NCT00242333已完成2 期
A Multi-Center Randomized, Double-Blind, Parallel Group, Placebo Controlled Study, Including an Additional Open Label Tiotropium Group, to Assess the Efficacy, Safety and Tolerability of 4 Doses of AD 237 Inhaled Once Daily for 28 Days in Subjects With COPD.
Sosei66 个研究点 分布在 4 个国家目标入组 300 人开始时间: 2005年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 66
- 主要终点
- Pulmonary function
研究概览
简要总结
The purpose of this study is to investigate the efficacy, safety and tolerability of AD 237 in patients with chronic obstructive pulmonary disease (COPD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with COPD, with symptoms of cough and chronic sputum production and/or dyspnea.
- •Post-bronchodilator FEV1 at no more than 65% and at least 30% of the predicted normal value.
- •Pre-bronchodilator FEV1/FVC ratio of less than 70%.
- •Current or ex-smokers with a smoking history of at least 10 pack years.
排除标准
- •History of asthma, atopy or allergic rhinitis.
- •Other serious respiratory or other medical conditions which may interfere with the outcome of the study.
结局指标
主要结局
Pulmonary function
次要结局
- Pulmonary function
研究者
研究点 (66)
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