Real Life Assessment of Biologics Efficacy in Severe Chronic Rhinosinusitis With Nasal Polyps
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 900
- 试验地点
- 3
- 主要终点
- Comparison of quality of life over 5 years according to the asthmatic status of the patients
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 the investigators 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.Patient-reported outcomes will be addressed according to their initial clinical profile (allergy, asthma, NSAID, gastroesophageal reflux disease, obstructive apnea, otologic disorder, smoke habit).
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 of over 18-year old requiring a biologic treatment for CRswNP in accordance with its marketing approval.
- •The patients already treated according to this criteria since August 2021 will be followed and their previous clinical and biological data retrospectively collected
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 of initiation of treatment apart from ongoing biotherapies for severe asthma or CRSwNP;
- •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.
研究组 & 干预措施
Biologic treatments available
Biologic treatments available in CRSwNP (dupilumab, mepolizumab and benralizumab according to their marketing approval).
干预措施: Biologic treatments available in Chronic Rhinosinusitis with Nasal Polyps (dupilumab, mepolizumab and benralizumab according to their marketing approval). (Drug)
结局指标
主要结局
Comparison of quality of life over 5 years according to the asthmatic status of the patients
时间窗: 5-year follow-up
Assessment of disease control with the Sino-nasal outcome test-22. from 0 to 110, 110=worst outcome
次要结局
- Quality of life progression in patients with Chronic Rhinosinusitis with Nasal Polyps(Evaluation after 6 months of treatment with biologics)
- Time to first surgical procedure since the beginning of biologic treatment(MMonth 0, Month 3, Month 6, and every 6 months until 5 years)
- Blood eosinophil count and total IgE blood concentrations evolution during the course of the 5-year follow-up(Month 0, Month 3, Month 6, and every 6 months until 5 years)
- Patient reported symptoms measurement(Month 0, Month 3, Month 6, and every 6 months until 5 years)