Challenge Test for Acetylsalicylic Acid Hypersensitivity

Not Applicable

• Conditions: Asthma Aspirin-sensitive; ASA Intolerant Asthma; Asthma, Aspirin-Induced; Asthma, Nasal Polyps, and Aspirin Intolerance
• Interventions: Drug: Isotonic NaCl; Drug: Acetylsalicylate

• Registration Number: NCT01681615
• Lead Sponsor: Helse Stavanger HF

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 Timeline

• Study First Submitted: 2012-08-09
• Status Verified: 2012-09
• Study Start: 2012-09
• Study First Submitted QC: 2012-09-05
• Study First Posted: 2012-09-10
• Last Update Submitted: 2012-09-12
• Last Update Posted: 2012-09-13
• Primary Completion: 2013-03
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
isotonic NaCl	Isotonic NaCl	Saline Eyedrops
Acetylsalicylate	Acetylsalicylate	Acetylsalicylic Acid Eyedrops

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Conjunctival symptoms	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	Within 45 minutes from challenge	Rhinorrhea, congestion and sneezing is considered as positive test.
Bronchial and laryngeal symptoms	Within 45 minutes from challenge	Bronchospasm. tight chest, wheezing or laryngospasm is considered as positive test.

Trial Locations

Locations (2)

Stavanger University Hospital; 🇳🇴 Stavanger, Rogaland, Norway

Akershus University Hospital; 🇳🇴 Lørenskog, Akershus, Norway