NCT00421655已完成3 期
A Phase III Trial Assessing the Efficacy and Safety of Grazax in Subjects With Seasonal Grass Pollen Induced Rhinoconjunctivitis With or Without Asthma
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 329
- 试验地点
- 1
- 主要终点
- Recording of allergy symptoms
研究概览
简要总结
The trial is performed to evaluate the efficacy and safety of specific immunotherapy with Grazax for treatment of grass pollen induced allergy.
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, 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
- •History of grass pollen allergy
- •Positive skin prick test to grass
- •Positive specific IgE to grass
- •Exclusion Criteria
- •FEV1 <70% of predicted value
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
干预措施: Grazax (Drug)
2
Placebo Comparator
干预措施: Grazax (Drug)
结局指标
主要结局
Recording of allergy symptoms
时间窗: Grass pollen season 2007
次要结局
未报告次要终点
研究者
研究点 (1)
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