Pollution Intervention to Impact Kids Asthma Study (PIKAS)

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.

Study Overview

• Status: Recruiting
• Conditions: Asthma Exacerbation; Childhood Asthma; Air Pollution, Risk Reduction Behaviors; Asthma Control
• Intervention / Treatment: Behavioral: Education and plan; Behavioral: EPA-AQI; Behavioral: Commerical-AQI

• Study Type: Interventional
• Enrollment (Estimated): 351
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pediatric Asthma Center; Phone Number: 877-296-9026; Email: franziska.rosser2@chp.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • Recruiting
      • UPMC Children's Hospital of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control (Standard outdoor air pollution education + asthma action plan); Control	Behavioral: Education and plan; Standardized outdoor air pollution education and standard asthma action plan
Experimental: EPA-AQI (Education+ plan + EPA-AQI); EPA-AQI	Behavioral: Education and plan; Standardized outdoor air pollution education and standard asthma action plan; 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.
Experimental: Commercial-AQI (Education+ plan + commercial-AQI); Commercial-AQI	Behavioral: Education and plan; Standardized outdoor air pollution education and standard asthma action plan; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pediatric Asthma Quality of Life (PAQLQ) score over-time between groups	Asthma quality of life will be measured using the validated Pediatric Asthma Quality of Life Questionnaire (PAQLQ) and administered by research coordinators at all in-person visits: randomization (Visit 1), Visit 7 (24 weeks), and exit (Visit 13). The PAQLQ ranges from 1 to 7, with higher scores indicating higher quality of life.	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	Self-reported severe asthma exacerbations (SAE) will be measured every 4 weeks via questionnaire, administered at all study visits (Visits 1- 13). SAE are defined by American Thoracic Society criteria and include increased asthma symptoms requiring at least 3 days of systemic steroids OR increased asthma symptoms for which Emergency Department or Urgent Care evaluation was sought and for which systemic steroids were administered/prescribed). SAE will be categorized as yes or no for a study visit.	Baseline through 48 weeks, measured at 4 week intervals

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differential nasal gene expression in children with asthma reporting increased susceptibility to outdoor air pollution	A component of our EPA-AQI and commercial-AQI intervention is to encourage participants to learn their own personal susceptibility to outdoor air pollution. We will assess if participants report symptoms to specific AQI categories at all visits via questionnaire (yes, no). Questionnaires are administered every 4 weeks at all study visits (Visits 1-13). Transcriptome-wide differential gene expression (obtained at baseline visit) will be compared between children who report low susceptibility to specific AQI category versus those who do not, with susceptibility being defined by reported susceptibility during the 48 week study, measured every 4 weeks.	Baseline through 48 weeks, measured at 4 week intervals

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: National Institute of Environmental Health Sciences (NIEHS)
• Investigators: Principal Investigator: Franziska Rosser, MD MPH, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2026
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030

Study Registration Dates

• First Submitted: November 22, 2025
• First Submitted That Met QC Criteria: November 22, 2025
• First Posted (Actual): December 3, 2025

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: childhood asthma; air quality index; AQI
• Additional Relevant MeSH Terms: Behavior; Risk Reduction Behavior; Socioeconomic Factors; Population Characteristics; Educational Status
• Other Study ID Numbers: STUDY25060085; R01ES036965 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Select de-identified data will be made available after study completion and as per Data Management and Sharing Plan.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No