Challenge Test for Acetylsalicylic Acid Hypersensitivity
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Inspiratory nasal flow measured by Rhinomanometry
研究概览
简要总结
The investigators want to find new challenge test for Acetylsalicylic hypersensitivity / Aspirin hypersensitivity. The investigators suggest that this new test will be as efficient as the already established protocols in terms of sensitivity and specificity.
详细描述
Hypersensitivity to Acetylsalicylic Acid or Aspirin (and other NSAIDS) is a condition that affects up to 2,5% of the population. Most cases are seen in a complex of such hypersensitivity with chronic eosinophilic rhinosinusitis with nasal polyposis and asthma. Despite research in finding a reliable in-vitro-test for the condition, challenge tests are still considered gold standard. So far oral, nasal, inhalation and intravenous routes of administration has been described in literature.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persons between 18 and 60 years of age
- •Suspected Acetylsalicylic Acid Hypersensitivity
排除标准
- •History on anaphylactic shock after NSAIDS intake
- •History on gastric ulcer after NSAIDS intake
- •Patients previously gone through testing or desensitisation for Aspirin hypersensitivity
- •Clinical unstable asthma or baseline FEV1<70%
- •Severe disease of the heart, digestive tract, liver or kidney
- •Severe chronic urticaria
- •Present conjunctivitis
- •Pregnancy
研究组 & 干预措施
Acetylsalicylate
Acetylsalicylic Acid Eyedrops
干预措施: Acetylsalicylate (Drug)
isotonic NaCl
Saline Eyedrops
干预措施: Isotonic NaCl (Drug)
结局指标
主要结局
Inspiratory nasal flow measured by Rhinomanometry
时间窗: Within 45 min from challenge
Bilateral flow reduction \>40% considered positive test.
Expiratory nasal flow measured by Rhinomanometry
时间窗: Within 45 min from challenge
Bilateral expiratory flow reduction \>40% considered positive.
Pulmonary forced expiratory volume in 1 second (FEV1)
时间窗: Within 45 min from challenge
Reduction in FEV1 \>20% is considered as positive test.
次要结局
- Conjunctival symptoms(Within 45 days from challenge)
- Nasal symptoms(Within 45 minutes from challenge)
- Bronchial and laryngeal symptoms(Within 45 minutes from challenge)