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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Study 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?

Eligibility

Primary outcome measure(s)

• Proportion of Participants with Clinically Meaningful Improvement in the Sniffin' Sticks test — Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, and 12 weeks after the initiation of treatment.
  Proportion of participants achieving a clinically meaningful improvement in Sniffin' Sticks TDI score at Week 12. A responder is defined as a participant with an increase in the composite TDI score of ≥5.5 points from baseline. The TDI score is calculated as the sum of odor Threshold (T), Discrimination (D), and Identification (I) scores.

Trial sites (1)

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