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

Not Applicable
Completed
Conditions
Asthma
Interventions
Other: integrated pest management
Other: 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
Inclusion Criteria
  • grades K-8 with asthma attending sampling/intervention schools
Exclusion Criteria
  • moving schools

Study & Design

Study Type
INTERVENTIONAL
Study Design
FACTORIAL
Arm && Interventions
GroupInterventionDescription
Environmental Interventionintegrated pest managementActive Classroom air purifiers and school integrated pest management environmental intervention
Environmental Interventionair purifierActive 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 Pestintegrated pest managementSham air purifiers and active school integrated pest management
Active Air Purifier and Controlair purifierActive air purifiers and no school integrated pest management environmental intervention
Primary Outcome Measures
NameTimeMethod
Maximum Number of Days With Asthma Symptoms Within 2 Weeksup 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
NameTimeMethod

Trial Locations

Locations (1)

Boston Children's Hospital

🇺🇸

Boston, Massachusetts, United States

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