A RANDOMIZED TRIAL TO REDUCE ETS IN CHILDREN WITH ASTHMA

减少哮喘儿童 ETS 的随机试验

• 批准号: 6390894
• 负责人: BRUCE P LANPHEAR
• 金额: $ 54.47万
• 依托单位: CINCINNATI CHILDRENS HOSP MED CTR
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-09-01 至 2004-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6390894
• 关键词: air filtration; asthma; behavioral /social science research tag; child (0-11); clinical research; clinical trials; disease /disorder proneness /risk; environmental exposure; hair; health care service utilization; health services research tag; human subject; longitudinal human study; nicotine; nitric oxide; passive smoking; respiratory function; spirometry; urinalysis

DESCRIPTION (Adapted from applicant's abstract): The objective of this proposal is to improve our understanding of the role that environmental tobacco smoke (ETS) plays in asthma. 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. This proposed study will be the first large scale, controlled trial utilizing passive controls designed to test the effects of reducing indoor ETS on asthma symptoms, pulmonary function, airway inflammation (as measured with expired nitric oxide), and health services utilization. We request 48 months of support to conduct a randomized, double-blind prospective trial involving 240 children with doctor-diagnosed asthma who are exposed to environmental tobacco smoke, to test the efficacy of reducing such exposure on asthma symptoms. The intervention consists of placement of 2 high efficiency air filtration with activated carbon, potassium permanganate and zeolite filter insert (HEPA-CPZ) to reduce exposure to ETS in the experimental homes and inactive (placebo) units in the control group homes. We will test the following hypotheses: (1.0) Children assigned to the ETS reduction group will have significant improvements in asthma symptoms and pulmonary function compared with children in the control group. (1.1) Children assigned to the ETS reduction group will have >25 percent reduction in exacerbations of asthma during one year of follow-up compared with those in the control group. (1.2) Children assigned to the ETS reduction group will have improvement in pulmonary function as measured by >10 percent difference in forced expiratory volume at 1 second (FEV 1) and >15 percent difference in forced expiratory fraction of 25 percent-75 percent (FEF25-75 percent) at 12-month follow-up compared with those in the control group. (1.3) Children assigned to the ETS reduction group will have > 10 percent reduction in exhaled nitric oxide, a measure of airway inflammation during one year of follow-up compared with the control group. (1.4) Children assigned to the ETS reduction group will have a >20 percent reduction in health services utilization for asthma during one-year follow-up compared with those in the control group. (2.0) Children who are exposed to higher levels of ETS, as measured by cotinine, will experience higher rates of asthma symptoms and diminished pulmonary function in a dose-response relationship. Our proposed randomized, controlled trial, consisting of biologic markers of exposure, will provide evidence of a causal pathway between the exposure to environmental tobacco smoke and asthma, substantially improve our understanding of the contribution of environmental tobacco smoke to childhood asthma, and provide important information to develop prevention strategies.

描述（改编自申请人的摘要）：该提案的目的 是为了提高我们对环境烟草烟的作用的理解 （ET）玩哮喘。哮喘，一种以气道增加为特征的疾病 反应性和炎症响应各种刺激，正在出现，因为 儿童中最普遍，最严重的环境健康问题 美国。许多研究，无论是前瞻性还是横断面， 表明接触ET是主要风险因素之一 童年哮喘，但这尚未在对照试验中得到证实。这 拟议的研究将是第一个大规模的对照试验。 被动控制旨在测试减少室内ETS对哮喘的影响 症状，肺功能，气道炎症（如过期测量 一氧化氮）和卫生服务利用。我们要求48个月的支持 进行一项随机的双盲前瞻性试验，涉及240名儿童 与医生诊断的哮喘患者暴露于环境烟草烟雾， 测试减少这种暴露于哮喘症状的功效。这 干预措施包括2个高效空气过滤的放置 活性碳，高锰酸钾和沸石滤清器插入物（HEPA-CPZ） 减少实验室和无活性（安慰剂）中ETS的接触 对照组房屋中的单位。我们将测试以下假设：（1.0） 分配给ETS减少组的孩子将有重大改善 与对照的儿童相比，在哮喘症状和肺功能 团体。 （1.1）分配给ETS减少组的儿童将拥有> 25％ 与 对照组的人。 （1.2）分配给ETS减少组的儿童 肺功能将改善> 10％ 1秒（FEV 1）和> 15％的强迫呼气量差 强迫呼气分数为25％-75％（FEF25-75） 与对照组相比，在12个月的随访中）。 （1.3） 分配给ETS减少组的儿童将减少10％ 在呼出的一氧化氮中，一年的气道炎症度量 与对照组相比，随访。 （1.4）分配给ETS的儿童 还原小组的卫生服务将降低20％ 与之相比 对照组。 （2.0）暴露于ETS较高水平的儿童 通过cotinine测量，将经历更高的哮喘症状和 剂量反应关系中肺功能的降低。 我们提出的随机，对照试验，由 暴露，将提供有关暴露之间因果途径的证据 环境烟草烟雾和哮喘，大大提高了我们的理解 环境烟草对儿童哮喘的贡献，以及 提供重要信息以制定预防策略。