Challenge Test for Acetylsalicylic Acid Hypersensitivity

September 12, 2012 updated by: Helse Stavanger HF
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Norway
    • Akershus
      • Lørenskog, Akershus, Norway, 1478
        • Akershus University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gregor Bachmann-Harildstad, MD, PhD
        • Sub-Investigator:
          • Mohammad Sohrabi, MD
    • Rogaland
      • Stavanger, Rogaland, Norway, 4068
        • Stavanger University Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Anders Torp, MD
        • Sub-Investigator:
          • Jörg Törpel, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Acetylsalicylate
Acetylsalicylic Acid Eyedrops
Drug: Acetylsalicylate
1-2 drops
Placebo Comparator: isotonic NaCl
Saline Eyedrops
Drug: Isotonic NaCl
1 drop

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inspiratory nasal flow measured by Rhinomanometry
Time Frame: Within 45 min from challenge
Bilateral flow reduction >40% considered positive test.
Within 45 min from challenge
Expiratory nasal flow measured by Rhinomanometry
Time Frame: Within 45 min from challenge
Bilateral expiratory flow reduction >40% considered positive.
Within 45 min from challenge
Pulmonary forced expiratory volume in 1 second (FEV1)
Time Frame: Within 45 min from challenge
Reduction in FEV1 >20% is considered as positive test.
Within 45 min from challenge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within 45 days from challenge
Nasal symptoms
Time Frame: Within 45 minutes from challenge
Rhinorrhea, congestion and sneezing is considered as positive test.
Within 45 minutes from challenge
Bronchial and laryngeal symptoms
Time Frame: Within 45 minutes from challenge
Bronchospasm. tight chest, wheezing or laryngospasm is considered as positive test.
Within 45 minutes from challenge

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within 45 days after challenge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helse Stavanger HF

Collaborators

University Hospital, Akershus

Investigators

  • Study Chair: Gregor Bachmann-Harildstad, MD, PhD, University in Oslo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Anticipated)

March 1, 2013

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

August 9, 2012

First Submitted That Met QC Criteria

September 5, 2012

First Posted (Estimate)

September 10, 2012

Study Record Updates

Last Update Posted (Estimate)

September 13, 2012

Last Update Submitted That Met QC Criteria

September 12, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASA-ST-OS
  • 2012-000698-22 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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