Overview
To assess the safety and efficacy of one (single) application of Betamethasone Dipropionate Nasal Cream (BMDP CREAM) onto the sinus mucosa.
Description
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
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.