Effect of Dupilumab on Nasal Epithelial Barrier Function in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) - an Exploratory Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Barrier function in CRSwNP with Dupilumab
研究概览
简要总结
The investigators aim to investigate two major so far unresolved topics in CRSwNP research: (1) Thorough functional and molecular characterisation of barrier function in patients suffering from CRSsNP and CRSwNP and (2) effect of dupilumab treatment on barrier function in polyp patients. This will be achieved in patient-derived samples by employing measurement of barrier function in primary cell cultures in combination with a mass cytometry based imaging approach, transcriptomic analysis as well as cytokine and microbiome data of individual patients.
详细描述
Primary objective 1: Characterization of differences in barrier function of the nasal epithelium in patients suffering from CRSsNP, CRSwNP with and without asthma or N-ERD (in absence of therapy with monoclonal antibodies). T Primary objective 2: Effect of dupilumab treatment on barrier function of the nasal epithelium in patients suffering from CRSwNP with and without asthma or N-ERD.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-99 years of age
- •Willingness to participate in the study
- •Suffer from chronic rhinosinusitis defined as in EPOS 2020 criteria, see main text
- •Group 1 (n=20, CRSsNP): Absence of nasal polyps
- •Group 2 (N=60, CRSwNP): Presence of nasal polyps as confirmed by endoscopy or CT and planned therapy with dupilumab
- •Presence or absence of non-steroidal anti-inflammatory drug (NSAID)-Exacerbated Respiratory Disease (N-ERD)
- •Patients with a history of treatment with monoclonal antibodies will only be included if at least a washout period of 6 months has passed
排除标准
- •Pregnancy (as determined by ß-HCG test) or breast feeding
- •Patients with severe anatomic variations or deviations that do not allow access to all areas in the nasal cavity
- •Patients with cystic fibrosis or primary ciliary dyskinesia
- •Patients with permanent immunosuppression
- •A mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
- •Patients with clinically meaningful comorbidity as determined by the evaluating committee
- •Patients with a history of exacerbation of chronic rhinosinusitis 4 weeks prior to the screening visit
- •Intake of a burst of systemic corticosteroids for the treatment of CRS 4 weeks prior to the screening visit
研究组 & 干预措施
CRSwNP
Dupilumab
干预措施: Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT] (Drug)
结局指标
主要结局
Barrier function in CRSwNP with Dupilumab
时间窗: 3 Visits (baseline, 3 months, 6 months)
Cell index (xCELLigence)
Barrier function in CRSsNP and CRSwNP
时间窗: 1 Visit (baseline)
Cell index (xCELLigence)
次要结局
未报告次要终点
研究者
Sven Schneider, MD
MD
Medical University of Vienna