Détermination de la réactivité cutanée de Volontaires Allergiques au Pollen de Bouleau Contre Des Peptides dérivés de Bet v 1
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- skin prick test reactivity
研究概览
简要总结
Assessment of skin reactivity by skin prick tests to synthetic peptides derived from the major birch allergen bet v 1, in subjects allergic to birch pollen.
详细描述
The study tested - all by skin tests - in the same group of 20 trial subjects, one positive control (histamine solution), one negative control (placebo saline) and five experimental peptides called T1, T2, T3, T4 and T5. Results of the skin prick tests were scored as negative (no reaction) or positive (wheal diameter > 4 mm with erythema)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •history of allergy symptoms during previous birch pollen season
- •positive skin prick test to birch pollen extract
排除标准
- •pregnancy
- •uncontrolled asthma
- •other significant clinical conditions or immune disorders
- •subjects taking antihistamines or drugs with antihistamine activity
研究组 & 干预措施
All subjects
placebo histamine T1 T2 T3 T4 T5 T1-T2-T3 T4-T5
干预措施: mix of AllerT1-T2-T3 (Drug)
All subjects
placebo histamine T1 T2 T3 T4 T5 T1-T2-T3 T4-T5
干预措施: placebo (Drug)
All subjects
placebo histamine T1 T2 T3 T4 T5 T1-T2-T3 T4-T5
干预措施: Histamine (Drug)
All subjects
placebo histamine T1 T2 T3 T4 T5 T1-T2-T3 T4-T5
干预措施: AllerT1 (Drug)
All subjects
placebo histamine T1 T2 T3 T4 T5 T1-T2-T3 T4-T5
干预措施: AllerT2 (Drug)
All subjects
placebo histamine T1 T2 T3 T4 T5 T1-T2-T3 T4-T5
干预措施: AllerT3 (Drug)
All subjects
placebo histamine T1 T2 T3 T4 T5 T1-T2-T3 T4-T5
干预措施: AllerT4 (Drug)
All subjects
placebo histamine T1 T2 T3 T4 T5 T1-T2-T3 T4-T5
干预措施: AllerT5 (Drug)
All subjects
placebo histamine T1 T2 T3 T4 T5 T1-T2-T3 T4-T5
干预措施: mix of AllerT4-T5 (Drug)
结局指标
主要结局
skin prick test reactivity
时间窗: 15 minutes
次要结局
未报告次要终点