School Inner-City Asthma Intervention Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Boston Children's Hospital
- Enrollment
- 236
- Locations
- 1
- Primary Endpoint
- Maximum Number of Days With Asthma Symptoms Within 2 Weeks
Study Overview
Brief Summary
The investigators goal is to determine the efficacy of school/classroom based environmental intervention in reducing asthma morbidity in urban schoolchildren.
Detailed Description
Our proposal builds upon our established, successful school-based infrastructure to determine whether a school/classroom intervention will efficiently and effectively improve asthma morbidity by reducing these exposures. Our goal is to determine the efficacy of school/classroom based environmental intervention in reducing asthma morbidity in urban schoolchildren. Our central hypothesis is that reducing classroom/school exposure to mouse allergen, mold, and particulate pollutants will decrease asthma morbidity in students with asthma. The investigators plan to test this hypothesis in an intervention study of 300 elementary students with asthma from multiple classrooms in inner-city elementary schools. Our clinical trial aims are to determine the effectiveness of a school/classroom based environmental intervention (school integrated pest management and classroom air purifying filter units within these schools) to reduce asthma morbidity. Our mechanistic aim is to test the hypothesis that effects of school/classroom-based environmental interventions on symptoms/other measures of asthma control occur through changes in gene methylation or expression in pathways (and secondarily, in genes) relevant to airway function and asthma. This will expand our understanding of asthma immunopathogenesis and create opportunities to identify potential novel targets for asthma therapy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 4 Years to 15 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •grades K-8 with asthma attending sampling/intervention schools
Exclusion Criteria
- •moving schools
Arms & Interventions
Environmental Intervention
Active Classroom air purifiers and school integrated pest management environmental intervention
Intervention: integrated pest management (Other)
Environmental Intervention
Active Classroom air purifiers and school integrated pest management environmental intervention
Intervention: air purifier (Other)
Sham and Control (control)
Sham air purifiers and no school integrated pest management environmental intervention
Intervention: No intervention (control) (Other)
Active Air Purifier and Control
Active air purifiers and no school integrated pest management environmental intervention
Intervention: air purifier (Other)
Sham and Inegrated Pest
Sham air purifiers and active school integrated pest management
Intervention: integrated pest management (Other)
Outcomes
Primary Outcomes
Maximum Number of Days With Asthma Symptoms Within 2 Weeks
Time Frame: up to 12 months
Maximum number of 1. Days with wheezing, tightness in the chest, or cough and/or 2. Nights with disturbed sleep as a result of asthma and/or 3. Days on which the child had to slow down or discontinue play activities because of asthma This is defined as a cumulative assessment from the different variables listed in the Measure Description
Secondary Outcomes
No secondary outcomes reported
Investigators
Wanda Phipatanakul
Professor of Pediatrics
Boston Children's Hospital