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