Challenge Test for Acetylsalicylic Acid Hypersensitivity

Helse Stavanger HF

Status: Unknown

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

Treatments: Drug: Acetylsalicylate; Drug: Isotonic NaCl

Study type: Interventional

Funder types: Other

Identifiers

NCT01681615

2012-000698-22 (EudraCT Number)

ASA-ST-OS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

Acetylsalicylate

Active Comparator group

Description:

Acetylsalicylic Acid Eyedrops

Treatment:

Drug: Acetylsalicylate

isotonic NaCl

Placebo Comparator group

Description:

Saline Eyedrops

Treatment:

Drug: Isotonic NaCl