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Pediatric AsthmaNCT07047430

The Airports, Air Quality, and Asthma (AAA) Study

A study testing Portable air cleaner with HEPA filter and Less effective portable air cleaner (no HEPA) in people with Pediatric Asthma, run by University of Washington at 1 site 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

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… Read more about this study

Who is it for?
Ages 6 to 12 years
Conditions the study is for
Pediatric Asthma
What is being tested?
Portable air cleaner with HEPA filter and Less effective portable air cleaner (no HEPA)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteUnited States
Study dates
1 Jun 2024to 1 Jun 2027
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 6 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

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

Christine Loftus, PhD, MPH contact

206-753-9079

cloftus@uw.edu

United States1 site, 1 recruiting
  • University of Washington

    Seattle, Washington, 98195

    Elena Austin, ScD, 206-221-6301, elaustin@uw.edu

    Maria Tchong-French, 206-685-0465, mtchong@uw.edu

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

Communities in proximity to airports face increased exposures to air pollution generated from both roadway and aircraft traffic. Exposure to particulate air pollution increases risk of an asthma exacerbation ("asthma attack") and, consequently, the possibility of an emergency room or urgent care visit. Puget Sound communities near flight paths have higher baseline rates of asthma and higher rates of asthma-related emergency room visits. For this study, the investigators will test whether an indoor air quality intervention involving HEPA air filtration units can address disparities in indoor air pollution and asthma health in neighborhoods around the Seattle Tacoma (SeaTac) International airport. Previous studies have reported benefits to deploying HEPA filters in indoor spaces, including improved air quality, as well as, reduced frequency of asthma symptoms and exacerbations, which can lead to urgent care visits and hospitalizations. However, it is unknown whether a similar intervention will be effective for children with asthma exposed to airport-related pollution, specifically.

Researchers with the University of Washington, Department of Environmental and Occupational Health Sciences, with experience in pediatric airway health, air pollution monitoring, methods for improving air quality, and epidemiology will conduct this work. They will assess the effectiveness of an indoor air quality intervention in reducing exposure to indoor pollutants and avoiding asthma symptom flare-ups for children with asthma living near SeaTac International airport.

To conduct this study, a sample of children referred to the Public Health - Seattle \& King County (PHSKC) Community Health Worker (CHW) Asthma Program and their caregivers will be recruited. Enrolled children and caregivers will be followed for 3 months in the AAA research study before they begin the CHW Asthma Education Program. Each will be randomized to an intervention group, which involves indoor air filtration using a HEPA air filter unit, or a control group, which receives an air filtration unit that may not reduce PM2.5 and ultrafine particulates, types of pollution specific to air and road traffic. About 60 families will participate in total across the two-year study period (January 2024 through June 2025).

The primary research questions assessed in this study are A) Does adding a HEPA filter intervention to the existing asthma education program improve asthma outcomes? and B) Is there an indoor air quality benefit to using an indoor HEPA filter in the homes impacted by aircraft-related air pollution?

Currently, the Community Health Worker (CHW) Asthma Program provides a range of educational services, a green cleaning kit, a HEPA vacuum and mattress encapsulation materials. It does not provide a portable HEPA filter for the participant's home bedroom. The purpose of this project is to assess the added benefit of adding the HEPA unit to future asthma education program interventions.

Caregivers will complete weekly questionnaires to track the occurrence of asthma symptoms, a marker of asthma exacerbations, and health care utilization for asthma. Air quality inside and outside the homes will be monitored. When the study is completed, the investigators will determine whether families in the intervention group had better air quality and improved asthma symptoms during the follow-up period. These findings will be disseminated to the community with the help of the CHWs.

Being tested
Portable air cleaner with HEPA filter, Less effective portable air cleaner (no HEPA)
Keywords
air quality, indoor air, portable air cleaner, pediatric asthma, community health workers

What participants receive

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

  • Portable air cleaner with HEPA filterDevice

    Also called HEPA, Portable air cleaner, Air 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.

  • Less effective portable air cleaner (no HEPA)Device

    Also called portable air cleaner, HEPA filter removed

    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.

Study groups in NCT07047430
Study groupRoleWhat they receive
Effective portable air cleaner (HEPA)ExperimentalDuring 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.
Receives: Device: Portable air cleaner with HEPA filter
Control portable air cleaner (less effective).Sham comparatorDuring 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.
Receives: Device: Less effective portable air cleaner (no HEPA)

What is being measured

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

  1. Symptom days over 7 days

    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.

    Measured: Repeated measure, assessed on a weekly basis throughout the 3 month observation period.

  2. Change in Asthma Control Score

    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.

    Measured: From the baseline visit until the end of study follow-up, 3 months later.

Timeline

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

  1. First posted2 Jul 2025
  2. Study start1 Jun 2024
  3. Primary completion1 Jun 2026 (estimated)
  4. Study completion1 Jun 2027 (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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
The design is a parallel group, two-arm randomized superiority trial. After enrollment, participating households are block randomized to either an intervention group or a control group in a 1:1 ratio overall and further balanced 1:1 within groups by household smoking status, defined as reported presence vs. absence of smoking household members. At the start of the trial, an indoor air cleaner is set up in the bedroom of the participating child. Air cleaners in intervention group homes are outfitted with a set of three filters (pre-filter, activated carbon filter, and HEPA filter) while those in control group homes receive an air cleaner with only a pre-filter. All households are followed for a three-month observation period that coincides with administration of the intervention.
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07047430
Sponsor's protocol ID
STUDY00019144
Status last verified
Jun 2025
First submitted
4 Jun 2025
Last updated
2 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified information on indoor and outdoor air quality over the course of the study period will be shared through an open source publication. De-identified weekly symptom questionnaire will be shared, however identifiable participant information including age, gender/sex and home address will be redacted.

Publications

  • Loftus CT, Lim P, Capps J, Shirai JH, Tchong-French M, Austin E. The Airport Air Quality and Asthma (AAA) indoor air intervention trial for children with asthma: Protocol for a community-based study in South King County, Washington State. Trials. 2025 Nov 27;26(1):596. doi: 10.1186/s13063-025-09286-8.

    PubMed 41310837
  • Loftus C, Lim P, Capps J, Shirai J, Tchong-French M, Austin E. The Airport, Air Quality and Asthma (AAA) Indoor Air Intervention Trial for Children with Asthma: Protocol for a Community Based Study in South King County, Washington State. Res Sq [Preprint]. 2025 Sep 22:rs.3.rs-7181465. doi: 10.21203/rs.3.rs-7181465/v1.

    PubMed 41041530

Questions about this trial

What is this clinical trial studying?

A study testing Portable air cleaner with HEPA filter and Less effective portable air cleaner (no HEPA) in people with Pediatric Asthma, run by University of Washington at 1 site 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 5 inclusion and 2 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 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 Christine Loftus, PhD, MPH (206-753-9079, cloftus@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Symptom days over 7 days (time frame: Repeated measure, assessed on a weekly basis throughout the 3 month observation period.). 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 NCT07047430, which also lists 2 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 2 Jul 2025.

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