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

• Sponsor: Chulalongkorn University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00815126
• Collaborator: (none)
• Enrollment: 34
• Location: 1
• Arms: 3
• Duration (Months): 5
• Patients Per Site Per Month: 6.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aspirin Hypersensitivity; NSAIDs Hypersensitivity	Procedure: Lysine-ASA Nasal ProvocationTest	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 34 participants
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• 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
• Study Start Date: Nov 1, 2008
• Actual Primary Completion Date: Mar 1, 2009
• Actual Study Completion Date: Apr 1, 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine, Chulalongkorn University	Bangkok		Thailand	10330

Sponsors and Collaborators

• Chulalongkorn University

Investigators

• Principal Investigator: Jettanong Klaewsongkram, MD, Chulalongkorn University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00815126
• Other Study ID Numbers: Chula-ARC 002/08
• First Posted: Dec 29, 2008
• Last Update Posted: Nov 18, 2010
• Last Verified: Nov 1, 2010

• Additional relevant MeSH terms: Hypersensitivity

Study Results

No Results Posted as of Nov 18, 2010