Treatment of Eosinophilic Chronic Rhinosinusitis Utilizing Betamethasone Dipropionate Nasal Cream (OT-007)

The Effect of Betamethasone Dipropionate on Patients With Eosinophilic Chronic Rhinosinusitis

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).

Study Overview

• Status: Terminated
• Conditions: Chronic Rhinosinusitis (Diagnosis)
• Intervention / Treatment: Drug: Betamethasone Dipropionate Nasal Cream 0.0644%; Device: Pre-filled syringe and applicator device

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.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2000
      • Oticara Clinical Trial Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Drug: Betamethasone Dipropionate Nasal Cream 0.0644%; Betamethasone Dipropionate Nasal Cream 0.0644%, up to 5g per sinus.; Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 4 cardinal symptoms score (4CSS) from Baseline to Week 3.	Participants score their 4-Cardinal Symptom score (4CSS) daily on a Likert scale of 0-5; where 0= no problem - 5= problem as bad as can be, higher scores indicate higher severity of symptoms.	Baseline to Week 3
Change in Visual Analogue Scale (VAS) (0-10) evaluating global disease severity score from Baseline to Week 3.	Participants score their global disease severity assessment daily on a Visual Analogue Scale (VAS) (0-10), higher score indicating greater disease severity.	Baseline to Week 3
Change in SNOT-22 Score from Baseline to Week 3.	Participants complete the SNOT-22 questionnaire at Baseline and Week 3,analysis will focus on the nasal and ear/facial subdomains. Higher scores indicate greater severity.	Baseline to Week 3
Change in Modified Lund Mackay Postoperative Endoscopy Score from Baseline to Week 3.	Change in Modified Lund Mackay Postoperative Endoscopy Score is evaluated by experienced ENT at Baseline to Week 3.	Baseline to Week 3
Overall Patient Global Impression of Change at Week 3.	Patient Global Impression of Change (recorded on a Likert scale 1-7, where 1= very much improved - 7= very much worse) will be completed by the participant at Week 3.	Week 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMDP Cream retention time on the sinus	Visual inspection of cream retention time on the sinus via endoscope.	Treatment visit to Week 3
To assess the safety of one application of BMDP CREAM onto the sinus	Adverse event and intraocular pressure monitoring	Treatment visit to Week 3

Collaborators and Investigators

• Sponsor: Oticara Australia PTY LTD
• Investigators: Study Director: Oticara Clinical, Oticara Australia PTY LTD

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2022
• Primary Completion (Actual): December 30, 2023
• Study Completion (Actual): December 30, 2023

Study Registration Dates

• First Submitted: January 21, 2022
• First Submitted That Met QC Criteria: January 21, 2022
• First Posted (Actual): February 2, 2022

Study Record Updates

• Last Update Posted (Actual): May 2, 2024
• Last Update Submitted That Met QC Criteria: April 30, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: eosinophilic Chronic Rhinosinusitis
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Rhinitis; Sinusitis; Rhinosinusitis; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Asthmatic Agents; Respiratory System Agents; Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Betamethasone sodium phosphate
• Other Study ID Numbers: OT-007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is not a plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes