Actively Recruiting
The Effect of Intra-sinus Application of Betamethasone Dipropionate Nasal Cream on Patients with Chronic Rhinosinusitis Post Functional Endoscopic Sinus Surgery (FESS)
Led by Oticara Australia PTY LTD · Updated on 2024-11-12
24
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a single application of Betamethasone Dipropionate Nasal Cream (0.0644%) on the sinus mucosa in patients with chronic rhinosinusitis (CRS) who have had functional endoscopic sinus surgery (FESS) but still have suboptimal symptom control. This open-label Phase 2 study aims to monitor the treatment's impact on patient-reported symptoms and the condition of the sinus mucosa. Participants will receive one topical dose of Betamethasone Dipropionate Nasal Cream applied directly to the inflamed sinus tissue using a pre-filled syringe and applicator under endoscopic guidance. Up to 5 grams of the cream will be applied to each side of the sinus during this procedure. This single treatment is followed by monitoring over approximately four weeks. During the study, participants will have their symptoms assessed using the 4-Cardinal Symptom score and the SNOT-22 survey from baseline through about three weeks after treatment. Safety will be evaluated throughout the study period. Endoscopic examinations will assess the sinus mucosa before and after treatment. The total participation time is about four weeks, during which researchers will track symptom changes and any side effects related to the treatment.
CONDITIONS
Brief Title
The Effect of Intra-sinus Application of Betamethasone Dipropionate Nasal Cream on Patients with Chronic Rhinosinusitis Post Functional Endoscopic Sinus Surgery (FESS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients with a clinically confirmed diagnosis of chronic rhinosinusitis by an ear, nose, and throat specialist undergoing maximal medical therapy.
- Have undergone functional endoscopic sinus surgery (FESS) at least 6 months prior to enrollment.
- Have an endoscopic nasal polyp score of 0, 1, or 2 in each nostril.
- Visible middle turbinates and access to the ethmoid sinuses for dosing confirmed by endoscopic exam.
- Disease severity visual analogue scale (VAS) score greater than 2 at screening and pre-treatment.
- Body weight at least 40 kilograms and body mass index (BMI) of 39 or less at screening.
- Use adequate birth control if of childbearing potential and not planning pregnancy during the study.
- Willingness to give written informed consent and comply with study procedures.
- Age 18 years or older but less than 80 years.
You will not qualify if you...
- Known allergy or contraindication to betamethasone dipropionate, mometasone, or topical anaesthesia.
- Presence of sino-nasal abnormalities, diseases, or implanted devices preventing therapy application.
- Previous participation in this study.
- Current or recent (within 4 weeks) use of systemic corticosteroids or biologic therapy.
- History of glaucoma, cataracts, or abnormal intraocular pressure above 21 mm Hg.
- Acute sinusitis.
- Known immunodeficiency.
- Type 1 diabetes.
- Cystic fibrosis.
- Pregnant, trying to get pregnant, or currently breastfeeding.
- Unable to give informed consent due to mental illness, dementia, or communication difficulties.
- Diagnosis of Cushing's disease within the past 12 months.
- Severe septal deviation or previous total removal of the middle turbinate.
- Any laboratory abnormalities or medical conditions deemed exclusionary by the investigator.
- Unlikely to comply with study procedures and requirements as determined by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 day
Participants receive a single dose of Betamethasone Dipropionate Nasal Cream applied under endoscopic guidance to the sinus mucosa.
1 treatment visit (in-person)
Duration - About 3 weeks
Participants are monitored for safety and treatment benefits through patient-reported symptoms and endoscopic assessments.
Approximately 2 follow-up visits (in-person)
Trial Site Locations
Total: 4 locations
1
Oticara Investigational Site
Sydney, New South Wales, Australia, 2153
Actively Recruiting
2
Oticara Investigational Site
Brisbane, Queensland, Australia, 4029
Actively Recruiting
3
Oticara Investigational Site
Adelaide, South Australia, Australia, 5042
Actively Recruiting
4
Oticara Investigational Site
Perth, Western Australia, Australia, 6163
Actively Recruiting
Research Team
O
Oticara Clinical
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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