The 'Real World' Olfactory Outcomes Treating Nasal Polyposis With Dupilumab
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Change from Baseline in the Smell Threshold, Identification and Discrimination (TDI score) at week 12 and week 24.
研究概览
简要总结
The study aims to investigate the olfactory TDI score (Threshold, Discrimination, Identification) using the Sniffin' sticks test for patients with chronic rhinosinusitis with nasal polyps (CRSwNP) on dupilumab. Twenty-seven adult patients will be followed up during the treatment with dupilumab on three visits to the Otolaryngology Clinic (Baseline, 3 months and 6 months).
The primary endpoint will be the TDI score. Nasal polyp score, Quality of Olfactory Disorders - negative symptoms (QOD-NS symptom scores), SNOT-22 will be secondary endpoints.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 years old
- •Chronic rhinosinusitis with Nasal Polyps
- •Olfactory loss
- •Clinical indication for treatment with Dupilumab
排除标准
- •Patients with olfactory loss from other causes such as:
- •Sinonasal malignancies
- •Idiopathic olfactory loss
- •Use of cocaine
- •COVID-19 related olfactory loss
- •Pregnancy
研究组 & 干预措施
Dupilumab group
Patients with CRSwNP will have an initial dose of 600 mg of dupilumab, and 5 additional doses of 300mg every 4 weeks for 6 months.
干预措施: Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT] (Drug)
结局指标
主要结局
Change from Baseline in the Smell Threshold, Identification and Discrimination (TDI score) at week 12 and week 24.
时间窗: Baseline, 12 weeks and 24 weeks.
The Sniffin' Sticks test involves testing odor for threshold and discrimination whilst blind folded and secondly odor identification. The sum of four odors responses ranges from 0-16. The sum of total score from odor Threshold, Discrimination and Identification (TDI) is a maximum of 48 points. The total score is graded as; normosmia equals or over 30.5 points, hyposmia 16.5-30 points and anosmia less than 16.5 points.
次要结局
- Change from Baseline in the Nasal Polyps score at weeks 12 and 24.(Baseline, 12 weeks and 24 weeks.)
- Change from Baseline in the QOD-NS at weeks 12 and 24.(Baseline, 12 weeks and 24 weeks.)
- Change from Baseline in the Sino-nasal outcome test- 22 (SNOT-22) at weeks 12 and 24.(Baseline, 12 weeks and 24 weeks.)
研究者
Leigh Sowerby
Principal Investigator
London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's