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临床试验/NCT05807958
NCT05807958已完成不适用

Validation of the Benefit of Allergy Testing of Soldiers Prepared for International Mission with Specific Allergen Panels

Queen Astrid Military Hospital2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2023年3月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
160
试验地点
2
主要终点
Allergens with positive skin reaction

研究概览

简要总结

The goal of this prospective mono centric study is to identify relevant commercially available allergen extracts for allergy testing in soldiers prepared for international mission.

Participants will receive a skin prick test with the skin prick automated test device including 22 allergens and 2 controls on both forearms.

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

入选标准

  • Adult military personnel (18-65y) will be included. Soldiers with and without previous exposure to allergens in the regions of interest will be included. Soldiers who are performing desk tasks and not selected for international missions will serve as controls.

排除标准

  • Skin pathology like chronic or exuberant urticaria, dermographism, chronic dermatitis that needs daily treatment
  • Use of antihistaminic medication < 7 days before the start of the study
  • Use of tricyclic antidepressants (antihistamine activity) < 7 days before the start of the study
  • Use of topical corticoids on the forearm < 7 days before the start of the study
  • Use of Omalizumab < 6 months before the start of the study
  • Pregnancy: there is a remote possibility of inducing a systemic allergic reaction that could induce uterine contractions or necessitate the use of epinephrine (thought to cause constriction of the umbilical artery).

结局指标

主要结局

Allergens with positive skin reaction

时间窗: baseline

Positive skin reactions of top ranked allergens required to identify 95% of sensitised individuals

次要结局

  • Work Performance & Activity Impairment(baseline)
  • Self-reported allergic diseases(baseline)

研究者

发起方
Queen Astrid Military Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ilan Baron

Medical doctor

Queen Astrid Military Hospital

研究点 (2)

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