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首页> 外文期刊>Controlled clinical trials >The Prevention of Early Asthma in Kids study: design, rationale and methods for the Childhood Asthma Research and Education network.
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The Prevention of Early Asthma in Kids study: design, rationale and methods for the Childhood Asthma Research and Education network.

机译：预防儿童早期哮喘研究：儿童哮喘研究和教育网络的设计，原理和方法。

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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 microg 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.
机译：小儿哮喘仍然是一个重要的公共卫生问题，因为其患病率和对医疗保健系统的费用不断上升。为了促进哮喘疗法的创新研究，美国国家心肺血液研究所于1999年创建了儿童哮喘研究和教育网络。作为其首次研究，儿童哮喘研究和教育网络的指导委员会设计了一项随机临床试验。确定是否可以预防高发患病儿童的持续性哮喘。该通讯介绍了其首个临床试验的设计，儿童哮喘预防（PEAK）试验以及开发和实施该试验的儿童哮喘研究与教育网络的组织。对哮喘自然史的研究表明，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，将哮喘预测指数阳性的2岁和3岁儿童通过定量吸入器和Aerochamber（R）随机接受每日两次两次fluticasone 88 microg或安慰剂治疗，为期2年。在双盲治疗期之后是一年的观察期。在整个研究过程中，肺功能通过肺活量测定和示波法以4个月的间隔进行测量。在治疗和观察期结束时进行了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。其他次要结局包括加重次数，哮喘药物的使用和肺功能。选择这些措施是为了反映疾病从间歇性喘息发展到持续性哮喘的进展以及对气流受限程度和气道反应性的测量。

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