The Efficacy of Olfactory Cleft Steroid Drops in Patients With CRS With Olfactory Cleft Obstruction
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
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
Treatments tested in this trial
- Nasal Drops
- Nasal Spray
Treatment groups
54 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov