EUCTR2011-003732-31-ES进行中（未招募）不适用
A randomized, double-blind, parallel-group, 26-week study comparing the efficacy and safety of indacaterol (Onbrez® Breezhaler® 150 mcg o.d.) with salmeterol/fluticasone propionate (Seretide® Accuhaler® 50 mcg/500 mcg b.i.d.) in patients with moderate chronic obstructive pulmonary disease.
ovartis Farmacéutica SA0 个研究点目标入组 600 人开始时间: 2012年2月15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
- 600
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
- •- Patients with moderate COPD (Stage II)
- •- Able to perform spirometry assessments
- •- Current or ex-smokers
- •- On treatment with the fixed-dose combination of salmeterol 50 ?g /fluticasone propionate 500 ?g MDDPI b.i.d. for the treatment of COPD for ?3 months directly
- •Other protocol-defined inclusion/exclusion criteria may apply.
- •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 450
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
排除标准
- •- Having had a COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization in the past year.
- •- A history of, or current ECG abnormality.
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究者
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