JEFFERSON INTERACTIVE ASTHMA CLINICAL RESEARCH GROUP

杰斐逊互动哮喘临床研究小组

• 批准号: 3560416
• 负责人: James E Fish
• 金额: $ 35.73万
• 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 1998-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3560416
• 关键词: antiinflammatory agents; asthma; bronchodilators; clinical trials; colchicine; cooperative study; enzyme inhibitors; human subject; human therapy evaluation; leukotrienes; lipoxygenase; patient care management; respiratory disorder chemotherapy

This seeks to establish an interactive asthma clinical research group at Thomas Jefferson University. The overall goal of participating as part of a collaborative, multi-centered network is to explore novel approaches to the treatment of asthma and to create avenues for disseminating information gained from this research. The Jefferson Clinical Research Group would be based on existing comprehensive and multi-disciplinary research and clinical programs in asthma. Two protocols are proposed to evaluate novel approaches to the treatment of asthma. The first protocol examines the effects of colchicine in the long-term management of severe, steroid-dependent asthma. This is a double-blind, randomized, two-year study using numbers of hospitalizations, doctors' visits, and steroid requirements as primary efficacy measures. The second protocol is designed to define the anti-inflammatory potential of a leukotriene-D4 receptor antagonist and a 5-Lipoxygenase inhibitor and to determine whether either compound can serve as a corticosteroid substitute. For this study, the inflammatory component of asthma is defined as that component which is unresponsive to bronchodilator therapy, but responsive to steroid therapy. This is a double-blind, randomized fourteen-week study using pulmonary function, symptoms, and other drug use as primary outcome measures. A further aim of this proposal is to develop a patient stratification scheme based on clinical, demographic, and laboratory data with the goal of identifying subgroups of asthmatics who are most likely to benefit from a specific intervention and also to gain information regarding disease pathogenesis. The basic premise of this application is that asthma is not a single nosologic entity; rather, it is a syndrome comprising multiple disorders having common clinical manifestations but their own distinct pathogenetic mechanisms. Studies attempting to discern these differences are critical not only to achieve a better understanding of asthma, but also to enhance our ability to recognize the benefits of newer and more specific antiasthmatic agents.

这寻求建立一个互动的哮喘临床研究小组，地址为 托马斯·杰斐逊大学。作为一部分参与的总体目标 合作、多中心网络的关键是探索新的方法 治疗哮喘，并建立传播途径 从这项研究中获得的信息。杰斐逊临床研究 该小组将以现有的综合性和多学科为基础 哮喘的研究和临床项目。提出了两个协议来 评估治疗哮喘的新方法。第一个协议 探讨秋水仙碱在重症急性胰腺炎长期治疗中的作用。 类固醇依赖型哮喘。这是一项双盲、随机、为期两年的 使用住院次数、医生就诊次数和类固醇的研究 要求作为主要的疗效衡量标准。第二个协议是 用于确定白三烯-D4的抗炎潜力 受体拮抗剂和5-脂氧合酶抑制剂的测定 其中一种化合物是否可以作为皮质类固醇的替代品。为 在本研究中，哮喘的炎症成分被定义为 对支气管扩张剂治疗无效，但有效的成分 去接受类固醇治疗。这是一个双盲、随机的14周 以肺功能、症状和其他药物使用为主要指标的研究 结果衡量标准。这项提议的另一个目的是培养一名患者 基于临床、人口统计学和实验室数据的分层方案 目标是确定哮喘患者亚群中最有可能 为了从特定的干预中受益，也为了获得信息 关于疾病的发病机制。这个应用程序的基本前提是 哮喘不是单一的病因学实体；相反，它是一种综合征 包括具有共同临床表现的多种疾病，但 它们各自独特的致病机制。一些研究试图 认清这些差异不仅对于实现更好的 了解哮喘，也是为了增强我们认识哮喘的能力 新的和更具体的抗哮喘药物的好处。