The Airports, Air Quality, and Asthma (AAA) Study
Part of paid clinical trials in Seattle, Washington.
- Sponsor
- University of Washington
- Study ID
- NCT07047430
- Status
- Recruiting
Conditions
- Pediatric Asthma
Eligibility Criteria
- Sex
- ALL
- Age
- 6 Years - 12 Years
- Healthy Volunteers
- Not accepted
Interventions
- Portable air cleaner with HEPA filter — DEVICEThe Winix 9800 is a true HEPA air cleaner that has been AHAM (Association of Home Appliance Manufacturers) Verifide® for rooms that are 500 square feet in size. The air cleaner has a washable fine mesh pre-filter that captures large airborne particles, an activated carbon filter that reduces volatile organic compounds and odors, and a true HEPA filter that captures 99.99% of airborne allergens as small as 0.003 microns in size.
- Less effective portable air cleaner (no HEPA) — DEVICEWinix 9800 air cleaner, with data logging energy use monitor is installed in the child's bedroom. In the sham group, the Winix 9800 true HEPA filter and activated carbon filter were removed. This was an internal modification and not visible to the user. The air cleaner still included a washable fine mesh pre-filter that captures large airborne particles.
Study Details
For children with asthma, exposure to indoor air pollution increases the risk of a serious asthma exacerbation, which can be life-threatening. Interventions aimed at improving indoor air quality, including use of a portable air cleaner with a high-efficiency particulate air (HEPA) filter, can reduce this risk, but the effectiveness, feasibility and acceptability of HEPA air cleaners varies by setting. In collaboration with a community health worker (CHW) delivered asthma education program, the investigators are conducting a randomized clinical trial to evaluate the effectiveness of HEPA air cleaners to improve indoor air quality and child asthma health in South King County of Washington state, a vulnerable community impacted by air pollution from airports and highway traffic. Key features of the Airports, Air Quality and Asthma (AAA) design include integration of CHWs into study procedures, including CHWs recruited from community-based organizations, into multiple aspects of the trial protocol. The investigators aim to recruit up to N=60 children with asthma randomized into intervention and control groups in a 1:1 ratio, conduct baseline assessments of indoor air quality and airway health, and collect repeated assessments of air quality and airway health during the three-month intervention period and after the trial concludes. Study findings will inform future approaches to integrate HEPA air cleaners into existing CHW asthma education programs in this and similar communities.
Key Dates
- Start date
- Jun 1, 2024
- Status verified
- Jun 2025
- Primary completion
- Jun 1, 2026
- Completion
- Jun 1, 2027
Study Design
- Enrollment
- 60 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: Effective portable air cleaner (HEPA)During the baseline home visit, a Winix 9800 air cleaner is installed in the child's bedroom and paired with data logging energy use monitor as well as air quality monitor. Households randomized to the intervention group receive an air cleaner with a pre-filter, carbon filter, and with the HEPA air filter pre-installed.
- Sham Comparator: Control portable air cleaner (less effective).During the baseline home visit, a Winix 9800 air cleaner is installed in the child's bedroom. In the sham group, the Winix 9800 true HEPA filter and activated carbon filter which were removed via an internal modification not visible to the user. The air cleaner still included a washable fine mesh pre-filter that captures large airborne particles. Households randomized to the sham group receive an air cleaner with only the pre-filter and without the carbon filter, and HEPA air filter.
Primary Outcome Measure
Symptom days over 7 days [ Time Frame: Repeated measure, assessed on a weekly basis throughout the 3 month observation period. ]
Central Contacts
- Christine Loftus, PhD, MPH206-753-9079
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98195 | Elena Austin, ScD (PRINCIPAL_INVESTIGATOR) |
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