Observational Prospective Study to Assess the Safety and Effectiveness Profile of Beltavac® Polymerized With Alternaria Alternata
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 13
- 主要终点
- Numbers of treatment-related local and systemic reactions
研究概览
简要总结
Non-interventional Study to Assess the Safety and Effectiveness Profile of a SCIT Therapy With Beltavac® Polymerized With Alternaria alternata in allergic patients
详细描述
This prospective open multi-centre non-interventional study assess the safety and effectiveness profile of the subcutaneous allergen-specific immunotherapy with Beltavac® Polymerized in Alternaria alternata allergic patients (children and adults) in routine medical care.
Patients receive a rush schedule administration every month for a year. They attend at least 4 study visits to inform about the adverse reactions, the self reported symptoms and the medication intake.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of the age of 5 years and older suffering from a clinically relevant Alternaria alternata induced allergic rhinitis
- •Positive skin testing or IgE determination to the relevant allergen
排除标准
- •Patients suffering from acute or chronic infections or inflammations Patients suffering from uncontrolled asthma Patients with a known autoimmune disease Patients with active malignant disease Patients requiring beta-blockers Patients having any contraindication for the use of adrenaline
结局指标
主要结局
Numbers of treatment-related local and systemic reactions
时间窗: 1 year
Number of adverse reactions occurred during the treatment period and classified according to the WAO standard
次要结局
- Rhinoconjuntivitis medication intake(1 year)
- Visual analogue Scale Score(1 year)
- IgE and IgG4 specific quantification(1 year)