NL-OMON38572已完成3 期
DB2116134: A randomized, multi-center, double-blind, double-dummy, parallel group study to evaluate the efficacy and safety of umeclidinium/vilanterol compared with fluticasone propionate/salmeterol over 12 weeks in subjects with COPD - DB2116134
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 65
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 (see protocol page 23 for details).
- •* (Ex) smokers, at least 10 pack years.
- •* Pre and post salbutamol FEV1/FVC ratio <70%.
- •* Post salbutamol FEV1 *30% and *70% of predicted.
- •* A score of at least 2 on the Modified Medical Research Council Dyspnea Scale.
- •* Safe contraception for women of childbearing potential.
排除标准
- •* Pregnancy.
- •* Bronchial asthma.
- •* Documented COPD exacerbation in the past 12 months.
- •* Hospitalization for COPD or pneumonia in the past 12 weeks.
- •* Significant ECG abnormalities (see protocol page 24 for details).
- •* Treatment with specified (mainly COPD) therapies within a specified time frame (see protocol page 24-25 for details).
研究者
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