ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00815126
Recruitment Status : Completed
First Posted : December 29, 2008
Last Update Posted : November 18, 2010
Sponsor:
Information provided by:
Chulalongkorn University

December 26, 2008
December 29, 2008
November 18, 2010
November 2008
March 2009   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00815126 on ClinicalTrials.gov Archive Site
Correlation between clinical manifestations and laboratory results (basophil activation test, etc.) [ Time Frame: 5 months ]
Same as current
Not Provided
Not Provided
 
Nasal Provocation Test With Lysine-Acetylsalicylate (ASA) in Patients With Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Hypersensitivity
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
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.
Not Provided
Interventional
Not Applicable
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
  • Aspirin Hypersensitivity
  • NSAIDs Hypersensitivity
Procedure: Lysine-ASA Nasal ProvocationTest
Lysine-ASA 80 µl (16 mg of aspirin) will be installed in both nostrils with pipette
  • Active Comparator: Mucocutaneous symptoms from NSAIDs
    Intervention: Procedure: Lysine-ASA Nasal ProvocationTest
  • Active Comparator: Respiratory symptoms from NSAIDs
    Intervention: Procedure: Lysine-ASA Nasal ProvocationTest
  • Active Comparator: NSAIDs tolerant individuals
    Intervention: Procedure: Lysine-ASA Nasal ProvocationTest
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
30
April 2009
March 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
15 Years to 70 Years   (Child, Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Thailand
 
 
NCT00815126
Chula-ARC 002/08
No
Not Provided
Not Provided
Jettanong Klaewsongkram, MD, Chulalongkorn University
Chulalongkorn University
Not Provided
Principal Investigator: Jettanong Klaewsongkram, MD Chulalongkorn University
Chulalongkorn University
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP