TO EVALUATE ANTI-INFLAMMATORY AGENTS IN PATIENTS WITH CYSTIC FIBROSIS

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。这项研究是一项三臂、多中心、随机、开放对照、平行分组试验，比较布洛芬、塞来昔布或不治疗28天对患有轻中度囊性纤维化(CF)的10岁受试者诱导痰中炎症标志物的影响。这项研究将测量慢性阻塞性肺疾病患者在使用布洛芬或塞来昔布治疗前(基准期)、治疗期间和(恢复期)治疗前(基准期)、治疗期间和(恢复期)后获得的诱导痰中下呼吸道炎症标志物的变化，并将这些变化与未接受抗炎治疗的对照组进行比较。纳入NO治疗组的目的是确定对通过痰诱导(SI)获得的样本进行的测量的可变性，并作为布洛芬和塞来昔布治疗组的对照组。这项研究的主要目的是了解SI被证明是一种可行的方法来衡量抗炎药在轻到中度CF患者中的有效性。第二个目的是确定抗炎剂塞来昔布的益处--这种药物在肺循环中的抗炎特性是否与布洛芬相似。第三，数据银行是该协议的一个辅助组成部分。在参与者同意的情况下，参与者的医疗保健信息将被输入研究数据库。来自参与治疗发展网络(TDN)的所有中心的数据将从这项研究中收集数据，供以后使用。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This study is a three-arm, multicenter, randomized, open-label, controlled, parallel-group trial comparing the effects of 28 days of Ibuprofen, Celecoxib, or no treatment on inflammatory markers in induced sputum obtained from subjects, > to age 10, with mild to moderate cystic fibrosis (CF). This study will measure changes in markers of lower airway inflammation in samples of induced sputum obtained before (Baseline Period), during (Treatment Period), and after (Recovery Period) treatment with Ibuprofen or Celecoxib in subjects with CF, and compare these changes with those observed in a control group of CF subjects who receive no anti-inflammatory treatment. The purpose for including the no treatment group is to define the variability of measurements performed on samples obtained by Sputum Induction (SI) and to serve as a control group for the Ibuprofen and Celecoxib treatment arms. The primary purpose of this study is to access that an SI proves to be a viable method of measuring the effectiveness of anti-inflammatory agents in patients with mild to moderate CF. The secondary purpose is to determine the benefit of the anti-inflammatory agent, Celecoxib -- Whether this drug's anti-inflammatory properties in the CF lung are similar to those of Ibuprofen. Third, data banking is an ancillary component of this protocol. Upon the particpant's consent, health care information about the participant will be entered into a study database. Data from all centers participating in the Therapeutic Development Network (TDN) will be collecting data from this study to be used at a later time.