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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00815126

Enrollment

Registered

2008-12-29

Start date

2008-11-30

Completion date

2009-04-30

Last updated

2010-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aspirin Hypersensitivity, NSAIDs Hypersensitivity

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.

Interventions

PROCEDURELysine-ASA Nasal ProvocationTest

Lysine-ASA 80 µl (16 mg of aspirin) will be installed in both nostrils with pipette

Study design

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

15 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Correlation between clinical manifestations and laboratory results (basophil activation test, etc.)	5 months

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026