EUCTR2008-006625-14-SI进行中（未招募）1 期
Phase II, Randomised, Double-Blind, Cross-over Study to Compare the 24-hour FEV1-time Profile of Orally Inhaled Olodaterol, delivered with the Respimat® Inhaler, after 3 Weeks of Olodaterol Once Daily 5 µg [2 actuations of 2.5 µg], Twice Daily 2.5 µg [2 actuations of 1.25 µg] and Placebo or after 3 Weeks of Once Daily 10 µg [2 actuations of 5 µg], Twice Daily 5 µg [2 actuations of 2.5 µg] and Placebo Administration in Patients with Moderate to Severe Persistent Asthma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 180
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
入选标准
- •Patients of either sex; aged =18 = 70 years; a current diagnosis and a documented
- •minimum 3 month history of asthma (GINA treatment steps 3 and 4); prebronchodilator FEV1=60% predicted and <90% predicted (ECSC); increase in FEV1 =12% and =200 ml 15 min. after 400 µg salbutamol (albuterol); stable on medium to high dose ICS or low to high dose ICS in combination with a LABA for at least 6 weeks prior to screening; stable on ICS mono component of the former fixed
- •LABA/ICS treatment for at least 48 hours prior to Visit 1b.
- •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
- •History of frequent seasonal exacerbations of asthma (defined as one or more seasonal exacerbations every year for the past three years), upper respiratory tract infection in the past 4 weeks prior to screening visit 1b, oral or other systemic corticosteroids in the past 6 weeks; Patients with allergen desensitization therapy if started within 2 years, if they are not on stable dose.
研究者
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