- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00006565
Randomized Trial to Reduce Environmental Tobacco Smoke in Children With Asthma
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 3단계
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 1
HEPA Air Cleaners
|
Placement of two active HEPA air cleaners in the homes of children
다른 이름들:
|
|
위약 비교기: 2
Inactive (placebo) filtration unit
|
Placement of inactive filtration unit in the homes
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Unscheduled asthma visits
기간: Measured at 12 months
|
Measured at 12 months
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Asthma symptoms
기간: Measured at 12 months
|
Measured at 12 months
|
|
Exhaled nitric oxide
기간: Measured at 12 months
|
Measured at 12 months
|
|
Tobacco smoke exposure, measured using air nicotine dosimeters, serum cotinine and hair cotinine
기간: Measured at 12 months
|
Measured at 12 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Bruce P Lanphear, MD, MPH, Simon Fraser University
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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