NCT00890734已完成2 期
A Double-blind, Placebo-controlled Study to Assess Pharmacodynamic and Clinical Efficacy of CYT003-QbG10 in Patients With Persistent Allergic Asthma Bronchial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Markers for inflammation and asthma
研究概览
简要总结
The purpose of the study is to test whether treatment with CYT003-QbG10 can improve asthma symptoms in patients with allergic bronchial asthma. The active treatment will be compared against placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persistent allergic asthma bronchial requiring long-term treatment with inhaled corticosteroids
- •Further criteria as defined in the study protocol
排除标准
- •Use of oral corticosteroids within past 3 months
- •Hospitalization for asthma exacerbation within past 6 months
- •Uncontrolled asthma
- •Contraindication to any study test or procedure
- •Further criteria as defined in the study protocol
研究组 & 干预措施
1
Experimental
干预措施: CYT003-QbG10 (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Markers for inflammation and asthma
时间窗: 1-3 months
次要结局
未报告次要终点
研究者
研究点 (1)
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