EUCTR2013-002243-29-FI进行中（未招募）不适用
A randomised, double-blind, placebo- and active-controlled parallel group study to assess the efficacy of 12 weeks of once daily treatment of two doses of orally inhaled tiotropium + olodaterol fixed dose combination (delivered by the Respimat inhaler) in patients with Chronic Obstructive Pulmonary Disease (COPD) - OTEMTO 1
Boehringer Ingelheim Ky0 个研究点目标入组 1,066 人开始时间: 2013年9月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,066
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
- •- Diagnosis chronic obstructive pulmonary disease
- •- Relatively stable airway obstruction with post FEV1 >=30 and
- •< 80% predicted normal and post FEV1/ FVC < 70%
- •- Male or female patients, 40 years of age or more
- •- Smoking history more than 10 pack years
- •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 500
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 300
排除标准
- •- Significant diseases other than COPD
- •- History of asthma
- •- COPD exacerbation in previous 3 months
- •- Completion of pulmonary rehabilitation program within previous 6 weeks or current participation in pulmonary rehabilitation program.
- •- Pregnant or nursing women
- •- Patients unable to comply with pulmonary medication restrictions
研究者
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撤回
3 期
A randomised, double-blind, placebo- and active-controlled parallel group study to assess the efficacy of 12 weeks of once daily treatment of two doses of orally inhaled tiotropium + olodaterol fixed dose combination (delivered by the Respimat inhaler) in patients with Chronic Obstructive Pulmonary Disease (COPD)chronic obstructive pulmonary disease (COPD)10038716NL-OMON38556Boehringer Ingelheim62