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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorOticara Australia PTY LTD

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Betamethasone Dipropionate Nasal Cream 0.0644%
  • Pre-filled syringe and applicator device

Treatment groups

24 Participants
are divided into 1 treatment group

Sponsors and collaborators