The Effect of Intra-sinus Application of Betamethasone Dipropionate Nasal Cream on Patients With Chronic Rhinosinusitis Post Functional Endoscopic Sinus Surgery (FESS)

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oticara Australia PTY LTD
• Treatments: Betamethasone; Betamethasone benzoate; Betamethasone sodium phosphate; Betamethasone Valerate; Betamethasone-17,21-dipropionate

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.