NL-OMON35802已完成3 期
A randomised, double-blind, parallel group study to assess the efficacy and safety of 52 weeks of once daily treatment of orally inhaled tiotropium + olodaterol fixed dose combination (2.5 µg / 5 µg; 5 µg / 5 µg) (delivered by the RESPIMAT) compared with the individual components (2.5 µg and 5 µg tiotropium, 5 µg olodaterol) (delivered by the RESPIMAT) in patients with Chronic Obstructive Pulmonary Disease (COPD) [TOnadoTM 1] - Efficacy and safety tiotropium plus olodaterol
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 90
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
- •1. Patients with COPD with specific spirometric criteria(FEV1 < 80% of predicted normal and post-bronchodilator FEV1/FVC < 70% bij visite 1)
- •2. current or ex-smokers with smoking history of more than 10 pack years
- •3. male or female patients, 40 years of age or older
- •See protocol page 22
排除标准
- •1. Other significant disease other than COPD
- •2. Clinically relevant abnormal baseline lab values
- •3. History of Asthma
- •See protocol page 22/23
研究者
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