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
93 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To assess the safety and efficacy of one (single) application of Betamethasone Dipropionate Nasal Cream (BMDP CREAM) onto the sinus mucosa.
CONDITIONS
Official 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 confirmed diagnosis of chronic rhinosinusitis by an ear, nose, and throat specialist receiving maximum medical therapy
- Underwent functional endoscopic sinus surgery at least 6 months before joining the study
- Each nostril has a nasal polyp score of 0, 1, or 2 based on endoscopic examination
- Visible middle turbinates and access to ethmoid sinuses confirmed by endoscopy
- Disease severity score greater than 2 on the visual analogue scale at screening and before treatment
- Body weight of at least 40 kilograms and body mass index of 39 or less at screening
- If able to have children, using effective birth control and not planning pregnancy during the study
- Willing and able to provide written informed consent and follow study procedures
- Aged 18 years or older but younger than 80 years
You will not qualify if you...
- Known allergy or contraindication to betamethasone dipropionate, mometasone, or topical anesthesia
- Conditions or devices in the nose or sinuses that prevent treatment application
- Prior participation in this study
- Using systemic corticosteroids currently or within the past 4 weeks, or receiving biologic therapy
- History of glaucoma, cataracts, or abnormal eye pressure above 21 mm Hg
- Having acute sinusitis at the time of screening
- Known immune system deficiencies
- Type 1 diabetes
- Cystic fibrosis
- Pregnant, breastfeeding, or trying to get pregnant
- Unable to give informed consent due to mental illness, dementia, or communication problems
- Diagnosed with Cushing's disease within the past 12 months
- Severe nasal septum deviation or previous total removal of the middle turbinate
- Any laboratory or medical condition considered exclusionary by the investigator
- Unlikely to follow study procedures and requirements as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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