Daxas for COPD Therapy (DACOTA)
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
- 否
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)
