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

Not Applicable

Completed

• Conditions: Aspirin Hypersensitivity; NSAIDs Hypersensitivity
• Interventions: Procedure: Lysine-ASA Nasal ProvocationTest

• Registration Number: NCT00815126
• Lead Sponsor: Chulalongkorn University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-12-26
• Study First Submitted QC: 2008-12-26
• Study First Posted: 2008-12-29
• Primary Completion: 2009-03
• Study Completion: 2009-04
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-17
• Last Update Posted: 2010-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mucocutaneous symptoms from NSAIDs	Lysine-ASA Nasal ProvocationTest	-
Respiratory symptoms from NSAIDs	Lysine-ASA Nasal ProvocationTest	-
NSAIDs tolerant individuals	Lysine-ASA Nasal ProvocationTest	-

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Faculty of Medicine, Chulalongkorn University; 🇹🇭 Bangkok, Thailand