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NOT YET RECRUITING
NCT07386873
NA

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

Sponsor: Peking University Third Hospital

View on ClinicalTrials.gov

Summary

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?

Official title: Position-Directed Budesonide Nasal Drops for Olfactory Dysfunction in Eosinophilic Chronic Rhinosinusitis: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

78

Start Date

2026-09-25

Completion Date

2028-12-31

Last Updated

2026-09-16

Healthy Volunteers

No

Interventions

DEVICE

Nasal Drops

Participants will receive budesonide suspension (2 mL:1 mg) as nasal drops, 20 drops per nostril twice daily (morning and evening) for 12 weeks. The drops will be administered in the Wu's position (Wu's 45° Head-Hanging Reclination Position), with the head suspended and tilted backward approximately 45° and the nostrils facing upward. The position will be maintained for approximately 5 minutes after instillation.

DEVICE

Nasal Spray

Participants will administer conventional budesonide nasal spray in the standard upright sitting position according to routine clinical practice, 2 actuations per nostril once daily. Participants will be instructed to sniff gently after each spray. Treatment will continue for 12 weeks.

Locations (1)

Dawei Wu

Beijing, Beijing Municipality, China