NCT01433510已完成4 期
Observational National Clinical Trial of Safety and Tolerance in Patients Suffering of an Allergic Grass Pollen Rhinitis and Treated by Grazax in Real Life Settings
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 628
- 试验地点
- 1
- 主要终点
- Adverse Events related to Grazax
研究概览
简要总结
The purpose of this study is to assess the safety profile of specific immunotherapy with Grazax for three consecutive grass pollen seasons.
详细描述
To assess the safety profile with Grazax according to the presence or not of polysensitization and/or asthma at enrollment
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（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 and/or positive specific IgE to grass
排除标准
- •Severe, unstable or uncontrolled asthma (FEV1<70% of predicted value)
研究组 & 干预措施
Grazax Tablets 75000 SQT
Experimental
Timothy Extract
干预措施: Grazax (Drug)
结局指标
主要结局
Adverse Events related to Grazax
时间窗: From November 2007 to October 2010 (3 years)
All adverse events were reported according to the MedDRA dictionary
次要结局
未报告次要终点
研究者
研究点 (1)
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