NCT07047430 · University of Washington
The Airports, Air Quality, and Asthma (AAA) Study
What this study is about
For children with asthma, exposure to indoor air pollution increases the risk of a serious asthma exacerbation, which can be life-threatening.
View original scientific description
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.
Interventions
DEVICE
Portable air cleaner with HEPA filter
The 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.
DEVICE
Less effective portable air cleaner (no HEPA)
Winix 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.
Primary outcome measures
Symptom days over 7 days
Time frame: Repeated measure, assessed on a weekly basis throughout the 3 month observation period.
Symptom days were assessed through brief weekly online surveys sent to caregivers. A symptom-day was defined as any day in the past week when the child had asthma symptoms or used quick-relief medication. Caregivers reported the number of days with symptoms (e.g., coughing, wheezing, shortness of breath, nighttime awakenings), any unscheduled medical visits, and whether the child had a respiratory infection. They also noted how many nights the child slept at home, any issues with the indoor air cleaner, and its usage frequency. Symptom scores ranged from 0 to 7, with high scores indicating more days experienced for that symptom. Study staff monitored the weekly caregiver survey to ensure that the child's symptoms were not worsening over the course of the study.
Change in Asthma Control Score
Time frame: From the baseline visit until the end of study follow-up, 3 months later.
The Child Asthma Control Test (C-ACT) is a short seven-question survey used to characterize child asthma control based on parent and child report of symptoms over the prior 30 days. The C-ACT has been validated for ages 4-11 years old and shown to have good psychometric properties. A C-ACT score is calculated based on responses, ranging from 0 to 27, with higher values reflecting better asthma control, and a score of 19 or lower considered to reflect inadequate, or "poor," control. This test is administered at the beginning and at the end of the research study. The change in child Asthma Control Test (C-ACT) score between baseline and post-intervention is used to assess the benefit of reducing indoor air pollution in the child's bedroom. Study team staff review responses on the baseline survey to address missing data or participant confusion during the study visit.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Child is 6-12 years old with a health care provider-diagnosed asthma.
- Caregiver is comfortable in participating in all study activities in English (communicating with study staff by phone and completing online surveys).
- Caregiver is familiar with the child's daily asthma health.
- Residence within 10 miles of Seattle-Tacoma International Airport as determined by zip code
- Child resides in caregiver's home at least five nights a week on a regular basis and has no plans to move in the next three months.
Exclusion criteria
- Child has severe asthma at baseline. Severe asthma was defined in consultation with pediatric pulmonologists to be caregiver-reported asthma symptoms every day over the past 14 days and/or two or more inpatient hospitalizations for asthma in the past 12 months.
- Households were excluded if there were multiple individuals within the same household with asthma eligible for the King County CHW Asthma Program or had severe asthma.
Where
- Seattle, Washington
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 2, 2025 · Source of record for eligibility and locations