Idiopathic Pulmonary Fibrosis Clinical Research Network

描述（由申请人提供）： 该计划的目的是：1）建立一个由6至7个临床中心组成的临床研究网络（CRN），以设计和执行多项治疗试验，用于治疗新诊断的特发性肺纤维化（称为IPF）-常见型间质性肺炎患者。 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。 这些试验可能会评估现有或新的药物、药物组合以及定义的管理策略。 威尔医学院在地理位置上准备从全国最大的纽约大都市区招募患者，并拥有成功满足该IPF CRN要求的所有必要基础设施。 我们组织了我们的中心，每年为来自众多学术中心和医院的>200名新诊断的IPF患者提供转诊。 这将为每年入组40-50例新诊断的IPF患者提供足够的患者基础。 该项目的具体目标是：1）在康奈尔大学威尔医学院/纽约长老会医院为特发性肺纤维化患者建立一个最先进的临床研究中心，2）开展随机多中心试验，以评估治疗特发性肺纤维化的新疗法。 拟议的研究包括 (a)单药：[1.雷帕霉素+2。低剂量泼尼松]对比单独的低剂量泼尼松;和（B）多种药物：[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.低剂量泼尼松]与单独的低剂量泼尼松。 (End摘要）

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)