Status:
TERMINATED
Treatment of Eosinophilic Chronic Rhinosinusitis Utilizing Betamethasone Dipropionate Nasal Cream
Lead Sponsor:
Oticara Australia PTY LTD
Conditions:
Chronic Rhinosinusitis (Diagnosis)
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
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 eosinophil...
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 s...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2023
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT05220293
Start Date
February 23 2022
End Date
December 30 2023
Last Update
May 2 2024
Active Locations (1)
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1
Oticara Clinical Trial Site
Sydney, New South Wales, Australia, 2000