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

StatusNot Yet Recruiting
PhaseNot applicable
Started2026-09-25
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from Peking University Third Hospital

Amendment history

2026-09-17
critical
Primary endpoint(s) modified1 entry, revised
WasThe Sniffin' Sticks test
NowProportion of Participants with Clinically Meaningful Improvement in the Sniffin' Sticks test
Enrollment increased: 54 → 78 participants
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?
Trial Details
NCT Number NCT07386873
Lead Sponsor Peking University Third Hospital
Conditions Chronic Rhinosinusitis (CRS), Olfactory Dysfunction
Enrollment 78 participants
Start Date 2026-09-25
Primary Completion 2028-12-31 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-16