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

NCT07196436 | Recruiting

• 2 other identifiers: 2025-0280HUD TXHHU0097-24
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Asthma; Asthma Control; Pulmonary Function; Lung Function; Quality of Life; Stress; Sleep Quality; Indoor Air Quality; Residential Ventilation; Air Cleaner; Air Filtration; Mold

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline; 6 months; 18 months; 24 months

• 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.

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

Secondary Outcomes (4)

• Asthma-Related Quality Of Life (Adults)

  Baseline; 6 months; 18 months; 24 months

• Asthma-Related Quality Of Life (Children)

  Baseline; 6 months; 18 months; 24 months

• Stress Levels

  Baseline; 6 months; 18 months; 24 months

• Sleep Quality

  Baseline; 6 months; 18 months; 24 months

Study Arms (4)

Active ERV

ACTIVE COMPARATOR

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

Device: Energy Recovery Ventilator

Sham ERV

SHAM COMPARATOR

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

Device: Energy Recovery Ventilator (Sham)

Active PAC

ACTIVE COMPARATOR

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

Device: Portable Air Cleaner

Sham PAC

SHAM COMPARATOR

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

Device: Portable Air Cleaner (Sham)

Interventions

Energy Recovery Ventilator 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

Also known as: ERV

Active ERV

Portable Air Cleaner DEVICE

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

Also known as: PAC, HEPA Air Cleaner, Residential Air Cleaner, Room Air Cleaner, Air Purifier

Active PAC

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.

Sham ERV

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

Sham PAC

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Participants living in homes with any smokers

Sponsors & Collaborators

• The University of Texas at Arlington: lead
• Rebuilding Together North Texas: collaborator

Study Sites (2)

University of Texas at Arlington

Arlington, Texas, 76010, United States

RECRUITING

Rebuilding Together North Texas

Plano, Texas, 75025, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 12139193 BACKGROUND

• 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.

  PMID: 36450925 BACKGROUND

• 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.

  PMID: 34798726 BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Asthma

Interventions

Air Filters

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Filtration; Chemistry Techniques, Analytical; Investigative Techniques; Equipment and Supplies

Study Officials

• Insung Kang, Ph.D.

  The University of Texas at Arlington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Insung Kang, Ph.D.

CONTACT

817-272-2167; insung.kang@uta.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: September 29, 2025
• Study Start: October 10, 2025
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): February 28, 2028
• Last Updated: October 29, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)