To assess the safety and efficacy of one (single) application of Betamethasone Dipropionate Nasal Cream (BMDP CREAM) onto the sinus mucosa.
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 chronic rhinosinusitis (CRS) condition is suboptimal under the current standard of care. The safety and benefits of this treatment will be monitored by patient-reported symptoms and endoscopic assessment of the sinus mucosa.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Betamethasone 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).
Cream is pre-filled to a syringe and applicator device to facilitate the topical application direct to the sinus under endoscopic guidance.
Oticara Investigational Site
Sydney, New South Wales, Australia
RECRUITINGOticara Investigational Site
Brisbane, Queensland, Australia
RECRUITINGOticara Investigational Site
Adelaide, South Australia, Australia
RECRUITINGChange 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.
Time frame: Baseline through study completion, an average of 4 weeks
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.
Time frame: Baseline through study completion, an average of 4 weeks
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.
Time frame: Informed consent through study completion, an average of 3 weeks
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Oticara Investigational Site
Perth, Western Australia, Australia
RECRUITING