School Inner-City Asthma Intervention Study (SICAS-2)
- Conditions
- Asthma
- Interventions
- Other: integrated pest managementOther: No intervention (control)Other: air purifier
- Registration Number
- NCT02291302
- Lead Sponsor
- Boston Children's Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 236
- grades K-8 with asthma attending sampling/intervention schools
- moving schools
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Environmental Intervention integrated pest management Active Classroom air purifiers and school integrated pest management environmental intervention Environmental Intervention air purifier Active Classroom air purifiers and school integrated pest management environmental intervention Sham and Control (control) No intervention (control) Sham air purifiers and no school integrated pest management environmental intervention Sham and Inegrated Pest integrated pest management Sham air purifiers and active school integrated pest management Active Air Purifier and Control air purifier Active air purifiers and no school integrated pest management environmental intervention
- Primary Outcome Measures
Name Time Method Maximum Number of Days With Asthma Symptoms Within 2 Weeks 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 Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States