NL-OMON37459已完成3 期
A study to compare the efficacy and safety of once daily QVA149 vs. the once daily concurrent administration of QAB149 plus NVA237 in patients with moderate to severe chronic obstructive pulmonary disease (CQVA149A2326) - CQVA149A2326
ovartis Pharma BV0 个研究点目标入组 70 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
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
- •Male or female adults aged >=40 years.
- •Patients with moderate to severe COPD (Stage II-III) according to the (GOLD Guidelines, 2010).
- •Current or ex-smokers who have a smoking history of at least 10 pack years.
- •Post-bronchodilator FEV1 >=30% of the predicted normal value, and postbronchodilator FEV1/FVC < 0.70.
- •COPD symptoms during run-in phase.
排除标准
- •Diabetes type I and uncontrolled diabetes type 2.
- •History of long QT syndrome or QTc measured at Visit 2 (Fridericia method) is prolonged (>450 ms for males and females).
- •BMI >=40 kg/m2.
- •Patients who have had a COPD exacerbation in the 6 weeks prior to Visit 1.
- •Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1.
- •Pregnancy and breast feeding. Inadequate contraception, if relevant.
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