NCT00408616已完成3 期
A Phase III Trial Investigating the Efficacy and Safety of Grazax in Children Aged 5-16 Years With Grass Pollen Induced Rhinoconjunctivitis With or Without Asthma
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 253
- 试验地点
- 2
- 主要终点
- Hayfever symptoms
研究概览
简要总结
The purpose of this study is to investigate if immunotherapy with Grazax is safe and reduces the hayfever symptoms and the use of symptom relieving medications in children during the grass pollen season
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
- 5 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Boys and girls 5-16 years of age
- •A clinical history of grass pollen induced hayfever
- •Positive Skin Prick Test to Phleum pratense
- •Positive specific IgE against Phleum pratense
排除标准
- •History of seasonal hayfever symptoms (and/or asthma) caused by another allergen than Phleum pratense during or overlapping the grass pollen season
- •History of perennial hayfever (and/or asthma) that needs medication due to an allergen to which the child is regularly exposed
- •History of severe asthma
- •Current severe atopic dermatitis
结局指标
主要结局
Hayfever symptoms
时间窗: Grass pollen season 2007
Intake of hayfever symptom relieving medication
时间窗: Grass pollen season 2007
次要结局
- Combined hayfever symptom and medication scores(Grass pollen season 2007)
- Asthma symptoms and medication(Grass pollen season 2007)
- Global Evaluation of treatment efficacy(Grass pollen season 2007)
- Adverse Events(9 months)
- Pharmacoeconomic Assessment(9 months)
- Immunological Assessment(9 months)
研究者
研究点 (2)
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