study completion, an average of 1 year
St. George's
Time frame: At the end of study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Derived from this study: PubMed 40468409Stephens 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Israel Rubinstein, MD principal investigator
Jesse Brown VA Medical Center
Mohammad Heidarinejad, PhD principal investigator
Illinois Institute of Technology
Zane Elfessi, PharmD principal investigator
Jesse Brown VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Air cleaner in people with Pulmonary Disease, Chronic Obstructive, run by Illinois Institute of Technology at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COPD exacerbations (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05913765, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2024.