NCT02231424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 Airways Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 713
- 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
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of either sex, including children over 6 years
- •Chronic obstructive respiratory tract disease. Every doctor was asked to include in this study the first patients coming after each other, who were treated for the first time with Berodual® metered dose inhaler (MDI)
排除标准
- •Contraindications listed in the Instructions for Use/Summary of Product Characteristics of Berodual® metered-dose inhaler
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 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 rated on a 4-point scale(after 3 and 6 weeks)
- Assessment of efficacy 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)
- Assessment of tolerability on a 4-point scale(after 3 and 6 weeks)
- Changes in dyspnea and/or asthma attacks rated on a 4-point scale(after 3 and 6 weeks)
- Number of patients with adverse drug reactions(up to 6 weeks)
- Changes in pathological auscultation findings rated on a 3-point scale(after 3 and 6 weeks)
研究者
相似试验
已完成
不适用
Postmarketing Surveillance Study of Berodual® Metered-dose Inhaler in Chronic Obstructive Respiratory Tract DiseasePulmonary Disease, Chronic ObstructiveNCT02232594Boehringer Ingelheim834
已完成
不适用
Post-marketing Surveillance of Berodual® Metered-dose Inhaler in the Treatment of Chronic Obstructive Respiratory Tract DiseasePulmonary Disease, Chronic ObstructiveNCT02231437Boehringer Ingelheim3,488
已完成
不适用
Harvoni in Patients With Chronic Hepatitis C Virus (HCV) Infection in KoreaHepatitis C VirusNCT02951364Gilead Sciences1,081
已完成
不适用
Evaluate the Safety and Effectiveness of Sovaldi in Participants With Chronic Hepatitis C Virus (HCV) Infection in KoreaHepatitis C VirusNCT02907996Gilead Sciences2,033
已完成
不适用
Postmarketing Surveillance Study of Anticholinergics - Prescribing Pattern and Therapeutic Long Term Value in Patients Suffering From Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD)Pulmonary Disease, Chronic ObstructiveNCT02238184Boehringer Ingelheim105