School Inner-City Asthma Intervention Study (SICAS-2)

Study Overview
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Brief Summary
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The investigators goal is to determine the efficacy of school/classroom based environmental intervention in reducing asthma morbidity in urban schoolchildren.

Detailed Description
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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.

Official Title
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School Inner-City Asthma Intervention Study

Conditions
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Asthma

Intervention / Treatment
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* Other: integrated pest management
* Other: air purifier
* Other: No intervention (control)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: grades K-8 with asthma attending sampling/intervention schools Exclusion Criteria: moving schools

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Environmental Intervention<br>Active Classroom air purifiers and school integrated pest management environmental intervention | Other: integrated pest management<br>* integrated pest management and environmental strategy<br>Other: air purifier<br>* air purifiers<br>|
| Placebo Comparator: Sham and Control (control)<br>Sham air purifiers and no school integrated pest management environmental intervention | Other: No intervention (control)<br>* no integrated pest management and sham air purifier<br>|
| Placebo Comparator: Active Air Purifier and Control<br>Active air purifiers and no school integrated pest management environmental intervention | Other: air purifier<br>* air purifiers<br>|
| Sham Comparator: Sham and Inegrated Pest<br>Sham air purifiers and active school integrated pest management | Other: integrated pest management<br>* integrated pest management and environmental strategy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Number of Days With Asthma Symptoms Within 2 Weeks | Maximum number of Days with wheezing, tightness in the chest, or cough and/or Nights with disturbed sleep as a result of asthma and/or 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 | up to 12 months |