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临床试验/NCT05621356
NCT05621356招募中不适用

Monitoring Allergen Immunotherapy in Allergic Rhinitis; is Nasal Fluid the Way to Precision Medicine?

Rijnstate Hospital1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2022年10月25日最近更新:
适应症

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

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)

研究者

发起方
Rijnstate Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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