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

August 9, 2012
September 10, 2012
September 13, 2012
September 2012
March 2013   (Final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01681615 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
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.
Same as current
Challenge Test for Acetylsalicylic Acid Hypersensitivity
Challenge Test for Acetylsalicylic Acid Hypersensitivity
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.
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.
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
  • Asthma Aspirin-sensitive
  • ASA Intolerant Asthma
  • Asthma, Aspirin-Induced
  • Asthma, Nasal Polyps, and Aspirin Intolerance
  • Drug: Acetylsalicylate
    1-2 drops
  • Drug: Isotonic NaCl
    1 drop
  • Active Comparator: Acetylsalicylate
    Acetylsalicylic Acid Eyedrops
    Intervention: Drug: Acetylsalicylate
  • Placebo Comparator: isotonic NaCl
    Saline Eyedrops
    Intervention: Drug: Isotonic NaCl

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Unknown status
December 2013
March 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
2012-000698-22 ( EudraCT Number )
Not Provided
Not Provided
Helse Stavanger HF
Helse Stavanger HF
University Hospital, Akershus
Study Chair: Gregor Bachmann-Harildstad, MD, PhD University in Oslo
Helse Stavanger HF
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP