Clinical trial NCT05882903: The Effect of Intra-sinus Application of Betamethasone Dipropionate Nasal Cream on Patients with Chronic Rhinosinusitis Post Functional Endoscopic Sinus Surgery (FESS)
Official title: The Effect of Intra-sinus Application of Betamethasone Dipropionate Nasal Cream on Patients with Chronic Rhinosinusitis Post Functional Endoscopic Sinus Surgery (FESS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Chronic Rhinosinusitis (Diagnosis)
Lead sponsor: Oticara Australia PTY LTD
Sponsor class: INDUSTRY
First posted: 2023-05-31
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in 4-Cardinal Symptom score (4CSS) Baseline to Week 3.
timeFrame: Baseline through study completion, an average of 4 weeks
measure: Change in SNOT-22 Baseline to Week 3.
timeFrame: Baseline through study completion, an average of 4 weeks
Secondary outcomes:
measure: Safety of one application of BMDP Cream onto the sinus mucosa.
timeFrame: Informed consent through study completion, an average of 3 weeks
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Oticara Investigational Site
state: New South Wales
city: Brisbane
country: Australia
facility: Oticara Investigational Site
state: Queensland
city: Adelaide
country: Australia
facility: Oticara Investigational Site
state: South Australia
city: Perth
country: Australia
facility: Oticara Investigational Site
state: Western Australia
Study officials:
References: