Challenge Test for Acetylsalicylic Acid Hypersensitivity

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01681615

Enrollment

Registered

2012-09-10

Start date

2012-09-30

Completion date

2013-12-31

Last updated

2012-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Challenge test for Aspirin Hypersensitivity, Challenge test for Acetylsalicylic 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.

Interventions

DRUGAcetylsalicylate

1-2 drops

DRUGIsotonic NaCl

1 drop

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Pulmonary forced expiratory volume in 1 second (FEV1)	Within 45 min from challenge	Reduction in FEV1 \>20% is considered as positive test.
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.

Secondary

Measure	Time frame	Description
Bronchial and laryngeal symptoms	Within 45 minutes from challenge	Bronchospasm. tight chest, wheezing or laryngospasm is considered as positive test.
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.

Other

Measure	Time frame	Description
Other significant and relevant symptoms	Within 45 days after challenge	Erythema in upper body or face, nausea or abdominal pain is considered as positive test.

Countries

Norway

Contacts

Primary ContactGregor Bachmann-Harlidstad, MD, PhD

Gregor.Bachmann-Harlidstad2@ahus.no0047 02900 (central)

Backup ContactJörg Törpel, MD

jörg.törpel@sus.no0047 05151 (central)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026