The Prevention of Early Asthma in Kids study: design, rationale and methods for the Childhood Asthma Research and Education network

Theresa W Guilbert , Wayne J Morgan , Marzena Krawiec , Robert F Lemanske Jr. , Chris Sorkness , Stanley J Szefler , Gary Larsen , Joseph D Spahn , Robert S Zeiger , Gregory Heldt , Robert C Strunk , Leonard B Bacharier , Gordon R Bloomberg , Vernon M Chinchilli , Susan J Boehmer , Elizabeth A Mauger , David T Mauger , Lynn M Taussig , Fernando D Martinez
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引用次数: 167

Abstract

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 μg or placebo via metered-dose inhaler and Aerochamber® 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.

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儿童早期哮喘的预防研究:儿童哮喘研究和教育网络的设计、原理和方法
儿童哮喘仍然是一个重要的公共卫生问题,因为它的患病率和卫生保健系统的成本正在上升。为了促进哮喘治疗方面的创新研究,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。作为第一项研究,儿童哮喘研究和教育网络指导委员会设计了一项随机临床试验,以确定是否可以预防患有这种疾病的高风险儿童的持续性哮喘。本通讯介绍了其首个临床试验的设计,即儿童哮喘预防(PEAK)试验,以及开发和实施该试验的儿童哮喘研究和教育网络的组织。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头几年。因此,在儿童哮喘预防研究中,哮喘预测指数阳性的2岁和3岁儿童随机分为两组,每天两次使用氟替卡松88 μg或安慰剂,通过计量吸入器和Aerochamber®治疗2年。双盲治疗期后为1年观察期。在整个研究过程中,每隔4个月用肺活量测定法和振荡测定法测量肺功能。在治疗和观察期结束时进行支气管扩张剂可逆性和呼出一氧化氮(ENO)研究。主要结局指标是无哮喘天数。其他次要结局包括急性发作次数、哮喘药物的使用和肺功能。选择这些措施是为了反映疾病的进展,从间歇性喘息到持续性哮喘,并测量气流限制的程度和气道反应性。
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