跳至主要内容
临床试验/NCT02233907
NCT02233907已完成不适用

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

Boehringer Ingelheim0 个研究点目标入组 595 人开始时间: 1999年10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
595
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 long-term 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 Ventilat® 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 pulmonary disease 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: up to 12 months

次要结局

  • Assessment of efficacy by patient on a 4-point scale(after 12 months)
  • Assessment of efficacy by investigator on a 4-point scale(after 12 months)
  • Assessment of tolerability by investigator on a 4-point scale(after 12 months)
  • Assessment of tolerability by patient on a 4-point scale(after 12 months)
  • Number of patients with adverse drug reactions(up to 12 months)

研究者

申办方类型
Industry
责任方
Sponsor

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