This is an open-label, single dose, pilot study, to assess the efficacy and safety of Betamethasone Dipropionate Nasal Cream 0.0644% (equivalent to 0.05% Betamethasone) for the treatment of eosinophilic Chronic Rhinosinusitis (eCRS).
In this open-label study, a single dose of the corticosteroid Betamethasone Dipropionate Nasal Cream 0.0644% (equivalent to 0.05% Betamethasone) will be administered under endoscopic guidance to the sinus mucosa of post-FESS patients whose eCRS condition is suboptimal under the current standard of care. The safety and benefits of this treatment will be monitored by patient-reported symptoms and visualization of the sinus mucosa.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Betamethasone Dipropionate Nasal Cream 0.0644%, up to 5g per sinus.
Cream is pre-filled to a syringe and applicator device to facilitate the topical application direct to the sinus under endoscopic guidance.
Oticara Clinical Trial Site
Sydney, New South Wales, Australia
Change in 4 cardinal symptoms score (4CSS) from Baseline to Week 3.
Participants score their 4-Cardinal Symptom score (4CSS) daily on a Likert scale of 0-5; where 0= no problem - 5= problem as bad as can be, higher scores indicate higher severity of symptoms.
Time frame: Baseline to Week 3
Change in Visual Analogue Scale (VAS) (0-10) evaluating global disease severity score from Baseline to Week 3.
Participants score their global disease severity assessment daily on a Visual Analogue Scale (VAS) (0-10), higher score indicating greater disease severity.
Time frame: Baseline to Week 3
Change in SNOT-22 Score from Baseline to Week 3.
Participants complete the SNOT-22 questionnaire at Baseline and Week 3,analysis will focus on the nasal and ear/facial subdomains. Higher scores indicate greater severity.
Time frame: Baseline to Week 3
Change in Modified Lund Mackay Postoperative Endoscopy Score from Baseline to Week 3.
Change in Modified Lund Mackay Postoperative Endoscopy Score is evaluated by experienced ENT at Baseline to Week 3.
Time frame: Baseline to Week 3
Overall Patient Global Impression of Change at Week 3.
Patient Global Impression of Change (recorded on a Likert scale 1-7, where 1= very much improved - 7= very much worse) will be completed by the participant at Week 3.
Time frame: Week 3
BMDP Cream retention time on the sinus
Visual inspection of cream retention time on the sinus via endoscope.
Time frame: Treatment visit to Week 3
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To assess the safety of one application of BMDP CREAM onto the sinus
Adverse event and intraocular pressure monitoring
Time frame: Treatment visit to Week 3