An interventional study of EPA-AQI and Commerical-AQI in Childhood Asthma, Asthma Control and Asthma Exacerbation, sponsored by University of Pittsburgh. Recruiting at 1 site in United States. Open to participants aged 8 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Treatment
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:
Researchers will compare EPA-AQI and the commercial-AQI groups to a control group to either AQI works to improve asthma.
Participants will:
291 studies on the registry are indexed under Risk Reduction Behavior; 39 are open to participants now.
This study's planned enrollment of 351 is above the median of 201 across 250 interventional studies indexed under Risk Reduction Behavior.
Browse Risk Reduction Behavior studies →University of Pittsburgh is the lead sponsor of 1,419 studies on the registry; 168 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Control
Behavioral: Education and plan
EPA-AQI
Behavioral: EPA-AQI · Behavioral: Education and plan
Commercial-AQI
Behavioral: Commerical-AQI · Behavioral: Education and plan
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.
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.
Standardized outdoor air pollution education and standard asthma action plan
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.
Time frame: Baseline through 48 weeks, measured at 4 week intervals
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.
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
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.
Time frame: Baseline through 48 weeks, measured at 4 week intervals
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.
Time frame: Baseline through 48 weeks, measured at 4 week intervals
Plan to share: Yes — Select de-identified data will be made available after study completion and as per Data Management and Sharing Plan.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
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.
No publications or documents are linked to this record.
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