NCT02435238已完成不适用
AWARE: A World-wide Antihistamine-Refractory Chronic Urticaria Patient Evaluation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Measuring responses to PROs from patients on different treatments
研究概览
简要总结
Non interventional study collecting patient reported outcomes. The study aims to assess the disease burden of chronic urticaria patients and to record the therapies used in daily clinical practice in the UK and the impact they have on the quality of life and work productivity of individual patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Subjects must be 18 years old Subject must be willing and able to provide written informed consent for collection and analysis of routine data and PROs Subject must have medically confirmed diagnosis of chronic urticaria present for more than 2 months.
- •Subject must be refactory to at least one H1 antihistamine
排除标准
- •Subjects who in the estimation of the treating physician are unlikely to be available for the full duration of the follow-up period of 24 months.
- •Subjects taking must not take part in any other concurrent urticarial study.
结局指标
主要结局
Measuring responses to PROs from patients on different treatments
时间窗: 24 months
Measuring quality of life, work productivity and changes in disease for patients on different treatment.
次要结局
- To record use of clinical resources(24 months)
- Previous, current and future medication(24 months)
- Rates of spontaneous remission(24 months)
- Co-morbidities of refractory CU patients(24 months)
- first onset of chronic urticaria(24 months)
- Number of angioedema episodes during the observational phase(24 months)
- Diagnosis of CSU(24 months)
- Treatment algorithms and trends(24 months)
- Prevalence of inducible urticaria(24 months)
- The disease burden of chronic urticaria(24 months)
- Number of patients with angiodema(24 months)
研究者
研究点 (1)
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