Treatment of Eosinophilic Chronic Rhinosinusitis Utilizing Betamethasone Dipropionate Nasal Cream

NCT05220293 | Terminated Phase 1 FDA Drug FDA Device

• 1 other identifier: OT-007
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Rhinosinusitis (Diagnosis)

Keywords

eosinophilic Chronic Rhinosinusitis

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• BMDP Cream retention time on the sinus

  Treatment visit to Week 3

• To assess the safety of one application of BMDP CREAM onto the sinus

  Treatment visit to Week 3

Study Arms (1)

Betamethasone Dipropionate Nasal Cream 0.0644% Treatment

EXPERIMENTAL

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%; Device: Pre-filled syringe and applicator device

Interventions

Betamethasone Dipropionate Nasal Cream 0.0644% DRUG

Betamethasone Dipropionate Nasal Cream 0.0644%, up to 5g per sinus.

Betamethasone Dipropionate Nasal Cream 0.0644% Treatment

Pre-filled syringe and applicator device DEVICE

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

Betamethasone Dipropionate Nasal Cream 0.0644% Treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oticara Australia PTY LTD: lead

Study Sites (1)

Oticara Clinical Trial Site

Sydney, New South Wales, 2000, Australia

Location

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Oticara Clinical

  Oticara Australia PTY LTD

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2022
• First Posted: February 2, 2022
• Study Start: February 23, 2022
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: May 2, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)