Challenge Test for Acetylsalicylic Acid Hypersensitivity
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.
ASA Intolerant Asthma
Asthma, Nasal Polyps, and Aspirin Intolerance
Drug: Isotonic NaCl
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
|Official Title:||Challenge Test for Acetylsalicylic Acid Hypersensitivity|
- Inspiratory nasal flow measured by Rhinomanometry [ Time Frame: Within 45 min from challenge ] [ Designated as safety issue: No ]Bilateral flow reduction >40% considered positive test.
- Expiratory nasal flow measured by Rhinomanometry [ Time Frame: Within 45 min from challenge ] [ Designated as safety issue: No ]Bilateral expiratory flow reduction >40% considered positive.
- Pulmonary forced expiratory volume in 1 second (FEV1) [ Time Frame: Within 45 min from challenge ] [ Designated as safety issue: No ]Reduction in FEV1 >20% is considered as positive test.
- Conjunctival symptoms [ Time Frame: Within 45 days from challenge ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]Rhinorrhea, congestion and sneezing is considered as positive test.
- Bronchial and laryngeal symptoms [ Time Frame: Within 45 minutes from challenge ] [ Designated as safety issue: Yes ]Bronchospasm. tight chest, wheezing or laryngospasm is considered as positive test.
- Other significant and relevant symptoms [ Time Frame: Within 45 days after challenge ] [ Designated as safety issue: Yes ]Erythema in upper body or face, nausea or abdominal pain is considered as positive test.
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Acetylsalicylate
Acetylsalicylic Acid Eyedrops
Placebo Comparator: isotonic NaCl
Drug: Isotonic NaCl
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01681615
|Contact: Gregor Bachmann-Harlidstad, MD, PhD||0047 02900 (central)||Gregor.Bachmann-Harlidstad2@ahus.no|
|Contact: Jörg Törpel, MD||0047 05151 (central)||jörg.törpel@sus.no|
|Akershus University Hospital||Not yet recruiting|
|Lørenskog, Akershus, Norway, 1478|
|Contact: Gregor Bachmann-Harlidstad, MD, PhD 0047 02900 (central) firstname.lastname@example.org|
|Contact: Mohammad Sohrabi, MD 0047 02900 (central) email@example.com|
|Principal Investigator: Gregor Bachmann-Harildstad, MD, PhD|
|Sub-Investigator: Mohammad Sohrabi, MD|
|Stavanger University Hospital||Not yet recruiting|
|Stavanger, Rogaland, Norway, 4068|
|Contact: Anders Torp, MD 0047 05151 (central) firstname.lastname@example.org|
|Contact: Jörg Törpel, MD 0047 05151 (central) jörg.törpel@sus.no|
|Sub-Investigator: Anders Torp, MD|
|Sub-Investigator: Jörg Törpel, MD|
|Study Chair:||Gregor Bachmann-Harildstad, MD, PhD||University in Oslo|