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Challenge Test for Acetylsalicylic Acid Hypersensitivity
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2012 by Helse Stavanger HF.
Recruitment status was: Not yet recruiting
Recruitment status was: Not yet recruiting
Sponsor:
Helse Stavanger HF
Collaborator:
University Hospital, Akershus
Information provided by (Responsible Party):
Helse Stavanger HF
ClinicalTrials.gov Identifier:
NCT01681615
First received: August 9, 2012
Last updated: September 12, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
| Asthma Aspirin-sensitive ASA Intolerant Asthma Asthma, Aspirin-Induced Asthma, Nasal Polyps, and Aspirin Intolerance | Drug: Acetylsalicylate Drug: Isotonic NaCl |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double Blind (Participant, Investigator) Primary Purpose: Diagnostic |
| Official Title: | Challenge Test for Acetylsalicylic Acid Hypersensitivity |
Resource links provided by NLM:
Further study details as provided by Helse Stavanger HF:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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 Outcome Measures:
- 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.
| Estimated Enrollment: | 50 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Acetylsalicylate
Acetylsalicylic Acid Eyedrops
|
Drug: Acetylsalicylate
1-2 drops
|
|
Placebo Comparator: isotonic NaCl
Saline Eyedrops
|
Drug: Isotonic NaCl
1 drop
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01681615
Please refer to this study by its ClinicalTrials.gov identifier: NCT01681615
Contacts
| 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 |
Locations
| 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 | |
Sponsors and Collaborators
Helse Stavanger HF
University Hospital, Akershus
Investigators
| Study Chair: | Gregor Bachmann-Harildstad, MD, PhD | University in Oslo |
More Information
Publications:
Stevenson D SR, Zuraw BL. Sensitivity to aspirin and NSAIDs. Adkinson NJ YJ, Busse WW, et al., editor. Philadelphia: CV Mosby and Co.; 2003
Stevenson DD, Szczeklik A. Clinical and pathologic perspectives on aspirin sensitivity and asthma. J Allergy Clin Immunol. 2006 Oct;118(4):773-86; quiz 87-8. 9. Mastalerz L, Setkowicz M, Sanak M, Szczeklik A. Hypersensitivity to aspirin: common eicosanoid alterations in urticaria and asthma. J Allergy Clin Immunol. 2004 Apr;113(4):771-5
| Responsible Party: | Helse Stavanger HF |
| ClinicalTrials.gov Identifier: | NCT01681615 History of Changes |
| Other Study ID Numbers: |
ASA-ST-OS 2012-000698-22 ( EudraCT Number ) |
| Study First Received: | August 9, 2012 |
| Last Updated: | September 12, 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 |
ClinicalTrials.gov processed this record on June 23, 2017