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临床试验/NCT02233894
NCT02233894已完成不适用

Post-marketing Surveillance (as Per § 67(6) AMG [German Drug Law]) of Atrovent® Inhalets in Chronic Obstructive Pulmonary Disease

Boehringer Ingelheim0 个研究点目标入组 526 人开始时间: 2001年2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
526
主要终点
Change in overall severity of the clinical picture

研究概览

简要总结

Study to obtain further information on the tolerability and efficacy of Atrovent® inhalets 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
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients of both genders older than 40 years, who suffer from Chronic Obstructive Pulmonary Disease
  • Only patients who have not been treated with Atrovent® 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 Atrovent® metered dose inhaler

研究组 & 干预措施

Chronic obstructive pulmonary disease patients

干预措施: Atrovent® - inhalets (Drug)

结局指标

主要结局

Change in overall severity of the clinical picture

时间窗: 3 months

次要结局

  • Number of patients with adverse drug reactions(3 months)
  • Assessment of efficacy by investigator on a 4-point scale(after 3 months)
  • Assessment of efficacy by patient on a 4-point scale(after 3 months)
  • Assessment of tolerability by investigator on a 4-point scale(after 3 months)
  • Assessment of tolerability by patient on a 4-point scale(after 3 months)

研究者

申办方类型
Industry
责任方
Sponsor

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