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Clinical Trials/NCT02291302
NCT02291302
Completed
Not Applicable

School Inner-City Asthma Intervention Study

Boston Children's Hospital1 site in 1 country236 target enrollmentJanuary 2015
ConditionsAsthma

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Asthma
Sponsor
Boston Children's Hospital
Enrollment
236
Locations
1
Primary Endpoint
Maximum Number of Days With Asthma Symptoms Within 2 Weeks
Status
Completed
Last Updated
last year

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.

Registry
clinicaltrials.gov
Start Date
January 2015
End Date
June 2020
Last Updated
last year
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Wanda Phipatanakul

Professor of Pediatrics

Boston Children's Hospital

Eligibility Criteria

Inclusion Criteria

  • grades K-8 with asthma attending sampling/intervention schools

Exclusion Criteria

  • moving schools

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

Study Sites (1)

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