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

描述(由申请者提供)：为了响应哮喘网络RFA，我们建立了大西洋海岸哮喘联盟(ACC-A)作为临床站点。它包括维克森林大学健康科学(SP彼得斯，PI，首席研究员，成人)，弗吉尼亚大学(WG蒂格，联合-PI，首席研究员，儿童)，埃默里大学(A Fitzpatrick，Co-I，现场主任)和北卡罗来纳州临床研究(C LaForce，Co-I，医学主任)。聚集的研究人员团队在国家哮喘网络中拥有丰富的参与者和首席研究人员的经验，这些网络包括哮喘临床研究网络(ACRN)1和2、重症哮喘研究计划(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，以及现有流行病学数据中与多种表型相关的SNP分型(STAMPEED，全基因组哮喘与肺功能协会)，以及各种哮喘临床试验。凭借这一经验和广泛的资源，我们同意参与哮喘网络的所有方面，并提出两个主要方案(附带探索性和机械性方案)，重点关注成人和儿童严重哮喘患者的特定亚组。重度哮喘的基于基因的抗肿瘤坏死因子疗法(gene-BATTS)是一项在成人中进行的随机、双盲、安慰剂对照的基因分层试验，旨在测试具有肿瘤坏死因子受体基因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肿瘤坏死因子的反应更好这一假设。儿童重症哮喘治疗方案(MOSAIC)是一项随机、双盲、平行分组试验，旨在确定3种治疗方案的疗效：单用氟替卡松880兆克/天，氟替卡松440兆克/天+沙美特罗2次，以及氟替卡松440兆克/天+异丙托溴铵2次/天，对氟替卡松440兆克/天控制不佳的重症哮喘儿童的疗效。配套方案将检查成人的皮质类固醇耐药(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)在儿童中的疗效。

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.