Evaluation of the Efficacy of Allergen-specific Immunotherapy Using Assessment in an Allergen Exposure chamber-a Randomized Placebo-controlled Double-blind Study

Summary

The main objective of the study is to measure and correlate clinical parameters suitable for the assessment of allergen immunotherapy (AIT) with an aluminum hydroxide-adsorbed preparation of house dust mite (Dermatophagoides pteronyssinus/ Dermatophagoides farinae) allergens in adults with moderate to severe allergic rhinitis/rhinoconjunctivitis with or without controlled allergic bronchial asthma caused by house dust mite (HDM) allergens. The assessment of clinical responses will be evaluated following an allergen challenge in allergen exposure chamber (AEC) before and during the course of AIT. Patients' response to therapy will be evaluated as well as in the AEC and by patient's personal environment (Diary).

Timeline

Start

2024-11-02

Primary completion

2026-04-02

Completion

2026-12-01

Publications

• Background Jutel M, Zemelka-Wiacek M, Okamoto Y, Pfaar O. Algorithms in Allergy: Assessment of Rhinitis Using Allergen Exposure Chambers. Allergy. 2025 Mar;80(3):904-907. doi: 10.1111/all.16444. Epub 2024 Dec 17. No abstract available.
• Background Zemelka-Wiacek M, Kosowska A, Jutel M. Symptom Assessment of Patients with Allergic Rhinitis Using an Allergen Exposure Chamber. J Vis Exp. 2023 Mar 3;(193). doi: 10.3791/64801.
• Results Zemelka-Wiacek M, Kosowska A, Winiarska E, Sobanska E, Jutel M. Validated allergen exposure chamber is plausible tool for the assessment of house dust mite-triggered allergic rhinitis. Allergy. 2023 Jan;78(1):168-177. doi: 10.1111/all.15485. Epub 2022 Sep 1.
• Results Kosowska A, Zemelka-Wiacek M, Smolinska S, Wyrodek E, Adamczak B, Jutel M. Clinical validation of grass pollen exposure chamber in patients with allergic rhinitis triggered by timothy grass. Clin Exp Allergy. 2024 Jul;54(7):489-499. doi: 10.1111/cea.14482. Epub 2024 Apr 14.

Drugs

Indications