Challenge Test for Acetylsalicylic Acid Hypersensitivity
|ClinicalTrials.gov Identifier: NCT01681615|
Recruitment Status : Unknown
Verified September 2012 by Helse Stavanger HF.
Recruitment status was: Not yet recruiting
First Posted : September 10, 2012
Last Update Posted : September 13, 2012
|Condition or disease||Intervention/treatment||Phase|
|Asthma Aspirin-sensitive ASA Intolerant Asthma Asthma, Aspirin-Induced Asthma, Nasal Polyps, and Aspirin Intolerance||Drug: Acetylsalicylate Drug: Isotonic NaCl||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Challenge Test for Acetylsalicylic Acid Hypersensitivity|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||March 2013|
|Estimated Study Completion Date :||December 2013|
Active Comparator: Acetylsalicylate
Acetylsalicylic Acid Eyedrops
Placebo Comparator: isotonic NaCl
Drug: Isotonic NaCl
- 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.
- 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.
- Other significant and relevant symptoms [ Time Frame: Within 45 days after challenge ]Erythema in upper body or face, nausea or abdominal pain is considered as positive test.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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) email@example.com|
|Contact: Mohammad Sohrabi, MD 0047 02900 (central) firstname.lastname@example.org|
|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) email@example.com|
|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|