JEFFERSON INTERACTIVE ASTHMA CLINICAL RESEARCH GROUP

杰斐逊互动哮喘临床研究小组

• 批准号: 2228760
• 负责人: James E Fish
• 金额: $ 55.81万
• 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/2228760
• 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.

该项目旨在建立一个交互式哮喘临床研究小组 托马斯·杰斐逊大学。 参与的总体目标 协作、多中心网络的核心是探索新方法 治疗哮喘并创造传播途径 从这项研究中获得的信息。 杰斐逊临床研究 集团将基于现有的综合性和多学科 哮喘研究和临床项目。 提出了两个协议 评估治疗哮喘的新方法。 第一个协议 检查秋水仙碱在严重、 类固醇依赖性哮喘。 这是一项双盲、随机、为期两年的研究 使用住院次数、就诊次数和类固醇进行研究 要求作为主要功效措施。 第二个协议是 旨在确定白三烯-D4 的抗炎潜力 受体拮抗剂和5-脂氧合酶抑制剂并确定 任一化合物是否可以作为皮质类固醇替代品。 为了 在这项研究中，哮喘的炎症成分被定义为 对支气管扩张剂治疗无反应但有反应的成分 类固醇治疗。 这是一项双盲、随机、为期十四周的研究 以肺功能、症状和其他药物使用为主要指标的研究 结果措施。 该提案的另一个目的是开发一种患者 基于临床、人口统计和实验室数据的分层方案 目的是确定最有可能患有哮喘病的亚组 从特定干预中受益并获取信息 关于疾病发病机制。 本申请的基本前提 哮喘不是一个单一的疾病学实体；相反，这是一种综合症 包括具有共同临床表现的多种疾病，但 各自独特的发病机制。 研究试图 辨别这些差异不仅对于实现更好的目标至关重要 对哮喘的认识，也增强了我们认识哮喘的能力 更新和更具体的抗哮喘药物的好处。