The Effect of Intra-sinus Application of Betamethasone Dipropionate Nasal Cream on Patients with … (NCT05882903) | Clinical Trial Compass
RecruitingPhase 2
The Effect of Intra-sinus Application of Betamethasone Dipropionate Nasal Cream on Patients with Chronic Rhinosinusitis Post Functional Endoscopic Sinus Surgery (FESS)
Australia24 participantsStarted 2023-08-17
Plain-language summary
To assess the safety and efficacy of one (single) application of Betamethasone Dipropionate Nasal Cream (BMDP CREAM) onto the sinus mucosa.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 betam…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 2 trial testing betamethasone dipropionate nasal cream applied directly inside the sinuses after FESS, what is currently known about the safety of using this cream this way, and what side effects should I watch for?
2The trial measures changes in symptoms and quality of life over just 3 weeks — does that short window tell us enough about whether this treatment might help me in the longer term, or would you expect to see meaningful improvement that quickly after FESS?
3I already had FESS — is my recovery stage or the current state of my sinuses likely to affect whether I could participate in this trial, and would joining it interfere with my standard post-surgery care?
4Are there established post-FESS treatments for chronic rhinosinusitis, like standard steroid rinses or sprays, that might be a better-proven option for me right now instead of enrolling in a Phase 2 study?
5The trial uses a symptom score called the 4CSS and a quality-of-life questionnaire called the SNOT-22 to measure results — can you help me understand what a meaningful improvement on those scales would actually feel like in my day-to-day life?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in 4-Cardinal Symptom score (4CSS) Baseline to Week 3.
Timeframe: Baseline through study completion, an average of 4 weeks
2
Change in SNOT-22 Baseline to Week 3.
Timeframe: Baseline through study completion, an average of 4 weeks