ASTHMA CLINICAL RESEARCH NETWORK

哮喘临床研究网络

• 批准号: 6097233
• 负责人: Jeffrey Mark Drazen
• 金额: $ 7.2万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 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/6097233
• 关键词: albuterol; antiinflammatory agents; asthma; beta adrenergic agent; bronchodilators; clinical research; clinical trials; colchicine; cooperative study; corticosteroids; dosage; drug screening /evaluation; enzyme inhibitors; human subject; human therapy evaluation; information dissemination; inhalation drug administration; leukotrienes; lipoxygenase; patient care management; pharmacogenetics; respiratory disorder chemotherapy

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.

此申请是为了继续进行哮喘临床研究 网络或ACRN。 ACRN是一个由6项研究组成的互动网络， 研究新的哮喘治疗方法的中心。 流行病学数据表明需要建立这样一个网络 显示死亡率，发病率，患病率和成本的增加， 哮喘，临床和基础研究表明，哮喘是 与呼吸道炎症有关， 开发潜在的高效，但也可能昂贵的 哮喘的新疗法 定义这些新疗法的地位 被视为需要协作的多中心研究， 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， 人口 ACRN完成并发表了关于 在轻度哮喘（BAGS）受试者中定期使用β受体激动剂， 抗炎剂秋水仙碱作为一种 在中度哮喘中替代吸入性皮质类固醇。 现在 进行另外两项试验，比较长效 β-激动剂、吸入性皮质类固醇以及两者的组合 在改变临床结果、生理结果和气道 中度或重度哮喘的炎症。 第五项研究，建立 不同剂量的吸入皮质类固醇具有相同的作用， 皮质醇分泌即将开始来自已完成试验的数据， 以及相关的辅助研究，已在全国会议上提交 ATS、ACCP和AAAAI。 该应用程序特别概述了ACRN的目标， 未来五年 建议的研究包括：1）比较 不同剂量吸入皮质类固醇激素的临床疗效 等同的全身效应（根据上述研究估计）， 2)一项关于定期使用吸入性β- 按β-肾上腺素能受体基因型分层的受试者中的激动剂 受体，3）一项分析白三烯途径功效的研究 能够减少或消除吸入的拮抗剂 皮质类固醇治疗轻度或中度持续性 哮喘;以及4）其他6项研究，其中3项将被选择用于 在未来五年内执行。 将考虑其他研究 如果有新的信息表明需要增加 审判