Chronic Rhinosinusitis (Diagnosis)
Conditions
Keywords
eosinophilic Chronic Rhinosinusitis
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).
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.
Interventions
Betamethasone Dipropionate Nasal Cream 0.0644%, up to 5g per sinus.
Cream is pre-filled to a syringe and applicator device to facilitate the topical application direct to the sinus under endoscopic guidance.
Sponsors
Oticara Australia PTY LTD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Visual Analogue Scale (VAS) (0-10) evaluating global disease severity score from Baseline to Week 3. | 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 Modified Lund Mackay Postoperative Endoscopy Score from Baseline to Week 3. | 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. | 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. |
| Change in 4 cardinal symptoms score (4CSS) from Baseline to Week 3. | 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 SNOT-22 Score from Baseline to Week 3. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To assess the safety of one application of BMDP CREAM onto the sinus | Treatment visit to Week 3 | Adverse event and intraocular pressure monitoring |
| BMDP Cream retention time on the sinus | Treatment visit to Week 3 | Visual inspection of cream retention time on the sinus via endoscope. |
Countries
Australia
Outcome results
None listed