Pollution Intervention to Impact Kids Asthma Study

NCT07261423 | Recruiting

• 2 other identifiers: STUDY25060085R01ES036965
• Study Type: interventional
• Target: 351
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Childhood Asthma; Asthma Control; Asthma Exacerbation; Air Pollution, Risk Reduction Behaviors

Keywords

childhood asthma; air quality index; AQI

Outcome Measures

Primary Outcomes (1)

• Change in asthma control scores, over-time, between groups

  Asthma control will be measured via the validated Asthma Control Test (ACT) and Childhood-ACT (CACT). Asthma control will be evaluated at all study visits (Visits 1-13), every 4 weeks. The ACT will be used for children aged 12 -17 years, the CACT will be used for children aged 8-11 years. The ACT is a 5 question instrument with scores from 5-25, with higher scores generally indicating better control. The CACT is a 7 question instrument with scores from 0-27, with higher scores generally indicating better control. For both ACT and CACT, scores of 19 or less are concerning for poor asthma control and both measure control in the past 4 weeks.

  Baseline through 48 weeks, measured at 4 week intervals

Secondary Outcomes (2)

• Change in Pediatric Asthma Quality of Life (PAQLQ) score over-time between groups

  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

  Baseline through 48 weeks, measured at 4 week intervals

Other Outcomes (1)

• Differential nasal gene expression in children with asthma reporting increased susceptibility to outdoor air pollution

  Baseline through 48 weeks, measured at 4 week intervals

Study Arms (3)

Control (Standard outdoor air pollution education + asthma action plan)

ACTIVE COMPARATOR

Control

Behavioral: Education and plan

EPA-AQI (Education+ plan + EPA-AQI)

EXPERIMENTAL

EPA-AQI

Behavioral: EPA-AQI; Behavioral: Education and plan

Commercial-AQI (Education+ plan + commercial-AQI)

EXPERIMENTAL

Commercial-AQI

Behavioral: Commerical-AQI; Behavioral: Education and plan

Interventions

EPA-AQI BEHAVIORAL

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.

EPA-AQI (Education+ plan + EPA-AQI)

Commerical-AQI BEHAVIORAL

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.

Commercial-AQI (Education+ plan + commercial-AQI)

Education and plan BEHAVIORAL

Standardized outdoor air pollution education and standard asthma action plan

Commercial-AQI (Education+ plan + commercial-AQI); Control (Standard outdoor air pollution education + asthma action plan); EPA-AQI (Education+ plan + EPA-AQI)

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute of Environmental Health Sciences (NIEHS): collaborator

Study Sites (1)

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

RECRUITING

MeSH Terms

Conditions

Risk Reduction Behavior

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Franziska Rosser, MD MPH

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pediatric Asthma Center

CONTACT

877-296-9026; franziska.rosser2@chp.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Unblinded, randomized controlled parallel trial, stratified by age group (8-12 year, 13-17 year).

Study Record Dates

• First Submitted: November 22, 2025
• First Posted: December 3, 2025
• Study Start: February 24, 2026
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: De-identified data generated from this project will be made available no later than the time of publication or the end of the funding period, whichever comes first.
• Access Criteria: Raw data and identifiable data will not be shared except where institutional agreements, certifications, and informed consent allows. De-identified data will be available by controlled access only within data repositories.

Locations

US (1)