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临床试验/NCT01756391
NCT01756391已完成不适用

Allergens in Inner-City Schools and Childhood Asthma

Boston Children's Hospital1 个研究点 分布在 1 个国家目标入组 351 人开始时间: 2008年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
351
试验地点
1
主要终点
Maximum Symptom Days/14 Days

研究概览

简要总结

Asthma is a disease that affects more than 12% of Americans under the age of 18 for over 14 million missed school days per year, and is the number one cause of school absences in America. Elementary school children spend 6 to 10 hours a day in school, and most of that time is spent in one classroom. The goals of this project are to provide an understanding of exposure risk factors specific to the classroom. This is critical, because the classroom environment could potentially be considered as an effective target for prevention of inner-city asthma morbidity by reducing exposures to many symptomatic children through an intervention in the school classrooms.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Grades K-8 the school year following spring recruitment (Ages 4-15)
  • Attend one of the schools in the fall where permission obtained for classroom sampling.
  • Able to provide assent and parent/guardian able to provide informed consent Physician-Diagnosed asthma AND Wheezing in the previous 12 months

排除标准

  • Significant pulmonary diseases other than asthma that might influence test results or pose risks (e.g., cystic fibrosis, sarcoidosis, bronchiectasis)
  • Cardiovascular disease that requires daily medication
  • Taking a beta blocker
  • Active smoker
  • Unable to follow through with study visit or complete study procedures

结局指标

主要结局

Maximum Symptom Days/14 Days

时间窗: 14 days

Largest value among the following: Number of days with wheezing, tightness in the chest, or cough Number of nights with disturbed sleep as a result of asthma Number of days on which the child had to slow down or discontinue play activities because of asthma

次要结局

  • Days of Slowed Activity Due to Asthma(12 months)
  • Days of Exercise-induced Symptoms(12 months)
  • Days of Cough Without an Upper Respiratory Infection(12 months)
  • Nights of Wakening Due to Asthma Symptoms(12 months)
  • Number of Hospitalizations(12 months)
  • Emergency Department Visits(12 months)
  • Unscheduled Physician/Health Care Visits(12 months)
  • Prednisone Bursts(12 months)
  • FEV1/FVC(12 months)
  • FEV1 Percent Predicted(12 months)
  • Percent Change in FEV1 After Short-acting Beta Agonist(12 months)
  • Exhaled Nitric Oxide Levels(12 months)

研究者

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

Wanda Phipatanakul

Associate Professor of Pediatrics

Boston Children's Hospital

研究点 (1)

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