Treatment of Eosinophilic Chronic Rhinosinusitis Utilizing Betamethasone Dipropionate Nasal Cream

• Status: Recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oticara Australia PTY LTD
• Treatments: Betamethasone; Betamethasone benzoate; Betamethasone sodium phosphate; Betamethasone Valerate; Betamethasone-17,21-dipropionate

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.