A Multicentre, Double-blind, Placebo-Controlled, Randomized Trial to Assess the Efficacy and Tolerability of Two Dosing Regimens of AllerT in Adults With Birch Pollen Allergic Rhinitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 421
- 试验地点
- 36
- 主要终点
- Combined Symptom and Medication Score (CSMS)
研究概览
简要总结
A multicentre, Double-blind, Placebo-Controlled, Randomized Trial to Assess the Efficacy and Tolerability of Two Dosing Regimens of AllerT, a Combination of Contiguous Overlapping Peptides Derived from Bet v 1, in Adults with Birch Pollen Allergic Rhinitis/Rhinoconjunctivitis
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult subjects 18 to 65 yrs old, male or female
- •moderate to severe allergic Rhinitis/Rhinoconjunctivitis to birch pollen during the two preceding birch pollen seasons
- •positive Skin Prick Test (SPT) to birch pollen extract
- •positive specific IgE CAP to Bet v1.
排除标准
- •persistent non-controlled asthma (Forced Expiratory Volume, FEV1 < 85% of predicted),
- •previous specific immunotherapy (SIT) to tree pollens,
- •previous SIT to any allergen within 5 years,
- •previous history of severe anaphylactic reaction,
- •perennial allergic Rhinitis/Rhinoconjunctivitis,
- •other disorder possibly influencing the trial outcomes,
- •pregnancy,
- •any severely debilitating disease,
- •primary or secondary immunodeficiency or treatment with immunosuppressor drugs within one month prior to randomization (oral steroids, other immunosuppressors).
研究组 & 干预措施
placebo
5 SC injections in 2 months
干预措施: placebo (Drug)
AllerT 50 ug
5 SC injections in 2 months
干预措施: AllerT (Drug)
AllerT 10 ug
5 SC injections in 2 months
干预措施: AllerT (Drug)
结局指标
主要结局
Combined Symptom and Medication Score (CSMS)
时间窗: 2 to 6 months after the end of treatment
the CSMS will be assessed daily throughout the first birch pollen season following the end of the preseasonal 2-month treatment. The difference in average daily CSMS per treatment group will be compared taking into account all days of the birch pollen season at each study center. All patients will receive treatment during the preceding winter or spring and will thus have the primary outcome assessment performed between 2 and 6 months after the end of treatment.
次要结局
未报告次要终点