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临床试验/NCT00815126
NCT00815126已完成不适用

Association Between Nasal Provocation Test With Lysine-Acetylsalicylate(ASA) and Clinical Diagnosis in Patients With Aspirin/Nonsteroidal Anti-Inflammatory Drugs(NSAIDs) and/or Acetaminophen Immediate Sensitivity Reactions

Chulalongkorn University2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2008年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
2
主要终点
Symptom scores and/or acoustic rhinometry result upon Lysine-ASA nasal provocation test in patients with history of mucocutaneous or respiratory symptoms from NSAIDs

研究概览

简要总结

This study aims to compare the efficacy of nasal provocation test with Lysine-Acetylsalicylate in patients with history of NSAIDs hypersensitivity between mucocutaneous symptoms and respiratory symptoms and laboratory outcomes.

研究设计

研究类型
Interventional
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
15 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with history of ASA/NSAIDs hypersensitivity with mucocutaneous symptoms and/or respiratory symptoms

排除标准

  • Patients who cannot discontinue drugs before the test as follow
  • Nasal corticosteroids/Oral corticosteroids/Leukotriene modifiers for 1 week
  • Short-acting antihistamines for 3 days
  • Nasal a-mimetics/Oral a-mimetics/Local cromones for 24 hours
  • Contraindicated for nasal provocation test: pregnant, exacerbation of allergic rhinitis/asthma, having upper respiratory tract infection within 2 weeks prior to the test, having nose surgery within 8 weeks prior to the test, having severe systemic disease(s)
  • Having factors interfere nasal provocation test with Lysine-ASA such as massive nasal polyp, nasal septal perforation, total nasal obstruction at least 1 nostril

结局指标

主要结局

Symptom scores and/or acoustic rhinometry result upon Lysine-ASA nasal provocation test in patients with history of mucocutaneous or respiratory symptoms from NSAIDs

时间窗: 5 months

次要结局

  • Correlation between clinical manifestations and laboratory results (basophil activation test, etc.)(5 months)

研究者

申办方类型
Other

研究点 (2)

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