NL-OMON32333已完成3 期
A phase III, randomized, double-blind, double-dummy, placebo-controlled, multicenter, 3-period incomplete block, multidose crossover study to determine the effect on lung function of indacaterol (150 and 300 mcg o.d.) in patients with moderate to severe COPD, using tiotropium (18 mcg o.d.) as an active control - CQAB149B2331
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- ovartis
- 入组人数
- 26
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* Male or female patients aged 40 years and older
- •* Patients with moderate to severe stable COPD according to the COLD Guidelines 2006
- •* Patients with a smoking history of at least 10 pack years
- •* Patients with a post-brochodilator FEV1 equal or greater than 30% of the predicted normal value and less than 80% of the predicted normal value, and post bronchodilator FEV1/FVC less than 0.7
排除标准
- •* Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to Visit 1 or during the run-in period
- •* Patients requiring long term oxygen therapy
- •* Patients who have had a respiratory tact infection within 6 weeks prior to V1
- •* Patients with a history of Asthma
- •* Patients with diabetes Type 1 and uncontrolled diabetes type II
- •* Patients with a hostory of long QT syndrome or whose QTc interval measured at visti 1 or 3 is prolonged
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