CARE Network-UCSD Clinical Center

描述(由申请人提供)： 1999年1月，NHLBI创建了一个由联邦政府资助的研究儿童哮喘的临床研究计划，并竞争性地选择了5个学术临床中心和一个数据协调中心参与1999年9月开始工作的儿童哮喘研究和教育(CARE)网络。CARE网络成功启动了四项临床试验：(1)题为《预防儿童早期哮喘》(PEAGE)的长期早期继发性哮喘预防干预方案；(2)表征对白三烯拮抗剂和吸入皮质类固醇(CLIC)的反应的方案；(3)正面比较持续哮喘控制器治疗方案有效性的方案[儿科哮喘控制器试验(PACT)]；(4)评估两种不同急性干预管理策略(AIMS)的方案，用于治疗与显著发病率相关的反复喘息发作的幼儿。本申请介绍了护理网络如何建立了进行临床研究的成功基础设施，审查了目前进行和/或完成的试验取得的进展，并提出了三个样本方案，该网络认为这些方案具有足够的科学价值，可以保证再延长五年的资金。β-肾上腺素能基因反应评估(BADGRE)是一项为期54周的平行分组、随机、交叉研究，按a2-肾上腺素能受体的基因型分层，以评估在小剂量ICS的基础上增加一倍ICS剂量的疗效，以及在6-18岁患有轻度至中度持续性哮喘且在小剂量ICS单一治疗中控制不充分的受试者中是否存在基因归因效应。通过治疗肥胖预防哮喘(PATO)是一项为期24周的随机、对照、多中心试验，将用于确定基于家庭的交通灯饮食与行为改变是否会导致7-18岁中度持续性哮喘儿童使用控制性药物的需求显著减少，这些儿童的体重比第50个百分位数的体重高出20%至100%。重度哮喘的最大限度干预(MAXISA)是一项为期49周的再随机、双掩蔽、前瞻性安慰剂对照试验，目的是确定抗IgE在严重持续性哮喘的治疗中是否具有潜在的作用，如现有的第三步或第四步儿童和青少年治疗指南所分类的那样。所有这些方案都结合了客观反应测量的最先进技术、哮喘控制的有效测量以及生物标记物和遗传分析，以确定与干预反应相关的患者个体特征。

DESCRIPTION (provided by applicant): In January 1999, the NHLBI created a federally sponsored clinical research program to study childhood asthma and competitively selected 5 academic Clinical Centers and a Data Coordinating Center to participate in the Childhood Asthma Research and Education (CARE) Network that began work in September 1999. The CARE Network successfully initiated four clinical trials: (1) a long-term early secondary asthma prevention intervention protocol entitled Prevention of Early Asthma in Kids (PEAK); (2) a protocol to characterize the response to a leukotriene antagonist and an inhaled corticosteroid (CLIC); (3) a protocol to compare head-to-head the efficacy of the controller treatment regimens for persistent asthma [Pediatric Asthma Controller Trial (PACT)]; and (4) a protocol to evaluate two different acute intervention management strategies (AIMS) for young children with recurrent episodes of wheezing associated with significant morbidity. This application presents how the CARE network has established a successful infrastructure to conduct clinical research, reviews progress made with the currently conducted and/or completed trials and presents three sample protocols that the network considers to be of sufficient scientific merit to warrant renewed funding for an additional five years. Beta Adrenergic Genotype Response Evaluation (BADGRE) is a 54-week parallel group, randomized, crossover study, stratified by genotype at the a2-adrenergic receptor, to evaluate the efficacy of doubling the dose of ICS versus adding a long-acting beta-agonist (LABA) to a low dose of ICS and whether there is a genotype-attributable effect in subjects 6-18 years of age who have mild to moderate persistent asthma and are inadequately controlled on monotherapy of low dose ICS. Preventing Asthma by Treating Obesity (PATO) is a 24 week, randomized, controlled, multicenter trial that will be used to determine if a family-based, traffic-light diet associate with behavioral change, will result in a significant decrease in the need to use controller medications in children with moderate persistent asthma aged 7-18 years, with weight 20 to 100% greater than the weight at the 50th percentile. MAXimizing Intervention in Severe Asthma (MAXISA) is a 49-week reandomized, double-masked, prospective placebo-controlled trial to determine whether there is a potential role for anti-IgE in the treatment of severe persistent asthma as classified by current guidelines for children and adolescents on existing Step 3 or Step 4 therapy. All of these protocols incorporate state of the art technology for objective measures of response, validated measures of asthma control, and biomarker and genetic analyses to identify individual patient characteristics associated with response to the intervention.