NCT05882903 The Effect of Intra-sinus Application of Betamethasone Dipropionate Nasal Cream on Patients with Chronic Rhinosinusitis Post Functional Endoscopic Sinus Surgery (FESS)
| NCT ID | NCT05882903 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Oticara Australia PTY LTD |
| Condition | Chronic Rhinosinusitis (Diagnosis) |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2023-08-17 |
| Primary Completion | 2025-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 24 participants in total. It began in 2023-08-17 with a primary completion date of 2025-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To assess the safety and efficacy of one (single) application of Betamethasone Dipropionate Nasal Cream (BMDP CREAM) onto 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05882903 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Chronic Rhinosinusitis (Diagnosis). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05882903 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05882903 currently recruiting?
Yes, NCT05882903 is actively recruiting participants. Contact the research team at contact@oticara.com for enrollment information.
Where is the NCT05882903 trial being conducted?
This trial is being conducted at Sydney, Australia, Brisbane, Australia, Adelaide, Australia, Perth, Australia.
Who is sponsoring the NCT05882903 clinical trial?
NCT05882903 is sponsored by Oticara Australia PTY LTD. The trial plans to enroll 24 participants.