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Recruiting NCT07261423

Pollution Intervention to Impact Kids Asthma Study

No phase Interventional Childhood Asthma Asthma Control Asthma Exacerbation Air Pollution, Risk Reduction Behaviors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: EPA-AQI, Commerical-AQI, Education and plan.
Who it may be relevant to
Registry conditions: Childhood Asthma, Asthma Control, Asthma Exacerbation, Air Pollution, Risk Reduction Behaviors. Basic parameters: 8 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

The goal of this clinical trial is to learn if adding Air Quality Index (AQI) information to asthma action plans works to improve asthma outcomes in children. It will also learn about children with asthma who report being more sensitive to outdoor air pollution. The main questions it aims to answer are: * Does adding either information about the EPA-AQI or commercial AQI improve asthma outcomes over time? * Are there changes in nasal gene expression in children with asthma who report they are more sensitive to outdoor air pollution? Researchers will compare EPA-AQI and the commercial-AQI groups to a control group to either AQI works to improve asthma. Participants will: * Receive standardized outdoor air pollution education and an asthma action plan * Provide nose and blood specimens * Have visits every 4 weeks for 48 weeks, 10 will be conducted by telephone calls and 3 visits will be in person.

Interventions

  • Behavioral EPA-AQI
    The EPA-AQI group will receive standardized outdoor air pollution education, standardized AQI education, instructions for AQI usage, and an asthma action plan containing information specific for the EPA-AQI, and will demonstrate the ability to navigate to the EPA-AQI via smartphone app or website.
  • Behavioral Commerical-AQI
    The commercial-AQI group will receive standardized AQI education, instructions for commercial-AQI usage, and an asthma action plan containing information specific for the commercial-AQI, and will demonstrate the ability to navigate to the commercial-AQI via smartphone or website.
  • Behavioral Education and plan
    Standardized outdoor air pollution education and standard asthma action plan

Primary outcome measures

  • Change in asthma control scores, over-time, between groups [Time frame: Baseline through 48 weeks, measured at 4 week intervals]
Secondary outcome measures (2)
  • Change in Pediatric Asthma Quality of Life (PAQLQ) score over-time between groups [Time frame: Baseline through 48 weeks, measured at Visit 1 (time=0), Visit 7 (time=24 weeks), and Visit 13 (time=48 weeks).]
  • Severe asthma exacerbations, having at least one, over-time between groups [Time frame: Baseline through 48 weeks, measured at 4 week intervals]

Eligibility criteria

Inclusion criteria

  • A healthcare provider diagnosis of persistent asthma (Steps 2-5 as defined by US guidelines) or intermittent asthma (Step 1) + at least one severe asthma exacerbation (defined by American Thoracic Society (ATS)/European Respiratory Society (ERS) criteria as requiring at least 3 days of systemic steroids or an Emergency Department/Urgent Care visit requiring systemic steroids) in the prior 12 months
  • Home access to a smartphone or internet
  • Primary residence in Allegheny County, PA
  • One participant per household
  • Age 8 -17 years
  • Healthcare provider evaluation for asthma in the prior year

Exclusion criteria

  • Diagnosis of other active chronic respiratory diseases (e.g., cystic fibrosis, bronchopulmonary dysplasia, etc.)
  • Neuromuscular disorder
  • Chronic disorder limiting independent ambulation (e.g., spastic quadriplegia, etc.)
  • Cyanotic heart disease
  • Plans to relocate from Allegheny County, PA in the next year (12 months)
  • Use of intranasal or oral/intramuscular/intravenous corticosteroids 4 weeks prior to randomization
  • Current participation in another asthma intervention trial

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • UPMC Children's Hospital of Pittsburgh — Pittsburgh

Identifiers

NCT: NCT07261423 · STUDY25060085 · R01ES036965

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗