IPF Clinical Trial Center at Vanderbilt

范德比尔特 IPF 临床试验中心

基本信息

批准号：
7615152
负责人：
JAMES E LOYD
金额：
$ 20.48万
依托单位：
VANDERBILT UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2005
资助国家：
美国
起止时间：
2005-05-01 至 2012-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7615152
关键词：
Adverse event Award Cause of Death Chronic Clinical Clinical Research Clinical Trials Clinical Trials Data Monitoring Committees Communities Controlled Clinical Trials Data Data Coordinating Center Development Enrollment Hamman-Rich syndrome Lung Lung diseases Measures Methods National Heart, Lung, and Blood Institute Outcome Patient Care Patient Selection Patients Pharmacologic Substance Physicians Pirfenidone Placebo Control Policies Prednisone Prevalence Procedures Protocols documentation Publications Randomized Reporting Research Research Design Research Support Resources Respiratory Failure SDZ RAD Site Visit Staging Telephone Testing Therapeutic Intervention Transplantation U-Series Cooperative Agreements base capitate bone cost effectiveness design effective therapy improved meetings quality assurance randomized placebo controlled trial symposium treatment effect

项目摘要

DESCRIPTION (provided by applicant): Idiopathic Pulmonary Fibrosis (IPF) is a chronic progressive lung disease with no proven therapy. The outcome in most patients includes gradual progression of restrictive lung disease to respiratory failure in half the patients within a period of 3-5 years. Estimates for prevalence suggest that there are 100,000 patients in the US with IPF, and it is the commonest cause of death among patients awaiting lung transplant for end-stage lung disease. Many available pharmaceutical agents have actions which would predict improved outcomes in IPF but have not been tested in patients. It is crucial that well-designed, multi-center, randomized, placebo-controlled trials be conducted promptly to examine whether an effective therapy for IPF can be identified. We plan to determine the effects of treatment of IPF with everolimus in a multi-center, randomized, placebo-controlled clinical trial which will enroll 240 IPF patients. In a subsequent trial of 360 IPF patients, we will determine the effects of treatment of IPF with prednisone or pirfenidone, or both, in a multi-center, randomized, placebo-controlled clinical trial. Finally, we will participate fully as a clinical center in all of the multi-center, randomized, placebo-controlled trials as directed by the Steering Committee of the IPF Clinical Research Network. (End of Abstract)

描述（由申请人提供）：特发性肺纤维化（IPF）是一种慢性进行性肺部疾病，没有良好的治疗。大多数患者的结果包括在3 - 5年内逐步发展限制性肺疾病到一半患者的呼吸衰竭。患病率的估计表明，美国有100,000名患者患有IPF，这是等待肺部末期肺部疾病的肺移植的患者中最常见的死亡原因。许多可用的药物具有行动，可以预测IPF的预后改善，但尚未在患者中进行测试。至关重要的是，精心设计，多中心，随机，安慰剂对照试验进行迅速进行，以检查是否可以确定有效的IPF疗法。我们计划在多中心，随机，安慰剂对照的临床试验中确定IPF治疗的影响，该试验将招募240名IPF患者。在随后对360名IPF患者的试验中，我们将确定IPF用泼尼松或吡啶酮治疗的影响，或在多中心，随机的，安慰剂对照的临床试验中两者兼而有之。最后，我们将按照IPF临床研究网络指导委员会指示的所有多中心，随机，安慰剂对照试验的所有多中心。（抽象的结尾）