ASTHMA CLINICAL RESEARCH NETWORK

描述(由申请人提供)： 加州大学圣地亚哥分校的一个研究人员财团在哮喘领域的临床研究合作方面拥有丰富的经验和承诺，他们正在为NIH赞助的哮喘临床研究网络提出两项多中心临床试验。加州大学圣迭戈分校的财团由斯蒂芬·瓦瑟曼博士和乔·拉姆斯戴尔博士领导。研究1将在稳定的类固醇依赖型成人哮喘患者中进行。它将在这一人群中进行为期18周的双盲安慰剂对照临床试验，检查肿瘤坏死因子-α的抑制剂依那西普的效果。要评估的主要结果将是该药物是否能够显著减少吸入类固醇剂量而不会恶化。研究2还将采用双盲、安慰剂对照设计。这项试验将评估CPAP改善夜间哮喘的能力，在一群超重、患有中重度哮喘的成人患者中，他们也患有睡眠呼吸障碍。这些和其他网络试验的患者将从加州大学圣地亚哥分校的医学、肺部和过敏诊所、圣地亚哥退伍军人管理局、圣地亚哥美国海军医院和Kaiser-Permanente招募。现有人口众多，多种族和多民族，反映了圣地亚哥的环境。我们还提出了一个由安德鲁·里斯博士指导的教育计划，该计划将利用加州大学圣迭戈分校的广泛资源。

DESCRIPTION (provided by applicant): A consortium of investigators at the University of California, San Diego with extensive experience in, and a commitment to, clinical research collaborations in the area of asthma, are proposing two multi-center clinical trials for the NIH-sponsored Asthma Clinical Research Network. The UCSD consortium is led by Drs. Stephen Wasserman and Joe Ramsdell. Study 1 will be undertaken in stable steroid dependent asthmatic adults. It will examine the effect of etanercept, an inhibitor of TNF-alpha, in an 18-week, double-blind, placebo-controlled clinical trial in this population. The primary outcome to be evaluated will be the ability of this agent to permit significant reduction in inhaled steroid dosage without exacerbation. Study 2 will also employ a double-blind, placebo-controlled design. This trial will evaluate the ability of CPAP to improve nocturnal asthma, in a population of overweight, adult patients with moderate-to-severe asthma, who also suffer from sleep disordered breathing. Patients for these, and other Network trials, will be recruited from the Medicine, Pulmonary and Allergy clinics of UCSD, the San Diego VA, the San Diego US Naval Hospital, and Kaiser- Permanente. The available population is large, multi-racial and multi-ethnic, reflecting the San Diego environment. We are also proposing an educational program, under the direction of Dr. Andrew Ries, which will utilize the extensive resources available at UCSD.