NCT00389363已完成2 期
A Phase II-III Trial Assessing the Efficacy and Safety of Three Doses of the ALK HDM Tablet in House Dust Mite Allergic Patients
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 800
- 试验地点
- 2
- 主要终点
- Use of inhaled corticosteroid (ICS).
研究概览
简要总结
The purpose of the trial is to determine if treatment of asthma patients allergic to house dust mites with the ALK HDM tablet can reduce the need of inhaled corticosteroids (ICS).
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
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A history of house dust mite induced asthma
- •Use of inhaled corticosteroids (ICS)
- •Positive skin prick test to house dust mites
- •Positive specific IgE to house dust mites
排除标准
- •FEV1 lower than 70%
结局指标
主要结局
Use of inhaled corticosteroid (ICS).
次要结局
- Use of rescue medication and symptoms.
- Quality of Life.
研究者
研究点 (2)
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