Long-term Evaluation of Safety and Treatment Satisfaction With Levocetirizine in Routine Clinical Practice in the Czech and Slovak Republics - Non-interventional Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 7,870
- 试验地点
- 1
- 主要终点
- Number of patients with adverse events Number and type of serious adverse events Number of patients withdrawing levocetirizine treatment due to adverse events
研究概览
简要总结
To evaluate over a period of 6 months the safety and the treatment satisfaction of newly prescribed levocetirizine in patients of age ≥ 2 years with persistent allergic rhinitis.
详细描述
This is a non-interventional, prospective, post-authorization, multi-centre cohort study in patients treated with levocetirizine.
The baseline data will be collected at the visit to the physician when levocetirizine is prescribed for the first time for the patient for Persistent Allergic Rhinitis. The data will then be collected during 2 visits occurring within the first 6 months of treatment, as usually scheduled in normal clinical practice in the Czech and Slovak Republics. This is after approximately 4 weeks and 6 months of treatment or earlier, if the treatment is stopped
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
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of persistent allergic rhinitis
- •first prescription of levocetirizine for this diagnosis for this patient
- •age ≥ 2 years
排除标准
- •indications other than those defined in inclusion criteria
- •history of allergic or anaphylactic reactions to levocetirizine or other derivatives and excipients included
结局指标
主要结局
Number of patients with adverse events Number and type of serious adverse events Number of patients withdrawing levocetirizine treatment due to adverse events
时间窗: Six Months
次要结局
- To evaluate the global clinical improvement on levocetirizine compared to baseline at each follow up visit.(Six months)
- To evaluate the treating physician's perception of patient satisfaction of levocetirizine tolerability at each follow up visit(six months)
- To evaluate symptoms (nasal pruritus, rhinorrhea, nasal congestion, sneezing, ocular pruritus) at each follow up visit(six months)
- To evaluate the impact of co-morbidities (asthma, urticaria and inflammation of upper airways) at each follow up visit(six months)
- To evaluate the treating physician's perception of patient satisfaction of treatment regimen effectiveness at each follow up visit(six months)
- To evaluate the treating physician's prescription practice in the treatment of Persistent Allergic Rhinitis(six months)
- To evaluate concomitant medications prescribed with levocetirizine at each follow up visit(six months)
- The evaluate reason for discontinuation at last follow up visit(six months)
- To evaluate the overall physician´s treatment satisfaction in comparison with previously used antihistamines in patient population previously treated by antihistamines at last follow up visit(six months)
- To evaluate the dose prescribed by the treating physician at each follow up visit(six months)