EUCTR2012-002298-69-FR进行中（未招募）1 期
A Multi-Center, Randomized, Double Blind, Placebo and Active-Controlled study with exploratory dose-ranging, to investigate the efficacy and safety of 16 weeks treatment with subcutaneous QGE031 in asthma patients not adequately controlled with high-dose inhaled corticosteroids and long acting ß2-agonists
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 471
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
- •-A diagnosis of allergic asthma , uncontrolled on current medication.
- •-History of at least 1 asthma exacerbation during the last 1 year
- •-Forced Expiratory Volume in one second (FEV1) of = 40% and = 80% of the predicted normal value;
- •- reversibility following administration of bronchodilator must also be demonstrated (historical positive reversibility or bronchoprovocation result can be used).
- •Other inclusion criteria are listed in the clinical study protocol
- •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 366
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 91
排除标准
- •-Baseline IgE levels or body weight outside the omalizumab dosing table.
- •-Use of tobacco products within the previous 6 months (Social occasional smokers may be included).
- •-Recent asthma attack/exacerbation or asthma worsening/ respiratory infection.
- •Other exclusion criteria are listed in the clinical study protocol
研究者
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