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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
Sponsor:
Collaborator:
University Hospital, Akershus
Information provided by (Responsible Party):
Helse Stavanger HF

Study Description
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Brief Summary:
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 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

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.

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
Drug Information available for: Aspirin
U.S. FDA Resources

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Inspiratory nasal flow measured by Rhinomanometry [ Time Frame: Within 45 min from challenge ]
    Bilateral flow reduction >40% considered positive test.

  2. Expiratory nasal flow measured by Rhinomanometry [ Time Frame: Within 45 min from challenge ]
    Bilateral expiratory flow reduction >40% considered positive.

  3. 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 :
  1. 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.


  2. Nasal symptoms [ Time Frame: Within 45 minutes from challenge ]
    Rhinorrhea, congestion and sneezing is considered as positive test.

  3. 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:
  1. 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.


Eligibility Criteria
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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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 )
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