Chronic Rhinosinusitis (Diagnosis)Phase 1/2OT-007NCT05220293
Treatment of Eosinophilic Chronic Rhinosinusitis Utilizing Betamethasone Dipropionate Nasal Cream
A Phase 1/2 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 1 site in Australia.
Trial 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). 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
- 2 participants
- Where
- 1 siteAustralia
- Study dates
- 23 Feb 2022to 30 Dec 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Betamethasone Dipropionate on Patients With Eosinophilic Chronic Rhinosinusitis
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).
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 eCRS condition is suboptimal under the current standard of care. The safety and benefits of this treatment will be monitored by patient-reported symptoms and visualization of the sinus mucosa.
- Conditions
- Chronic Rhinosinusitis (Diagnosis)
- Being tested
- Betamethasone Dipropionate Nasal Cream 0.0644%, Pre-filled syringe and applicator device
- Keywords
- eosinophilic Chronic Rhinosinusitis
- 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%, up to 5g per sinus.
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 symptoms score (4CSS) from Baseline to Week 3.
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 to Week 3
Change in Visual Analogue Scale (VAS) (0-10) evaluating global disease severity score from Baseline to Week 3.
Participants score their global disease severity assessment daily on a Visual Analogue Scale (VAS) (0-10), higher score indicating greater disease severity.
Measured: Baseline to Week 3
Change in SNOT-22 Score from Baseline to Week 3.
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.
Measured: Baseline to Week 3
Change in Modified Lund Mackay Postoperative Endoscopy Score from Baseline to Week 3.
Change in Modified Lund Mackay Postoperative Endoscopy Score is evaluated by experienced ENT at Baseline to Week 3.
Measured: Baseline to Week 3
Overall Patient Global Impression of Change at Week 3.
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.
Measured: Week 3
Secondary outcomes (2)
BMDP Cream retention time on the sinus
Visual inspection of cream retention time on the sinus via endoscope.
Measured: Treatment visit to Week 3
To assess the safety of one application of BMDP CREAM onto the sinus
Adverse event and intraocular pressure monitoring
Measured: Treatment visit to Week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start23 Feb 2022
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Why it stopped: Single site study OT-007 re-opened as multi-site OT-007B study
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oticara Australia PTY LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Oticara Clinical, Study director, Oticara Australia PTY LTD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05220293
- Sponsor's protocol ID
- OT-007
- Acronym
- OT-007
- Status last verified
- Apr 2024
- First submitted
- 21 Jan 2022
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Betamethasone Dipropionate on Patients With Eosinophilic Chronic Rhinosinusitis
- ClinicalTrials.gov ID
- NCT05220293
- Acronym / sponsor ID
- OT-007 / OT-007
- Conditions
- Chronic Rhinosinusitis (Diagnosis)
- Keywords
- eosinophilic Chronic Rhinosinusitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Single site study OT-007 re-opened as multi-site OT-007B study
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Oticara Australia PTY LTDIndustry (pharma, biotech, devices)
- Study start
- 23 Feb 2022 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 2 Feb 2022 (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.
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).
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 eCRS condition is suboptimal under the current standard of care. The safety and benefits of this treatment will be monitored by patient-reported symptoms and visualization 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 (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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).
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%, up to 5g per sinus. | 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 symptoms score (4CSS) from Baseline to Week 3.
Time frame: Baseline to Week 3
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 Visual Analogue Scale (VAS) (0-10) evaluating global disease severity score from Baseline to Week 3.
Time frame: Baseline to Week 3
Participants score their global disease severity assessment daily on a Visual Analogue Scale (VAS) (0-10), higher score indicating greater disease severity.
Change in SNOT-22 Score from Baseline to Week 3.
Time frame: Baseline to Week 3
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.
Change in Modified Lund Mackay Postoperative Endoscopy Score from Baseline to Week 3.
Time frame: Baseline to Week 3
Change in Modified Lund Mackay Postoperative Endoscopy Score is evaluated by experienced ENT at Baseline to Week 3.
Overall Patient Global Impression of Change at Week 3.
Time frame: Week 3
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.
2 secondary outcomes
BMDP Cream retention time on the sinus
Time frame: Treatment visit to Week 3
To assess the safety of one application of BMDP CREAM onto the sinus
Time frame: Treatment visit to Week 3
Results and safety
The study was stopped early (reason given: Single site study OT-007 re-opened as multi-site OT-007B study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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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. This study is not recruiting at the moment.
Oticara Clinical study director
Oticara Australia PTY LTD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 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 1 site 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 8 inclusion and 11 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: stopped early, as of the sponsor's last update on 2 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study was stopped early (reason given: Single site study OT-007 re-opened as multi-site OT-007B study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 4 cardinal symptoms score (4CSS) from Baseline to Week 3. (time frame: Baseline to Week 3). The study lists 5 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 2 May 2024.