...
  • 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>COPD: Journal of Chronic Obstructive Pulmonary Disease >A randomised, placebo-controlled, dose-finding study of AZD9668, an oral inhibitor of neutrophil elastase, in patients with chronic obstructive pulmonary disease treated with tiotropium
【24h】

A randomised, placebo-controlled, dose-finding study of AZD9668, an oral inhibitor of neutrophil elastase, in patients with chronic obstructive pulmonary disease treated with tiotropium

机译：噻托溴铵治疗的慢性阻塞性肺疾病患者中性粒细胞弹性蛋白酶的口服抑制剂AZD9668的随机，安慰剂对照剂量寻找研究

获取原文
获取原文并翻译 | 示例
   

获取外文期刊封面封底 >>

       
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

AZD9668 is a fully reversible, selective, oral inhibitor of neutrophil elastase, a protease implicated in chronic obstructive pulmonary disease (COPD). Efficacy, safety and tolerability of AZD9668 (5, 20 and 60 mg bid) were compared with placebo in a randomised, double-blind, placebo-controlled, 12-week, Phase IIb trial (NCT00949975: approved by an Investigational Review Board), in patients with symptomatic COPD receiving maintenance tiotropium. The primary endpoint was pre-bronchodilator forced expiratory volume in 1 second (FEV 1). Secondary endpoints included forced vital capacity and inspiratory capacity, peak expiratory flow, Breathlessness, Cough and Sputum Scale score, exercise capacity, quality of life (QoL), exacerbation assessments, safety and pharmacokinetics. Exploratory endpoints included inflammatory and tissue degradation biomarkers. A total of 838 patients were randomised to AZD9668 5 mg bid (212 patients), 20 mg bid (206 patients), 60 mg bid (202 patients) or placebo (218 patients). AZD9668 showed no effect on lung function, respiratory signs and symptoms, QoL or biomarkers. At end of treatment, the change in mean pre-bronchodilator FEV 1 for AZD9668 60 mg bid compared with placebo was 0.00L (95% confidence interval: -0.05, 0.04; p = 0.873). Overall, AZD9668 was well tolerated; the numbers of patients with adverse events (AEs), serious AEs and AEs leading to discontinuation were similar in each of the four study groups. AZD9668 60 mg bid showed no clinical benefit and no effect on biomarkers of inflammation or tissue degradation when added to tiotropium in patients with COPD. These results raise important questions for future investigation of anti-inflammatory and disease-modifying agents in patients with COPD.
机译：AZD9668是嗜中性粒细胞弹性蛋白酶（一种与慢性阻塞性肺疾病（COPD）有关的蛋白酶）的完全可逆的，选择性的口服抑制剂。在一项随机，双盲，安慰剂对照，为期12周的IIb期临床试验（NCT00949975：由研究审查委员会批准）中，比较了AZD9668（5、20和60 mg bid）的疗效，安全性和耐受性，与安慰剂进行了比较，有症状的COPD患者接受维持噻托溴铵治疗。主要终点为1秒钟内支气管扩张剂前呼气量（FEV 1）。次要终点包括强迫肺活量和吸气量，呼气峰流量，呼吸困难，咳嗽和痰量表得分，运动能力，生活质量（QoL），病情恶化评估，安全性和药代动力学。探索性终点包括炎症和组织降解生物标志物。总共838名患者被随机分为AZD9668 5 mg bid（212名患者），20 mg bid（206名患者），60 mg bid（202名患者）或安慰剂（218名患者）。 AZD9668对肺功能，呼吸道症状和体征，QoL或生物标志物均无影响。在治疗结束时，与安慰剂相比，AZD9668 60 mg bid的平均支气管扩张剂FEV 1的变化为0.00L（95％置信区间：-0.05，0.04; p = 0.873）。总体而言，AZD9668的耐受性良好。在四个研究组中，具有不良事件（AE），严重AE和导致停药的AE的患者人数相似。当将60 mg bid的AZD9668注射到COPD患者的噻托溴铵中时，对临床无益处，对炎症或组织降解的生物标志物无影响。这些结果为COPD患者抗炎药和疾病改善剂的进一步研究提出了重要的问题。

著录项

相似文献

  • 外文文献
  • 中文文献
  • 专利
获取原文

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号