ASTHMA CLINICAL RESEARCH NETWORK

本申请是哮喘临床研究的延续。 网络或ACRN。ACRN是一个由6个研究人员组成互动网络 开展哮喘新治疗方法研究的中心。 流行病学数据表明有必要建立这样一个网络。 显示出死亡率、发病率、流行率和成本的增加 哮喘，通过临床和基础研究表明哮喘是 与呼吸道的炎症有关，并与加速的 开发可能非常有效，但也可能代价高昂的 治疗哮喘的新疗法。定义这些新疗法的位置 被认为需要合作的、多中心的研究 大量的主题反映了美国的多样性。 人口。在最初的5年里，ACRN建立了一个互动的 基础设施以满足这一需求，并增加了一个临床研究网站 在纽约的哈莱姆医院，该医院主要为少数族裔提供服务 人口。ACRN完成并发表了关于 轻度哮喘患者常规使用β-受体激动剂(包)和 抗炎药秋水仙碱作为一种 中度哮喘可替代吸入皮质类固醇。现在是时候了 进行两项额外的试验，比较长效 β-激动剂，一种吸入皮质类固醇，以及两者的组合 在改变临床结果、生理结果和呼吸道方面 中度或重度哮喘的炎症。第五项研究，建立 不同剂量吸入皮质类固醇对小鼠的影响 皮质醇分泌，即将开始。来自已完成试验的数据， 和相关的辅助研究，已在全国会议上提交 ATS、ACCP和AAAAI。 本申请特别概述了ACRN在 接下来的五年。建议的研究包括：1)比较 不同剂量吸入糖皮质激素的临床疗效观察 同等的系统影响(如上所述的研究估计)， 2)一项关于经常使用吸入性贝塔的效果的前瞻性研究- 按β-肾上腺素能基因分层的受试者中的激动剂 受体，3)一项分析白三烯途径有效性的研究 能够减少或消除吸入药物的拮抗剂 轻、中度持续性疾病患者的糖皮质激素治疗 哮喘；以及4)其他6项研究，其中3项将被选为 在接下来的五年里执行。我们会考虑其他研究。 如果有新的信息表明需要额外的 审判。

This application is for the continuation of the Asthma Clinical Research Network or ACRN . The ACRN is an interactive network of 6 research centers conducting studies of novel therapeutic approaches to asthma. 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 novel 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 clinical 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 the effects of a long-acting beta-agonist, an inhaled corticosteriod, and the combination of the two in altering clinical outcomes, 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. Data from completed trials, and associated ancillary studies, has been presented at national meeting to the ATS, ACCP, and AAAAI. This application specifically outlines the goals of the ACRN over the next five years. The studies proposed include: 1) A comparison of the clinical efficacy of doses of different inhaled corticosteriods with equal systemic effects (as estimated from the study described above), 2) A prospective study of the effects of regular use of an inhaled beta- agonist in subjects stratified by genotype for the beta-adrenergic receptor, 3) 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 4) six other studies from which 3 will be chosen for execution during the next five years. Other studies will be considered if new information becomes available suggesting the need for additional trials.