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

NCT ID: NCT00815126

Last Updated: 2010-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Aspirin Hypersensitivity NSAIDs Hypersensitivity

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Mucocutaneous symptoms from NSAIDs

Group Type ACTIVE_COMPARATOR

Lysine-ASA Nasal ProvocationTest

Intervention Type PROCEDURE

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

Respiratory symptoms from NSAIDs

Group Type ACTIVE_COMPARATOR

Lysine-ASA Nasal ProvocationTest

Intervention Type PROCEDURE

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

NSAIDs tolerant individuals

Group Type ACTIVE_COMPARATOR

Lysine-ASA Nasal ProvocationTest

Intervention Type PROCEDURE

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

Interventions

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Lysine-ASA Nasal ProvocationTest

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chulalongkorn University

OTHER

Sponsor Role lead

Responsible Party

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Chulalongkorn University

Principal Investigators

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Jettanong Klaewsongkram, MD

Role: PRINCIPAL_INVESTIGATOR

Chulalongkorn University

Locations

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Faculty of Medicine, Chulalongkorn University

Bangkok, , Thailand

Site Status

Countries

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Thailand

Other Identifiers

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Chula-ARC 002/08

Identifier Type: -

Identifier Source: org_study_id