Challenge Test for Acetylsalicylic Acid Hypersensitivity

This study is not yet open for participant recruitment.
Verified September 2012 by Helse Stavanger HF
University Hospital, Akershus
Information provided by (Responsible Party):
Helse Stavanger HF Identifier:
First received: August 9, 2012
Last updated: September 12, 2012
Last verified: September 2012

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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 ] [ 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.

Secondary Outcome Measures:
  • 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.

Other Outcome Measures:
  • 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.

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.


Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its identifier: NCT01681615

Contact: Gregor Bachmann-Harlidstad, MD, PhD 0047 02900 (central)
Contact: Jörg Törpel, MD 0047 05151 (central) jörg.tö

Akershus University Hospital Not yet recruiting
Lørenskog, Akershus, Norway, 1478
Contact: Gregor Bachmann-Harlidstad, MD, PhD    0047 02900 (central)   
Contact: Mohammad Sohrabi, MD    0047 02900 (central)   
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)   
Contact: Jörg Törpel, MD    0047 05151 (central)    jörg.tö   
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

Romano A, Torres MJ, Castells M, Sanz ML, Blanca M. Diagnosis and management of drug hypersensitivity reactions. J Allergy Clin Immunol. 2011 Mar;127(3 Suppl):S67-73
Kralinger MT, Stolba U, Velikay M, Egger S, Binder S, Wedrich A, et al. Safety and feasibility of a novel intravitreal tamponade using a silicone oil/acetyl-salicylic acid suspension for proliferative vitreoretinopathy: first results of the Austrian Clinical Multicenter Study. Graefes Arch Clin Exp Ophthalmol. 2010 Aug;248(8):1193-8

Responsible Party: Helse Stavanger HF Identifier: NCT01681615     History of Changes
Other Study ID Numbers: ASA-ST-OS, 2012-000698-22
Study First Received: August 9, 2012
Last Updated: September 12, 2012
Health Authority: Norway: Norwegian Medicines Agency
Norway: Ethics Committee

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
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action processed this record on April 15, 2014