Rhinosinusitis Italian Network (RINET): the Italian Registry for Severe, Uncontrolled Chronic Rhinosinusitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Nasal Polyp Score
研究概览
简要总结
This observatory aims to collect, as widely as possible, the Italian cases of patients with uncontrolled CRS. Patient will be enrolled by the centers of the Italian Network of Rhinosinusitis (Rhinosinusitis Italian Network: RINET), and they will be treated using a multidisciplinary team approach (allergists, otolaryngologists and pneumologists) in a real-world clinical set-up.
This real-life chronic rhinosinusitis registry aims at longitudinal data collection from patients attending specialist care centres across Italy.
详细描述
The primary objectives of the study are:
- to characterize and to describe the evolution of uncontrolled Chronic Rhinosinusitis (CRS);
- to facilitate and to characterize the phenotyping and endotyping of CRS;
- studying the efficacy and safety of the principal therapeutic strategies and approaches to uncontrolled CRS in real-life;
- supporting the development of diagnostic methodologies and innovative therapeutic strategies for CRS;
- to evaluate the clinical and economic-health impact of the different therapeutic approaches (including systemic corticosteroids) used for uncontrolled CRS;
- to describe factors associated with therapeutic choices and how much this factors influence natural history of the CRS;
- Studying and identifying biomarkers and predictors of response to different therapies;
- to increase the "awareness" of CRS in patients, in public opinion, in the national and international scientific community, and in the Italian clinical community of the otolaryngologists, the allergists and the pneumologists.
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
- •Participants with a confirmed diagnosis of bilateral Chronic Rhinosinusitis that have at least three (in case of patients previously treated with surgical approaches) or four (in case of patients never treated with nasal sinus surgery) of the following criteria:
- •Evidence of type 2 inflammation (at least 250 blood eosinophils per microliter and / or at least 10 eosinophils / HPF from a histological sample of sinus mucosa and / or at least one finding of moderate eosinophilia on nasal cytology and / or total serum IgE >100 IU / ml);
- •at least two Short courses of systemic corticosteroids or lorg-term Systemic Corticosteroids therapy for Chronic Rhinosinusitis;
- •Significant deterioration in the quality of life (Sinonasal Outcome Test 22 - SNOT-22>= 40 and / or Visual Analogue Scale - Global VAS of symptoms>= 5);
- •Loss of Smell (VAS for hyposmia> = 7)
排除标准
- 未提供
结局指标
主要结局
Nasal Polyp Score
时间窗: Every year to ten year
Change from baseline in total Nasal Polyp Score at year 1 to ten. The Nasal Polyp Score is the sum of the right and left nostril scores (maximum 8), as evaluated by nasal endoscopy.
次要结局
未报告次要终点