NL-OMON45240已完成3 期
A phase III, 52 week, randomized, double-blind, 3-arm parallel group study, comparing the efficacy, safety and tolerability of the fixed dose triple combination FF/UMEC/VI with the fixed dose dual combinations of FF/VI and UMEC/VI, all administered once-daily in the morning via a dry powder inhaler in subjects with chronic obstructive pulmonary disease - CTT116855
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 225
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
- •* COPD patients *40 years of age.
- •* (Ex) smokers, at least 10 pack years.
- •* Post salbutamol FEV1/FVC ratio <0,70.
- •* A score of *10 on the COPD Assessment Test (CAT).
- •* Post-bronchodilator FEV1 < 50% predicted normal and a documented history of * 1 moderate or severe COPD exacerbation in the previous 12 months OR a post-bronchodilator 50% *FEV1 < 80% predicted normal and a documented history of * 2 moderate exacerbations or a documented history of *1 severe COPD exacerbation (hospitalized) in the previous 12 months.
- •* Safe contraception for women of childbearing potential.
排除标准
- •* Pregnancy, lactation.
- •* Risk factors for pneumonia (see protocol page 33 for details).
- •* Abnormal Chest x-ray (see protocol page 33 for details).
研究者
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