ASTHMA CLINICAL RESEARCH NETWORK

哮喘临床研究网络

• 批准号: 6183435
• 负责人: Robert F Lemanske
• 金额: $ 66.73万
• 依托单位: UNIVERSITY OF WISCONSIN-MADISON
• 依托单位国家: 美国
• 财政年份: 1993
• 资助国家: 美国
• 起止时间: 1993-09-30 至 2003-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6183435
• 关键词: albuterol; antiinflammatory agents; asthma; beta adrenergic agent; bronchodilators; clinical research; clinical trials; colchicine; cooperative study; corticosteroids; dosage; drug screening /evaluation; human subject; human therapy evaluation; information dissemination; inhalation drug administration; leukotrienes; patient care management; pharmacogenetics; respiratory disorder chemotherapy

This application proposes to continue the participation of investigators at the University of Wisconsin in an interactive network of six centers in the U.S. (the Asthma Clinical Research Network or ACRN ) in conducing studies of novel therapeutic approaches to asthma and in disseminating findings to the practicing community. The need for such a network was suggested by epidemiological data showing increases in the mortality, morbidity, prevalence, and costs of asthma, by clinical and basic research studies showing that asthma is linked to inflammation in the airways, and by the accelerating rate of development of potentially highly effective, but also potentially costly treatments for asthma. Defining the place of these new therapies was seen as requiring collaborative, multi-center studies examining large numbers of subjects reflecting the diversity of the U.S. population. In its first 5 years, the ACRN established an interactive infrastructure to meet this need and has added a research site at Harlem Hospital in New York, which serves a predominantly minority population. The ACRN completed and published trials of the effects of regular use of a beta-agonist in subjects with mild asthma ( BAGS ) and of the efficacy of the anti-inflammatory agent, colchicine, as an alternate to an inhaled corticosteriod in moderate asthma. It is now conducting two additional trials comparing these effects of a long-acting beta-agonist, an inhaled corticosteriod, and the combination of the two in altering clinical and physiologic outcomes, and airway inflammation in moderate or severe asthma. A fifth study, establishing doses of different inhaled corticosteriods with equivalent effects on cortisol secretion, is about to be started. The trials completed have been presented at the ATS, ACCP, and AAAAI, as have been nearly a dozen ancillary studies designed to improve the performance of clinical research. Of these studies, three have so far been published in peer-reviewed journals. The ACRN has also reported, and is submitting for publication, the results of a subgroup analysis of subjects in the BAGS study showing that subjects with different genotypes for the beta-adrenergic receptor are differently affected by regular use of albuterol. This application specifically proposes continued participation of the University of Wisconsin Asthma Clinical Research group in the multicentered, collaborative trials of the ACRN. The studies proposed include a comparison of the clinical efficacy of doses of different inhaled corticosteriods with equal systemic effects (as estimated from the study described above), a prospective study of the effects of regular use of an inhaled beta-agonist in subjects stratified by genotype for the beta-adrenergic receptor, a study analyzing the efficacy of a leukotriene pathway antagonist in enabling reduction or elimination of inhaled corticosteriod therapy in subjects with mild or moderate persistent asthma, and other studies illustrated briefly in this application, but modified or replaced by the ACRN Steering Committee in response to new information or the release of new forms of therapy.

这项申请建议继续调查人员的参与 在威斯康星大学由六个中心组成的互动网络中 在美国(哮喘临床研究网络或ACRN) 开展哮喘和癌症的新治疗方法的研究 向执业社区传播调查结果。对这样的需求 流行病学数据表明，这是一个网络，显示出 哮喘的死亡率、发病率、患病率和成本，按临床和 基础研究表明哮喘与炎症有关 航空公司，以及潜在的发展速度的加快 治疗哮喘非常有效，但也可能代价高昂。 确定这些新疗法的位置被视为需要 检查大量受试者的协作性多中心研究 反映了美国人口的多样性。在最初的5年里， ACRN建立了一个互动基础设施来满足这一需求并 在纽约哈莱姆医院增加了一个研究网站，该网站为 以少数族裔为主的人口。ACRN完成并出版 常规使用β-受体激动剂对慢性阻塞性肺疾病患者影响的试验 轻度哮喘(袋)和抗炎剂的疗效， 秋水仙碱，作为吸入性皮质类固醇的替代药物 哮喘。它现在正在进行另外两项试验，比较这些 长效β-激动剂、吸入皮质类固醇和 二者在改变临床和生理方面的结合 结果，以及中度或重度哮喘的呼吸道炎症。五分之一 研究确定不同吸入皮质类固醇药物的剂量 对皮质醇分泌具有同等效果的研究即将开始。这个 已完成的试验已在ATS、ACCP和AAAAI上提交，如 已经进行了近12项辅助研究，旨在改善 临床研究的绩效。在这些研究中，到目前为止有三项 发表在同行评议的期刊上。ACRN还报道说， 正在提交一份亚组分析的结果供出版 在袋子里的受试者的研究表明，不同的受试者 β-肾上腺素能受体的基因型别受 经常使用沙丁胺醇。该应用程序特别提出了 威斯康星大学哮喘临床中心的持续参与 参与ACRN的多中心协作试验的研究小组。 建议的研究包括对两种药物的临床疗效进行比较。 全身作用相同的不同剂量吸入糖皮质激素 (根据上述研究估计)，一项前瞻性研究 吸入性β-受体激动剂的常规使用对受试者的影响 一项按β-肾上腺素能受体基因分型的研究 一种白三烯途径拮抗剂使能的疗效分析 受试者吸入糖皮质激素治疗的减少或取消 患有轻度或中度持续性哮喘，其他研究表明 在本申请中简要介绍，但由ACRN修改或取代 指导委员会回应新信息或发布新的 各种形式的治疗。