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

November 10, 2024 updated by: Oticara Australia PTY LTD
To assess the safety and efficacy of one (single) application of Betamethasone Dipropionate Nasal Cream (BMDP CREAM) onto the sinus mucosa.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2153
        • Recruiting
        • Oticara Investigational Site
    • Queensland
      • Brisbane, Queensland, Australia, 4029
        • Recruiting
        • Oticara Investigational Site
    • South Australia
      • Adelaide, South Australia, Australia, 5042
        • Recruiting
        • Oticara Investigational Site
    • Western Australia
      • Perth, Western Australia, Australia, 6163
        • Recruiting
        • Oticara Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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).
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.
Drug: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in 4-Cardinal Symptom score (4CSS) Baseline to Week 3.
Time Frame: Baseline through study completion, an average of 4 weeks
Change in average daily score prior to dosing (an average of 7 days) and the average daily score of the 7 days prior to exit (between week 2 and 3 weeks after dosing).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 through study completion, an average of 4 weeks
Change in SNOT-22 Baseline to Week 3.
Time Frame: Baseline through study completion, an average of 4 weeks
Participants complete the Sino-nasal Outcome Test (SNOT-22) questionnaire at Baseline and Week 3, analysis will focus on the nasal symptom subdomain. The SNOT-22 measures 22 symptoms 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. A higher total score indicates greater symptom severity.
Baseline through study completion, an average of 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of one application of BMDP Cream onto the sinus mucosa.
Time Frame: Informed consent through study completion, an average of 3 weeks
Monitoring of morning serum cortisol levels, glucose levels, treatment emergent changes in other chemistry or haematology results deemed clinically significant by the Investigator, intraocular pressure, and BMDP Cream application related adverse events.
Informed consent through study completion, an average of 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oticara Australia PTY LTD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 17, 2023

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

May 12, 2023

First Submitted That Met QC Criteria

May 22, 2023

First Posted (Actual)

May 31, 2023

Study Record Updates

Last Update Posted (Estimated)

November 12, 2024

Last Update Submitted That Met QC Criteria

November 10, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OT-007B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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