ASTHMA CLINICAL RESEARCH NETWORK

哮喘临床研究网络

• 批准号: 2605555
• 负责人: James E Fish
• 金额: $ 66.5万
• 依托单位: THOMAS JEFFERSON UNIVERSITY
• 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/2605555
• 关键词: antiinflammatory agents; asthma; beta adrenergic agent; beta adrenergic receptor kinase; 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 Thomas Jefferson University in an interactive network of six centers (the Asthma Clinical Research Network or ACRN ) in conducting 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 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 effective, but also potentially costly treatments for asthma. Defining the place of these 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 infrastructure to meet this need and has added another center at Harlem Hospital in New York, which serves a predominantly minority population. The ACRN has completed studies of the effects of regular beta-agonist use in mild asthma ( BAGS ) and of the efficacy of the anti-inflammatory agent, colchicine, as an alternative to an inhaled corticosteroid in moderate asthma. Now underway are two additional trials comparing the 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 corticosteroids with equivalent effects on cortisol secretion, is imminent. Completed trials as well as 10-12 ancillary studies designed to improve the performance of clinical research have been presented at meetings of the ATS, ACCP, and AAAAI. Three of these studies have thus far been published in peer- reviewed journals. The ACRN has also reported 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 proposes continued participation of the Jefferson Center in the multicentered, collaborative trials of the ACRN. Proposed studies include a comparison of the 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, and a study of the efficacy of a leukotriene pathway antagonist in enabling reduction or elimination of inhaled corticosteriods in subjects with mild or moderate persistent asthma. Other planned studies are also briefly discussed, with the understanding that they could be modified or replaced in response to new information, new therapies, or changing clinical research priorities.

本申请建议研究者继续参与 托马斯杰斐逊大学的六个中心的互动网络 （哮喘临床研究网络或 ACRN ）进行研究 哮喘的新治疗方法和传播研究结果 到实践社区。有人建议需要这样一个网络 流行病学数据显示死亡率、发病率增加， 临床和基础研究显示哮喘的患病率和费用 表明哮喘与气道炎症有关，并且 加速潜在有效的开发速度，而且 治疗哮喘的费用可能很高。 定义这些的位置 治疗被认为需要协作、多中心研究 研究反映美国多样性的大量主题 人口。 在其成立的头 5 年里，ACRN 建立了基础设施来满足 为了满足这一需求，我们在纽约哈莱姆医院增加了另一个中心， 主要服务于少数民族人口。 ACRN 有 已完成定期使用 β 激动剂对轻度患者的影响研究 哮喘（ BAGS ）和抗炎剂的功效， 秋水仙碱，作为中度吸入性皮质类固醇的替代品 哮喘。 目前正在进行另外两项比较效果的试验 长效β受体激动剂、吸入皮质类固醇和 两者结合改变临床和生理结果， 以及中度或重度哮喘的气道炎症。 第五项研究， 确定不同吸入皮质类固醇的剂量与等效剂量 对皮质醇分泌的影响迫在眉睫。 也完成了试验 作为 10-12 项旨在提高性能的辅助研究 临床研究已在 ATS、ACCP 和 AAAAI。 其中三项研究迄今已发表在同行杂志上 审阅期刊。 ACRN 还报告了一个小组的结果 BAGS 研究中的受试者分析表明，患有 不同基因型的β-肾上腺素受体的作用不同 受到经常使用沙丁胺醇的影响。 该申请建议杰斐逊继续参与 ACRN 多中心协作试验中心。 建议的 研究包括比较不同剂量的功效 吸入皮质类固醇具有相同的全身效应（根据估计 上述研究），一项关于影响的前瞻性研究 定期使用吸入性β受体激动剂分层受试者 β-肾上腺素能受体的基因型及其功效研究 白三烯途径拮抗剂在减少或消除中的作用 轻度或中度持续性受试者吸入皮质类固醇的研究 哮喘。 还简要讨论了其他计划的研究， 了解它们可以根据新的情况进行修改或替换 信息、新疗法或不断变化的临床研究重点。