A Prospective, Open, Multi-centre, Non-interventional Study to Assess the Tolerability, the Safety Profile and the Adherence of Different Up-dosing Schemes for a Sublingual Immunotherapy Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- Incidence of treatment-emergent adverse events (Safety and Tolerability)
研究概览
简要总结
This prospective open multi-centre non-interventional study initiated to document the up-dosing period of children and adults with allergic rhinoconjunctivitis and/or allergic asthma treated with a SLIT containing purified, aqueous extracts of birch, alder, and hazel pollen. The following up-dosing schemes are freely selectable: scheme A consists of an up-dosing period of 12 days at the patient´s home using the standardized pollen extract in three different solution strengths to reach the maximum dose; scheme B is performed only with the highest solution strength at the physician's office within 2 hours; and the new scheme C which is a regimen for initiation at the physician's office and continuation at the patient's home also exclusively using the highest solution strength and takes 4 days. Data are documented by physicians and in patients´ diaries.
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
- 2 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 2 years and older suffering from a tree pollen induced seasonal 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
ORALVAC COMPACT BÄUME
This non-interventional study was initiated to document the up-dosing period of children and adults with allergic rhinoconjunctivitis and/or allergic asthma treated with a SLIT containing purified, aqueous extracts of birch, alder, and hazel pollen. The following up-dosing schemes were freely selectable: scheme A consists of an up-dosing period of 12 days at the patient´s home using the standardized pollen extract in three different solution strengths to reach the maximum dose; scheme B performed only with the highest solution strength at the physician's office within 2 hours; and the new scheme C which is a regimen for initiation at the physician's office and continuation at the patient's home also exclusively using the highest solution strength and takes 4 days.
干预措施: ORALVAC COMPACT BÄUME (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events (Safety and Tolerability)
时间窗: up to 12 days of the up-dosing phase
Tolerability and safety will be assessed by the frequency and intensity of local reactions (mouth, lips, pharynx/throat, gastrointestinal tract) and systemic reactions (skin, airways, others) during the up-dosing phase.
Improvement of rhinoconjunctivitis symptoms and intake of rescue medication (efficacy)
时间窗: through study completion, tree pollen season 2017
Efficacy will be assessed by the improvement of rhinoconjunctivitis symptoms and intake of rescue medication during the tree pollen season 2017
次要结局
- Evaluation of tolerability and safety(up to 12 days of the up-dosing phase)
研究者
Prof. Dr. Ralph Mösges
Prof. Dr. med. Ralph Mösges
University Hospital of Cologne