EUCTR2006-001955-37-DE进行中（未招募）不适用
A 26-week treatment, multicenter, randomized, double-blind, double dummy, placebo-controlled, adaptive, seamless, parallel-group study to assess the efficacy, safety and tolerability of indacaterol (75, 150, 300 & 600 µg o.d.) in patients with chronic obstructive pulmonary disease using blinded formoterol (12 µg b.i.d) and open label tiotropium (18 µg o.d.) as active controls
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,945
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
- •1. Male and female adults aged = 40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure
- •2. Co-operative outpatients with a diagnosis of COPD (moderate to severe as classified by the GOLD Guidelines, 2005) and:
- •a) Smoking history of at least 20 pack years
- •b) Post-bronchodilator FEV1 < 80% and =30% of the predicted normal value.
- •c) Post-bronchodilator FEV1/FVC < 70%
- •(Post refers to within 30 min after inhalation of 400 µg of salbutamol at Visit 1)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Please see the Protocol
研究者
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