Gulf South IPF Clinical Research Network

南海湾 IPF 临床研究网络

• 批准号: 7060000
• 负责人: Joseph A Lasky
• 金额: $ 15.28万
• 依托单位: TULANE UNIVERSITY OF LOUISIANA
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-05-01 至 2010-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7060000
• 关键词: acetylcysteine; antioxidants; clinical research; clinical trial phase III; cooperative study; dosage; drug adverse effect; drug screening /evaluation; human mortality; human therapy evaluation; idiopathic pulmonary fibrosis; kinase inhibitor; longitudinal human study; medical outreach /case finding; outcomes research; pathologic process; patient oriented research; respiratory disorder chemotherapy; respiratory function; statistics /biometry; urokinase

DESCRIPTION (provided by applicant): Idiopathic pulmonary fibrosis (IPF) is a debilitating and fatal disease for which there is no known cure. Recent epidemiologic studies have discerned that IPF is more common than previously recognized with an estimated 30,000 newly diagnosed cases in the United States yearly. There have been numerous expert reviews of late that have called our attention to the lack of evidence regarding the effectiveness of previously recommended treatment regimens that rely solely on the use of corticosteroids with or without other immunosuppressants for the treatment of IPF. It is now time to test the efficacy of novel approaches derived from decades of support from the NIH, ALA and private foundations for clinical and basic science lung fibrosis research. The overall goal of this proposal is to test the hypothesis that the most effective therapy for preventing disease progression will require multiple agents and is based on the knowledge that multiple profibrotic pathways are activated, and many antifibrotic pathways are disrupted in the lungs of patients with IPF. This application includes two proposals supported by promising preliminary data from the laboratories of the investigators and others, which involve anti-oxidant therapy using N-acetylcysteine (NAC) in combination with either imatinib mesylate (an inhibitor of platelet-derived growth factor and transforming growth factor beta signal transduction) or urokinase (a potent fibrinolytic). The investigators for this proposal have clearly demonstrated that they are capable of enrolling the number of patients required to support the proposed research mission of establishing an effective clinical IPF research network, through their past and current involvement in multi-center IPF clinical trials, as well as their establishment and conduct of an ongoing investigator-initiated IPF trial. The Gulf South Clinical Research Network combines the positive attributes of the investigators' experience in basic science and clinical lung fibrosis research with the ability to provide access to clinical IPF trials to the unique demographics of the Gulf South. (End of Abstract)

描述（由申请人提供）： 特发性肺纤维化（IPF）是一种令人衰弱的致命疾病，没有已知的治愈方法。 最近的流行病学研究表明，IPF比以前认可的更为普遍，估计在美国每年有30,000例新诊断的病例。 最近有许多专家评论，我们注意到缺乏有关先前建议的治疗方案的有效性的证据，这些治疗方案仅依赖于使用或没有其他免疫抑制剂治疗IPF的皮质类固醇。 现在是时候测试来自NIH，ALA和私人基础几十年来用于临床和基础科学肺纤维化研究的新方法的疗效。 该提案的总体目的是检验以下假设：预防疾病进展的最有效疗法将需要多种药物，并基于以下知识：多种纤维化途径被激活，并且在IPF患者的肺中破坏了许多抗纤维化途径。 该应用包括两个提案，这些建议由研究人员和其他实验室的有希望的初步数据支持，其中涉及使用N-乙酰基半胱氨酸（NAC）与伊马替尼甲伊赛酸酯（NAC）结合抗氧化治疗（NAC）（NAC）以及伊马替尼甲酸酯（imatinib celylate）（血型源性生长因子的抑制剂和生长因子β信号转导因子的抑制剂）或转化beta beta beta todinduction）或尿蛋白酶元素（毒fibriin）（一种potent fibrin）。 该提案的研究人员清楚地表明，他们能够通过过去和当前参与多中心IPF临床试验，以及他们正在进行的研究员IPF IPF试验的建立和行为来支持建立有效的临床IPF研究网络所需的患者数量。 海湾南部临床研究网络结合了研究人​​员在基础科学和临床肺纤维化研究方面的经验的积极属性，并能够为海湾南部的独特人口统计学提供临床IPF试验的访问。 （抽象的结尾）