Nasal Allergen Challenge Test as a Method to Detect Clinical Reactivity Against Birch Pollen
Status:
Recruiting
Trial end date:
2026-12-31
Target enrollment:
Participant gender:
Summary
Clinical efficacy and tolerability for allergen specific immunotherapy (AIT) with Itulazax
(birch pollen extract tablet) is well established.
Allergen challenges are used by clinicians to confirm correct diagnosis and by researchers to
evaluate the efficacy of different interventions, eg. AIT. The challenge is performed by
using a specific controlled administration schedule of an allergen product in the shock organ
(nose, eye, or airway) and then monitor the result. Nasal Allergen Challenge (NAC) is the
most common allergen challenge used.
Aquagen SQ (birch pollen extract) has since decades been golden standard for this purpose,
but production of this product ended 2019. Clinicians as well as researchers are now in need
for an alternative product.
To evaluate a new method for NAC would be of value from a clinical- and research perspective.
From a Nordic perspective a NAC study with dissolved Itulazax would be of special interest
since birch allergy is a dominant allergen in the region. In a recently published article it
was shown that dissolved Grazax and Aquagen Phleum pratense gave comparable result used in
grass allergic patients. Therefore, it seems reasonable to assume that the same method could
be used with dissolved Itulazax.
The aim of this clinical trial is to evaluate the feasibility of nasal allergen challenge
tests with dissolved Itulazax tablets. The main benefit of this proposal is that the allergen
composition of the provocation test product is the same as the final product to be treated
with. This is likely to increase the treatment motivation of the patient. In addition, the
dissolving process is easier for the physician compared to the dissolving of the previously
used Aquagen.