CARE Network-UCSD Clinical Center

描述（由申请人提供）： 1999年1月，NHLBI创建了一个联邦资助的临床研究计划，以研究儿童哮喘，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加1999年9月开始工作的儿童哮喘研究和教育（CARE）网络。 CARE网络成功地启动了四项临床试验：（1）一项长期早期二级哮喘预防干预方案，题为预防儿童早期哮喘（PEAK）;（2）一项描述对白三烯拮抗剂和吸入性皮质类固醇（CLIC）反应的方案;（3）一项比较持续性哮喘控制者治疗方案疗效的方案[儿科哮喘控制者试验（PACT）];以及（4）一项评估两种不同的急性干预管理策略（AIMS）的方案，用于与显著发病率相关的反复喘息发作的幼儿。 本申请介绍了CARE网络如何建立了一个成功的基础设施来进行临床研究，审查了目前进行和/或完成的试验所取得的进展，并提出了三个样本协议，该网络认为这些协议具有足够的科学价值，值得再提供五年的资金。 β肾上腺素能基因型反应评价（BADGRE）是一项54周平行组、随机、交叉研究，按α 2-肾上腺素能受体的基因型分层，评价ICS剂量加倍与在低剂量ICS基础上加用长效β-受体激动剂（LABA）的疗效，以及在6- 18岁，患有轻度至中度持续性哮喘，且低剂量ICS单药治疗控制不佳。 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，将用于确定以家庭为基础的交通灯饮食是否与行为改变相关，是否会导致7-18岁中度持续性哮喘儿童使用控制药物的需求显着减少，体重比第50百分位的体重大20 - 100%。 重度哮喘的最大化干预（MAXISA）是一项为期49周的再随机化、双盲、前瞻性安慰剂对照试验，旨在确定抗IgE抗体在治疗重度持续性哮喘（根据现行指南分类）中是否有潜在作用，适用于接受现有第3步或第4步治疗的儿童和青少年。 所有这些方案都采用了最先进的技术，用于客观测量反应、经验证的哮喘控制措施以及生物标志物和遗传分析，以确定与干预反应相关的个体患者特征。

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.