To assess the safety and efficacy of one (single) application of Betamethasone Dipropionate Nasal Cream (BMDP CREAM) onto the sinus mucosa.
Adult patients with a clinically confirmed diagnosis of CRS by an otolaryngologist (ENT) undergoing maximal medical therapy as part of their standard of care.
Having undergone functional endoscopic sinus surgery (FESS) at least 6 months prior to enrolment.
For each nostril, an endoscopic nasal polyp score of 0, 1, or 2 out of a maximum score of - (where 0= No polyps, 1= small polyps in the middle meatus not reaching below the inferior border of the middle turbinate , 2= nasal polyps reaching below the border of the middle turbinate, 3= large nasal polyps reaching the lower border of the inferior turbinate or nasal polyps medial to the middle turbinate, 4= large nasal polyps causing almost complete obstruction of the inferior nasal cavity) (Gevaert et al, 2023).
Visible middle turbinates and access to the ethmoid sinuses for dosing as established via endoscopic examination.
Subjects with known hypersensitivity or contraindications to betamethasone dipropionate, mometasone, or topical anaesthesia.
Subjects with sino-nasal abnormalities, disease, or implanted devices that prevents the application of the therapy.
Previous enrolment in this study.
Subjects currently receiving systemic corticosteroid or have received systemic corticosteroid in the prior 4 weeks or receiving biologic therapy.
Single group
Betamethasone Dipropionate Nasal Cream 0.0644%
DrugBetamethasone Dipropionate Nasal Cream 0.0644% is applied topically to the inflamed tissue of the sinus using a pre-filled syringe and applicator under the guidance of an endoscope. Up to 5g on each side of the sinus (10g in total).
Pre-filled syringe and applicator device
DeviceCream is pre-filled to a syringe and applicator device to facilitate the topical application direct to the sinus under endoscopic guidance.
Change in 4-Cardinal Symptom score (4CSS) Baseline to Week 3.
Change in average daily score prior to dosing (an average of 7 days) and the average daily score of the 7 days prior to exit (between week 2 and 3 weeks after dosing).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.
Change in SNOT-22 Baseline to Week 3.
Participants complete the Sino-nasal Outcome Test (SNOT-22) questionnaire at Baseline and Week 3, analysis will focus on the nasal symptom subdomain. The SNOT-22 measures 22 symptoms 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. A higher total score indicates greater symptom severity.
Safety of one application of BMDP Cream onto the sinus mucosa.
Monitoring of morning serum cortisol levels, glucose levels, treatment emergent changes in other chemistry or haematology results deemed clinically significant by the Investigator, intraocular pressure, and BMDP Cream application related adverse events.
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