Randomized Trial to Reduce Environmental Tobacco Smoke in Children With Asthma
研究概览
详细说明
BACKGROUND:
Asthma, a disease characterized by increased airway reactivity and inflammation in response to a variety of stimuli, is emerging as the most prevalent and serious environmental health problem among children in the United States. Numerous studies, both prospective and cross-sectional, suggest that exposure to ETS is one of the predominate risk factors for childhood asthma, but this has not been confirmed in a controlled trial.
DESIGN NARRATIVE:
The randomized, double-blind prospective trial involving 225 children with doctor-diagnosed asthma who are exposed to environmental tobacco smoke tests the efficacy of reducing such exposure on unscheduled asthma visits and asthma symptoms. The intervention consists of placement of 2 high efficiency air filtration with activated carbon, potassium permanganate and zeolite filter insert to reduce exposure to ETS in the experimental homes and inactive (placebo) units in the control group homes. The following hypotheses are tested. (1.0) Children assigned to the ETS reduction group will have a greater than 20 percent reduction in unscheduled asthma visits during one-year follow-up compared with those in the control group. (1.1) Children assigned to the ETS reduction group will have significant improvements in asthma symptoms compared with children in the control group. (1.2) Children assigned to the ETS reduction group will have greater than 10 percent reduction in ETS exposure and exhaled nitric oxide, a measure of airway inflammation during one year of follow-up compared with the control group.
研究类型
注册 (实际的)
阶段
- 第三阶段
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age 6-12 years at enrollment
- Doctor diagnosed asthma by ICD-9 billing codes (from billing records)
- Greater than 1 exacerbation(s) in the past year requiring an unscheduled asthma visit
- Exposed to the smoke of greater than or equal to 5 cigarettes in and around the house per day
- Lived within a 9-county area surrounding the city of Cincinnati
Exclusion Criteria:
- Already using a HEPA air cleaner
- Lacked electricity
- Had a coexisting medical problem
- Family planned to move in the next year
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:1
HEPA Air Cleaners
|
Placement of two active HEPA air cleaners in the homes of children
其他名称:
|
|
安慰剂比较:2
Inactive (placebo) filtration unit
|
Placement of inactive filtration unit in the homes
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Unscheduled asthma visits
大体时间:Measured at 12 months
|
Measured at 12 months
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Asthma symptoms
大体时间:Measured at 12 months
|
Measured at 12 months
|
|
Exhaled nitric oxide
大体时间:Measured at 12 months
|
Measured at 12 months
|
|
Tobacco smoke exposure, measured using air nicotine dosimeters, serum cotinine and hair cotinine
大体时间:Measured at 12 months
|
Measured at 12 months
|
合作者和调查者
调查人员
- 首席研究员:Bruce P Lanphear, MD, MPH、Simon Fraser University
出版物和有用的链接
一般刊物
- Wilson SE, Kahn RS, Khoury J, Lanphear BP. Racial differences in exposure to environmental tobacco smoke among children. Environ Health Perspect. 2005 Mar;113(3):362-7. doi: 10.1289/ehp.7379.
- Spanier AJ, Hornung RW, Kahn RS, Lierl MB, Lanphear BP. Seasonal variation and environmental predictors of exhaled nitric oxide in children with asthma. Pediatr Pulmonol. 2008 Jun;43(6):576-83. doi: 10.1002/ppul.20816.
- Spanier AJ, Hornung R, Lierl M, Lanphear BP. Environmental exposures and exhaled nitric oxide in children with asthma. J Pediatr. 2006 Aug;149(2):220-6. doi: 10.1016/j.jpeds.2006.04.001.
- Wilson SE, Kahn RS, Khoury J, Lanphear BP. The role of air nicotine in explaining racial differences in cotinine among tobacco-exposed children. Chest. 2007 Mar;131(3):856-862. doi: 10.1378/chest.06-2123.
- Lanphear BP, Hornung RW, Khoury J, Yolton K, Lierl M, Kalkbrenner A. Effects of HEPA air cleaners on unscheduled asthma visits and asthma symptoms for children exposed to secondhand tobacco smoke. Pediatrics. 2011 Jan;127(1):93-101. doi: 10.1542/peds.2009-2312. Epub 2010 Dec 13.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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