NCT01191359已完成2 期
A Multicentre Randomised Phase II Clinical Pilot Study to Compare the Pharmacodynamic Efficacy and Tolerability of the Sublingual and the Vestibular Administration Route for SLITonePLUS® Birch
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Pharmacodynamic efficacy of two different administration routes of SLITonePLUS Birch
研究概览
简要总结
Multicentre Phase II trial, comparing two different administration routes of SLITonePLUS Birch in regard to pharmacodynamic efficacy and tolerability.
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
- None
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
- •A history of Birch pollen allergy
- •Positive skin prick test to birch
- •Positive specific IgE to birch
- •Exclusion criteria:
- •Uncontrolled or severe asthma (FEV1<70% of predicted value in spite of adequate pharmacologic treatment)
- •Previous treatment by immunotherapy with birch or a cross-reactingtree pollen allergen within the previous 5 years
- •Concomitant SLIT with any allergen
排除标准
- 未提供
结局指标
主要结局
Pharmacodynamic efficacy of two different administration routes of SLITonePLUS Birch
时间窗: after 4, 8, 12, 24, 36 weeks of treatment
specific antibody determination
次要结局
- Comparison of the two administration routes with regard to safety aspects(36 weeks)
研究者
研究点 (2)
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