Dupilumab 治疗鼻息肉病的嗅觉结果
使用 Dupilumab 治疗鼻息肉病的“真实世界”嗅觉结果
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.
研究概览
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
-
-
Ontario
-
London、Ontario、加拿大、N5A 4V2
- St. Joseph's Health Care
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients older than 18 years old
- Chronic rhinosinusitis with Nasal Polyps
- Olfactory loss
- Clinical indication for treatment with Dupilumab
Exclusion Criteria:
Patients with olfactory loss from other causes such as:
- Sinonasal malignancies
- Trauma
- Idiopathic olfactory loss
- Use of cocaine
- COVID-19 related olfactory loss
- Pregnancy
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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. |
Dupilumab will be administered subcutaneously for 6 months (1 initial 600mg dose + 5 300mg doses every 4 weeks) |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from Baseline in the Smell Threshold, Identification and Discrimination (TDI score) at week 12 and week 24.
大体时间：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. |
Baseline, 12 weeks and 24 weeks.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from Baseline in the Nasal Polyps score at weeks 12 and 24.
大体时间：Baseline, 12 weeks and 24 weeks.
|
Nasal Polyps score is the sum of the right and left nostril scores (endoscopic assessment). Total score ranges from 0 (no polyps) to 8 (large polyps on for each nostril [4+4] ). |
Baseline, 12 weeks and 24 weeks.
|
|
Change from Baseline in the Sino-nasal outcome test- 22 (SNOT-22) at weeks 12 and 24.
大体时间：Baseline, 12 weeks and 24 weeks.
|
SNOT-22 is a validated questionnaire to assess the impact of chronic rhinosinusitis on patients' quality of life. Patient grades the impact of 22 potential symptoms in their life, by choosing from 0 [no problem] to 5 [problem as bad as it can be]. Highest possible score is 10 (worst quality of life); minimal clinically important change ≥ 8.90 |
Baseline, 12 weeks and 24 weeks.
|
|
Change from Baseline in the QOD-NS at weeks 12 and 24.
大体时间：Baseline, 12 weeks and 24 weeks.
|
Quality of Olfactory Disorders - negative symptoms (questionnaire) |
Baseline, 12 weeks and 24 weeks.
|
合作者和调查者
调查人员
- 首席研究员：Leigh J Sowerby, MD, FRCS、St. Joseph's Hospital London, ON, Canada
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 3618
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
No plan to make IPD available.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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