EUCTR2004-000025-29-SE进行中（未招募）不适用
Full title of the trial : A randomized, double-blind, placebo-controlled, parallel group, multi-center, multiple dose (7 days) dose-ranging study, to assess the efficacy and safety of 4 doses of QAB149 (50, 100, 200 & 400 µg) delivered via a multiple dose inhaler and 1 dose of QAB149 (400 µg) delivered via a single dose inhaler in patients with chronic obstructive pulmonary disease (COPD). - Not applicable
ovartis Sweden AB0 个研究点目标入组 660 人开始时间: 2004年6月11日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 660
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 and female patients between 40 and 75 years with moderate to severe COPD. A smoking history of at least 20 pack years. FEV1 at visits 1 and 2 in the range =40% of the Quanjer predicted normal and =1.0L. Ratio of recorded FEV1 at visit 2 to recorded FEV1 at visit 1 must be >0.85 and <1.18. Pre-bronchodilator FEV1/FVC<70%.
- •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
- •Pregnancy, hospitalisation for an exacerbation in the 6 months prior to visit 1 or between visits 1 and 2, respiratory infection within 1 month prior to visit 1, concomitant pulmonary disease, history of asthma, seasonal or perennial allergic rhinitis, patients with QTc interval above 430ms (males) and 450ms (females).
研究者
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