EUCTR2008-006625-14-DE进行中（未招募）不适用
Phase II, Randomised, Double-Blind, Cross-over Study to Compare the24-hour FEV1-time Profile of Orally Inhaled Olodaterol, delivered withthe Respimat® Inhaler, after 3 Weeks of Olodaterol Once Daily 5 µg [2actuations of 2.5 µg], Twice Daily 2.5 µg [2 actuations of 1.25 µg] andPlacebo 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 Administrationin Patients with Moderate to Severe Persistent Asthma
适应症
试验速览
- 阶段
- 不适用
- 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
- 性别
- All
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: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 170
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
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 two years, if they are not on an established maintenance regimen characterized by dose adjustments but no further increase to the tolerable maximum in the same course of immunotherapy.
研究者
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