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New treatment option for Chronic Rhinosinusitis (Diagnosis)
Official title The Effect of Intra-sinus Application of Betamethasone Dipropionate Nasal Cream on Patients with Chronic Rhinosinusitis Post Functional Endoscopic Sinus Surgery (FESS)
ClinicalTrials.gov ID: NCT05882903
What this study is testing
What is Betamethasone Dipropionate Nasal Cream 0.0644%?
Betamethasone Dipropionate Nasal Cream 0.0644% is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for chronic rhinosinusitis (diagnosis).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To assess the safety and efficacy of one (single) application of Betamethasone Dipropionate Nasal Cream (BMDP CREAM) onto the sinus mucosa.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Adult patients with a clinically confirmed diagnosis of CRS by an otolaryngologist (ENT) undergoing maximal medical therapy as part of their standard...
- 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...
- 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.
You likely can't join if
- people with known hypersensitivity or contraindications to betamethasone dipropionate, mometasone, or topical anaesthesia.
- people with sino-nasal abnormalities, disease, or implanted devices that prevents the application of the therapy.
- Previous enrolment in this study.
- people currently receiving systemic corticosteroid or have received systemic corticosteroid in the prior 4 weeks or receiving biologic therapy.
- people with a history of glaucoma or cataracts or have an abnormal intraocular pressure (IOP) at screening or pre-treatment (abnormal IOP is defined...
- people with acute sinusitis.
See the full eligibility 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=...
- 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.
- people with known hypersensitivity or contraindications to betamethasone dipropionate, mometasone, or topical anaesthesia.
- people with sino-nasal abnormalities, disease, or implanted devices that prevents the application of the therapy.
- Previous enrolment in this study.
- people currently receiving systemic corticosteroid or have received systemic corticosteroid in the prior 4 weeks or receiving biologic therapy.
- people 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).
- people with acute sinusitis.
- people with known immunodeficiency.
- people with diabetes (Type 1).
- people with cystic fibrosis.
- Pregnant people or people trying to get pregnant or currently lactating as the effect on human pregnancy is unknown.
- people who are unable to give an informed consent because of mental illness, dementia or communication difficulties.
- people 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.
- people who are unlikely to comply with study procedures, restrictions and requirements as determined by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Sydney, New South Wales, Australia
- Brisbane, Queensland, Australia
- Adelaide, South Australia, Australia
- Perth, Western Australia, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sydney, New South Wales, Australia; Brisbane, Queensland, Australia; Adelaide, South Australia, Australia; Perth, Western Australia, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.