Treatment of Eosinophilic Chronic Rhinosinusitis Utilizing Betamethasone Dipropionate Nasal Cream (OT-007)

Oticara

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Chronic Rhinosinusitis (Diagnosis)

Treatments: Device: Pre-filled syringe and applicator device; Drug: Betamethasone Dipropionate Nasal Cream 0.0644%

Study type: Interventional

Funder types: Industry

Identifiers

NCT05220293

OT-007

Details and patient eligibility

About

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).

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

Betamethasone Dipropionate Nasal Cream 0.0644% Treatment

Experimental group

Description:

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).

Treatment:

Drug: Betamethasone Dipropionate Nasal Cream 0.0644%

Device: Pre-filled syringe and applicator device