Clinical Trial

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

Study acronym: RANSES

Recruiting Phase 4

Record status

This record was last updated January 28, 2025 (before its estimated April 2, 2026 completion). Its status may not reflect the trial's current state.

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).

Protocol Amendment History 1 amendment

This ClinicalTrials.gov record has been amended once since 2025-01-10.

Trial Details

NCT Number	NCT06778213
Lead Sponsor	Wroclaw Medical University Collaborators: ALL-MED Medical Research Institute, Wroclaw, Poland, Allergopharma GmbH & Co. KG
Conditions	Allergic Rhinoconjunctivitis
Enrollment	67 participants
Start Date	2024-11-02
Primary Completion	2026-04-02 (estimated)
Study Completion	2026-12-01 (estimated)
Updated on ClinicalTrials.gov	2025-01-28