NCT02238184已完成不适用
Postmarketing Surveillance Study (as Per §67(6 )AMG [German Drug Law]) of Anticholinergics - Prescribing Pattern and Therapeutic Long Term Value in Patients Suffering From Moderate or Severe 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
- 105
- 主要终点
- Change in overall 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 prescribing pattern and therapeutic long term value in patients suffering from moderate or severs 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
- 40 Years 至 —（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 moderate or severe Chronic Obstructive Pulmonary Disease
- •Only patients who showed following diagnosis parameters were to be considered for inclusion
- •FEV1 (Forced expiratory volume in 1 second) and FEV1/VC (vital capacity) <70%
- •Reversibility FEV1 <12% in the last 6 months
- •Smoker or Ex-smoker (>10 Pack years)
- •Asthma to be excluded
排除标准
- •Contraindications listed in the Instructions for Use/Summary of Product Characteristics
研究组 & 干预措施
Chronic Obstructive Pulmonary Disease
patients receiving Atrovent®
干预措施: Atrovent® (Drug)
Cronic Obstructive Pulmonary Disease
patients receiving Ventilat®
干预措施: Ventilat® (Drug)
结局指标
主要结局
Change in overall severity of the clinical picture rated on a 4-point scale
时间窗: Up to 6 months after first study drug administration
Investigator assessment of improvement of thec linical picture rated on a 6-point symptom profile
时间窗: Up to 6 months after first study drug administration
次要结局
- Assessment of tolerability by patient on a 4-point scale(Up to 6 months after first study drug administration)
- Assessment of efficacy by patient on a 4-point scale(Up to 6 months after first study drug administration)
- Assessment of tolerability by investigator on a 4-point scale(Up to 6 months after first study drug administration)
- Assessment of efficacy by investigator on a 4-point scale(Up to 6 months after first study drug administration)
- Number of patients with adverse drug reactions(Up to 6 months after first study drug administration)
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