NCT00219622已完成2 期
Phase 2, Randomized, Double-Blind, Placebo-Controlled, Six Week Study Of The Efficacy And Safety Of Tofimilast Dry Powder For Inhalation In Adults Diagnosed With Chronic Obstructive Pulmonary Disease
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 300
- 试验地点
- 40
- 主要终点
- Change from baseline in FEV1 compared to placebo
研究概览
简要总结
This an initial proof of concept, phase to study to assess the safety and efficacy of tofimilast for the chronic maintenance treatment of adults with Chronic Obstructive Pulmonary Disease
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate-severe COPD (GOLD 2003 definition)
- •Smoking history of at least 10 pack-years
排除标准
- •Any significant co-morbid disease, particularly cardiovascular
- •Use of any maintenance therapy except short acting bronchodilators
结局指标
主要结局
Change from baseline in FEV1 compared to placebo
次要结局
- Change from baseline in other lung function parameters, dyspnea, quality of life compared to placebo
研究者
研究点 (40)
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