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

NCT ID: NCT07196436

Last Updated: 2025-10-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-10
• Study Completion Date: 2028-02-28

Brief 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 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.

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.

Conditions

Asthma Control; Pulmonary Function; Quality of Life; Stress; Sleep Quality

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Active ERV

A group that will receive an active energy recovery ventilator for 1 year

Group Type: ACTIVE_COMPARATOR

Energy Recovery Ventilator

Intervention Type: DEVICE

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

Sham ERV

A group that will receive a sham energy recovery ventilator (recirculation mode only) for 1 year

Group Type: SHAM_COMPARATOR

Energy Recovery Ventilator (Sham)

Intervention Type: 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.

Active PAC

A group that will receive an active portable air cleaner for 1 year

Group Type: ACTIVE_COMPARATOR

Portable Air Cleaner

Intervention Type: DEVICE

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

Sham PAC

A group that will receive a sham portable air cleaner (HEPA filter removed) for 1 year

Group Type: SHAM_COMPARATOR

Portable Air Cleaner (Sham)

Intervention Type: 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

Interventions

Energy Recovery Ventilator

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

Intervention Type: DEVICE

Portable Air Cleaner

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

Intervention Type: DEVICE

Energy Recovery Ventilator (Sham)

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.

Intervention Type: DEVICE

Portable Air Cleaner (Sham)

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

Intervention Type: DEVICE

Other Intervention Names

ERV; PAC; HEPA Air Cleaner; Residential Air Cleaner; Room Air Cleaner; Air Purifier

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Participants living in homes with any smokers

• Minimum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rebuilding Together North Texas

UNKNOWN

Sponsor Role: collaborator

The University of Texas at Arlington

OTHER

Sponsor Role: lead

Responsible Party

Insung Kang, PhD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Insung Kang, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

The University of Texas at Arlington

Locations

University of Texas at Arlington

Arlington, Texas, United States

Site Status: RECRUITING

Rebuilding Together North Texas

Plano, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Insung Kang, Ph.D.

Role: CONTACT

insung.kang@uta.edu

817-272-2167

Facility Contacts

Insung Kang, Ph.D.

Role: primary

insung.kang@uta.edu

312-342-5733

Tia LaFavor

Role: primary

tia@rtntx.org

972-245-6900

References

Bolen RM, Lamb JL. Guardian support of sexually abused children: a study of its predictors. Child Maltreat. 2002 Aug;7(3):265-76. doi: 10.1177/1077559502007003008.

Reference Type: BACKGROUND

PMID: 12139193 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36450925 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34798726 (View on PubMed)

Other Identifiers

HUD TXHHU0097-24

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2025-0280

Identifier Type: -

Identifier Source: org_study_id