Idiopathic Pulmonary Fibrosis Clinical Research Network

描述(由申请人提供)： 这项计划的目的是：1)建立一个由6到7个临床中心组成的临床研究网络(CRN)，为新诊断的特发性肺纤维化(IPF)--一种常见的间质性肺炎--的患者设计和进行多种治疗试验。该CRN将为以相对速度和效率进行多个协作治疗试验创建基础设施。这些试验可以评估现有的或新的药物、药物的组合，以及确定的管理策略。威尔医学院在地理上准备从美国最大的纽约大都会地区招收患者，并拥有成功实现IPF CRN要求的所有必要基础设施。我们组织了我们的中心，每年从众多学术中心和医院为200名新诊断的IPF患者提供转诊。这将提供一个充足的患者基础，每年从这些患者中招募40-50名新诊断的IPF患者参加治疗试验。该项目的具体目标是：1)在康奈尔大学/纽约长老会医院的威尔医学院为特发性肺纤维化患者建立一个最先进的临床研究研究中心；2)开发随机多中心试验，以评估治疗特发性肺纤维化的新疗法。建议进行的研究包括 (A)单药：[1.雷帕霉素+2.小剂量泼尼松]与单用小剂量强的松；以及(B)多药：[1.血管紧张素转换酶抑制剂(ACE-I)+2.3-羟基-3-甲基戊二酰辅酶A还原酶抑制剂(他汀类)+3.小剂量强的松]与单用小剂量强的松。(摘要结束)

DESCRIPTION (provided by applicant): The purpose of this initiative is to: 1) establish a Clinical Research Network (CRN) of 6 to 7 clinical centers to design and perform multiple therapeutic trials for treatment of patients with newly diagnosed idiopathic pulmonary fibrosis (termed IPF) - usual interstitial pneumonia variety. This CRN will create the infrastructure for conducting multiple, collaborative therapeutic trials with relative speed and efficiency. These trials may evaluate existing or new medications, combinations of medications, and defined management strategies. Weill Medical College is geographically poised to recruit patients from the New York metropolitan area, the largest in the country, and has all the necessary infrastructure to successfully carry out the requirements of this IPF CRN. We have organized our center to provide referral of >200 newly diagnosed IPF patients per year from numerous academic centers and hospitals. This will provide an adequate patient base from which to enroll 40-50 newly diagnosed IPF patients per year into therapeutic trials. The specific aims of the project are: 1) to develop a center for state-of-the-art clinical research studies for patients with idiopathic pulmonary fibrosis at Weill Medical College of Cornell University/New York Presbyterian Hospital, and 2) to develop randomized multi-center trials to evaluate new therapies for treatment of idiopathic pulmonary fibrosis. The studies proposed are (a) single drug: [1. rapamycin + 2. low dose prednisone] vs. low dose prednisone alone; and (b) multi-drug: [1. angiotensin converting enzyme inhibitor (ACE-I) + 2.3-hydroxy-3-methylglutaryl co-enzyme A reductase inhibitor (statin) + 3. low dose prednisone] vs. low dose prednisone alone. (End of Abstract)