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The Efficacy of Olfactory Cleft Steroid Drops in Patients With CRS With Olfactory Cleft Obstruction

NCT07386873 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2026-02-04

No results posted yet for this study

Summary

This study aims to compare the efficacy of steroid nasal drops targeting the olfactory cleft versus traditional intranasal steroid sprays in improving olfactory function in patients with chronic rhinosinusitis (CRS) with olfactory cleft obstruction. 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?

Conditions

  • Chronic Rhinosinusitis (CRS)
  • Smell Dysfunction

Interventions

DEVICE

Nasal Drops

Patients will assume the Mygind position (supine with head extended over the edge of the bed, nostrils facing upward). Five drops of budesonide suspension (2ml:1mg) will be administered into each nostril to ensure delivery to the olfactory cleft at the nasal apex. The position will be maintained for approximately 5 minutes, after which any residual medication in the oral or nasal cavity may be expelled. This procedure will be performed twice daily (morning and evening) for 3 months. During the first month, olfactory function will be assessed weekly, with a nasal sinus CT scan at the end of the month. In the second month, olfactory evaluations will be conducted biweekly, followed by a final assessment at the end of the third month.

DEVICE

Nasal Spray

Patients will use budesonide nasal spray administered in the same Mygind position, with 2 sprays per nostril (total daily dose: 200μg). After administration, patients will gently sniff to facilitate drug dispersion. The treatment duration and follow-up schedule will be identical to the experimental group.

Sponsors & Collaborators

  • Peking University Third Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07386873 on ClinicalTrials.gov