Clinical trial NCT05220293: Treatment of Eosinophilic Chronic Rhinosinusitis Utilizing Betamethasone Dipropionate Nasal Cream
Official title: The Effect of Betamethasone Dipropionate on Patients With Eosinophilic Chronic Rhinosinusitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Chronic Rhinosinusitis (Diagnosis)
Keywords: eosinophilic Chronic Rhinosinusitis
Lead sponsor: Oticara Australia PTY LTD
Sponsor class: INDUSTRY
First posted: 2022-02-02
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in 4 cardinal symptoms score (4CSS) from Baseline to Week 3.
timeFrame: Baseline to Week 3
measure: Change in Visual Analogue Scale (VAS) (0-10) evaluating global disease severity score from Baseline to Week 3.
timeFrame: Baseline to Week 3
measure: Change in SNOT-22 Score from Baseline to Week 3.
timeFrame: Baseline to Week 3
measure: Change in Modified Lund Mackay Postoperative Endoscopy Score from Baseline to Week 3.
timeFrame: Baseline to Week 3
measure: Overall Patient Global Impression of Change at Week 3.
timeFrame: Week 3
Secondary outcomes:
measure: BMDP Cream retention time on the sinus
timeFrame: Treatment visit to Week 3
measure: To assess the safety of one application of BMDP CREAM onto the sinus
timeFrame: Treatment visit to Week 3
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Oticara Clinical Trial Site
state: New South Wales
Study officials:
affiliation: Oticara Australia PTY LTD
name: Oticara Clinical
role: STUDY_DIRECTOR
References: