NCT02159833已完成不适用
Phase 1/2 Study to Determine the Intranasal Allergen Threshold to Food Proteins in Children With Food Allergy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Physiological response to intranasal challenge with a food protein
研究概览
简要总结
The investigators will conduct low-dose intranasal allergen challenges on children/adolescents with a diagnosis of food allergy to egg/cow's milk/soya/wheat/peanut. The data will be used to determine the safety and potential utility of intranasal food challenges in the diagnosis of food allergy.
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
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 6 - 17 years old
- •Physician-diagnosis of food allergy on the basis of:
- •Positive oral food challenge to the causative food (conducted under medical supervision) within the last 12 months; OR
- •History of convincing clinical reaction to the causative food within the last 12 months AND positive skin prick test within last 12 months; OR
- •Evidence of >95% likelihood of food allergy (on the basis of serum specific IgE or skin prick test (SPT) 8mm or above to the causative food allergen within past 12 months
- •Written informed consent from parent/guardian, with assent from children aged 8 years and above wherever possible. Participants aged over 16 years will need to provide their owned informed consent.
排除标准
- •Contraindicated as acutely unwell or current unstable asthma:
- •Acute wheeze in last 72 hours requiring treatment
- •Febrile ≥38.0oC in last 72 hours
- •Recent admission to hospital in last 2 weeks for acute asthma
- •Current medication
- •Use of asthma reliever medication in last 72 hours
- •Recent administration of a medication containing antihistamine within the last 4 days
- •Current oral steroid for asthma exacerbation or course completed within last 2 weeks
结局指标
主要结局
Physiological response to intranasal challenge with a food protein
时间窗: 20mins
The physiological response to food (egg/cow's milk/soya/wheat/peanut) protein when administered into the human nasal airway in food-allergic children with the corresponding food allergy. This will be assessed objectively (using acoustic rhinometry and peak nasal inspiratory flow) as well as subjectively (using a validated Symptom Scoring questionnaire).
次要结局
- Intranasal threshold to food protein(20 mins)
研究者
研究点 (2)
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