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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
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Scientific title
The Effect of Betamethasone Dipropionate on Patients With Eosinophilic Chronic Rhinosinusitis
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Secondary ID [1]
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OT-007
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Universal Trial Number (UTN)
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Trial acronym
OT-007
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Rhinosinusitis (Diagnosis)
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Condition category
Condition code
Infection
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Other infectious diseases
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Respiratory
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in 4 cardinal symptoms score (4CSS) from Baseline to Week 3.
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline to Week 3
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Primary outcome [2]
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Change in Visual Analogue Scale (VAS) (0-10) evaluating global disease severity score from Baseline to Week 3.
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Assessment method [2]
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Participants score their global disease severity assessment daily on a Visual Analogue Scale (VAS) (0-10), higher score indicating greater disease severity.
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Timepoint [2]
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Baseline to Week 3
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Primary outcome [3]
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Change in SNOT-22 Score from Baseline to Week 3.
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Assessment method [3]
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Participants complete the SNOT-22 questionnaire at Baseline and Week 3,analysis will focus on the nasal and ear/facial subdomains. Higher scores indicate greater severity.
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Timepoint [3]
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Baseline to Week 3
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Primary outcome [4]
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Change in Modified Lund Mackay Postoperative Endoscopy Score from Baseline to Week 3.
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Assessment method [4]
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Change in Modified Lund Mackay Postoperative Endoscopy Score is evaluated by experienced ENT at Baseline to Week 3.
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Timepoint [4]
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Baseline to Week 3
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Primary outcome [5]
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Overall Patient Global Impression of Change at Week 3.
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Assessment method [5]
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Patient Global Impression of Change (recorded on a Likert scale 1-7, where 1= very much improved - 7= very much worse) will be completed by the participant at Week 3.
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Timepoint [5]
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Week 3
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Secondary outcome [1]
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BMDP Cream retention time on the sinus
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Assessment method [1]
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Visual inspection of cream retention time on the sinus via endoscope.
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Timepoint [1]
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Treatment visit to Week 3
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Secondary outcome [2]
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To assess the safety of one application of BMDP CREAM onto the sinus
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Assessment method [2]
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Adverse event and intraocular pressure monitoring
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Timepoint [2]
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Treatment visit to Week 3
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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.
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
23/02/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
30/12/2023
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Sample size
Target
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Accrual to date
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Final
2
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Oticara Clinical Trial Site - Sydney
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Recruitment postcode(s) [1]
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2000 - Sydney
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Oticara Australia PTY LTD
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Address
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Country
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Ethics approval
Ethics application status
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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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05220293
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Oticara Clinical
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Address
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Oticara Australia PTY LTD
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05220293
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