ASTHMA CLINICAL RESEARCH NETWORK

哮喘临床研究网络

• 批准号: 6056270
• 负责人: James E Fish
• 金额: $ 61.17万
• 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/6056270
• 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.

这份申请书提议继续让调查人员参与 在托马斯杰斐逊大学的六个中心的互动网络中， (the哮喘临床研究网络或ACRN）进行研究 新的哮喘治疗方法， 实践社区。有人提出需要这样一个网络 流行病学数据显示，死亡率、发病率、 哮喘的患病率和费用，通过临床和基础研究 表明哮喘与气道炎症有关， 加快发展速度的潜在有效，而且 治疗哮喘的潜在成本。 定义这些地方 治疗被视为需要合作，多中心研究 研究大量反映美国多样性的主题。 人口 在最初的5年里，ACRN建立了一个基础设施， 这种需要，并增加了另一个中心在哈莱姆医院在纽约， 主要服务于少数民族人口。 ACRN已经 已完成的关于经常使用β-激动剂对轻度 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 现在正在进行另外两项试验， 一种长效β-受体激动剂，一种吸入性皮质类固醇， 两者的结合改变了临床和生理结果， 和中度或重度哮喘的气道炎症。 第五项研究， 确定不同吸入性皮质类固醇的剂量， 对皮质醇分泌的影响，迫在眉睫。 已完成的审判 作为10-12项辅助研究，旨在提高 临床研究已经在ATS、ACCP和 AAAAI。 其中三项研究已发表在《同行》杂志上。 审查期刊。 ACRN还报告了一个小组的结果， BAGS研究中受试者的分析显示， β-肾上腺素能受体的不同基因型 受沙丁胺醇的影响 这项申请建议继续参与杰斐逊 ACRN的多中心协作试验中心。 提出 研究包括比较不同剂量的 吸入性皮质类固醇具有相同的全身效应（根据 上述研究），一项前瞻性研究， 受试者中定期使用吸入性β-受体激动剂的情况，按以下因素分层 β-肾上腺素能受体的基因型，以及对 白三烯途径拮抗剂在减少或消除 吸入性皮质类固醇在轻度或中度持续性 哮喘 还简要讨论了其他计划中的研究， 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优先事项。