Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05220293




Registration number
NCT05220293
Ethics application status
Date submitted
21/01/2022
Date registered
2/02/2022
Date last updated
2/05/2024

Titles & IDs
Public title
Treatment of Eosinophilic Chronic Rhinosinusitis Utilizing Betamethasone Dipropionate Nasal Cream
Scientific title
The Effect of Betamethasone Dipropionate on Patients With Eosinophilic Chronic Rhinosinusitis
Secondary ID [1] 0 0
OT-007
Universal Trial Number (UTN)
Trial acronym
OT-007
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%, up to 5g per sinus.

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 symptoms score (4CSS) from Baseline to Week 3.
Timepoint [1] 0 0
Baseline to Week 3
Primary outcome [2] 0 0
Change in Visual Analogue Scale (VAS) (0-10) evaluating global disease severity score from Baseline to Week 3.
Timepoint [2] 0 0
Baseline to Week 3
Primary outcome [3] 0 0
Change in SNOT-22 Score from Baseline to Week 3.
Timepoint [3] 0 0
Baseline to Week 3
Primary outcome [4] 0 0
Change in Modified Lund Mackay Postoperative Endoscopy Score from Baseline to Week 3.
Timepoint [4] 0 0
Baseline to Week 3
Primary outcome [5] 0 0
Overall Patient Global Impression of Change at Week 3.
Timepoint [5] 0 0
Week 3
Secondary outcome [1] 0 0
BMDP Cream retention time on the sinus
Timepoint [1] 0 0
Treatment visit to Week 3
Secondary outcome [2] 0 0
To assess the safety of one application of BMDP CREAM onto the sinus
Timepoint [2] 0 0
Treatment visit to Week 3

Eligibility
Key inclusion criteria
- Adult patients with a clinically confirmed diagnosis of eCRS by a ENT undergoing
maximal medical therapy as part of their standard of care.

- Having undergone functional endoscopic sinus surgery at least 6 months prior to
enrolment.

- Participants with an endoscopic bilateral nasal polyp score of =5 out of a maximum
score of 8

- Score > 2 on disease severity visual analogue scale (VAS)

- A minimum body weight >=40 kilograms (kg) at screening visit

- Gender: Male or female (females of childbearing potential must use adequate birth
control methods and not plan to get pregnant during the course of the study).

- Informed consent: Willingness to give written informed consent and willingness to
participate to 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, corticosteroids or topical anaesthesia.

- Subjects with sino-nasal abnormalities, disease or implanted devices that prevent
application of the therapy.

- Previous enrolment in this study.

- Subjects currently required systemic corticosteroid use or receiving biologic therapy
as part of their disease management plan or who meet the PBS criteria for severe lower
airway disease.

- Subjects with history or current glaucoma or cataract or if they have abnormal IOP at
screening or pre-treatment (abnormal IOP is defined as greater than 21 mm Hg).

- Subjects with other conditions that could lead to elevated eosinophils such as
Hypereosinophilic Syndromes, including Churg-Strauss Syndrome, or Eosinophilic
Esophagitis.

- Subjects with acute sinusitis.

- Subjects with known immunodeficiency.

- Subjects with Diabetes (Type 1).

- Subjects with cystic fibrosis.

- Pregnant subjects or subjects currently lactating as the effect on human pregnancy is
unknown.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/02/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/12/2023
Sample size
Target
Accrual to date
Final
2
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Oticara Clinical Trial Site - Sydney
Recruitment postcode(s) [1] 0 0
2000 - Sydney

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

Ethics approval
Ethics application status

Summary
Brief summary
This is an open-label, single dose, pilot study, to assess the efficacy and safety of
Betamethasone Dipropionate Nasal Cream 0.0644% (equivalent to 0.05% Betamethasone) for the
treatment of eosinophilic Chronic Rhinosinusitis (eCRS).
Trial website
https://clinicaltrials.gov/ct2/show/NCT05220293
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Oticara Clinical
Address 0 0
Oticara Australia PTY LTD
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05220293