NCT02231437已完成不适用
Post-marketing Surveillance (in Accordance With § 67,6 AMG) of Berodual® Metered-dose Inhaler in the Treatment of 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
- 3,488
- 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 post-marketing surveillance is to obtain further information about the tolerability 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
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with diagnosis of Chronic obstructive respiratory tract disease
- •Patients of either sex, including children over 6 years
排除标准
- •Contraindications listed in the Instructions of Use/Summary of Product Characteristics of 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
- Changes in dyspnea and/or asthma attacks rated on a 4-point scale(after 3 and 6 weeks)
- Assessment of tolerability on a 4-point scale(after 3 and 6 weeks)
- Number of dyspnea episodes rated on a 4-point scale(after 3 and 6 weeks)
- Number of patients with adverse drug reactions(up to 6 weeks)
- Assessment of efficacy on a 4-point scale(after 3 and 6 weeks)
- Changes in pathological auscultation findings rated on a 3-point scale(after 3 and 6 weeks)
- Changes in concomitant medication(up to 6 weeks)
- Number of awakenings due to night-time dyspnea rated on a 4-point scale(after 3 and 6 weeks)
- Assessment of morning coughing with expectoration on a 4-point scale(after 3 and 6 weeks)
研究者
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