Treatment of Eosinophilic Chronic Rhinosinusitis Utilizing Betamethasone Dipropionate Nasal Cream

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Betamethasone Dipropionate on Patients With Eosinophilic Chronic Rhinosinusitis

Conditions
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Chronic Rhinosinusitis (Diagnosis)

Intervention / Treatment
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* Drug: Betamethasone Dipropionate Nasal Cream 0.0644%
* Device: Pre-filled syringe and applicator device


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Betamethasone Dipropionate Nasal Cream 0.0644% Treatment<br>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%<br>* Betamethasone Dipropionate Nasal Cream 0.0644%, up to 5g per sinus.<br>Device: Pre-filled syringe and applicator device<br>* Cream is pre-filled to a syringe and applicator device to facilitate the topical application direct to the sinus under endoscopic guidance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | Week 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMDP Cream retention time on the sinus | Visual inspection of cream retention time on the sinus via endoscope. | Treatment visit to Week 3 | 
| To assess the safety of one application of BMDP CREAM onto the sinus | Adverse event and intraocular pressure monitoring | Treatment visit to Week 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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eosinophilic Chronic Rhinosinusitis