Challenge Test for Acetylsalicylic Acid Hypersensitivity

Study Overview
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Brief Summary
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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
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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.

Official Title
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Challenge Test for Acetylsalicylic Acid Hypersensitivity

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

Intervention / Treatment
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* Drug: Acetylsalicylate
* Drug: Isotonic NaCl


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inspiratory nasal flow measured by Rhinomanometry | Bilateral flow reduction >40% considered positive test. | Within 45 min from challenge | 
| Expiratory nasal flow measured by Rhinomanometry | Bilateral expiratory flow reduction >40% considered positive. | Within 45 min from challenge | 
| Pulmonary forced expiratory volume in 1 second (FEV1) | 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 | 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 | Rhinorrhea, congestion and sneezing is considered as positive test. | Within 45 minutes from challenge | 
| Bronchial and laryngeal symptoms | Bronchospasm. tight chest, wheezing or laryngospasm is considered as positive test. | Within 45 minutes from challenge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Challenge test for Aspirin Hypersensitivity, Challenge test for Acetylsalicylic Hypersensitivity