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臨床試験

Position-Directed Budesonide Nasal Drops for CRS-associated Olfactory Dysfunction

NCT: NCT07386873 · NOT_YET_RECRUITING

NCT識別子NCT07386873
ステータスNOT_YET_RECRUITING
開始日2026-09-25
完了2028-12-31
SponsorPeking University Third Hospital (OTHER)
First posted
Last updated

概要

This single-center randomized controlled trial evaluates whether budesonide nasal drops delivered in the Wu's position (Wu's 45° Head-Hanging Reclination Position) improve olfactory function more effectively than conventional budesonide nasal spray in adults with type 2 chronic rhinosinusitis (CRS)-related olfactory dysfunction. The study also evaluates patient-reported symptoms and quality of life, olfactory cleft structural abnormalities on sinus CT, computational fluid dynamics (CFD)-derived airflow parameters, safety, and whether baseline peripheral blood eosinophil count and clinical phenotype predict treatment response. The main questions this clinical trial aims to answer are: 1. Efficacy Comparison: Is olfactory improvement greater with olfactory cleft-targeted steroid nasal drops compared to standard nasal steroid sprays in CRS patients? 2. Mechanism Exploration: How do changes in inflammatory markers, obstruction severity, and olfactory test results explain the potential benefits of this treatment approach? 3. Disease Classification: Can post-treatment olfactory dysfunction be categorized as fully reversible, partially reversible, or non-responsive/irreversible using Week-12 TDI recovery?

公式ソース

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