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

基本信息

批准号：
8491784
负责人：
Anne Mentro Fitzpatrick
金额：
$ 81.61万
依托单位：
WAKE FOREST UNIVERSITY HEALTH SCIENCES
依托单位国家：
美国
项目类别：
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/8491784
关键词：
Adrenal Cortex Hormones Adult Advair Agonist American Lung Association Anti-Tumor Necrosis Factor Therapy Asthma Breathing Catabolism Child Childhood Asthma Clinical Clinical Management Clinical Research Clinical Trials Clinical Trials Design Companions Dose Double-Blind Method Eosinophilia Epidemiology Failure Genes Genetic Genotype Haplotypes Health Sciences Immunophilins Inflammation Intramuscular Injections Ipratropium Bromide Lead Natural History North Carolina Nuclear Translocation Outcome Participant Patient Rights Patients Phenotype Physician Executives Placebo Control Placebos Protocols documentation Questionnaires Randomized Receptor Gene Refractory Relative (related person)Replacement Therapy Research Research Personnel Resistance Resources Respiratory physiology Risk Running S-Nitrosoglutathione S-Nitrosothiols Salmeterol School-Age Population Site Sputum Steroid Resistance Symptoms Testing Treatment Protocols Triamcinolone Acetonide Tumor Necrosis Factor Receptor Tumor Necrosis Factor-alpha Universities Variant Virginia Weight base clinical research site cohort design eosinophil epidemiologic data experience fluticasone forest genetic variant genome wide association study health care service utilization improved meetings programs resistance mechanism response tacrolimus binding protein 4 trial comparing

项目摘要

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，我们已经建立了大西洋海岸联盟的哮喘（ACC-A）作为临床部位。它由弗吉尼亚大学（WG Teague，Co-Pi，Co-Pi，首席研究员，儿童），Emory University（Fitzpatrick，Fitzpatrick，Co-I，Co-I，现场主任）和北卡罗来纳州临床研究（C LAFORCE，CO-I，CO-I，CO-I，医学总监）。一组研究人员聚集在一起，在包括哮喘临床研究网络（ACRN）1和2，严重的哮喘研究计划（SARP），美国肺部哮喘协会的哮喘临床研究中心（ALA-ACRC）（ALA-ACRC），《流行病学学和对诸如Asthma：Outcomes and Outemens and Outemens and STERSTEMENT》（TERP）（TENOR的计划）（Tenor anp）（Tenor）（Tenor anp anp of Comesipt）（SARP）（SARP）（SARP）（SARP）（SARP）（SARP）（SARP）（SARP）（SARP）（SARP）中拥有丰富的经验。从现有的流行病学数据（Stampeed，基因组广泛的哮喘和肺功能关联），以及各种哮喘临床试验。凭借这种经验和丰富的资源，我们同意参与哮喘的各个方面，并提出了两个主要协议（具有伴侣探索性和机械方案），重点是成人和儿童的严重哮喘患者的特定子集。在严重哮喘（Gene Batts）中，基于基因的抗TNF治疗是一种随机，双盲，安慰剂控制的基因型分层试验，旨在检验以下假设，即在肿瘤坏死因子（TNF）受体基因中对不含抗抗TNF的患者的肿瘤坏死因子（TNF）受体反应更好。儿童严重哮喘的管理选择（马赛克）是一项随机，双重，平行的小组试验，旨在确定3种治疗方案的功效：仅880兆/天氟替卡酮，440兆/天氟替卡酮 + bid salmeterol，440兆/天的fluticasone + bid ipratim bromine ins in in 440 meg/day bromasine ins in in in Proticatim bromasine ins in in in bid imimidatim ins in in in in in bromasine in n in in in in in bromines ins in in in in in in bim bromasine in in in in in in in bim bromasine in 440兆/天。伴随方案将检查成人耐药性（Immost）的皮质类固醇耐药性（RASS）和可能在儿童中吸入的S-硝基戊二酸（N30-201）（SNORT）的遗传机制（Immost）。