Olfactory Cleft Obstruction and Electrophysiological Olfactory Bulb Generated Beta Field Potentials Predict Olfactory Restoration by Dupilumab in CRSwNP Patients.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Status change of the Brief Smell Identification Test
研究概览
简要总结
The goal of this observational study is to learn what can predict the return of the sense of smell in patients with chronic rhinosinusitis with nasal polyps being treated with dupilumab. The main questions it aims to answer are:
- Does obstruction of the olfactory cleft predict return of the sense of smell?
- Do electrophysiological signals generated by breathing and sniffing behavior predict return of the sense of smell?
Participants starting dupilumab will undergo assessment for their degree of olfactory cleft obstruction, and an electrophysiologic assessment of their olfactory cleft and be followed over 6 months of treatment with dupilumab.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Well documented history of CRSwNP
- •BSIT age/sex classified as "abnormal" score
- •Self-reported stable olfactory deficit of moderate to severe quality > 3 months
- •Prior endoscopic sinus surgery >3 months, <10 years prior
排除标准
- 未提供
研究组 & 干预措施
Dupilumab Treatment
Patients who had prior endoscopic sinus surgery for CRSwNP with persistent smell loss initiating dupilumab
干预措施: Dupilumab - Standard Dose (Drug)
结局指标
主要结局
Status change of the Brief Smell Identification Test
时间窗: 26 weeks
The brief smell identification test will be administered and patients classified into normal/age-related deficit vs abnormal.
次要结局
未报告次要终点
研究者
Bruce Tan
Professor
Northwestern University