Health TrialsbyHealthPanel

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

ConditionsChronic Rhinosinusitis (CRS)Smell Dysfunction
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorPeking University Third Hospital

About this trial

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?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

54 Participants
are divided into 2 treatment groups
Group A: Nasal Drops GroupExperimental treatment 1 intervention
Group B: Standard Nasal Spray GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

The Sniffin' Sticks test

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

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

Secondary outcomes

1

Subjective Olfactory Improvement and Nasal Symptoms

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.

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

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

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

Adverse Event

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking University Third Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: