Real Life Assessment of Biologics Efficacy in Severe Chronic Rhinosinusitis With Nasal Polyps
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- 6-month rate of patients with a SNOT-22 (Sinonasal Outcome test -22) score change over the minimal clinically important difference of 8.9 by comparison of SNOT-22 scores measured at Month 0 and Month 6
研究概览
简要总结
With a prevalence of 2-4% in western countries, Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) is of major concern regarding its substantial impact on the social and physical quality of life. So far, endoscopic sinus surgery remains the treatment of choice when the first line of medical treatment with corticosteroid has failed.
During the last 15 years, several studies have shown that CRSwNP is associated with a T helper 2 (T2) immune response leading to B cell release of IgE, mucosal recruitment of eosinophils from bone marrow via Interleukin (IL)-5, IL-4 and IL-13 mediated chemoattractant production.
New biologic agents capable of blocking T2 cytokines have been developed in the field of eosinophil-associated diseases, shifting the paradigm of treatment for patients with CRSwNP. In the near future, endotype profiling with accurate biomarkers will be mandatory to tailor the treatment of nasal polyposis with specific biologic therapies.
Herein we propose a prospective study monitoring medical records of CRSwNP patients who undergo biologic treatments. The objectives are to assess treatment efficacy on quality of life, to report clinical and biological criteria for prescription and to measure tolerance and compliance.
详细描述
New biologic agents capable of blocking T2 cytokines have been developed in the field of eosinophil-associated diseases, shifting the paradigm of treatment for patients with CRSwNP. In the near future, endotype profiling with accurate biomarkers will be mandatory to tailor the treatment of nasal polyposis with specific biologic therapies.
Herein we propose a prospective study monitoring medical records of CRSwNP patients who undergo biologic treatments. The objectives are to assess treatment efficacy on quality of life, to report clinical and biological criteria for prescription and to measure tolerance and compliance.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of over 18-year old requiring a biologic treatment for CRswNP in accordance with its marketing approval
排除标准
- •Oral corticotherapy in the previous month;
- •Biologic treatment with anti-IgE (omalizumab), anti-IL-5/IL-5R (mepolizumab, benralizumab) or anti-IL-4/IL-13R (dupilumab) or any other biotherapy for inflammatory diseases in the previous 6 months apart from ongoing biotherapies for severe asthma;
- •Hypersensitivity to humanized antibodies ;
- •Documented SARS-Cov2 infection in the last 3 months with persistent olfactory disorders related to COVID;
- •Pregnant or breast-feeding women;
- •Patient without social coverage
结局指标
主要结局
6-month rate of patients with a SNOT-22 (Sinonasal Outcome test -22) score change over the minimal clinically important difference of 8.9 by comparison of SNOT-22 scores measured at Month 0 and Month 6
时间窗: Day0, Month 6
from 0 to 110 , 110 = worst outcome
次要结局
- SNOT 22 (Sinonasal Outcome Test-22) scores(Day 0, Month 3, Month 6, Month 12 and Month 18)
- Visual analogical scale (VAS) for nasal obstruction(Day 0, Month 3, Month 6, Month 12 and Month 18)
- Visual analogical scale (VAS) for smell lost(Day 0, Month 3, Month 6, Month 12 and Month 18)
- Visual analogical scale (VAS) for rhinorrhea(Day 0, Month 3, Month 6, Month 12 and Month 18)
- Visual analogical scale (VAS) for craniofacial pain(Day 0, Month 3, Month 6, Month 12 and Month 18)
- Number of systemic corticosteroid treatment courses between each visit(Day 0, Month 3, Month 6, Month 12 and Month 18)
- Blood eosinophil count(Day 0, Month 3, Month 6, Month 12 and Month 18)
- Blood total IgE concentrations(Day 0, Month 3, Month 6, Month 12 and Month 18)
- Delay to first surgical procedure(Day 0, Month 3, Month 6, Month 12 and Month 18)