Berodual® Respimat® 20/50µg/Dose Solution for Inhalation in Patients With Chronic Obstructive Airways Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,006
- 主要终点
- Assessment of tolerability on a 5-point scale
研究概览
简要总结
Tolerability, efficacy and handling of Berodual® Respimat® 20/50µg/dose solution for inhalation in patients with chronic obstructive airways disease in 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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women presenting with the symptoms of chronic obstructive airways disease were given Berodual® Respimat® 20/50µg/dose solution for inhalation only where this was considered necessary in medical terms
- •Patients who have not been treated prior to the post-marketing surveillance study as well as patients who have been treated with Berodual® metered dose inhaler (MDI) or other respiratory medications prior to the Post-Marketing Surveillance Study could be included
排除标准
- •Patients presenting with the general and specific contraindications listed in the Patient Information Leaflet and the Basic Product Information
研究组 & 干预措施
chronic obstructive airways disease patients
干预措施: Berodual® Respimat® solution for inhalation (Drug)
结局指标
主要结局
Assessment of tolerability on a 5-point scale
时间窗: after 4, 8 and 12 weeks
Change in overall severity of clinical picture rated on 3-point scale
时间窗: up to 12 weeks
Change in breathlessness rated on a 4-point scale
时间窗: up to 12 weeks
Change in restriction of activity due to breathlessness rated on a 4-point scale
时间窗: up to 12 weeks
Number of patients with adverse drug reactions
时间窗: up to 12 weeks
Change in number of awakening due to nocturnal breathlessness rated on 4-point scale
时间窗: up to 12 weeks
Global assessment of efficacy by the investigator rated on 5-point scale
时间窗: after 4, 8 and 12 weeks
Global assessment of efficacy by the patients rated on 5-point scale
时间窗: after 4, 8 and 12 weeks
次要结局
未报告次要终点