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

PHASE2RECRUITING

To assess the safety and efficacy of one (single) application of Betamethasone Dipropionate Nasal Cream (BMDP CREAM) onto the sinus mucosa.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2023-08-17

Primary completion: 2023-12-01

Study completion finish: 2023-12-01

Study type

TREATMENT

Phase

PHASE2

Trial ID

NCT05882903

Intervention or treatment

DRUG: Betamethasone Dipropionate Nasal Cream 0.0644%

DEVICE: Pre-filled syringe and applicator device

Conditions

• Chronic Rhinosinusitis (Diagnosis)

Image related to Chronic Rhinosinusitis (Diagnosis)

Condition: Chronic Rhinosinusitis (Diagnosis)
DRUG: Betamethasone Dipropionate Nasal Cream 0.0644% and other drugs
Sydney, New South Wales, Australia and more
Sponsor: Oticara Australia PTY LTD

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Oticara Investigational Site

Research sites nearby

Select from list below to view details:

Oticara Investigational Site
Sydney, New South Wales, Australia
Oticara Investigational Site
Brisbane, Queensland, Australia

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?

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% 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

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Change in 4-Cardinal Symptom score (4CSS) Baseline to Week 3.	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.	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

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Safety of one application of BMDP Cream onto the sinus mucosa.	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

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References

Clinical Trials Gov: The Effect of Intra-sinus Application of Betamethasone Dipropionate Nasal Cream on Patients With Chronic Rhinosinusitis Post Functional Endoscopic Sinus Surgery (FESS)