The prevention of early asthma in kids study: design, rationale and methods for the childhood asthma research and education network
The prevention of early asthma in kids study: design, rationale and methods for the childhood asthma research and education network
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DOI：
10.1016/j.cct.2004.03.002
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发表时间：
2004-06-01
期刊：
影响因子：
--
通讯作者：
Martinez, FD
中科院分区：
文献类型：
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作者：
Guilbert, TW;Morgan, WJ;Martinez, FD
小儿哮喘仍然是一个重要的公共卫生问题，因为其患病率以及对医疗保健系统造成的成本都在上升。为了促进哮喘治疗方面的创新研究，美国国家心肺血液研究所于1999年创建了儿童哮喘研究与教育网络。作为其第一项研究，儿童哮喘研究与教育网络的指导委员会设计了一项随机临床试验，以确定在哮喘发病高风险的儿童中是否可以预防持续性哮喘。本文介绍了其第一项临床试验——儿童哮喘预防（PEAK）试验的设计，以及开展和实施该试验的儿童哮喘研究与教育网络的组织情况。
对哮喘自然病史的研究表明，在持续性哮喘中，最初的哮喘样症状和肺功能丧失主要发生在生命的最初几年。因此，在儿童哮喘预防研究中，哮喘预测指数为阳性的2岁和3岁儿童被随机分为两组，一组通过定量吸入器和储雾罐每日两次接受88微克氟替卡松治疗，另一组接受安慰剂治疗，为期2年。双盲治疗期之后是1年的观察期。在整个研究过程中，每隔4个月通过肺活量测定法和脉冲振荡法测量肺功能。在治疗期和观察期结束时进行支气管扩张剂可逆性和呼出气一氧化氮（ENO）研究。主要结局指标是无哮喘天数。其他次要结局包括病情加重次数、哮喘药物的使用和肺功能。选择这些指标是为了反映疾病从间歇性喘息到持续性哮喘的进展，以及测量气流受限和气道反应性的程度。（C）2004爱思唯尔公司。保留所有权利。
Pediatric asthma remains an important public health concern as its prevalence and cost to the health care system is rising. In order to promote innovative research in asthma therapies, the National Heart, Lung and Blood Institute created the Childhood Asthma Research and Education Network in 1999. As its first study, the steering committee of the Childhood Asthma Research and Education Network designed a randomized clinical trial to determine if persistent asthma could be prevented in children at a high risk to develop the disease. This communication presents the design of its first clinical trial, the Prevention of Asthma in Kids (PEAK) trial and the organization of the Childhood Asthma Research and Education Network that developed and implemented this trial.Studies of the natural history of asthma have shown that, in persistent asthma, the initial asthma-like symptoms and loss of lung function occur predominately during the first years of life. Therefore, in the Prevention of Asthma in Kids study, children 2 and 3 years old with a positive asthma predictive index were randomized to twice daily treatment with fluticasone 88 mug or placebo via metered-dose inhaler and Aerochamber(R) for 2 years. The double blind treatment period was followed by a 1-year observational period. Lung function was measured by spirometry and oscillometry technique at 4-month intervals throughout the study. Bronchodilator reversibility and exhaled nitric oxide (ENO) studies were performed at the end of the treatment and observation periods. The primary outcome measure was the number of asthma-free days. Other secondary outcomes included number of exacerbations, use of asthma medications and lung function. These measures were chosen to reflect the progression of the disease from intermittent wheezing to persistent asthma and measurement of the extent of airflow limitation and airway reactivity. (C) 2004 Elsevier Inc. All rights reserved.