NCT00062582已完成3 期
A 24 Week, Placebo-Controlled, Randomized, Parallel Group Study Comparing Roflumilast 500 mcg Daily vs Placebo on Pulmonary Function and Respiratory Symptoms in Patients With Chronic Obstructive Pulmonary Disease (COPD)
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 1,000
- 试验地点
- 37
- 主要终点
- pulmonary function.
研究概览
简要总结
The aim of the study is to compare the effect of roflumilast and placebo on the lung function in patients with 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of COPD (Chronic Obstructive Pulmonary Disease)
- •Currently stable COPD with no change in COPD treatment in the prior 4 weeks
排除标准
- •Clinical diagnosis of asthma
- •Poorly controlled COPD
- •Regular need for daily oxygen therapy
结局指标
主要结局
pulmonary function.
次要结局
- exacerbation rate
- quality of life
- symptoms
- use of rescue medication
- safety and tolerability.
研究者
研究点 (37)
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