Real-Life Chronic Rhinosinusitis Outcome Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 4,550
- 试验地点
- 13
- 主要终点
- Symptom severity total symptoms
研究概览
简要总结
An international consortium of leading medical experts in the field of chronic respiratory disease, the research team of Galenus Health and the non-profit organization EUFOREA (European Forum for Research and Education in Allergy and Airway diseases) has been conceived to conduct real-life outcome research. The Galenus Health digital platform consisting of a mobile application for patients and an online dashboard for physicians will be implemented in each of the participating centres. The data will be centralized in a pseudonymized database and will be the basis of the Chronic RhinoSinusitis Outcome Registry.
详细描述
This real-life chronic rhinosinusitis outcome registry aims at longitudinal data collection from patients attending specialist care centres across Europe.
As primary aim it intends to provide new insights on the burden of uncontrolled disease, the impact on health-related quality of life, productivity loss as well as the effect of disease severity and co-morbid disease on these outcome parameters.
In addition this outcome registry intends to identify patients eligible for type 2 targeted biologic therapy, evaluate treatment effectiveness and markers of treatment response.
Beyond that direct and indirect costs for society related to chronic rhinosinusitis and its' treatment will be studied.
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
- •Physician diagnosis of Chronic RhinoSinusitis
- •Capable of using a mobile application on a smartphone
排除标准
- •Patients with malignancies of the sinonasal cavity
- •Patients with inverted papilloma
- •Patients with unilateral disease
结局指标
主要结局
Symptom severity total symptoms
时间窗: 1 year
Baseline and change in VAS (visual analogue scale) total nasal, sinus, lung symptoms; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm
次要结局
- Symptom severity - facial pain(1 year)
- Symptom severity - wheeze(1 year)
- Blood eosinophil counts(1 year)
- Symptom severity - itchy eyes(1 year)
- Medication use(Registration at time of new prescription and intakes)
- Symptom severity - post-nasal drip(1 year)
- Symptom severity - chest tightness(1 year)
- Symptom severity - impaired smell(1 year)
- Symptom severity - nasal secretions(1 year)
- Symptom severity - dyspnoea(1 year)
- Symptom severity - sneeze(1 year)
- General health-related quality of life(1 year)
- CRS-specific quality of life(1 year)
- Symptom severity - nasal blockage(1 year)
- Symptom severity - cough(1 year)
- Disease impact - daily life activities(1 year)
- Healthcare utilisation(Registration at time of event)
- Nasal Polyp Score(1 year)
- Lund-Mackay score(1 year)
- Hospitalisations(1 year)
- Symptom severity - itchy nose(1 year)
- Disease impact - work or school(1 year)
- Disease impact - sleep quality(1 year)
- Serum total IgE(1 year)
- Work Performance and Activity Impairment(1 year)
- Oral corticosteroid use(1 year)