Monitoring Allergen Immunotherapy in Allergic Rhinitis; is Nasal Fluid the Way to Precision Medicine?
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- BAT outcome serum
研究概览
简要总结
Allergic rhinitis (hay fever) can be treated successfully with allergen-specific immunotherapy (AIT) for 3-5 years. This relative expensive and prolonged treatment is not suitable for everyone and therefore it is important to predict who will benefit from this therapy early after the start of treatment.
This project will investigate whether a BAT with nasal fluid can detect inhibition during immunotherapy in comparison with a BAT with blood.
详细描述
Allergic rhinitis (hay fever) can be treated successfully with allergen-specific immunotherapy (AIT) for 3-5 years. This relative expensive and prolonged treatment is not suitable for everyone and therefore it is important to predict who will benefit from this therapy early after the start of treatment. Biomarkers, like Basophil Activation Test (BAT) and IgE-facilitated allergen binding (FAB), using nasal fluid instead of blood, probably better reflect therapy effect (inhibition of an IgE-mediated allergic reaction) as the nose is the main target organ for AIT in allergic rhinitis.
This project will investigate whether a BAT with nasal fluid can detect inhibition during immunotherapy in comparison with a BAT with blood. Nasal fluid and blood samples are collected at baseline and after 8 and 16 weeks of treatment. A nasal fluid inhibition BAT is developed and validated by comparison with a BAT using serum and an IgE-FAB assay.
15 adults with birch pollen allergy, who are treated with AIT (Itulazax birch pollen tablet) and 10 adults with birch pollen allergy, who are treated with immunosuppressive medication (control group) will be included in the study.
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
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IgE-sensitized birch pollen allergy
- •Start of Itulazax therapy or immunosuppressive therapy (nasal corticosteroid and/or antihistamine eye drops)
- •Signed informed consent
排除标准
- •Other underlying chronic conditions (immunological (autoimmune or immunodeficiency), oncological)
- •Unstable uncontrolled asthma
结局指标
主要结局
BAT outcome serum
时间窗: 16 weeks
BAT outcome nasal fluid
时间窗: 16 weeks
次要结局
- IgG4/IgA-associated inhibitory activity in serum(16 weeks)
- IgG4/IgA-associated inhibitory activity in nasal fluid(16 weeks)
