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Challenge Test for Acetylsalicylic Acid Hypersensitivity

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Helse Stavanger HF.
Recruitment status was  Not yet recruiting
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
  Purpose

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01681615

Contacts
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

Locations
Norway
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
Investigators
Study Chair: Gregor Bachmann-Harildstad, MD, PhD University in Oslo
  More Information

Publications:
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
ClinicalTrials.gov 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:
Asthma
Asthma, Aspirin-Induced
Hypersensitivity
Nasal Polyps
Bronchial Diseases
Chemically-Induced Disorders
Drug Hypersensitivity
Drug-Related Side Effects and Adverse Reactions
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Nose Diseases
Otorhinolaryngologic Diseases
Pathological Conditions, Anatomical
Polyps
Respiratory Hypersensitivity
Respiratory Tract Diseases
Aspirin
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antipyretics
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Fibrin Modulating Agents

ClinicalTrials.gov processed this record on November 20, 2014