Challenge Test for Acetylsalicylic Acid Hypersensitivity
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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) 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|