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

Primary Purpose

Aspirin Hypersensitivity, NSAIDs Hypersensitivity

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Lysine-ASA Nasal ProvocationTest
Sponsored by
Chulalongkorn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Aspirin Hypersensitivity

Eligibility Criteria

15 Years - 70 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Faculty of Medicine, Chulalongkorn University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Mucocutaneous symptoms from NSAIDs

Respiratory symptoms from NSAIDs

NSAIDs tolerant individuals

Arm Description

Outcomes

Primary Outcome Measures

Symptom scores and/or acoustic rhinometry result upon Lysine-ASA nasal provocation test in patients with history of mucocutaneous or respiratory symptoms from NSAIDs

Secondary Outcome Measures

Correlation between clinical manifestations and laboratory results (basophil activation test, etc.)

Full Information

First Posted
December 26, 2008
Last Updated
November 17, 2010
Sponsor
Chulalongkorn University
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1. Study Identification

Unique Protocol Identification Number
NCT00815126
Brief Title
Nasal Provocation Test With Lysine-Acetylsalicylate (ASA) in Patients With Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Hypersensitivity
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 Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Chulalongkorn University

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aspirin Hypersensitivity, NSAIDs Hypersensitivity

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mucocutaneous symptoms from NSAIDs
Arm Type
Active Comparator
Arm Title
Respiratory symptoms from NSAIDs
Arm Type
Active Comparator
Arm Title
NSAIDs tolerant individuals
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Lysine-ASA Nasal ProvocationTest
Intervention Description
Lysine-ASA 80 µl (16 mg of aspirin) will be installed in both nostrils with pipette
Primary Outcome Measure Information:
Title
Symptom scores and/or acoustic rhinometry result upon Lysine-ASA nasal provocation test in patients with history of mucocutaneous or respiratory symptoms from NSAIDs
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Correlation between clinical manifestations and laboratory results (basophil activation test, etc.)
Time Frame
5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jettanong Klaewsongkram, MD
Organizational Affiliation
Chulalongkorn University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine, Chulalongkorn University
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand

12. IPD Sharing Statement

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

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