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NCT Number: NCT07386873

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

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?

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Key information

Conditions

Chronic Rhinosinusitis (CRS) Nervous System Diseases Neurologic Manifestations Olfaction Disorders Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Smell Dysfunction

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Olfactory dysfunction is one of the most common clinical symptoms in patients with chronic rhinosinusitis (CRS), affecting approximately 60%-80% of individuals with CRS. This condition significantly impairs quality of life and is associated with systemic health issues such as depression and nutritional imbalances. The olfactory cleft, a critical anatomical region housing the olfactory neuroepithelium, is often obstructed in CRS patients due to nasal polyps or mucosal hypertrophy, leading to conductive olfactory dysfunction.

Current first-line treatments for CRS, including oral or intranasal corticosteroids, have limitations. Oral steroids pose systemic side effects, while standard nasal sprays often fail to deliver adequate drug concentrations to the olfactory cleft. In contrast, targeted hormone nasal drops may achieve higher efficacy by directly addressing localized inflammation and edema in the olfactory cleft. Preliminary studies suggest that fluticasone nasal drops can reduce the need for sinus surgery in patients with CRS unresponsive to conventional sprays. However, no randomized controlled trials have systematically evaluated the efficacy of olfactory cleft-targeted hormone drops in improving olfactory function in CRS patients with confirmed olfactory cleft obstruction.

In this study, investigators planned to enroll 54 patients with olfactory cleft obstruction and assign them to one of two treatments: olfactory cleft-targeted steroid nasal drops or conventional nasal sprays. This study aims to investigate the efficacy and underlying mechanisms of olfactory cleft-targeted steroid nasal drops in improving olfactory function.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

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 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.

Primary outcomes

  1. The Sniffin' Sticks test

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

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

Secondary outcomes

  1. Subjective Olfactory Improvement and Nasal Symptoms

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

    Patient-reported olfactory improvement measured using the Olfactory-Visual Analogue Scale (VAS) and nasal symptoms assessed via the the Sino-Nasal Outcome Test 22 (SNOT-22) questionnaire. These measures evaluate treatment effects on self-perceived smell recovery and associated nasal complaints.

  2. CT Evaluation of Olfactory Cleft Blockage

    Time frame: Baseline and 4 weeks after the initiation of treatment.

  3. Inflammatory Marker Levels in Olfactory Mucosa

    Time frame: Baseline and 4 weeks after the initiation of treatment.

    Analysis of inflammatory cytokines via ELISA and single-cell sequencing from olfactory mucosal brush samples, with concurrent serum inflammatory marker testing.

  4. Adverse Event

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

    Documentation of local (nasal irritation, epistaxis) and systemic steroid-related adverse events using standardized case report forms during all follow-up visits.

Study contacts

Contact information is provided by the study sponsor or research team.

Dawei Wu, MD, PhD

CONTACT

[email protected]

13522503401

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study title

Randomized Controlled Trial on the Efficacy of Olfactory Cleft Steroid Drops in Patients With Chronic Rhinosinusitis With Olfactory Cleft Obstruction

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 4, 2026
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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