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临床试验/NCT01285167
NCT01285167已完成不适用

Daxas for COPD Therapy (DACOTA)

AstraZeneca1 个研究点 分布在 1 个国家目标入组 3,645 人开始时间: 2010年8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
发起方
AstraZeneca
入组人数
3,645
试验地点
1
主要终点
Pre-/post comparison of the COPD status based on patients health status

研究概览

简要总结

Chronic obstructive pulmonary disease (COPD) is a progressive and largely irreversible lung disease characterized by chronic bronchitis and/or emphysema, resulting in breathlessness, cough and sputum. As COPD progresses, patients experience increasing deterioration of their health-related quality of life, with greater impairment in their ability to work and declining participation in social and physical activities.

The aim of this non-interventional study is to evaluate data on quality of life in COPD patients in Germany in a real life medical setting under therapy with the phosphodiesterase-inhibitor (PDE-4) roflumilast (Daxas). Evaluation is based on two COPD specific questionnaires to assess the patient's health status over six months. During the study, lung function measurements such as spirometry will be conducted according to common medical standard. Daxas (tablet) will be administered once daily. The study will provide further data on the safety and tolerability of Daxas.

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

  • severe COPD

排除标准

  • Child pugh (classified B and C)

研究组 & 干预措施

DACOTA

干预措施: Daxas (Drug)

结局指标

主要结局

Pre-/post comparison of the COPD status based on patients health status

时间窗: after 6 months

Evaluation of treatment success by a COPD-specific patient questionnaire

次要结局

  • Effectiveness during treatment(after 6 months)
  • Pre-/post comparison of spirometry data(after 6 months)
  • Evaluation of tolerability(after 6 months)
  • Evaluation of symptom reduction of sputum and cough(after 6 months)

研究者

发起方
AstraZeneca
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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