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Nasal Allergen Challenge Test as a Method to Detect Clinical Reactivity Against Birch Pollen

NCT06085963 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2025-09-17

No results posted yet for this study

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.

Conditions

  • Allergic Rhinitis Due to Pollen

Interventions

DRUG

ITULAZAX 12 SQ-Bet

Active ingredients: Birch (Betula verrucosa) extracts Dosage form: Oral lyophilisate (referred to as allergy immunotherapy tablet in text) Dose/strength: 12 SQ-Bet Excipients: Gelatine (fish source), mannitol and sodium hydroxide

DRUG

Placebo tablet

Active ingredients: None Dosage form: Oral lyophilisate (referred to as allergy immunotherapy tablet in text) Excipients: Gelatine (fish source), mannitol and sodium hydroxide

DRUG

Nacl

Sodium chloride solution 9mg/ml

Sponsors & Collaborators

Principal Investigators

  • Lars-Olaf Cardell, Professor · Karolinska Institutet

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-01
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Sweden

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06085963 on ClinicalTrials.gov