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
1 other identifier
interventional
34
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2008
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 26, 2008
CompletedFirst Posted
Study publicly available on registry
December 29, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedNovember 18, 2010
November 1, 2010
4 months
December 26, 2008
November 17, 2010
Conditions
Outcome Measures
Primary Outcomes (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
5 months
Secondary Outcomes (1)
Correlation between clinical manifestations and laboratory results (basophil activation test, etc.)
5 months
Study Arms (3)
Mucocutaneous symptoms from NSAIDs
ACTIVE COMPARATORRespiratory symptoms from NSAIDs
ACTIVE COMPARATORNSAIDs tolerant individuals
ACTIVE COMPARATORInterventions
Lysine-ASA 80 µl (16 mg of aspirin) will be installed in both nostrils with pipette
Eligibility Criteria
You may qualify if:
- Patients with history of ASA/NSAIDs hypersensitivity with mucocutaneous symptoms and/or respiratory symptoms
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Medicine, Chulalongkorn University
Bangkok, 10330, Thailand
Study Officials
- PRINCIPAL INVESTIGATOR
Jettanong Klaewsongkram, MD
Chulalongkorn University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 26, 2008
First Posted
December 29, 2008
Study Start
November 1, 2008
Primary Completion
March 1, 2009
Study Completion
April 1, 2009
Last Updated
November 18, 2010
Record last verified: 2010-11