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临床试验/NCT02238132
NCT02238132已完成不适用

Postmarketing Surveillance Study (as Per §67(6)AMG[German Drug Law]) of Atrovent® Inhalets in Chronic Obstructive Airways Disease

Boehringer Ingelheim0 个研究点目标入组 374 人开始时间: 1998年12月最近更新:
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
374
主要终点
Investigator assessment of improvement in the clinical picture of the course on a 6-point symptoms profile

研究概览

简要总结

To obtain further information on the tolerability of Atrovent® inhalets in the treatment of Chronic Obstructive Airways 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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Primarily, Patients with chronic obstructive airways disease
  • Only patients who had not been treated with Atrovent® in the last year were to be considered for inclusion

排除标准

  • Contraindications listed in the Instructions for Use/Summary of Product Characteristics for Atrovent® inhalets

研究组 & 干预措施

Chronic Obstructive Airways Disease

干预措施: ATROVENT® inhalets (Drug)

结局指标

主要结局

Investigator assessment of improvement in 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

  • Investigator assessment of efficacy on a 4-point scale(Up to 4 weeks after first study drug administration)
  • Investigator assessment of tolerability on a 4-point scale(Up to 4 weeks after first study drug administration)
  • Number of patients who continued the treatment(Up to 4 weeks after first study drug administration)
  • Patient assessment of tolerability on a 4-point scale(Up to 4 weeks after first study drug administration)
  • Number of patients who withdrew from the study(Up to 4 weeks after first study drug administration)
  • Number of patients who changed the concomitant medication(Up to 4 weeks after first study drug administration)
  • Patient assessment of efficacy 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

申办方类型
Industry
责任方
Sponsor

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