NCT02244216已完成不适用
Postmarketing Surveillance Study (as Per § 67 (6) AMG [German Drug Law]) of Berotec® N 100 µg 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
- 2,914
- 主要终点
- Change in the clinical picture of chronic obstructive airways disease on switching from Berotec® 200 µg to Berotec® N 100 µg
研究概览
简要总结
Study to obtain data about changing from the chlorofluorocarbon (CFC) - containing Berotec® 200 µg metered - dose inhaler to the CFC - free Berotec® N 100 µg metered - dose inhaler
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
- •Patients were included in the study only if they had been treated with Berotec® 200 µg metered - dose inhaler before switching to the CFC-free Berotec® N 100 µg metered - dose inhaler
排除标准
- •Contraindications listed in the Instructions for Use/Summary of Product Characteristics for Berotec® N 100 µg metered - dose inhaler
研究组 & 干预措施
Chronic Obstructive Respiratory Tract Disease
干预措施: Berotec® N 100 µg Metered-dose Inhaler (Drug)
结局指标
主要结局
Change in the clinical picture of chronic obstructive airways disease on switching from Berotec® 200 µg to Berotec® N 100 µg
时间窗: After 3 weeks of first drug administration
次要结局
- Investigator assessment of efficacy on a 4-point scale(Up to 3 weeks after first drug administration)
- Patient assessment of efficacy on a 4-point scale(Up to 3 weeks after first drug administration)
- Number of patients who changed the concomitant medication(Up to 3 weeks after first drug administration)
- Number of patients who premature withdrew from the treatment(Up to 3 weeks after first drug administration)
- Patient assessment of tolerability on a 4-point scale(Up to 3 weeks after first drug administration)
- Number of patients who continued treatment(Up to 3 weeks after first drug administration)
- Investigator comparative overall assessment on a 4-point scale(After 3 weeks of first drug administration)
- Number of patients with adverse drug reactions(Up to 3 weeks after first drug administration)
研究者
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