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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
StatusRecruiting
PhasePhase 4
Started
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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.

Record History

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  1. Collaborators: 1 to 2v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT06778213
Lead Sponsor Wroclaw Medical University
Collaborators: ALL-MED Medical Research Institute, Wroclaw, Poland, Allergopharma GmbH & Co. KG
Conditions
(from sponsor)		 Allergic Rhinoconjunctivitis
Enrollment 67 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov