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

NCT ID: NCT05882903

Last Updated: 2024-11-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-17
• Study Completion Date: 2025-06-01

Brief Summary

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

Detailed 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.

Conditions

Chronic Rhinosinusitis (Diagnosis)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Betamethasone Dipropionate Nasal Cream 0.0644% Treatment

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).

Group Type: EXPERIMENTAL

Betamethasone Dipropionate Nasal Cream 0.0644%

Intervention Type: DRUG

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).

Pre-filled syringe and applicator device

Intervention Type: DEVICE

Cream is pre-filled to a syringe and applicator device to facilitate the topical application direct to the sinus under endoscopic guidance.

Interventions

Betamethasone Dipropionate Nasal Cream 0.0644%

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).

Intervention Type: DRUG

Pre-filled syringe and applicator device

Cream is pre-filled to a syringe and applicator device to facilitate the topical application direct to the sinus under endoscopic guidance.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oticara Australia PTY LTD

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Oticara Investigational Site

Sydney, New South Wales, Australia

Site Status: RECRUITING

Oticara Investigational Site

Brisbane, Queensland, Australia

Site Status: RECRUITING

Oticara Investigational Site

Adelaide, South Australia, Australia

Site Status: RECRUITING

Oticara Investigational Site

Perth, Western Australia, Australia

Site Status: RECRUITING

Countries

Australia

Central Contacts

Oticara Clinical

Role: CONTACT

contact@oticara.com

+1 279-217-0054

Other Identifiers

OT-007B

Identifier Type: -

Identifier Source: org_study_id