ASTHMA CLINICAL RESEARCH NETWORK

哮喘临床研究网络

• 批准号: 6183449
• 负责人: Jean Guillaume Ford
• 金额: $ 83.74万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 1995
• 资助国家: 美国
• 起止时间: 1995-12-08 至 2003-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6183449
• 关键词: albuterol; antiinfective agents; asthma; beta adrenergic agent; beta adrenergic receptor; 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 New York City Center in an interactive network of six centers, the Asthma Clinical Research Network (ACRN) in conducting studies of novel therapies for asthma and in disseminating findings to the practicing community. The need for such a network was suggested by increases in the mortality, morbidity, prevalence, and costs of asthma, by research studies showing that asthma is linked to airway inflammation, and by the accelerating rate of development of potentially effective, but also potentially costly treatments. Defining the place of these new therapies was seen as requiring collaborative, multi-center studies examining subjects reflecting the diversity of the U.S. population. In its first 5 years, the ACRN established an interactive infrastructure and added a research site at Harlem Hospital, 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 mild asthma ( BAGS ) and of the efficacy of colchicine as an alternate to an inhaled corticosteroid (ICS) in moderate asthma. It is now conducting trials comparing a long-acting beta-agonist, an ICS, and the combination of the two in moderate to severe asthma. We are about to start a 5th study to establish doses of different ICS with equivalent effects on cortisol secretion. These studies have been presented at meetings of the ATS, ACCP, and AAAAI, as have 10-12 ancillary studies analyzing the performance of clinical research. The ACRN has also reported its findings from subgroup analysis of the BAGS study: 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 NYC 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, a prospective study of regular use of an inhaled beta- agonist in subjects stratified by genotype for the beta-adrenergic receptor, a study of 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.

这份申请书提议继续让调查人员参与 在纽约市中心的六个中心的互动网络中， 哮喘临床研究网络（ACRN）进行研究， 哮喘的新疗法，并将研究结果传播给 实践社区。 有人建议建立这样一个网络， 哮喘的死亡率、发病率、患病率和费用增加， 研究表明哮喘与气道有关， 炎症，并通过潜在的发展速度加快 有效，但也可能昂贵的治疗。 定义地点 这些新疗法被视为需要协作，多中心， 研究反映美国多样性的主题。 人口 在最初的5年里，ACRN建立了一个互动的 基础设施，并在纽约的哈莱姆医院增加了一个研究地点， 主要服务于少数民族人口。 ACRN完成 并发表了关于定期使用β-激动剂的影响的试验， 轻度哮喘（BAGS）和秋水仙碱作为替代药物的疗效 吸入性皮质类固醇（ICS）治疗中度哮喘。 现在 进行试验比较长效β-激动剂，ICS和 在中度至重度哮喘中，两者联合使用。 我们即将 开始第5项研究，以确定不同ICS的剂量， 对皮质醇分泌的影响 这些研究报告已在 ATS、ACCP和AAAAI的会议，以及10-12项辅助研究 分析临床研究的绩效。 ACRN还 报告了BAGS研究亚组分析的结果： 具有不同β-肾上腺素能受体基因型的受试者是 不同的影响定期使用沙丁胺醇。 本申请建议继续参与纽约哮喘 临床研究小组在多中心，合作试验， ACRN。 拟议的研究包括比较临床 不同剂量吸入皮质类固醇激素的疗效 全身效应，一项定期使用吸入性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，一项关于白三烯通路拮抗剂功效的研究 能够减少或消除吸入皮质类固醇治疗 在轻度或中度持续性哮喘受试者中，以及其他研究 在本申请中简要地示出，但是被修改或替换， ACRN指导委员会对新信息或新闻稿的回应 新形式的治疗。