NCT01728298已完成2 期
A Dose Response Evaluation of SLITone Ultra HDM Mix Immunotherapy - The SUMMIT Trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 219
- 试验地点
- 2
- 主要终点
- Change from baseline in IgE-blocking factor after 6 months of treatment
研究概览
简要总结
The primary objective of the trial is to evaluate the dose-response relationship with regards to change in immunological parameters and safety for SLITone ULTRA house dust mite mix in adult subjects with moderate to severe HDM allergic rhinitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 or older
- •Moderate to severe persistent HDM allergic rhinitis with or without asthma
- •Moderate to severe HDM allergic rhinitis symptoms during a baseline period
- •Positive skin prick test response (wheal diameter ≥ 3 mm)
- •Positive specific IgE ≥ IgE Class 2, ≥ 0.70 kU/l)
排除标准
- •Previous treatment with immunotherapy with House dust mite immunotherapy
- •Ongoing treatment with any allergen specific immunotherapy product
- •Reduced lung function
- •Clinical history of uncontrolled asthma
- •Inflammatory conditions in the oral cavity with severe symptoms
- •History of anaphylaxis with cardiorespiratory symptoms
- •History of recurrent generalised urticaria
- •A history of drug induced facial angioedema or hereditary angiooedema
- •Any clinically relevant chronic disease (≥3 months duration)
- •Systemic disease affecting the immune system
- •Immunosuppressive treatment
- •Currently treated with tricyclic antidepressants; catecholamine-Methyltransferase inhibitors and mono amine oxidase inhibitors
结局指标
主要结局
Change from baseline in IgE-blocking factor after 6 months of treatment
时间窗: 6 months
次要结局
- Number of subjects with treatment related adverse events(6 months)
研究者
研究点 (2)
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