Applying Betamethasone Cream to Sinuses After Surgery for Chronic Rhinosinusitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: contact@oticara.com
• Phone: +1 279-217-0054

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.