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ClinicalTrials.gov ID

NCT01681615

Lead Sponsor

Helse Stavanger HFOTHER_GOV

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

50Estimated

Last Update Posted

Sep 13, 2012Estimated

Start Date

Sep 2012

Primary Completion Date

Mar 2013Estimated

Completion Date

Dec 2013Estimated

Official Title

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.

• Asthma Aspirin-sensitive
• ASA Intolerant Asthma
• Asthma, Aspirin-Induced
• Asthma, Nasal Polyps, and Aspirin Intolerance

• Acetylsalicylate
• Isotonic NaCl

Ages Eligible for Study

Adult (18-64)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility 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

Primary Purpose

Diagnostic

Allocation

Randomized

Interventional Model

Single Group Assignment

Masking

Double

Lead Sponsor

Helse Stavanger HFOTHER_GOV

Collaborators

University Hospital, AkershusOTHER

anders.torp@sus.no0047 05151 (central)