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: 7936919
• 负责人: Stephen P Peters
• 金额: $ 84.01万
• 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/7936919
• 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）作为临床研究中心。其由维克森林大学健康科学部（SP Peters，PI，主要研究者，成人）、弗吉尼亚大学（WG蒂格，Co-PI，主要研究者，儿童）、埃默里大学（A菲茨帕特里克，Co-I，研究中心总监）和北卡罗来纳州临床研究部（C LaForce，Co-I，医学总监）组成。聚集的研究者小组作为国家哮喘网络的参与者和主要研究者具有丰富的经验，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），哮喘的流行病学和自然史：结果和治疗方案（TENOR）计划，以及SNP分型与现有流行病学数据中多种表型的关联（STAMPEED，全基因组哮喘和肺功能协会），并与各种各样的哮喘临床试验。有了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（伴随探索性和机制协议），重点是成人和儿童严重哮喘的特定子集。基于基因的抗肿瘤坏死因子治疗严重哮喘（Gene BAT TS）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：具有肿瘤坏死因子（TNF）特定遗传变异的严重哮喘患者受体基因对抗肿瘤坏死因子的反应比没有这些变异的患者更好。儿童重度哮喘的管理选择（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：880 mcg/天氟替卡松单药、440 mcg/天氟替卡松+ BID沙美特罗和440 mcg/天氟替卡松+ BID异丙托溴铵治疗440 mcg/天氟替卡松控制不佳的重度哮喘儿童。配套方案将检查成人皮质类固醇抵抗（RASS）和抵抗的可能遗传机制（IMMOST），以及吸入S-亚硝基谷胱甘肽（N30-201）（SNORT）在儿童中的疗效。