Pollution Intervention to Impact Kids Asthma Study

NCT ID: NCT07261423

Last Updated: 2026-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

351 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-28

Study Completion Date

2030-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Unblinded, randomized controlled parallel trial, stratified by age group (8-12 year, 13-17 year).
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

Control

Group Type ACTIVE_COMPARATOR

Education and plan

Intervention Type BEHAVIORAL

Standardized outdoor air pollution education and standard asthma action plan

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

EPA-AQI

Group Type EXPERIMENTAL

EPA-AQI

Intervention Type 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.

Education and plan

Intervention Type BEHAVIORAL

Standardized outdoor air pollution education and standard asthma action plan

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

Commercial-AQI

Group Type EXPERIMENTAL

Commerical-AQI

Intervention Type 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.

Education and plan

Intervention Type BEHAVIORAL

Standardized outdoor air pollution education and standard asthma action plan

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Education and plan

Standardized outdoor air pollution education and standard asthma action plan

Intervention Type BEHAVIORAL

Eligibility Criteria

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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 corticosteroids 4 weeks prior to randomization
* Current participation in another asthma intervention trial
Minimum Eligible Age

8 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Environmental Health Sciences (NIEHS)

NIH

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Franziska Rosser, MD MPH

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Franziska Rosser, MD MPH

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Central Contacts

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Pediatric Asthma Center

Role: CONTACT

877-296-9026

Other Identifiers

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R01ES036965

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY25060085

Identifier Type: -

Identifier Source: org_study_id

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