NCT00773240已完成3 期
A Phase III Trial Assessing the Pharmacodynamic Effect and the Tolerability of Grazax Treatment Initiated in the Grass Pollen Season in Subjects With Seasonal Grass Pollen Induced Rhinoconjunctivitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 276
- 试验地点
- 1
- 主要终点
- Pharmacodynamics - Immunological assessments
研究概览
简要总结
The study assess the pharmacodynamic effect and the tolerability of Grazax treatment initiated in the grass pollen season in subjects with seasonal grass pollen induced rhinoconjunctivitis
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
- Triple (Participant, Care Provider, Investigator)
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
- •Positive skin prick test to Phleum pratense
- •Positive IgE to Phleum pratense
- •signed informed consent
- •A clinical history of moderate to severe persistent rhinoconjunctivitis symptoms
排除标准
- •No uncontrolled asthma in the past 12 months
- •No history of an IgE mediated systemic reaction due to food, insect venom, any kind of medication or induced by exercise, where there are symptoms both from the skin and the respiratory system with or without hypotension
- •No history of an IgE mediated systemic reaction due to food, insect venom, any kind of medication or induced by exercise, where there are symptoms both from the skin and the respiratory system with or without hypotension
研究组 & 干预措施
1
Experimental
Grazax
干预措施: Grazax (Drug)
2
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Pharmacodynamics - Immunological assessments
时间窗: Pre- and post treatment
次要结局
未报告次要终点
研究者
研究点 (1)
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