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:	Diagnostic, Open Label, Active Control, Parallel Assignment, Efficacy Study
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
Mucocutaneous symptoms from NSAIDs: Active Comparator	Procedure: Lysine-ASA Nasal ProvocationTest Lysine-ASA 80 µl (16 mg of aspirin) will be installed in both nostrils with pipette
Respiratory symptoms from NSAIDs: Active Comparator	Procedure: Lysine-ASA Nasal ProvocationTest Lysine-ASA 80 µl (16 mg of aspirin) will be installed in both nostrils with pipette
NSAIDs tolerant individuals: Active Comparator	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 65 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:	Chulalongkorn University ( Jettanong Klaewsongkram, MD )
Study ID Numbers:	Chula-ARC 002/08
Study First Received:	December 26, 2008
Last Updated:	September 24, 2009
ClinicalTrials.gov Identifier:	NCT00815126 History of Changes
Health Authority:	Thailand: Ethical Committee

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Cyclooxygenase Inhibitors
Hematologic Agents
Physiological Effects of Drugs
Fibrinolytic Agents
Enzyme Inhibitors
Cardiovascular Agents
Acetylsalicylic acid lysinate
Pharmacologic Actions
Fibrin Modulating Agents

Hypersensitivity
Aspirin
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Platelet Aggregation Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010