Treatment of Eosinophilic Chronic Rhinosinusitis Utilizing Betamethasone Dipropionate Nasal Cream

NCT ID: NCT05220293

Last Updated: 2024-05-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-23
• Study Completion Date: 2023-12-30

Brief Summary

This is an open-label, single dose, pilot study, to assess the efficacy and safety of Betamethasone Dipropionate Nasal Cream 0.0644% (equivalent to 0.05% Betamethasone) for the treatment of eosinophilic Chronic Rhinosinusitis (eCRS).

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 eCRS condition is suboptimal under the current standard of care. The safety and benefits of this treatment will be monitored by patient-reported symptoms and visualization 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%, up to 5g per sinus.

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%, up to 5g per sinus.

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 eCRS by a ENT undergoing maximal medical therapy as part of their standard of care.
• Having undergone functional endoscopic sinus surgery at least 6 months prior to enrolment.
• Participants with an endoscopic bilateral nasal polyp score of ≤5 out of a maximum score of 8
• Score > 2 on disease severity visual analogue scale (VAS)
• A minimum body weight >=40 kilograms (kg) at screening visit
• Gender: Male or female (females of childbearing potential must use adequate birth control methods and not plan to get pregnant during the course of the study).
• Informed consent: Willingness to give written informed consent and willingness to participate to and comply with the study.
• Age ≥18 but <80 years.

Exclusion Criteria

• Subjects with known hypersensitivity or contraindications to Betamethasone Dipropionate, corticosteroids or topical anaesthesia.
• Subjects with sino-nasal abnormalities, disease or implanted devices that prevent application of the therapy.
• Previous enrolment in this study.
• Subjects currently required systemic corticosteroid use or receiving biologic therapy as part of their disease management plan or who meet the PBS criteria for severe lower airway disease.
• Subjects with history or current glaucoma or cataract or if they have abnormal IOP at screening or pre-treatment (abnormal IOP is defined as greater than 21 mm Hg).
• Subjects with other conditions that could lead to elevated eosinophils such as Hypereosinophilic Syndromes, including Churg-Strauss Syndrome, or Eosinophilic Esophagitis.
• Subjects with acute sinusitis.
• Subjects with known immunodeficiency.
• Subjects with Diabetes (Type 1).
• Subjects with cystic fibrosis.
• Pregnant subjects or subjects currently lactating as the effect on human pregnancy is unknown.

• 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

Principal Investigators

Oticara Clinical

Role: STUDY_DIRECTOR

Oticara Australia PTY LTD

Locations

Oticara Clinical Trial Site

Sydney, New South Wales, Australia

Countries

Australia

Other Identifiers

OT-007

Identifier Type: -

Identifier Source: org_study_id