Challenge Test for Acetylsalicylic Acid Hypersensitivity
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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
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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 |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Diagnostic |
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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Acetylsalicylate
Acetylsalicylic Acid Eyedrops
|
Drug: Acetylsalicylate
1-2 drops
|
Placebo Comparator: isotonic NaCl
Saline Eyedrops
|
Drug: Isotonic NaCl
1 drop
|
- 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.

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Persons between 18 and 60 years of age
- Suspected Acetylsalicylic Acid Hypersensitivity
Exclusion Criteria:
- History on anaphylactic shock after NSAIDS intake
- History on gastric ulcer after NSAIDS intake
- Patients previously gone through testing or desensitisation for Aspirin hypersensitivity
- Clinical unstable asthma or baseline FEV1<70%
- Severe disease of the heart, digestive tract, liver or kidney
- Severe chronic urticaria
- Present conjunctivitis
- Pregnancy

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 |
Norway | |
Akershus University Hospital | Not yet recruiting |
Lørenskog, Akershus, Norway, 1478 | |
Contact: Gregor Bachmann-Harlidstad, MD, PhD 0047 02900 (central) gregor.bachmann.harlidstad2@ahus.no | |
Contact: Mohammad Sohrabi, MD 0047 02900 (central) mohammad.sohrabi@ahus.no | |
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) anders.torp@sus.no | |
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 |
Publications:
Responsible Party: | Helse Stavanger HF |
ClinicalTrials.gov Identifier: | NCT01681615 History of Changes |
Other Study ID Numbers: |
ASA-ST-OS 2012-000698-22 ( EudraCT Number ) |
First Posted: | September 10, 2012 Key Record Dates |
Last Update Posted: | September 13, 2012 |
Last Verified: | September 2012 |
Keywords provided by Helse Stavanger HF:
Challenge test for Aspirin Hypersensitivity Challenge test for Acetylsalicylic Hypersensitivity |
Additional relevant MeSH terms:
Asthma Hypersensitivity Nasal Polyps Asthma, Aspirin-Induced Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Polyps Pathological Conditions, Anatomical |
Drug Hypersensitivity Drug-Related Side Effects and Adverse Reactions Chemically-Induced Disorders Aspirin Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action |