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NCT Number: NCT00815126

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

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.

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Key information

Conditions

Aspirin Hypersensitivity NSAIDs Hypersensitivity

Age range

15 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, Chulalongkorn University

Bangkok, 10330, Thailand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lysine-ASA Nasal ProvocationTest

Procedure

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

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

    Time frame: 5 months

Secondary outcomes

  1. Correlation between clinical manifestations and laboratory results (basophil activation test, etc.)

    Time frame: 5 months

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Dec 29, 2008
Registry last updated
Nov 18, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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