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临床试验/NCT00006565
NCT00006565已完成3 期

Randomized Trial to Reduce Environmental Tobacco Smoke in Children With Asthma

National Heart, Lung, and Blood Institute (NHLBI)0 个研究点目标入组 225 人开始时间: 2000年9月1日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
入组人数
225
主要终点
Unscheduled asthma visits

研究概览

简要总结

The purpose of this study is to test the effects of reducing indoor environmental tobacco smoke (ETS) on unscheduled asthma visits, asthma symptoms, airway inflammation, and exposure to tobacco smoke measured using air nicotine dosimeters, serum and hair cotinine.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •Already using a HEPA air cleaner
  • •Lacked electricity
  • •Had a coexisting medical problem
  • •Family planned to move in the next year

研究组 & 干预措施

1

Experimental

HEPA Air Cleaners

干预措施: HEPA Air Cleaner (Device)

2

Placebo Comparator

Inactive (placebo) filtration unit

干预措施: Placebo Filtration Unit (Device)

结局指标

主要结局

Unscheduled asthma visits

时间窗: Measured at 12 months

次要结局

  • Exhaled nitric oxide(Measured at 12 months)
  • Asthma symptoms(Measured at 12 months)
  • Tobacco smoke exposure, measured using air nicotine dosimeters, serum cotinine and hair cotinine(Measured at 12 months)

研究者

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