Applying Betamethasone Cream to Sinuses After Surgery for Chronic Rhinosinusitis

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

This study is testing if applying a special cream to the sinuses after surgery can help people with chronic sinus issues feel better when other treatments haven't worked.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Oticara Australia PTY LTD (Industry-sponsored)
• Locations: 4 sites (Sydney, New South Wales and 3 other locations)
• Trial ID: NCT05882903 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of a single application of Betamethasone Dipropionate Nasal Cream on the sinus mucosa of patients suffering from chronic rhinosinusitis (CRS) after undergoing functional endoscopic sinus surgery (FESS). Conducted as an open-label trial, the treatment will be administered under endoscopic guidance to patients whose CRS symptoms remain inadequately managed by standard care. The outcomes will be assessed through patient-reported symptoms and endoscopic evaluations of the sinus mucosa.

Who should consider this trial

Good fit: Ideal candidates include adults with a confirmed diagnosis of chronic rhinosinusitis who have undergone FESS at least six months prior and are experiencing suboptimal symptom control.

Not a fit: Patients with severe nasal polyps or those who have not undergone FESS may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could significantly improve symptom relief for patients with chronic rhinosinusitis post-surgery.

How similar studies have performed: While this approach is novel, similar studies have shown promise in using corticosteroids for managing chronic rhinosinusitis.

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.

Where this trial is running

Sydney, New South Wales and 3 other locations

• Oticara Investigational Site — Sydney, New South Wales, Australia (Recruiting)
• Oticara Investigational Site — Brisbane, Queensland, Australia (Recruiting)
• Oticara Investigational Site — Adelaide, South Australia, Australia (Recruiting)
• Oticara Investigational Site — Perth, Western Australia, Australia (Recruiting)

Study contacts

• Study coordinator: Oticara Clinical

Conditions Chronic Rhinosinusitis