NCT00818181已完成2 期
A Multicentre Open Label Safety Study of a Sublingual Specific Immunotherapy With a Solution of Birch Pollen Allergen Extract in Patients With Clinically Relevant Birch Pollen Allergy
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
- 73
- 试验地点
- 1
- 主要终点
- number of patients with at least one adverse event
研究概览
简要总结
This trial is performed to assess safety of a sublingual birch pollen extract.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Allergic rhinoconjunctivitis attributable to birch pollen
- •Positive SPT
- •Positive EAST
排除标准
- •Serious chronic diseases
- •Other perennial allergies
- •Partly controlled asthma
研究组 & 干预措施
Solution of birch pollen allergen extract
Experimental
In total up to 4 drops (dose for maintainace therapy)are administered under the tongue.
干预措施: Biological: AL0206st (Drug)
结局指标
主要结局
number of patients with at least one adverse event
时间窗: 8 months
Between Visit 03 and Visit 05 (June 2008 - January 2009)
次要结局
- Systemic reactions(Entire treatment period)
研究者
研究点 (1)
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