Pollution Intervention to Impact Kids Asthma Study (PIKAS)

University of Pittsburgh

Status: Enrolling

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

Treatments: Behavioral: Education and plan; Behavioral: Commerical-AQI; Behavioral: EPA-AQI

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07261423

R01ES036965 (U.S. NIH Grant/Contract)

STUDY25060085

Details and patient eligibility

About

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.

Enrollment: 351 estimated patients

Sex: All

Ages: 8 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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351 participants in 3 patient groups

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

Active Comparator group

Description:

Control

Treatment:

Behavioral: Education and plan

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

Experimental group

Description:

EPA-AQI

Treatment:

Behavioral: EPA-AQI

Behavioral: Education and plan

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

Experimental group

Description:

Commercial-AQI

Treatment:

Behavioral: Commerical-AQI

Behavioral: Education and plan