Atlantic Coast Consortium for Asthma (ACC-A) AsthmaNet Clinical Site

大西洋海岸哮喘联盟 (ACC-A) AsthmaNet 临床网站

• 批准号: 7766873
• 负责人: Stephen P Peters
• 金额: $ 49.74万
• 依托单位: WAKE FOREST UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-30 至 2016-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7766873
• 关键词: Adrenal Cortex Hormones; Adult; American Lung Association; Anti-Tumor Necrosis Factor Therapy; Asthma; Breathing; Child; Childhood Asthma; Clinical Research; Clinical Trials; Clinical Trials Design; Companions; Double-Blind Method; Epidemiology; Genes; Genetic; Genotype; Health Sciences; Ipratropium Bromide; Lead; Natural History; North Carolina; Outcome; Participant; Patients; Phenotype; Physician Executives; Placebo Control; Protocols documentation; Randomized; Receptor Gene; Research; Research Personnel; Resistance; Resources; Respiratory physiology; Salmeterol; Site; Testing; Treatment Protocols; Tumor Necrosis Factor Receptor; Tumor Necrosis Factor-alpha; Tumor Necrosis Factors; Universities; Variant; Virginia; base; clinical research site; design; epidemiologic data; experience; fluticasone; forest; genetic variant; genome wide association study; programs; resistance mechanism; response

DESCRIPTION (provided by applicant): In response to the AsthmaNet RFA, we have established the Atlantic Coast Consortium for Asthma (ACC-A) to serve as a clinical site. It consists of Wake Forest University Health Sciences (SP Peters, PI, Lead Investigator, Adults), University of Virginia (WG Teague, Co-PI, Lead Investigator, Children), Emory University (A Fitzpatrick, Co-I, Site Director), and North Carolina Clinical Research (C LaForce, Co-I, Medical Director). The group of investigators assembled has extensive experience as participants and lead investigators in national asthma networks including the Asthma Clinical Research Network (ACRN) 1 and 2, the Severe Asthma Research Program (SARP), the American Lung Association's Asthma Clinical Research Centers (ALA-ACRC), The Epidemiology and Natural History of Asthma: Outcomes and Treatment Regimens (TENOR) program, and SNP Typing for Association with Multiple Phenotypes from Existing Epidemiologic Data (STAMPEED, Genome wide Association for Asthma and Lung Function), and with a wide variety of asthma clinical trials. With this experience and extensive resources, we agree to participate in all aspects of AsthmaNet and propose two major protocols (with companion exploratory and mechanistic protocols) focusing on specific sub-sets of severe asthmatics in adults and children. Gene-Based Anti-TNF Therapy in Severe Asthma (Gene BATTS) is a randomized, double-blind, placebo-controlled genotype-stratified trial in adults designed to test the hypothesis that severe asthmatics with specific genetic variants in tumor necrosis factor (TNF) receptor genes respond better to anti-TNF than patients without these variants. Management Options for Severe Asthma in Children (MOSAIC) is a randomized, double-blinded, parallel group trial designed to determine the efficacy of 3 treatment regimes: 880 meg/day fluticasone alone, 440 meg/day fluticasone + BID salmeterol, and 440 meg/day fluticasone + BID ipratropium bromide in severe asthmatic children inadequately controlled on fluticasone 440 meg/day. Companion protocols will examine corticosteroid resistance (RASS) and a possible genetic mechanism for resistance (IMMOST) in adults, and the efficacy of inhaled S-nitrosoglutathione (N30-201) (SNORT) in children.

描述（由申请人提供）：为了响应 AsthmaNet RFA，我们建立了大西洋海岸哮喘联盟 (ACC-A) 作为临床中心。它由维克森林大学健康科学部（SP Peters，首席研究员，成人首席研究员）、弗吉尼亚大学（WG Teague，联合首席研究员，儿童首席研究员）、埃默里大学（A Fitzpatrick，Co-I，站点主任）和北卡罗来纳州临床研究（C LaForce，Co-I，医学总监）组成。组成的研究小组作为国家哮喘网络的参与者和首席研究员拥有丰富的经验，包括哮喘临床研究网络 (ACRN) 1 和 2、严重哮喘研究计划 (SARP)、美国肺脏协会哮喘临床研究中心 (ALA-ACRC)、哮喘流行病学和自然史：结果和治疗方案 (TENOR) 计划以及与多种表型关联的 SNP 分型 来自现有的流行病学数据（STAMPEED，哮喘和肺功能全基因组协会）以及各种哮喘临床试验。凭借这些经验和广泛的资源，我们同意参与 AsthmaNet 的各个方面，并提出两个主要协议（附带探索性协议和机制协议），重点关注成人和儿童严重哮喘的特定子集。严重哮喘中基于基因的抗 TNF 疗法 (Gene BATTS) 是一项在成人中进行的随机、双盲、安慰剂对照基因型分层试验，旨在检验以下假设：肿瘤坏死因子 (TNF) 受体基因中具有特定遗传变异的严重哮喘患者比没有这些变异的患者对抗 TNF 的反应更好。儿童严重哮喘管理方案 (MOSAIC) 是一项随机、双盲、平行组试验，旨在确定 3 种治疗方案的疗效：单独使用 880 兆克/天氟替卡松、440 兆克/天氟替卡松 + BID 沙美特罗、以及 440 兆克/天氟替卡松 + BID 异丙托溴铵对氟替卡松控制不充分的严重哮喘儿童 440兆/天。配套方案将检查成人的皮质类固醇耐药性 (RASS) 和可能的耐药遗传机制 (IMMOST)，以及吸入 S-亚硝基谷胱甘肽 (N30-201) (SNORT) 对儿童的疗效。