Childhood Asthma Research and Education Network: Denver

儿童哮喘研究和教育网络：丹佛

• 批准号: 6950708
• 负责人: Stanley J Szefler
• 金额: $ 55.37万
• 依托单位: NATIONAL JEWISH HEALTH
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-09-30 至 2009-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6950708
• 关键词: asthma; behavior modification; beta adrenergic receptor; beta antiadrenergic agent; children; clinical research; clinical trials; comorbidity; cooperative study; corticosteroids; diet therapy; dosage; genotype; glucocorticoids; human subject; human therapy evaluation; immunoglobulin E; inhalation drug administration; inhibitor /antagonist; leukotrienes; longitudinal human study; obesity; patient oriented research; pediatrics; pharmacogenetics; respiratory disease /disorder therapy; respiratory disorder chemotherapy; respiratory function; weight control

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 ¿2-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. (End of abstract.)

描述（由申请人提供）： 1999年1月，NHLBI创建了一项由联邦赞助的临床研究计划，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，以参与1999年9月开始工作的儿童哮喘研究和教育（CARE）网络（CARE）。 （顶峰）; （2）表征对白三烯拮抗剂和遗传性皮质类固醇（CLIC）的反应的方案； （3）一种比较控制者治疗方案持续性哮喘[小儿哮喘控制器试验（PACT）的效率的方案； （4）一项评估与重大发病率相关的复发性发作的幼儿评估两种不同的急性干预管理策略（AIM）的方案。该应用程序介绍了护理网络如何建立成功进行临床研究的基础设施，审查对当前进行和/或完成的试验取得的进展，并提出了三个样本协议，该方案认为该方案具有足够的科学优点，可以保证续签资金，以换取另外五年。 Beta Adrenagic Genotype Response Evaluation (BADGRE) is a 54-week parallel group, randomized, crossover study, stratified by genotype at the ¿ 2-adrenagic receptor, to evaluate the effectiveness 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患有轻度至中度的持续性哮喘，并且对低剂量IC的单一疗法的控制不足。通过治疗肥胖症（PATO）预防哮喘是24周，随机，控制，多中心试验，将用于确定基于家庭的，流通的饮食与行为改变是否会导致在7-18岁持续的7-18岁儿童中使用控制器的儿童，重量为7-18岁，重量20至100％比100％比100％比50％的50％的儿童使用控制器大幅下降。最大化严重哮喘（Maxisa）的干预是一个为期49周的重新统治，双掩盖的，前瞻性的安慰剂对照试验，以确定在现有步骤3或第4步中对儿童和青少年的当前指南对严重的持久性哮喘进行治疗中是否具有抗IGE的潜在作用。所有这些方案都结合了艺术技术的状态，以实现反应的客观测量，经过验证的哮喘控制测量，生物标志物和遗传分析，以识别与干预反应相关的个体患者特征。 （摘要结束。）