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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

Tracking Information
First Submitted Date  ICMJE August 9, 2012
First Posted Date  ICMJE September 10, 2012
Last Update Posted Date September 13, 2012
Study Start Date  ICMJE September 2012
Estimated Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2012)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01681615 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2012)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 5, 2012)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Challenge Test for Acetylsalicylic Acid Hypersensitivity
Official Title  ICMJE Challenge Test for Acetylsalicylic Acid Hypersensitivity
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Asthma Aspirin-sensitive
  • ASA Intolerant Asthma
  • Asthma, Aspirin-Induced
  • Asthma, Nasal Polyps, and Aspirin Intolerance
Intervention  ICMJE
  • Drug: Acetylsalicylate
    1-2 drops
  • Drug: Isotonic NaCl
    1 drop
Study Arms  ICMJE
  • Active Comparator: Acetylsalicylate
    Acetylsalicylic Acid Eyedrops
    Intervention: Drug: Acetylsalicylate
  • Placebo Comparator: isotonic NaCl
    Saline Eyedrops
    Intervention: Drug: Isotonic NaCl
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 5, 2012)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2013
Estimated Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01681615
Other Study ID Numbers  ICMJE ASA-ST-OS
2012-000698-22 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Helse Stavanger HF
Study Sponsor  ICMJE Helse Stavanger HF
Collaborators  ICMJE University Hospital, Akershus
Investigators  ICMJE
Study Chair: Gregor Bachmann-Harildstad, MD, PhD University in Oslo
PRS Account Helse Stavanger HF
Verification Date September 2012

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