Correlation of the in Vivo Food Provocation Test With the in Vitro Basophile Activation Test in Hazelnut Allergic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 2
- 主要终点
- Number of patients with challenge confirmed food allergy to hazelnut and a positive basophile activation test
研究概览
简要总结
The proposed study intends to compare the outcome of food challenge in hazelnut allergic patients with the outcome of basophile activation tests using hazelnut extract and components.
详细描述
Accurate diagnosis of food allergy depends on food challenge outcome. The proposed study intends to compare the outcome of food challenge in hazelnut allergic patients with the outcome of basophile activation tests using hazelnut extract and components to evaluate the diagnostic utility of basophile activation testing.
With a view towards improved in vitro diagnostic methods, the investigators intend to evaluate the diagnostic potential of basophile activation testing in patients with hazelnut allergy confirmed by a positive provocation or supported by a convincing history of anaphylactic reaction(s) to hazelnut in the past, patients with pollinosis but no symptoms of hazelnut allergy and non-atopic control subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
In terms of study inclusion there will be no masking. Only the food challenge itself will be masked.
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Primary Inclusion criteria:
- •Male and female subjects, age ≥ 14 years
- •Informed Consent as documented by signature
- •Secondary inclusion criterion
- •Group A: positive case history of allergic reaction(s) to hazelnut positive double-blind placebo-controlled food challenge with hazelnut or positive titrated open food challenge with hazelnut or unambiguous case history of an anaphylactic reaction after hazelnut will be included without provocation
- •Group B:positive skin test (SPT) with birch pollen and hazelnut and negative food provocation with hazelnut.
- •Group C: negative case history of hazelnut and birch allergy and negative skin test (SPT) with hazelnut and birch pollen and negative food provocation with hazelnut
排除标准
- •Drugs not allowed due to interference with the food challenge (or shortest interval between last treatment and food challenge): corticosteroids systemically (2 weeks), antihistamines (3 days), beta blocker (1 day), angiotensin converting enzyme (ACE) inhibitors (2 days), omalizumab (2 months)
- •Women who are pregnant
- •Lack of safe contraception
- •Uncontrolled asthma, forced expiratory volume (1 second) <70% predicted value
- •Acute allergic disease
- •Chronic urticaria
- •Mastocytosis
- •Other clinically significant concomitant disease states
- •Known or suspected non-compliance, drug or alcohol abuse,
- •Inability to follow the procedures of the study
- •Participation in another study with investigational drug within the 30 days preceding and during the present study
结局指标
主要结局
Number of patients with challenge confirmed food allergy to hazelnut and a positive basophile activation test
时间窗: up to 3 years
outcome of food challenge in hazelnut allergic patients will be compared to the outcome of basophile activation using hazelnut extract and allergens
次要结局
未报告次要终点