Nasal allergen challenge with dissolved birch tree pollen tablets.

Area of Science:

• Allergy and immunology research
• Clinical diagnostics and therapeutics
• Respiratory medicine

Background:

• The nasal allergen challenge (NAC) is a key diagnostic method for allergies.
• The historical standard allergen extract for NAC in Europe ceased production in 2019.
• A need exists for a reliable alternative allergen source for NAC.

Purpose of the Study:

• To evaluate the feasibility of using dissolved birch pollen ITULAZAX tablets for NAC.
• To assess the diagnostic performance of ITULAZAX in NAC.
• To establish ITULAZAX as a potential replacement for the discontinued allergen extract.

Main Methods:

• A clinical trial involving 69 participants with birch pollen allergy and 20 healthy controls.
• Nasal allergen challenge (NAC) performed using dissolved ITULAZAX, dissolved placebo, or saline.
• Assessment of sensitivity and specificity of NAC using dissolved ITULAZAX.

Main Results:

• The NAC method using dissolved ITULAZAX demonstrated high diagnostic accuracy.
• Sensitivity was determined to be 96%.
• Specificity was determined to be 95%.

Conclusions:

• Dissolved ITULAZAX tablets are a feasible and effective alternative for NAC.
• ITULAZAX provides a reliable and accessible allergen source for clinical and research NAC.
• This validates ITULAZAX for allergy diagnosis and research applications.