CARE Network-UCSD Clinical Center

CARE 网络-UCSD 临床中心

• 批准号: 7248720
• 负责人: ROBERT S ZEIGER
• 金额: $ 31.16万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 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/7248720
• 关键词: 12 year old; 7 year old; Acute; Address; Adolescent; Adrenal Cortex Hormones; Adrenergic Agents; Adrenergic Receptor; Advair; Age; Age-Years; Agonist; Air; Amino Acids; Arts; Asthma; Behavioral; Biological Markers; Blood specimen; Breathing; Bronchodilator Agents; Characteristics; Chest; Child; Childhood Asthma; Clinical; Clinical Research; Clinical Trials; Collection; Consent; Count; Cross-Over Studies; Data; Data Coordinating Center; Diet; Dose; Education; Enrollment; Evaluation; Exhalation; Extrinsic asthma; Family; Family Study; Female; Funding; Genetic Polymorphism; Genetic screening method; Genotype; Grant; Guidelines; Head; Health Status; Hospitalization; Human Subject Research; Hypersensitivity; Hypersensitivity skin testing; IgE; Individual; Insurance Carriers; Intervention; Invasive; Investigational Therapies; Leukotriene Antagonists; Light; Lung; Masks; Measurement; Measures; Morbidity - disease rate; Multicenter Trials; Numbers; Obesity; Oscillometry; Parents; Participant; Patients; Pharmaceutical Preparations; Phase III Clinical Trials; Physical Examination; Physicians; Placebos; Plethysmography; Positioning Attribute; Prevention; Prevention intervention; Procedures; Protocols documentation; Pulmicort; Pulmonary function tests; Questionnaires; Radiation; Randomized; Recurrence; Research; Research Design; Research Infrastructure; Risk; Role; Safety; Sampling; Serum; Source; Spirometry; Techniques; Technology; Time; Treatment Protocols; United States Food and Drug Administration; Universities; Venipunctures; Visit; Week; Weight; Wheezing; Wisconsin; Work; Xolair; adrenergic; airborne allergen; anti-IgE; asthma inhaler; base; beta-adrenergic receptor; cohort; cost; eosinophil; ethnic minority population; fluticasone; formoterol; genetic analysis; human subject; methacholine; named group; omalizumab; placebo controlled study; prevent; programs; prospective; response; symbicort; trafficking

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.

描述（由申请人提供）： 1999 年 1 月，NHLBI 创建了一项联邦政府资助的临床研究计划来研究儿童哮喘，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来参与 1999 年 9 月开始工作的儿童哮喘研究和教育 (CARE) 网络。 CARE Network成功启动了四项临床试验：（1）长期早期哮喘二级预防干预方案，名为“儿童早期哮喘预防”（PEAK）； (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) 一项比较持续性哮喘控制者治疗方案疗效的方案[小儿哮喘控制者试验 (PACT)]； (4) 评估两种不同急性干预管理策略 (AIMS) 的方案，适用于患有与显着发病率相关的反复喘息发作的幼儿。 该申请介绍了 CARE 网络如何建立成功的基础设施来进行临床研究，审查当前进行和/或已完成的试验所取得的进展，并提出三个样本方案，该网络认为这些方案具有足够的科学价值，足以保证为一项临床研究提供新的资助。额外五年。 β 肾上腺素能基因型反应评估 (BADGRE) 是一项为期 54 周的平行组、随机、交叉研究，按 α2 肾上腺素能受体基因型分层，旨在评估加倍 ICS 剂量与添加长效 β 激动剂的疗效(LABA) 对低剂量 ICS 的影响，以及对 6-18 岁患有轻度至中度持续性症状的受试者是否存在基因型影响哮喘且低剂量 ICS 单一疗法无法充分控制。 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红绿灯饮食是否会与行为改变相关，从而显着减少哮喘的需要对年龄为 7-18 岁、体重比第 50 个百分位体重高 20% 至 100% 的中度持续性哮喘儿童使用控制药物。 严重哮喘最大化干预 (MAXISA) 是一项为期 49 周的重新随机、双盲、前瞻性安慰剂对照试验，旨在确定抗 IgE 在治疗当前儿童指南分类的严重持续性哮喘中是否具有潜在作用以及正在接受现有第 3 步或第 4 步治疗的青少年。 所有这些方案都结合了最先进的技术，用于客观的反应测量、经过验证的哮喘控制测量以及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。