Childhood AsthmaPIKASNCT07261423
Pollution Intervention to Impact Kids Asthma Study
A study testing EPA-AQI, Commerical-AQI and Education and plan in people with Childhood Asthma and Asthma Control, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Childhood Asthma, Asthma Control, Asthma Exacerbation
- What is being tested?
- EPA-AQI, Commerical-AQI and Education and plan
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 351 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2026to Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
About this study
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?
Read more
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
- Being tested
- EPA-AQI, Commerical-AQI, Education and plan
- Keywords
- childhood asthma, air quality index, AQI
- Medical subject headings
- Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPA-AQIBehavioural
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.
Commerical-AQIBehavioural
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 planBehavioural
Standardized outdoor air pollution education and standard asthma action plan
| Study group | Role | What they receive |
|---|---|---|
| Control (Standard outdoor air pollution education + asthma action plan) | Active comparator | Control Receives: Behavioral: Education and plan |
| EPA-AQI (Education+ plan + EPA-AQI) | Experimental | EPA-AQI Receives: Behavioral: EPA-AQI; Behavioral: Education and plan |
| Commercial-AQI (Education+ plan + commercial-AQI) | Experimental | Commercial-AQI Receives: Behavioral: Commerical-AQI; Behavioral: Education and plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: Baseline through 48 weeks, measured at 4 week intervals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start24 Feb 2026
- Primary completionJan 2030 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood AsthmaStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Unblinded, randomized controlled parallel trial, stratified by age group (8-12 year, 13-17 year).
- Masking
- None (open label)
- Enrolment
- 351 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS)
- Responsible party
- Principal investigator, Franziska Rosser, MD MPH, University of Pittsburgh
- Investigators
- Franziska Rosser, MD MPH, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07261423
- Sponsor's protocol ID
- STUDY25060085
- Other IDs
- R01ES036965
- Acronym
- PIKAS
- Status last verified
- Feb 2026
- First submitted
- 22 Nov 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Select de-identified data will be made available after study completion and as per Data Management and Sharing Plan.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pollution Intervention to Impact Kids Asthma Study
- ClinicalTrials.gov ID
- NCT07261423
- Acronym / sponsor ID
- PIKAS / STUDY25060085
- Conditions
- Childhood Asthma, Asthma Control, Asthma Exacerbation, Air Pollution, Risk Reduction Behaviors
- Keywords
- childhood asthma, air quality index, AQI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 351 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS)
- Study start
- 24 Feb 2026 (actual)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 3 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Unblinded, randomized controlled parallel trial, stratified by age group (8-12 year, 13-17 year).
| Arm | Type | Receives |
|---|---|---|
| Control (Standard outdoor air pollution education + asthma action plan) | Active comparator | Behavioral: Education and planControl |
| EPA-AQI (Education+ plan + EPA-AQI) | Experimental | Behavioral: EPA-AQI, Behavioral: Education and planEPA-AQI |
| Commercial-AQI (Education+ plan + commercial-AQI) | Experimental | Behavioral: Commerical-AQI, Behavioral: Education and planCommercial-AQI |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EPA-AQIThe 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. | Behavioural | EPA-AQI (Education+ plan + EPA-AQI) |
| Commerical-AQIThe 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. | Behavioural | Commercial-AQI (Education+ plan + commercial-AQI) |
| Education and planStandardized outdoor air pollution education and standard asthma action plan | Behavioural | Commercial-AQI (Education+ plan + commercial-AQI), Control (Standard outdoor air pollution education + asthma action plan), EPA-AQI (Education+ plan + EPA-AQI) |
Primary outcome
Change in asthma control scores, over-time, between groups
Time frame: Baseline through 48 weeks, measured at 4 week intervals
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.
2 secondary outcomes
Change in Pediatric Asthma Quality of Life (PAQLQ) score over-time between groups
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
Time frame: Baseline through 48 weeks, measured at 4 week intervals
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: Yes. Select de-identified data will be made available after study completion and as per Data Management and Sharing Plan.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Franziska Rosser, MD MPH principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EPA-AQI, Commerical-AQI and Education and plan in people with Childhood Asthma and Asthma Control, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pediatric Asthma Center (877-296-9026, franziska.rosser2@chp.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in asthma control scores, over-time, between groups (time frame: Baseline through 48 weeks, measured at 4 week intervals). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.