The Effect of Betamethasone Dipropionate on Patients With Eosinophilic Chronic Rhinosinusitis
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Change in 4 cardinal symptoms score (4CSS) from Baseline to Week 3.
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Betamethasone Dipropionate Nasal Cream 0.0644% Treatment
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).
干预措施: Betamethasone Dipropionate Nasal Cream 0.0644% (Drug)
Betamethasone Dipropionate Nasal Cream 0.0644% Treatment
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).
干预措施: Pre-filled syringe and applicator device (Device)
结局指标
主要结局
Change in 4 cardinal symptoms score (4CSS) from Baseline to Week 3.
时间窗: 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.
Change in Visual Analogue Scale (VAS) (0-10) evaluating global disease severity score from Baseline to Week 3.
时间窗: 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.
Change in SNOT-22 Score from Baseline to Week 3.
时间窗: 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.
Change in Modified Lund Mackay Postoperative Endoscopy Score from Baseline to Week 3.
时间窗: Baseline to Week 3
Change in Modified Lund Mackay Postoperative Endoscopy Score is evaluated by experienced ENT at Baseline to Week 3.
Overall Patient Global Impression of Change at Week 3.
时间窗: 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.
次要结局
- To assess the safety of one application of BMDP CREAM onto the sinus(Treatment visit to Week 3)
- BMDP Cream retention time on the sinus(Treatment visit to Week 3)