Observational Prospective Study to Assess the Safety and Effectiveness of Beltavac® Polymerized With House Dust Mites
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 97
- 试验地点
- 1
- 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® Polymerised With House Dust Mite in pediatric allergic patients
详细描述
This prospective open multi-center non-interventional study assess the safety and effectiveness profile of the subcutaneous allergen-specific immunotherapy with Beltavac polymerized with house dust mite pediatric allergic patients in routine medical care.
Patients receive a rush schedule administration every month for a year. They attend at least 5 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
- 3 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients from 3 to 11 years suffering from a clinically relevant Dermatophagoides farinae and Dermatophagoides pteronyssinus induced allergic rhinitis or rhinoconjunctivitis associated with or not with asthma
- •Positive skin testing
- •Positive Serum-Specific IgE determination
- •Parental or legal representative informed consent
- •Clinical sintomatology on the inclusion period
排除标准
- •Patients suffering from acute or chronic infections or inflammations
- •Patients suffering from uncontrolled and severe 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
- •Patients with previous immunotherapy with this allergen or another allergen with cross-reaction
- •Patients with immunotherapy treatment at the time of inclusion
结局指标
主要结局
Numbers of treatment-related local and systemic reactions
时间窗: 1 Year
次要结局
- IgE and IgG4 specific quantification(1 Year)
- Combined symtom and medication score of Asthma(1 Year)
- Combined symtom and medication score of Rhinoconjunctivitis(1 Year)
- Visual analogue Scale Score(1 Year)
研究者
Alfons Malet i Casajuana
Head of Allergy Service in Teknon Medical Center
Centro Medico Teknon