NCT02069535已完成2 期
An Open Trial to Assess the Tolerability of AVANZ® Cupressus Immunotherapy
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Frequency of patients with IMP-related AEs
研究概览
简要总结
This trial is an open, national, multi-centre trial. The main objective of this trial is to assess the tolerability of the up-dosing phase of AVANZ® Cupressus arizonica by measurement of related Adverse Events.
详细描述
The main objective of this trial is to assess the tolerability of the up-dosing phase of AVANZ® Cupressus arizonica, the measurement rate is the frequency of patients with investigational medicinal product (IMP)-related adverse events (AEs) will be the primary endpoint.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A documented clinically relevant history of Cupressus arizonica pollen induced allergic rhinoconjunctivitis with or without asthma for at least one year prior to trial entry.
- •Positive Skin Prick Test (SPT) response to Cupressus arizonica pollen (wheal diameter ≥ 3 mm)
排除标准
- •History of severe asthma exacerbation or emergency room visit or admission for asthma in the previous 12 months.
- •Previous treatment with immunotherapy with Cupressus arizonica pollen extract within the last 5 years (initiation of subcutaneous immunotherapy is acceptable if treatment has been discontinued before reaching maintenance dose; for SLIT 3 months in the last 5 years is accepted).
- •Ongoing treatment with any allergen-specific immunotherapy product.
- •A history of anaphylaxis with cardiorespiratory symptoms (immunotherapy, exercise-induced, food allergy, drugs or an idiopathic reaction).
- •A systemic disease affecting the immune system (e.g. insulin-dependent diabetes, autoimmune disease, immune complex disease, or immune deficiency disease whether acquired or not).
结局指标
主要结局
Frequency of patients with IMP-related AEs
时间窗: 6 treatment weeks
次要结局
- Frequency of patients with systemic reactions(6 weeks of treatment)
研究者
研究点 (1)
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