NCT02232594已完成不适用
Postmarketing Surveillance Study (as Per § 67 (6) AMG [German Drug Law]) of Berodual® Metered-dose Inhaler in Chronic Obstructive Respiratory Tract Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 834
- 主要终点
- Overall severity of the clinical picture rated on a 4- point scale
研究概览
简要总结
The aim of this postmarketing surveillance is to obtain further information about the tolerability and efficacy of Berodual® metered-dose inhaler in the treatment of chronic obstructive respiratory tract disease under conditions of daily practice
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of either sex over 40 years with the symptoms of a chronic obstructive airways disease
- •Only patients which have not been treated with Berodual® within the last year should be included
排除标准
- •Contraindications listed in the Instructions for Use/Summary of Product Characteristics for Berodual® metered-dose inhaler
研究组 & 干预措施
chronic obstructive respiratory tract disease patients
干预措施: Berodual® (Drug)
结局指标
主要结局
Overall severity of the clinical picture rated on a 4- point scale
时间窗: after 3 and 6 weeks
次要结局
- Assessment of efficacy by investigator on a 4-point scale(after 3 and 6 weeks)
- Assessment of tolerability by patient on a 4-point scale(after 3 and 6 weeks)
- Number of patients with adverse drug reactions(up to 6 weeks)
- Assessment of efficacy by patient on a 4-point scale(after 3 and 6 weeks)
- Assessment of tolerability by investigator on a 4-point scale(after 3 and 6 weeks)
研究者
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