The Effect of Intra-sinus Application of Betamethasone Dipropionate Nasal Cream on Patients with Chronic Rhinosinusitis Post Functional Endoscopic Sinus Surgery (FESS)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in 4-Cardinal Symptom score (4CSS) Baseline to Week 3.
研究概览
简要总结
To assess the safety and efficacy of one (single) application of Betamethasone Dipropionate Nasal Cream (BMDP CREAM) onto the sinus mucosa.
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 chronic rhinosinusitis (CRS) condition is suboptimal under the current standard of care. The safety and benefits of this treatment will be monitored by patient-reported symptoms and endoscopic assessment 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 CRS by an otolaryngologist (ENT) undergoing maximal medical therapy as part of their standard of care.
- •Having undergone functional endoscopic sinus surgery (FESS) at least 6 months prior to enrolment.
- •For each nostril, an endoscopic nasal polyp score of 0, 1, or 2 out of a maximum score of - (where 0= No polyps, 1= small polyps in the middle meatus not reaching below the inferior border of the middle turbinate , 2= nasal polyps reaching below the border of the middle turbinate, 3= large nasal polyps reaching the lower border of the inferior turbinate or nasal polyps medial to the middle turbinate, 4= large nasal polyps causing almost complete obstruction of the inferior nasal cavity) (Gevaert et al, 2023).
- •Visible middle turbinates and access to the ethmoid sinuses for dosing as established via endoscopic examination.
- •Participants must have a > 2 on the disease severity visual analogue scale (VAS) at screening and pre-treatment.
- •Body weight: A minimum body weight >=40 kilograms (kg) and a BMI of ≤ 39 at the screening visit.
- •Individuals of childbearing potential must use adequate birth control methods and not plan to get pregnant during the study.
- •Informed consent: Willingness to give written informed consent and willingness to participate in and comply with the study.
- •Age ≥18 but <80 years.
排除标准
- •Subjects with known hypersensitivity or contraindications to betamethasone dipropionate, mometasone, or topical anaesthesia.
- •Subjects with sino-nasal abnormalities, disease, or implanted devices that prevents the application of the therapy.
- •Previous enrolment in this study.
- •Subjects currently receiving systemic corticosteroid or have received systemic corticosteroid in the prior 4 weeks or receiving biologic therapy.
- •Subjects with a history of glaucoma or cataracts or have an abnormal intraocular pressure (IOP) at screening or pre-treatment (abnormal IOP is defined as greater than 21 mm Hg).
- •Subjects with acute sinusitis.
- •Subjects with known immunodeficiency.
- •Subjects with diabetes (Type 1).
- •Subjects with cystic fibrosis.
- •Pregnant subjects or subjects trying to get pregnant or currently lactating as the effect on human pregnancy is unknown.
- •Subjects who are unable to give an informed consent because of mental illness, dementia or communication difficulties.
- •Subjects with a Cushing's disease diagnosis within the previous 12 months.
- •Severe septal deviation and or previous total resection of the middle turbinate.
- •Any lab abnormality or underlying medical condition which, in the Investigator's opinion, should exclude the participant.
- •Subjects who are unlikely to comply with study procedures, restrictions and requirements as determined by the investigator.
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 Symptom score (4CSS) Baseline to Week 3.
时间窗: Baseline through study completion, an average of 4 weeks
Change in average daily score prior to dosing (an average of 7 days) and the average daily score of the 7 days prior to exit (between week 2 and 3 weeks after dosing).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 SNOT-22 Baseline to Week 3.
时间窗: Baseline through study completion, an average of 4 weeks
Participants complete the Sino-nasal Outcome Test (SNOT-22) questionnaire at Baseline and Week 3, analysis will focus on the nasal symptom subdomain. The SNOT-22 measures 22 symptoms 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. A higher total score indicates greater symptom severity.
次要结局
- Safety of one application of BMDP Cream onto the sinus mucosa.(Informed consent through study completion, an average of 3 weeks)