Challenge Test for Acetylsalicylic Acid Hypersensitivity

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2012 by Helse Stavanger HF
Sponsor:
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

August 9, 2012
September 12, 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 ] [ Designated as safety issue: No ]
    Bilateral flow reduction >40% considered positive test.
  • Expiratory nasal flow measured by Rhinomanometry [ Time Frame: Within 45 min from challenge ] [ Designated as safety issue: No ]
    Bilateral expiratory flow reduction >40% considered positive.
  • Pulmonary forced expiratory volume in 1 second (FEV1) [ Time Frame: Within 45 min from challenge ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    Rhinorrhea, congestion and sneezing is considered as positive test.
  • Bronchial and laryngeal symptoms [ Time Frame: Within 45 minutes from challenge ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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.
 
Not yet recruiting
50
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
Both
18 Years to 60 Years
No
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
 
NCT01681615
ASA-ST-OS, 2012-000698-22
No
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