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

Primary Purpose

Chronic Rhinosinusitis (Diagnosis)

Status

Recruiting

Phase

Phase 1

Locations

Australia

Study Type

Interventional

Intervention

Betamethasone Dipropionate Nasal Cream 0.0644%

Pre-filled syringe and applicator device

About this trial

This is an interventional treatment trial for Chronic Rhinosinusitis (Diagnosis) focused on measuring eosinophilic Chronic Rhinosinusitis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sydney Ear Nose and Throat Clinic Pty LtdRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Betamethasone Dipropionate Nasal Cream 0.0644% Treatment

Arm Description

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).

Outcomes

Primary Outcome Measures

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.

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.

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.

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.

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.

Secondary Outcome Measures

BMDP Cream retention time on the sinus

Visual inspection of cream retention time on the sinus via endoscope.

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

Adverse event and intraocular pressure monitoring

Full Information

NCT ID

NCT05220293

First Posted

January 21, 2022

Last Updated

September 19, 2022

Sponsor

Oticara Australia PTY LTD

1. Study Identification

Unique Protocol Identification Number

NCT05220293

Brief Title

Treatment of Eosinophilic Chronic Rhinosinusitis Utilizing Betamethasone Dipropionate Nasal Cream

Acronym

OT-007

Official Title

The Effect of Betamethasone Dipropionate on Patients With Eosinophilic Chronic Rhinosinusitis

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Recruiting

Study Start Date

February 23, 2022 (Actual)

Primary Completion Date

December 31, 2022 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Oticara Australia PTY LTD

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Rhinosinusitis (Diagnosis)

Keywords

eosinophilic Chronic Rhinosinusitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Betamethasone Dipropionate Nasal Cream 0.0644% Treatment

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Betamethasone Dipropionate Nasal Cream 0.0644%

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Pre-filled syringe and applicator device

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in 4 cardinal symptoms score (4CSS) from Baseline to Week 3.

Description

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.

Time Frame

Baseline to Week 3

Title

Change in Visual Analogue Scale (VAS) (0-10) evaluating global disease severity score from Baseline to Week 3.

Description

Participants score their global disease severity assessment daily on a Visual Analogue Scale (VAS) (0-10), higher score indicating greater disease severity.

Time Frame

Baseline to Week 3

Title

Change in SNOT-22 Score from Baseline to Week 3.

Description

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.

Time Frame

Baseline to Week 3

Title

Change in Modified Lund Mackay Postoperative Endoscopy Score from Baseline to Week 3.

Description

Change in Modified Lund Mackay Postoperative Endoscopy Score is evaluated by experienced ENT at Baseline to Week 3.

Time Frame

Baseline to Week 3

Title

Overall Patient Global Impression of Change at Week 3.

Description

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.

Time Frame

Week 3

Secondary Outcome Measure Information:

Title

BMDP Cream retention time on the sinus

Description

Visual inspection of cream retention time on the sinus via endoscope.

Time Frame

Treatment visit to Week 3

Title

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

Description

Adverse event and intraocular pressure monitoring

Time Frame

Treatment visit to Week 3

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Raquel Alvarado

Phone

02 9360 4811

raquel@sydneyentclinic.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard Harvey

Organizational Affiliation

Principal Investigator

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sydney Ear Nose and Throat Clinic Pty Ltd

City

Darlinghurst

State/Province

New South Wales

ZIP/Postal Code

2036

Country

Australia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Raquel Alvarado

Phone

02 9360 4811

Raquel@sydneyentclinic.com

First Name & Middle Initial & Last Name & Degree

Richard Harvey

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

There is not a plan to make IPD available.

Learn more about this trial

Treatment of Eosinophilic Chronic Rhinosinusitis Utilizing Betamethasone Dipropionate Nasal Cream

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