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临床试验/NCT02884583
NCT02884583Unknown不适用

Association Between Asthma and Food Allergy in Children and Adults

University Hospital, Montpellier2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2016年4月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
200
试验地点
2
主要终点
Number of patient with bronchospasm in OFC

研究概览

简要总结

Prevalences of food allergies and asthma increased in the population during the last decades. These two pathologies, responsible for a real burden, are often associated and are to be considered as comorbidities; this aspect is more and more studied in the literature and many authors tried to find a link between diets and asthma. The narrow link between these two atopic pathologies and the fact that food allergy can come along with respiratory symptoms also in patients without history of asthma must be better understood, considered into the management of food allergy. The main objective of this study is to study the prevalence of signs and/or symptoms suggestive of bronchial hyperreactivity, during an oral food challenge (OFC) in patients older than 5 years. The secondary objective is to study the risk factors to develop asthma during a food allergy reaction.

This historical-prospective single center study , was realized in the Allergy Unit of the University Hospital of Montpellier. All the patients having been hospitalized for a positive OFC between January, 2001 and January, 2016 were included. The diagnosis of asthma was established according to the recommended international clinical and physiological criteria. Prevalence of bronchial hyperreactivity during OFC among those with positive OFC, was calculated. The search for risk factors was made by a logistic regression univariate then multivariate, completed by a decision tree.

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
5 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient hospitalized for oral food challenge at the hospital

排除标准

  • Patient want to leave the protocol
  • Patient take medication forbidden during the study

研究组 & 干预措施

Pulmonary function test

Experimental

Patients hospitalized for Oral Food Challenge realize pulmonary function test

干预措施: Pulmonary function test (Other)

结局指标

主要结局

Number of patient with bronchospasm in OFC

时间窗: up to 3 hours

次要结局

  • Questionnaire for the assessment of the responsible food of allergy(up to 3 hours)
  • the eliciting dose(up to 3 hours)
  • The grade of the allergic reaction shown during the last food ingestion of the concerned food(up to 3 hours)
  • The presence of one or several sensitisations associated with respiratory allergens(up to 3 hours)
  • The level of specific immunoglobulin E of the concerned food(up to 3 hours)
  • The time of appearance of the first signs of atopy(up to 3 hours)
  • questionnaire for the assessment of the mode of clinical expression of food allergies(up to 3 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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