Pollution Intervention to Impact Kids Asthma Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-17
SponsorUniversity of Pittsburgh
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
EPA-AQI
BehavioralThe 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-AQI
BehavioralThe 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
BehavioralStandardized outdoor air pollution education and standard asthma action plan
Treatment groups
351 Participants
are divided into 3 treatment groupsGroup A: Control (Standard outdoor air pollution education + asthma action plan)Active comparator 1 intervention
Group B: EPA-AQI (Education+ plan + EPA-AQI)Experimental treatment 2 interventions
Group C: Commercial-AQI (Education+ plan + commercial-AQI)Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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 intervalsSecondary outcomes
1
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).2
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 intervalsOther outcomes
1
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 intervalsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Pittsburgh
Lead sponsor
National Institute of Environmental Health Sciences (NIEHS)
Collaborator
Source ClinicalTrials.gov