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

NCT07386873 | Not Yet Recruiting DMC

• 1 other identifier: 9059107
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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. 1.Efficacy Comparison: Is olfactory improvement greater with olfactory cleft-targeted steroid nasal drops compared to standard nasal steroid sprays in CRS patients?
2. 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

Keywords

Olfactory dysfunction; Chronic rhinosinusitis; Steroid nasal drops; Olfactory cleft obstruction

Outcome Measures

Primary Outcomes (1)

• The Sniffin' Sticks test

  A clinically significant olfactory improvement as measured by Sniffin' Sticks threshold, discrimination, and identification(TDI)

  Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, and 12 weeks after the initiation of treatment.

Secondary Outcomes (4)

• Subjective Olfactory Improvement and Nasal Symptoms

  1 week, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, and 12 weeks after the initiation of treatment.

• CT Evaluation of Olfactory Cleft Blockage

  Baseline and 4 weeks after the initiation of treatment.

• Inflammatory Marker Levels in Olfactory Mucosa

  Baseline and 4 weeks after the initiation of treatment.

• Adverse Event

  1 week, and 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, and 12 weeks after the initiation of treatment.

Study Arms (2)

Nasal Drops Group

EXPERIMENTAL

Device: Nasal Drops

Standard Nasal Spray Group

ACTIVE COMPARATOR

Device: Nasal Spray

Interventions

Nasal Drops DEVICE

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.

Nasal Drops Group

Nasal Spray DEVICE

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.

Standard Nasal Spray Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Prospective enrollment of otolaryngology clinic patients aged 18-65 years with olfactory dysfunction. Diagnosis of chronic rhinosinusitis-related olfactory dysfunction is based on the EPOS 2020 guidelines. Participants must demonstrate olfactory impairment via Sniffin' Sticks testing, with TDI scores (sum of Threshold, Discrimination, and Identification) meeting:(1) Hyposmia: 16 \< TDI \< 30.75; (2) 3.Anosmia: TDI \< 15.
• Sinus CT scans confirming obstruction in the olfactory cleft region.
• Willingness to participate and signed informed consent.

You may not qualify if:

• Use of systemic corticosteroids within 4 weeks or intranasal steroids within 2 weeks prior to enrollment.
• Severe nasal septum deviation, nasal tumors, acute upper respiratory infections, or uncontrolled allergic rhinitis.
• Severe cardiovascular disease, hepatic/renal insufficiency, uncontrolled diabetes, or immune system disorders.
• Current or planned pregnancy.
• Investigator-determined inability to comply with study requirements (e.g., memory/behavioral disorders, depression, heavy alcohol use, prior non-compliance).

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Dawei Wu

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Conditions

Olfaction Disorders

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Dawei Wu, MD, PhD

CONTACT

13522503401; davidwuorl@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Researcher

Study Record Dates

• First Submitted: January 24, 2026
• First Posted: February 4, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)