Nasal Provocation Test With Lysine-Acetylsalicylate (ASA) in Patients With Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Hypersensitivity

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Aspirin Hypersensitivity, NSAIDs Hypersensitivity

Intervention / Treatment
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* Procedure: Lysine-ASA Nasal ProvocationTest


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with history of ASA/NSAIDs hypersensitivity with mucocutaneous symptoms and/or respiratory symptoms Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mucocutaneous symptoms from NSAIDs<br> | Procedure: Lysine-ASA Nasal ProvocationTest<br>* Lysine-ASA 80 µl (16 mg of aspirin) will be installed in both nostrils with pipette<br>|
| Active Comparator: Respiratory symptoms from NSAIDs<br> | Procedure: Lysine-ASA Nasal ProvocationTest<br>* Lysine-ASA 80 µl (16 mg of aspirin) will be installed in both nostrils with pipette<br>|
| Active Comparator: NSAIDs tolerant individuals<br> | Procedure: Lysine-ASA Nasal ProvocationTest<br>* Lysine-ASA 80 µl (16 mg of aspirin) will be installed in both nostrils with pipette<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom scores and/or acoustic rhinometry result upon Lysine-ASA nasal provocation test in patients with history of mucocutaneous or respiratory symptoms from NSAIDs |  | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between clinical manifestations and laboratory results (basophil activation test, etc.) |  | 5 months |