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

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ClinicalTrials.gov Identifier: NCT00815126
Recruitment Status : Completed
First Posted : December 29, 2008
Last Update Posted : November 18, 2010
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Aspirin Hypersensitivity NSAIDs Hypersensitivity Procedure: Lysine-ASA Nasal ProvocationTest Not Applicable

Study Type : Interventional  (Clinical Trial)
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 : November 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

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




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 [ Time Frame: 5 months ]

Secondary Outcome Measures :
  1. Correlation between clinical manifestations and laboratory results (basophil activation test, etc.) [ Time Frame: 5 months ]


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Ages Eligible for Study:   15 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00815126


Locations
Thailand
Faculty of Medicine, Chulalongkorn University
Bangkok, Thailand, 10330
Sponsors and Collaborators
Chulalongkorn University
Investigators
Principal Investigator: Jettanong Klaewsongkram, MD Chulalongkorn University

Responsible Party: Jettanong Klaewsongkram, MD, Chulalongkorn University
ClinicalTrials.gov Identifier: NCT00815126     History of Changes
Other Study ID Numbers: Chula-ARC 002/08
First Posted: December 29, 2008    Key Record Dates
Last Update Posted: November 18, 2010
Last Verified: November 2010

Additional relevant MeSH terms:
Hypersensitivity
Immune System Diseases
Acetylsalicylic acid lysinate
Anti-Inflammatory Agents
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Fibrinolytic Agents
Fibrin Modulating Agents
Antipyretics