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

This study has been completed.
Sponsor:
Information provided by:
Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT00815126
First received: December 26, 2008
Last updated: November 17, 2010
Last verified: November 2010
  Purpose

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 Intervention
Aspirin Hypersensitivity
NSAIDs Hypersensitivity
Procedure: Lysine-ASA Nasal ProvocationTest

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Chulalongkorn University:

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 [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Correlation between clinical manifestations and laboratory results (basophil activation test, etc.) [ Time Frame: 5 months ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: November 2008
Study Completion Date: April 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   15 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00815126

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

No publications provided

Responsible Party: Jettanong Klaewsongkram, MD, Chulalongkorn University
ClinicalTrials.gov Identifier: NCT00815126     History of Changes
Other Study ID Numbers: Chula-ARC 002/08
Study First Received: December 26, 2008
Last Updated: November 17, 2010
Health Authority: Thailand: Ethical Committee

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

ClinicalTrials.gov processed this record on September 18, 2014