EUCTR2015-003879-29-FR进行中（未招募）1 期
A 4-week, randomised, double-blind, parallel group study to evaluate the efficacy and safety of tiotropium + olodaterol fixed dose combination (5/5 µg) delivered by the Respimat® inhaler versus the free combination of tiotropium 5 µg and olodaterol 5 µg delivered by separate Respimat® inhalers in patients with chronic obstructive pulmonary disease (COPD) - Fixed dose combination versus free combination of tiotropium and olodaterol in COPD
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 350
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Male or female patients.
- •- Patients 40 years of age or older.
- •- Patients with a smoking history > 10 pack years.
- •- Diagnostic of COPD with Post-bronchodilator FEV1 >= 30% and <80% of predicted normal and Post-bronchodilator FEV1/FVC <70% at screening.
- •- Symptomatic patients with CAT score >= 10 at screening.
- •- Further inclusion criteria apply.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 110
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 110
排除标准
- •- COPD exacerbation or symptoms of lower respiratory tract infection within 6 weeks prior to screening.
- •- Patients with history of asthma.
- •- Further exclusion criteria apply.
研究者
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