NCT00046748已完成3 期
Ph III, 28-wk, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess Efficacy, Safety, Tolerability of SC Omalizumab in Adults and Adolescents w/ Severe Persist. Allergic Asthma & Are Inadequately Controlled Despite GINA (2002) Step 4 Tx
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 484
- 主要终点
- Clinically significant asthma exacerbation
研究概览
简要总结
The purpose of this study is to determine the effect of omalizumab, compared to placebo, on clinically significant asthma exacerbation rates in adolescents and adults with 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
- 12 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Clinically significant asthma exacerbation
次要结局
- Quality of Life assessment at baseline, last visit
- Medical resource utilization
- Time to first asthma exacerbation
- Frequency of asthma rescue medication use
- Safety/tolerability of omalizumab
研究者
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