NCT02233920已完成不适用
Postmarketing Surveillance Study (as Per § 67(6) AMG [German Drug Law]) of Ventilat® Metered-dose Inhaler in Chronic Obstructive Bronchitis
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 716
- 主要终点
- Change in the clinical picture
研究概览
简要总结
Study to obtain further information on the tolerability and efficacy of Ventilat® metered-dose inhaler in the treatment of Chronic Obstructive bronchitis 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
- •Primarily Patients of both genders older than 40 years, who suffer from Chronic Obstructive bronchitis
- •Only patients who have not been treated with an anticholinergic within the last year are to be considered for inclusion
排除标准
- •Contraindications listed in the Instructions for Use/Summary of Product Characteristics for Ventilat® metered dose inhaler
研究组 & 干预措施
Chronic obstructive bronchitis patients
干预措施: Ventilat® - metered dose inhaler (Drug)
结局指标
主要结局
Change in the clinical picture
时间窗: after 4 weeks
次要结局
- Assessment of efficacy by investigator on a 4-point scale(after 4 weeks)
- Assessment of tolerability by investigator on a 4-point scale(after 4 weeks)
- Assessment of efficacy by patient on a 4-point scale(after 4 weeks)
- Number of patients with adverse drug reactions(up to 4 weeks)
- Assessment of patient by investigator on a 4-point scale(after 4 weeks)
研究者
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