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临床试验/NCT02291302
NCT02291302已完成不适用

School Inner-City Asthma Intervention Study

Boston Children's Hospital1 个研究点 分布在 1 个国家目标入组 236 人开始时间: 2015年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
236
试验地点
1
主要终点
Maximum Number of Days With Asthma Symptoms Within 2 Weeks

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
4 Years 至 15 Years(Child)
性别
All
接受健康志愿者
是

入选标准

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

排除标准

  • •moving schools

研究组 & 干预措施

Environmental Intervention

Active Comparator

Active Classroom air purifiers and school integrated pest management environmental intervention

干预措施: integrated pest management (Other)

Environmental Intervention

Active Comparator

Active Classroom air purifiers and school integrated pest management environmental intervention

干预措施: air purifier (Other)

Sham and Control (control)

Placebo Comparator

Sham air purifiers and no school integrated pest management environmental intervention

干预措施: No intervention (control) (Other)

Active Air Purifier and Control

Placebo Comparator

Active air purifiers and no school integrated pest management environmental intervention

干预措施: air purifier (Other)

Sham and Inegrated Pest

Sham Comparator

Sham air purifiers and active school integrated pest management

干预措施: integrated pest management (Other)

结局指标

主要结局

Maximum Number of Days With Asthma Symptoms Within 2 Weeks

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wanda Phipatanakul

Professor of Pediatrics

Boston Children's Hospital

研究点 (1)

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