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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05882903




Registration number
NCT05882903
Ethics application status
Date submitted
12/05/2023
Date registered
31/05/2023
Date last updated
30/08/2023

Titles & IDs
Public title
The Effect of Intra-sinus Application of Betamethasone Dipropionate Nasal Cream on Patients With Chronic Rhinosinusitis Post Functional Endoscopic Sinus Surgery (FESS)
Scientific title
The Effect of Intra-sinus Application of Betamethasone Dipropionate Nasal Cream on Patients With Chronic Rhinosinusitis Post Functional Endoscopic Sinus Surgery (FESS)
Secondary ID [1] 0 0
OT-007B
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Rhinosinusitis (Diagnosis) 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Betamethasone Dipropionate Nasal Cream 0.0644%
Treatment: Devices - Pre-filled syringe and applicator device

Experimental: Betamethasone Dipropionate Nasal Cream 0.0644% Treatment - Betamethasone Dipropionate Nasal Cream 0.0644% is applied topically to the inflamed tissue of the sinus using a pre-filled syringe and applicator under the guidance of an endoscope. Up to 5g on each side of the sinus (10g in total).


Treatment: Drugs: Betamethasone Dipropionate Nasal Cream 0.0644%
Betamethasone Dipropionate Nasal Cream 0.0644% is applied topically to the inflamed tissue of the sinus using a pre-filled syringe and applicator under the guidance of an endoscope. Up to 5g on each side of the sinus (10g in total).

Treatment: Devices: Pre-filled syringe and applicator device
Cream is pre-filled to a syringe and applicator device to facilitate the topical application direct to the sinus under endoscopic guidance.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in 4-Cardinal Symptom score (4CSS) Baseline to Week 3.
Timepoint [1] 0 0
Baseline through study completion, an average of 4 weeks
Primary outcome [2] 0 0
Change in SNOT-22 Baseline to Week 3.
Timepoint [2] 0 0
Baseline through study completion, an average of 4 weeks
Secondary outcome [1] 0 0
Safety of one application of BMDP Cream onto the sinus mucosa.
Timepoint [1] 0 0
Informed consent through study completion, an average of 3 weeks

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subjects with known hypersensitivity or contraindications to betamethasone dipropionate, mometasone, or topical anaesthesia.
* Subjects with sino-nasal abnormalities, disease, or implanted devices that prevents the application of the therapy.
* Previous enrolment in this study.
* Subjects currently receiving systemic corticosteroid or have received systemic corticosteroid in the prior 4 weeks or receiving biologic therapy.
* Subjects 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).
* Subjects with acute sinusitis.
* Subjects with known immunodeficiency.
* Subjects with diabetes (Type 1).
* Subjects with cystic fibrosis.
* Pregnant subjects or subjects trying to get pregnant or currently lactating as the effect on human pregnancy is unknown.
* Subjects who are unable to give an informed consent because of mental illness, dementia or communication difficulties.
* Subjects 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.
* Subjects who are unlikely to comply with study procedures, restrictions and requirements as determined by the investigator.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/08/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2023
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Oticara Investigational Site - Sydney
Recruitment hospital [2] 0 0
Oticara Investigational Site - Brisbane
Recruitment postcode(s) [1] 0 0
2153 - Sydney
Recruitment postcode(s) [2] 0 0
4029 - Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Oticara Australia PTY LTD
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To assess the safety and efficacy of one (single) application of Betamethasone Dipropionate Nasal Cream (BMDP CREAM) onto the sinus mucosa.
Trial website
https://clinicaltrials.gov/study/NCT05882903
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Oticara Clinical
Address 0 0
Country 0 0
Phone 0 0
+1 279-217-0054
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05882903