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

Sponsor:	Chulalongkorn University
Information provided by:	Chulalongkorn University
ClinicalTrials.gov Identifier:	NCT00815126

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:

MedlinePlus related topics: Allergy

Drug Information available for: Acetylsalicylic acid Lysine Lysine acetate Aspirin DL-lysine Lysine hydrochloride

U.S. FDA Resources

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

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 February 09, 2012