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

Aspirin Hypersensitivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00815126
• Other study ID #: Chula-ARC 002/08
• Status: Completed
• Phase: N/A
• First received: December 26, 2008
• Last updated: November 17, 2010
• Start date: November 2008
• Est. completion date: April 2009

Study information

• Verified date: November 2010
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: April 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years to 70 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Aspirin Hypersensitivity
• Hypersensitivity
• NSAIDs Hypersensitivity

Intervention

Procedure:
• Lysine-ASA Nasal ProvocationTest
Lysine-ASA 80 µl (16 mg of aspirin) will be installed in both nostrils with pipette

Locations

Country	Name	City	State
Thailand	Faculty of Medicine, Chulalongkorn University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Correlation between clinical manifestations and laboratory results (basophil activation test, etc.)		5 months	No