TO EVALUATE ANTI-INFLAMMATORY AGENTS IN PATIENTS WITH CYSTIC FIBROSIS

评估囊性纤维化患者的抗炎药物

• 批准号: 7375258
• 负责人: RICHARD Barry MOSS
• 金额: $ 0.27万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7375258
• 关键词: EVALUATE; ANTI; INFLAMMATORY; AGENTS; PATIENTS

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.

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。所列机构为中心机构，不一定为研究者机构。本研究是一项三臂、多中心、随机、开放标签、对照、平行组试验，比较了28天的伊曲康、塞来昔布或不治疗对诱导痰中炎症标志物的影响，诱导痰来自年龄> 10岁的轻度至中度囊性纤维化（CF）受试者。 本研究将测量CF受试者接受伊曲康或塞来昔布治疗前（基线期）、治疗期间（治疗期）和治疗后（恢复期）采集的诱导痰样本中下气道炎症标志物的变化，并将这些变化与未接受抗炎治疗的CF受试者对照组中观察到的变化进行比较。纳入无治疗组的目的是定义对痰液诱导（SI）获得的样本进行测量的变异性，并作为伊立替康和塞来昔布治疗组的对照组。 本研究的主要目的是评估SI被证明是一种测量轻度至中度CF患者抗炎药物有效性的可行方法。第二个目的是确定抗炎药塞来昔布的益处--这种药物在CF肺中的抗炎特性是否与Iceloxib相似。第三，数据银行是该协议的辅助组成部分。在受试者同意后，将有关受试者的医疗保健信息输入研究数据库。将从参与治疗开发网络（TDN）的所有中心收集本研究的数据，以便在以后使用。