An interventional study of Acetylsalicylate and Isotonic NaCl in Asthma Aspirin-sensitive, ASA Intolerant Asthma and Asthma, Aspirin-Induced, sponsored by Helse Stavanger HF. Status unknown at 2 sites in Norway. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2012-09-13.
Sponsored by Helse Stavanger HF · Not applicable, Interventional, and Diagnostic
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.
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.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's planned enrollment of 50 is below the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →Helse Stavanger HF is the lead sponsor of 93 studies on the registry; 17 are open to participants now.
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Exclusion Criteria:
Acetylsalicylic Acid Eyedrops
Drug: Acetylsalicylate
Saline Eyedrops
Drug: Isotonic NaCl
1-2 drops
1 drop
Inspiratory nasal flow measured by Rhinomanometry
Bilateral flow reduction \>40% considered positive test.
Time frame: Within 45 min from challenge
Expiratory nasal flow measured by Rhinomanometry
Bilateral expiratory flow reduction \>40% considered positive.
Time frame: Within 45 min from challenge
Pulmonary forced expiratory volume in 1 second (FEV1)
Reduction in FEV1 \>20% is considered as positive test.
Time frame: Within 45 min from challenge
Conjunctival symptoms
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.
Time frame: Within 45 days from challenge
Nasal symptoms
Rhinorrhea, congestion and sneezing is considered as positive test.
Time frame: Within 45 minutes from challenge
Bronchial and laryngeal symptoms
Bronchospasm. tight chest, wheezing or laryngospasm is considered as positive test.
Time frame: Within 45 minutes from challenge
Other significant and relevant symptoms
Erythema in upper body or face, nausea or abdominal pain is considered as positive test.
Time frame: Within 45 days after challenge
This study is status unknown, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.
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Helse Stavanger HF