Randomized Trial to Reduce Environmental Tobacco Smoke in Children With Asthma
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ 3
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:防止
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的:1
HEPA Air Cleaners
|
Placement of two active HEPA air cleaners in the homes of children
他の名前:
|
プラセボコンパレーター:2
Inactive (placebo) filtration unit
|
Placement of inactive filtration unit in the homes
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
---|---|
Unscheduled asthma visits
時間枠:Measured at 12 months
|
Measured at 12 months
|
二次結果の測定
結果測定 |
時間枠 |
---|---|
Asthma symptoms
時間枠:Measured at 12 months
|
Measured at 12 months
|
Exhaled nitric oxide
時間枠:Measured at 12 months
|
Measured at 12 months
|
Tobacco smoke exposure, measured using air nicotine dosimeters, serum cotinine and hair cotinine
時間枠:Measured at 12 months
|
Measured at 12 months
|
協力者と研究者
捜査官
- 主任研究者:Bruce P Lanphear, MD, MPH、Simon Fraser University
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
HEPA Air Cleanerの臨床試験
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Argon Medical DevicesNAMSAまだ募集していません
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Johns Hopkins UniversityNational Institute of Environmental Health Sciences (NIEHS)完了
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UConn HealthBoston University; Tufts University; National Institute of Environmental Health Sciences (NIEHS); Somerville Transportation Equity Partnership, Inc... と他の協力者募集
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Johns Hopkins UniversityNational Institute of Environmental Health Sciences (NIEHS); Environmental Protection Agency...完了
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University of South CarolinaEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National...完了
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University of South CarolinaNational Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health (NIH)完了
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China National Biotec Group Company LimitedBeijing Institute of Biological Products Co Ltd.; Hubei Provincial Center for Disease Control... と他の協力者わからない
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Simon Fraser UniversityCanadian Institutes of Health Research (CIHR)完了