Idiopathic Pulmonary Fibrosis Clinical Research Network

描述(由申请人提供)： 特发性肺纤维化(IPF)是一种进行性肺部疾病，通常会导致呼吸衰竭和死亡，确诊后中位生存期为三年。最近的研究表明，由皮质类固醇和细胞毒剂组成的传统疗法在提高存活率方面无效。目前还没有有效的治疗方法来治疗这种疾病。在IPF发病机制的基础研究和新型治疗药物的开发方面的最新进展增加了在评估新的治疗策略方面对合作临床研究网络的需求。一个长期对IPF感兴趣并有良好记录的临床研究小组(梅奥间质性肺病小组)建议在梅奥诊所建立一个临床中心，以参与NIH资助的IPF临床研究网络，以进行协作治疗试验。这些临床研究人员和他们在肺部临床研究中心的研究人员在招募和保留IPF和其他肺部疾病的临床试验受试者方面拥有相当丰富的经验。这个临床中心提出了两项治疗研究，供网络考虑。第一项研究将考察伊马替尼和己酮可可碱联合方案与安慰剂治疗IPF的效果。第二个项目将研究秋水仙素和N-乙酰半胱氨酸联合治疗与安慰剂治疗的效果。为了进行这些和其他IPF临床研究网络研究，这个临床中心将从每年在梅奥诊所罗切斯特看到的200-250名IPF新患者中挑选出来。梅奥间质性肺病诊所登记和计算机化的数据库将允许识别和参与以前在该临床中心看到的其他IPF受试者。该临床中心还将接触到在梅奥诊所杰克逊维尔(FL)和梅奥诊所斯科茨代尔(AZ)看到的其他潜在参与者。(摘要结束)

DESCRIPTION (provided by applicant): Idiopathic pulmonary fibrosis (IPF) is a progressive lung disease that commonly results in respiratory failure and death with a median survival of three years after diagnosis. Recent studies demonstrate traditional therapy consisting of corticosteroids and cytotoxic agents to be ineffective in improving survival. There is currently no effective treatment for this disorder. Recent advances in basic research on the pathogenesis of IPF and the development of novel therapeutic agents have increased the need for a cooperative clinical research network in evaluating new management strategies. An established group of clinical investigators (Mayo Interstitial Lung Disease Group) with a longstanding interest and track record in IPF proposes the development of a clinical center at Mayo Clinic to participate in the NIH-funded IPF Clinical Research Network for conducting collaborative therapeutic trials. These clinical investigators and their research staff of the Pulmonary Clinical Research Center have considerable experience in recruitment and retention of subjects for clinical trials in IPF and other lung diseases. This clinical center proposes two treatment studies for consideration by the network. The first study will examine the effects of combined imatinib and pentoxifylline regimen compared to placebo in the treatment of IPF. The second project will study the effects of combined colchicines and N-acetylcysteine therapy compared to placebo. To conduct these and other IPF Clinical Research Network studies, this clinical center will draw from 200-250 new patients with IPF seen each year at Mayo Clinic Rochester. The Mayo Interstitial Lung Disease Clinic registry and computerized databases will allow identification and participation of other subjects with IPF previously seen at this clinical center. This clinical center will also have access to other potential participants seen at Mayo Clinic Jacksonville (FL) and Mayo Clinic Scottsdale (AZ). (End of Abstract)