NCT02238197已完成不适用
Postmarketing Surveillance Study (as Per §67 (6) AMG [German Drug Law]) of Atrovent® 500µg/2ml Inhalation Solution in Chronic Obstructive Pulmonary 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
- 477
- 主要终点
- Change in total severity of the clinical picture rated on a 4-point scale
研究概览
简要总结
To obtain further information on the tolerability and efficacy of Atrovent® 500µg/2ml inhalation solution in the treatment of Chronic Obstructive Pulmonary 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
- 13 Years 至 89 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both genders, older than 40 years,who suffer from chronic obstructive Pulmonary disease
- •Only patients who had not been treated with Atrovent® within the last year were to be considered for inclusion
排除标准
- •Contraindication listed in the instructions for use/summary of product characteristics for Atrovent® 500µg/2ml Inhalation Solution
- •Patients who exhibited adverse drug reactions
研究组 & 干预措施
Chronic Obstructive Pulmonary Disease
干预措施: Atrovent® Inhalation Solution (Drug)
结局指标
主要结局
Change in total severity of the clinical picture rated on a 4-point scale
时间窗: Up to 4 weeks after first study drug administration
Investigator assessment of improvement of the clinical picture of the course on a 6-point symptoms profile
时间窗: up to 4 weeks after first study drug administration
次要结局
- Assessment of efficacy by patient on a 4-point scale(Up to 4 weeks after first study drug administration)
- Assessment of tolerability by investigator on a 4-point scale(Up to 4 weeks after first study drug administration)
- Assessment of efficacy by investigator on a 4-point scale(Up to 4 weeks after first study drug administration)
- Assessment of tolerability by patient on a 4-point scale(Up to 4 weeks after first study drug administration)
- Number of patients with adverse drug reactions(Up to 4 weeks after first study drug administration)
研究者
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