Chronic Rhinosinusitis (Diagnosis)Phase 2NCT05882903
The Effect of Intra-sinus Application of Betamethasone Dipropionate Nasal Cream on Patients with Chronic Rhinosinusitis Post Functional Endoscopic Sinus Surgery (FESS)
A Phase 2 study testing Betamethasone Dipropionate Nasal Cream 0.0644% and Pre-filled syringe and applicator device in people with Chronic Rhinosinusitis (Diagnosis), run by Oticara Australia PTY LTD at 4 sites in Australia.
Trial summary
To assess the safety and efficacy of one (single) application of Betamethasone Dipropionate Nasal Cream (BMDP CREAM) onto the sinus mucosa. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Rhinosinusitis (Diagnosis)
- What is being tested?
- Betamethasone Dipropionate Nasal Cream 0.0644% and Pre-filled syringe and applicator device
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 4 sitesAustralia
- Study dates
- 17 Aug 2023to 1 Jun 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia4 sites, 4 recruiting
- Recruiting
Oticara Investigational Site
Adelaide, South Australia, 5042
- Recruiting
Oticara Investigational Site
Brisbane, Queensland, 4029
- Recruiting
Oticara Investigational Site
Perth, Western Australia, 6163
- Recruiting
Oticara Investigational Site
Sydney, New South Wales, 2153
About this study
To assess the safety and efficacy of one (single) application of Betamethasone Dipropionate Nasal Cream (BMDP CREAM) onto the sinus mucosa.
Read the detailed description
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.
- Conditions
- Chronic Rhinosinusitis (Diagnosis)
- Being tested
- Betamethasone Dipropionate Nasal Cream 0.0644%, Pre-filled syringe and applicator device
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Betamethasone Dipropionate Nasal Cream 0.0644%Drug
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).
Pre-filled syringe and applicator deviceDevice
Cream is pre-filled to a syringe and applicator device to facilitate the topical application direct to the sinus under endoscopic guidance.
| Study group | Role | What they receive |
|---|---|---|
| Betamethasone Dipropionate Nasal Cream 0.0644% Treatment | Experimental | 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). Receives: Drug: Betamethasone Dipropionate Nasal Cream 0.0644%; Device: Pre-filled syringe and applicator device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline through study completion, an average of 4 weeks
Secondary outcomes (1)
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.
Measured: Informed consent through study completion, an average of 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start17 Aug 2023
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Rhinosinusitis (Diagnosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oticara Australia PTY LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05882903
- Sponsor's protocol ID
- OT-007B
- Status last verified
- Nov 2024
- First submitted
- 12 May 2023
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intra-sinus Application of Betamethasone Dipropionate Nasal Cream on Patients with Chronic Rhinosinusitis Post Functional Endoscopic Sinus Surgery (FESS)
- ClinicalTrials.gov ID
- NCT05882903
- Acronym / sponsor ID
- OT-007B
- Conditions
- Chronic Rhinosinusitis (Diagnosis)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Oticara Australia PTY LTDIndustry (pharma, biotech, devices)
- Study start
- 17 Aug 2023 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 31 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the safety and efficacy of one (single) application of Betamethasone Dipropionate Nasal Cream (BMDP CREAM) onto the sinus mucosa.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Betamethasone Dipropionate Nasal Cream 0.0644% Treatment | Experimental | Drug: Betamethasone Dipropionate Nasal Cream 0.0644%, Device: Pre-filled syringe and applicator deviceBetamethasone 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). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (15 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Drug | Betamethasone Dipropionate Nasal Cream 0.0644% Treatment |
| Pre-filled syringe and applicator deviceCream is pre-filled to a syringe and applicator device to facilitate the topical application direct to the sinus under endoscopic guidance. | Device | Betamethasone Dipropionate Nasal Cream 0.0644% Treatment |
Primary outcome
Change in 4-Cardinal Symptom score (4CSS) Baseline to Week 3.
Time frame: Baseline through study completion, an average of 4 weeks
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.
Change in SNOT-22 Baseline to Week 3.
Time frame: Baseline through study completion, an average of 4 weeks
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.
1 secondary outcome
Safety of one application of BMDP Cream onto the sinus mucosa.
Time frame: Informed consent through study completion, an average of 3 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Betamethasone Dipropionate Nasal Cream 0.0644% and Pre-filled syringe and applicator device in people with Chronic Rhinosinusitis (Diagnosis), run by Oticara Australia PTY LTD at 4 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oticara Clinical (+1 279-217-0054, contact@oticara.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 4-Cardinal Symptom score (4CSS) Baseline to Week 3. (time frame: Baseline through study completion, an average of 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.