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Asthma ControlNCT07196436

Asthma Intervention With Residential Ventilation and Air Cleaner (AIRVAC) Study

A study testing Energy Recovery Ventilator and Portable Air Cleaner in people with Asthma Control and Pulmonary Function, run by The University of Texas at Arlington at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The primary goal of this study is to investigate the comparative long-term (i.e., 1-year) effectiveness of energy recovery ventilators (ERVs) and portable air cleaners (PACs) in reducing indoor air pollutants and mold levels and improving asthma-related health outcomes in inner-city children and adults with asthma in… Read more about this study

Who is it for?
Ages 5 years and older
What is being tested?
Energy Recovery Ventilator and Portable 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
2 sitesUnited States
Study dates
10 Oct 2025to 28 Feb 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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 5 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Individuals with physician-diagnosed asthma, including both adults and children aged 5-17
  • Homeowners living in the DFW metropolitan area, TX

Who cannot join

  • Participants living in homes with any smokers

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Insung Kang, Ph.D. contact

817-272-2167

insung.kang@uta.edu

United States2 sites, 2 recruiting
  • University of Texas at Arlington

    Arlington, Texas, 76010

    Insung Kang, Ph.D., 312-342-5733, insung.kang@uta.edu

    June Young Park, Ph.D.

    Recruiting
  • Rebuilding Together North Texas

    Plano, Texas, 75025

    Tia LaFavor, 972-245-6900, tia@rtntx.org

    Recruiting

Other trials in United States

About this study

Official title: Energy Recovery Ventilation and Air Cleaner Interventions to Improve Indoor Air Quality, Mold Control, and Asthma-Related Health Outcomes Among Inner-City Children and Adults in Low-Income Households

The primary goal of this study is to investigate the comparative long-term (i.e., 1-year) effectiveness of energy recovery ventilators (ERVs) and portable air cleaners (PACs) in reducing indoor air pollutants and mold levels and improving asthma-related health outcomes in inner-city children and adults with asthma in low-income households in the Dallas-Fort Worth (DFW) metropolitan area, TX. Secondary goals include: (1) examining associations among asthma outcomes, exposure to indoor air pollutants and mold, and housing-related factors, (2) conducting a cost-benefit analysis of ERV and PAC interventions for improving IAQ, mold control, and health outcomes, and (3) evaluating the utility of cost-effective methods and protocols for measuring IAQ and mold for indoor air pollution epidemiology studies and for providing practical information to patients and their physicians. Using a double-blind, placebo-controlled randomized controlled trial, 80 households will be assigned to receive active or placebo versions of ERVs or PACs. Environmental exposures and housing conditions will be monitored alongside comprehensive health assessments, including lung function tests and validated surveys on asthma control, quality of life, stress, and sleep quality.

Read the detailed description

This study will evaluate the long-term effectiveness of energy recovery ventilators (ERVs) and portable air cleaners (PACs) in reducing indoor concentrations of air pollutants and mold, and improving health outcomes among children and adults with asthma. The study design will utilize a double-blind, placebo-controlled, 4-arm, parallel-group, randomized controlled trial with 1-year observation and 1-year intervention periods. Eligible children (n ≥ 40) and adults (n ≥ 40) with asthma from 80 households will be recruited from an applicant pool for RTNTX home retrofit programs. Participants will be randomized to receive one of four different interventions midway through the study: (1) ERV, (2) sham/placebo ERV, (3) PAC, or (4) sham/placebo PAC. All participants and field research team will be blinded to whether participants receive the active or sham/placebo intervention. ERVs will be equipped with minimum efficiency reporting value (MERV) 13 filters to capture particulate matter from incoming outdoor air, while sham/placebo ERVs will be modified to operate only in recirculation mode (no outdoor air ventilation). PACs will have high efficiency particulate air (HEPA) and carbon filters, whereas sham/placebo PACs will have the HEPA and carbon filters removed, leaving only the pre-filters. These objectives will be achieved through a combination of (i) baseline housing condition assessments for characterizing housing-related factors such as housing conditions, health and safety issues, and basic building performance, that may contribute to asthma exacerbations and affect the installation of ERVs, (ii) field measurements of indoor air pollutants (i.e., PM, VOCs, NO2, CO, and CO2) and mold levels (both air and surface samples), and (iii) comprehensive asthma outcome assessments via participant-reported health surveys for asthma control, asthma-related quality of life, stress, and sleep quality. Asthma control will be tracked monthly using the Asthma Control Test (ACT) for adults and the Childhood Asthma Control Test (C-ACT) for children. Quality of life, stress, and sleep will be assessed during home visits using validated instruments, including the 36-Item Short Form Health Survey (SF-36) and the Pediatric Quality of Life Inventory (PedsQL) for quality of life; the Perceived Stress Scale (PSS) and the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Stress measure for stress; and PROMIS Adult and Pediatric Sleep measures for sleep quality.

Results from the research are expected to identify practical and effective commercially available systems that can (1) investigate the long-term effects of different mechanisms between ERVs and PACs on IAQ, mold, and health outcomes in asthmatic children and adults; (2) provide novel data on associations among asthma outcomes, indoor air pollution and mold exposure, and housing-related factors; (3) evaluate the long-term health benefits, including reduced direct costs for asthma and estimated mortality attributable to improved IAQ and mold, versus the total costs of interventions; and (4) investigate the utility of low-cost sensors for assessing housing-related hazards and epidemiology studies, and for providing actionable information on IAQ and mold levels to patients and their physicians.

Being tested
Energy Recovery Ventilator, Portable Air Cleaner, Energy Recovery Ventilator (Sham), Portable Air Cleaner (Sham)
Keywords
Asthma, Asthma Control, Pulmonary Function, Lung Function, Quality of Life, Stress, Sleep Quality, Indoor Air Quality, Residential Ventilation, Air Cleaner, Air Filtration, Mold
Medical subject headings
Sleep Initiation and Maintenance Disorders, Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Energy Recovery VentilatorDevice

    Also called ERV

    A mechanical ventilation system that exchanges stale indoor air with fresh outdoor air while transferring heat and moisture between the incoming and outgoing air streams

  • Portable Air CleanerDevice

    Also called PAC, HEPA Air Cleaner, Residential Air Cleaner, Room Air Cleaner

    A standalone home device that filters indoor air to remove particulate matter, allergens, and other pollutants

  • Energy Recovery Ventilator (Sham)Device

    A home-installed ERV unit that operates in recirculation mode only, providing no fresh air exchange or heat/moisture transfer, serving as a placebo for study purposes.

  • Portable Air Cleaner (Sham)Device

    A portable air cleaner that appears to operate like an active unit but does not contain a HEPA filter and does not clean the air, serving as a placebo for study purposes

Study groups in NCT07196436
Study groupRoleWhat they receive
Active ERVActive comparatorA group that will receive an active energy recovery ventilator for 1 year
Receives: Device: Energy Recovery Ventilator
Sham ERVSham comparatorA group that will receive a sham energy recovery ventilator (recirculation mode only) for 1 year
Receives: Device: Energy Recovery Ventilator (Sham)
Active PACActive comparatorA group that will receive an active portable air cleaner for 1 year
Receives: Device: Portable Air Cleaner
Sham PACSham comparatorA group that will receive a sham portable air cleaner (HEPA filter removed) for 1 year
Receives: Device: Portable Air Cleaner (Sham)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pulmonary Function (Spirometry)

    Pulmonary function will be assessed using an EasyOne Air spirometer. The primary parameters measured include Forced Expiratory Volume in 1 second (FEV₁), Forced Vital Capacity (FVC), and the FEV₁/FVC ratio.

    Measured: Baseline; 6 months; 18 months; 24 months

  2. Asthma Control Test Score

    Asthma Control Test (ACT) for adults and Childhood Asthma Control Test (C-ACT) for children every month throughout the 2-year study.

    ACT score range: 5-25; higher scores indicate better asthma control. C-ACT score range: 0-27; higher scores indicate better asthma control.

    Measured: From enrollment to the end of intervention at 1 month (24 months in total)

Secondary outcomes (4)
  1. Asthma-Related Quality Of Life (Adults)

    36-Item Short Form Health Survey (SF-36) for adult participants.

    SF-36 score range: 0-100; higher scores indicate better health status.

    Measured: Baseline; 6 months; 18 months; 24 months

  2. Asthma-Related Quality Of Life (Children)

    Pediatric Quality of Life Inventory (PedsQL) for child participants.

    PedsQL score range: 0-100; higher scores indicate better quality of life.

    Measured: Baseline; 6 months; 18 months; 24 months

  3. Stress Levels

    Perceived Stress Scale (PSS) for adults and Perceived Stress Scale for Children (PSS-C) for children.

    PSS score range: 0-40; higher scores indicate worse perceived stress. PSS-C score range: 0-39; higher scores indicate worse perceived stress.

    Measured: Baseline; 6 months; 18 months; 24 months

  4. Sleep Quality

    PROMIS Sleep Disturbance Survey for both adult and child participants.

    PROMIS Sleep Disturbance score range: 20-80 (mean = 50, SD = 10); higher scores indicate worse sleep disturbance.

    Measured: Baseline; 6 months; 18 months; 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2025
  2. Study start10 Oct 2025
  3. Primary completion31 Jan 2028 (estimated)
  4. Study completion28 Feb 2028 (estimated)

Resources

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
Masking
Single blind
Who is masked
Participant
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07196436
Sponsor's protocol ID
2025-0280
Other IDs
HUD TXHHU0097-24
Status last verified
Oct 2025
First submitted
2 Sep 2025
Last updated
29 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared due to privacy and confidentiality concerns for participants and because the consent forms do not include provisions for public data sharing

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
  • Kang I, McCreery A, Azimi P, Gramigna A, Baca G, Hayes W, Crowder T, Scheu R, Evens A, Stephens B. Impacts of residential indoor air quality and environmental risk factors on adult asthma-related health outcomes in Chicago, IL. J Expo Sci Environ Epidemiol. 2023 May;33(3):358-367. doi: 10.1038/s41370-022-00503-z. Epub 2022 Nov 30.

    PubMed 36450925
  • Kang I, McCreery A, Azimi P, Gramigna A, Baca G, Abromitis K, Wang M, Zeng Y, Scheu R, Crowder T, Evens A, Stephens B. Indoor air quality impacts of residential mechanical ventilation system retrofits in existing homes in Chicago, IL. Sci Total Environ. 2022 Jan 15;804:150129. doi: 10.1016/j.scitotenv.2021.150129. Epub 2021 Sep 8.

    PubMed 34798726

Questions about this trial

What is this clinical trial studying?

A study testing Energy Recovery Ventilator and Portable Air Cleaner in people with Asthma Control and Pulmonary Function, run by The University of Texas at Arlington at 2 sites 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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 29 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Insung Kang, Ph.D. (817-272-2167, insung.kang@uta.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pulmonary Function (Spirometry) (time frame: Baseline; 6 months; 18 months; 24 months). The study lists 2 primary outcomes in all. 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 NCT07196436, which also lists 3 linked publications.

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 29 Oct 2025.

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