the effect of intra-sinus application of betamethasone dipropionate nasal cream on patients with chronic rhinosinusitis post functional endoscopic sinus surgery (fess)

Conditions: Chronic Rhinosinusitis (Diagnosis)

Summary: 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.

Eligibility criteria:
inclusion criteria: * 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. * participants must have a \> 2 on the disease severity visual analogue scale (vas) at screening and pre-treatment. * body weight: a minimum body weight \>=40 kilograms (kg) and a bmi of ≤ 39 at the screening visit. * individuals of childbearing potential must use adequate birth control methods and not plan to get pregnant during the study. * informed consent: willingness to give written informed consent and willingness to participate in and comply with the study. * age ≥18 but \<80 years. exclusion criteria: * 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. * subjects with a history of glaucoma or cataracts or have an abnormal intraocular pressure (iop) at screening or pre-treatment (abnormal iop is defined as greater than 21 mm hg). * subjects with acute sinusitis. * subjects with known immunodeficiency. * subjects with diabetes (type 1). * subjects with cystic fibrosis. * pregnant subjects or subjects trying to get pregnant or currently lactating as the effect on human pregnancy is unknown. * subjects who are unable to give an informed consent because of mental illness, dementia or communication difficulties. * subjects with a cushing's disease diagnosis within the previous 12 months. * severe septal deviation and or previous total resection of the middle turbinate. * any lab abnormality or underlying medical condition which, in the investigator's opinion, should exclude the participant. * subjects who are unlikely to comply with study procedures, restrictions and requirements as determined by the investigator.