A Dose-response Evaluation of ALK Tree AIT
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 637
- 试验地点
- 4
- 主要终点
- Allergy symptom severity scores on a scale from 0-3
研究概览
简要总结
The primary aim of this trial is to evaluate the dose-response relationship for the ALK tree AIT administered once daily in order to define a dose-range that would be suitable for at-home administration.
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
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A history of moderate to severe birch pollen allergy
- •Use of symptomatic medication for treatment of birch pollen allergy
- •Positive skin prick test to birch extract
- •Positive specific IgE against Bet v 1
排除标准
- •Overlapping perennial allergies
- •History of uncontrolled asthma within the last 3 months
- •FEV1 < 70% of predicted value in adults or FEV1 < 80% of predicted value in adolescents
- •Previous or ongoing treatment with immunotherapy
结局指标
主要结局
Allergy symptom severity scores on a scale from 0-3
时间窗: During the birch pollen season 2013, an expected average of 3 weeks
Determine the dose-efficacy response relationship of the ALK tree AIT. This information will, in combination with the evaluation of the frequency and severity of adverse events, form the basis of the conclusion on the primary endpoint.
Adverse events frequency
时间窗: Throughout the trial, an expected average of 8 months
Determine the dose-safety response relationship of the ALK tree AIT. This information will, in combination with the evaluation of the allergy symptoms, form the basis of the conclusion on the primary endpoint.
次要结局
- Adverse events severity(Throughout the trial, an expected average of 8 months)