Clinical Trial: Challenge Test for Acetylsalicylic Acid Hypersensitivity

Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Challenge Test for Acetylsalicylic Acid Hypersensitivity

Brief Summary: The investigators want to find new challenge test for Acetylsalicylic hypersensitivity / Aspirin hypersensitivity. The investigators suggest that this new test will be as efficient as the already established protocols in terms of sensitivity and specificity.

Detailed Summary: Hypersensitivity to Acetylsalicylic Acid or Aspirin (and other NSAIDS) is a condition that affects up to 2,5% of the population. Most cases are seen in a complex of such hypersensitivity with chronic eosinophilic rhinosinusitis with nasal polyposis and asthma. Despite research in finding a reliable in-vitro-test for the condition, challenge tests are still considered gold standard. So far oral, nasal, inhalation and intravenous routes of administration has been described in literature.
Sponsor: Helse Stavanger HF

Current Primary Outcome:

  • Inspiratory nasal flow measured by Rhinomanometry [ Time Frame: Within 45 min from challenge ]
    Bilateral flow reduction >40% considered positive test.
  • Expiratory nasal flow measured by Rhinomanometry [ Time Frame: Within 45 min from challenge ]
    Bilateral expiratory flow reduction >40% considered positive.
  • Pulmonary forced expiratory volume in 1 second (FEV1) [ Time Frame: Within 45 min from challenge ]
    Reduction in FEV1 >20% is considered as positive test.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Conjunctival symptoms [ Time Frame: Within 45 days from challenge ]

    0=no symptoms, 1=limited redness and / or itching, 2=conjunctival redness and /or itching / swelling or bullae within 5 minutes from testing.

    Value 1 and 2 is considered positive if unilateral.

  • Nasal symptoms [ Time Frame: Within 45 minutes from challenge ]
    Rhinorrhea, congestion and sneezing is considered as positive test.
  • Bronchial and laryngeal symptoms [ Time Frame: Within 45 minutes from challenge ]
    Bronchospasm. tight chest, wheezing or laryngospasm is considered as positive test.


Original Secondary Outcome: Same as current

Information By: Helse Stavanger HF

Dates:
Date Received: August 9, 2012
Date Started: September 2012
Date Completion: December 2013
Last Updated: September 12, 2012
Last Verified: September 2012