NCT00150397已完成2 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Six-Week Study Of The Efficacy And Safety Of Tofimilast Dry Powder For Inhalation In Adults With Persistent Asthma
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
- 112
- 试验地点
- 23
- 主要终点
- Change from baseline in FEV1 compared to placebo
研究概览
简要总结
This is an initial proof of concept, phase to study to assess the safety and efficacy tofimilast for the chronic maintenance treatment of adults with persistent asthma
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild to moderate persistent asthma (NAEPP/GINA Step 2-3)
- •Reversibility to albuterol at least 12% and 200 mL
排除标准
- •Any significant co-morbid disease, particularly cardiovascular
- •Use of any maintenance therapy except short acting bronchodilators
- •Smoking history > or = 10 years
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, disease control and quality of life compared to placebo
研究者
研究点 (23)
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