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The Effect of Intra-sinus Application of Betamethasone Dipropionate Nasal Cream on Patients With Chronic Rhinosinusitis Post Functional Endoscopic Sinus Surgery (FESS)
To assess the safety and efficacy of one (single) application of Betamethasone Dipropionate Nasal Cream (BMDP CREAM) onto the sinus mucosa.
Study details:
In this open-label study, a single dose of the corticosteroid Betamethasone Dipropionate Nasal Cream 0. 0644% (equivalent to 0. 05% Betamethasone) will be administered under endoscopic guidance to the sinus mucosa of post-FESS patients whose chronic rhinosinusitis (CRS) condition is suboptimal under the current standard of care.
The safety and benefits of this treatment will be monitored by patient-reported symptoms and endoscopic assessment of the sinus mucosa.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-08-17
Primary completion: 2023-12-01
Study completion finish: 2023-12-01
Study type
TREATMENT
Phase
PHASE2
Trial ID
NCT05882903
Intervention or treatment
DRUG: Betamethasone Dipropionate Nasal Cream 0.0644%
DEVICE: Pre-filled syringe and applicator device
Conditions
- • Chronic Rhinosinusitis (Diagnosis)
Find a site
Closest Location:
Oticara Investigational Site
Research sites nearby
Select from list below to view details:
Oticara Investigational Site
Sydney, New South Wales, Australia
Oticara Investigational Site
Brisbane, Queensland, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Betamethasone Dipropionate Nasal Cream 0.0644% Treatment
| DRUG: Betamethasone Dipropionate Nasal Cream 0.0644%
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Change in 4-Cardinal Symptom score (4CSS) Baseline to Week 3. | Change in average daily score prior to dosing (an average of 7 days) and the average daily score of the 7 days prior to exit (between week 2 and 3 weeks after dosing).Participants score their 4-Cardinal Symptom score (4CSS) daily on a Likert scale of 0-5; where 0= no problem - 5= problem as bad as can be, higher scores indicate higher severity of symptoms. | Baseline through study completion, an average of 4 weeks |
Change in SNOT-22 Baseline to Week 3. | Participants complete the Sino-nasal Outcome Test (SNOT-22) questionnaire at Baseline and Week 3, analysis will focus on the nasal symptom subdomain. The SNOT-22 measures 22 symptoms on a Likert scale of 0-5; where 0= no problem - 5= problem as bad as can be, higher scores indicate higher severity of symptoms. A higher total score indicates greater symptom severity. | Baseline through study completion, an average of 4 weeks |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Safety of one application of BMDP Cream onto the sinus mucosa. | Monitoring of morning serum cortisol levels, glucose levels, treatment emergent changes in other chemistry or haematology results deemed clinically significant by the Investigator, intraocular pressure, and BMDP Cream application related adverse events. | Informed consent through study completion, an average of 3 weeks |
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