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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
ClinicalTrials.gov Identifier:
First Posted: September 10, 2012
Last Update Posted: September 13, 2012
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.
University Hospital, Akershus
Information provided by (Responsible Party):
Helse Stavanger HF
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 (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.

Information from the National Library of Medicine

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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
  Contacts and Locations
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

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)    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
Study Chair: Gregor Bachmann-Harildstad, MD, PhD University in Oslo
  More Information

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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 Submitted: August 9, 2012
First Posted: September 10, 2012
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:
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
Pathological Conditions, Anatomical
Drug Hypersensitivity
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
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

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