A Prospective, Open, Non-interventional Study to Assess the Tolerability and the Safety Profile of SCIT Therapy With Acarovac® Hausstaubmilbe in Patients With HDM-induced Rhinoconjunctivitis With or Without Allergic Asthma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Numbers of treatment-related local and systemic reactions following SCIT administration
研究概览
简要总结
Non-interventional Study to Assess the Tolerability and the Safety Profile of SCIT therapy With Acarovac® Hausstaubmilbe
详细描述
This prospective open multi-centre non-interventional study was initiated to document the tolerability and the safety profile of the subcutaneous allergen-specific immunotherapy with Acarovac® in house dust mite allergic patients in routine medical care.
During the up-dosing phase with Acarovac®, patients will receive 4 injections in 1-2 week intervals with increasing allergen amount up to the individual maximum tolerable dose. After reaching the individual maximum tolerable dose patients will receive one maintenance dose in a 4 - 8 week interval.
Data on tolerability are documented by the physicians.
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 house dust mite induced allergic rhinitis
排除标准
- •Patients suffering from acute or chronic infections or inflammations
- •Patients suffering from secondary modifications of the target organ with function impairment (emphysema, bronchiectasis)
- •Patients suffering from severe and uncontrolled asthma
- •Patients with a known severe autoimmune disease
- •Patients with active malignant disease
- •Patients requiring beta-blockers
- •Patients having any contraindication for the use of adrenaline
- •Patients with a hypersensitivity to the excipients of the drug
研究组 & 干预措施
Acarovac Hausstaubmilbe
This prospective open multi-centre non-interventional study was initiated to document the tolerability and the safety profile of the subcutaneous allergen-specific immunotherapy with Acarovac in house dust mite allergic patients (children and adults) in routine medical care.
During the up-dosing phase with Acarovac, patients will receive 4 injections in 1-2 week intervals with increasing allergen amount up to the individual maximum tolerable dose. After reaching the individual maximum tolerable dose patients will receive one maintenance dose in a 4 - 8 week interval.
Data on tolerability are documented by the physicians.
干预措施: Acarovac (Drug)
结局指标
主要结局
Numbers of treatment-related local and systemic reactions following SCIT administration
时间窗: over the overall duration of the study
Tolerability and safety will be assessed by the frequency and intensity of local reactions at the injection site (wheal size 5-10 cm, \> 10 cm ) and systemic reactions (skin, airways, others) through study completion. The study covers the four injections of the up-dosing phase and one injection of the maintenance phase of the immunotherapy course.
次要结局
- Safety and Tolerability - local reactions at injection site(over the overall duration of the study)
- Safety and Tolerability - frequency and intensity of adverse events(over the overall duration of the study)
- Safety and Tolerability - Number of systemic reactions(over the overall duration of the study)
- Changes in rhinoconjunctivitis score(baseline and 3-6 month, depending on the intervals between the injections and the applied up-dosing scheme)
研究者
Prof. Dr. Ralph Mösges
Prof. Dr. med. Ralph Mösges
University Hospital of Cologne