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临床试验/NCT02231346
NCT02231346已完成不适用

Berodual® Respimat® 20/50 Microgram/Dose Solution for Inhalation: Assessment of Handling and Patient Satisfaction in Comparison to a Powder Inhaler

Boehringer Ingelheim0 个研究点目标入组 150 人开始时间: 2005年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
150
主要终点
Number of patients with adverse events

研究概览

简要总结

New perceptions about handling and patient satisfaction of the everyday use of Berodual® Respimat® compared to a powder inhaler in patients with chronic obstructive lung disease (COLD). Moreover, further knowledge should be attained about the tolerability of Berodual® Respimat®

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

  • Male and female patients aged at least 18 years
  • Patients who are suffering from symptoms of a chronic obstructive lung disease (COLD) can be included in the PMS. To reduce influences caused by the use of a variety of different powder inhaler, only patients who are already regularly using Diskus® powder inhaler should be included, as the Diskus® as well as the Berodual® Respimat® are multiple dose devices
  • During the PMS the Diskus® therapy is to be continued

排除标准

  • Patients who meet one or more of the general or specific contraindications mentioned in the Summary of Product Characteristics (SmPC) are excluded from the Postmarketing Surveillance (PMS)

研究组 & 干预措施

chronic obstructive pulmonary disease patients

干预措施: Berodual® Respimat® - inhaler (Drug)

结局指标

主要结局

Number of patients with adverse events

时间窗: up to 4 weeks

Number of patients who prematurely discontinued therapy with Berodual® Respimat®

时间窗: up to 4 weeks

次要结局

  • Assessment of patient satisfaction with regard to handling of Berodual® Respimat® inhaler(up to 4 weeks)
  • Assessment of patient satisfaction with regard to handling of Diskus® inhaler(Baseline)

研究者

申办方类型
Industry
责任方
Sponsor

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