EUCTR2012-000031-59-DK进行中（未招募）不适用
A dose-response evaluation of ALK tree AIT
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male or females aged 12-65 (adolescents ages 12 - <18 years will only be recruited in selected countries).
- •Subjectcs with a documented clinical relevant history of moderate to severe birch pollen induced allergic rhinoconjunctivitis (with or without asthma) with symptoms despite having received symptomatic medication.
- •Subjects with a minimum level of birch pollen allergic rhinoconjunctivitis symptoms.
- •Presence of one or more of the following ARIA quality of life items during the previous birch pollen season: a. Sleep disturbance, b. Impairment of daily activities, leisure and/or sport, c. Impairment of school or work, d. Troublesome symptoms
- •A positive SPT response (wheal diameter = 3 mm larger than the negative control to Betula verrucosa)
- •Positive specific IgE against Bet v1 (= IgE Class 2, =0.70 kU/L) at screening.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 50
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 550
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •A clinically relevant history of perennial allergic rhinitis and/or asthma having received regular medication due to an allergen to which the subject is regularly exposed.
- •A clinical history of uncontrolled asthma within 3 month prior to randomisation
- •Reduced lung function, defined as FEV-1 < 70% of predicted value after adequate pharmacological treatment.
- •Previous treatment with immunotherapy with birch pollen allergen - or a cross-reacting allergen such as hazel or alder.
研究者
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