试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 5,472
- 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
Daxas (roflumilast) is the first oral anti-inflammatory phosphodiesterase inhibitor (PDE-4) for patients with severe chronic obstructive pulmonary disease (COPD) experiencing chronic cough and sputum and with a history of exacerbations as add-on to bronchodilator treatment. With its mode of action Daxas can reduce exacerbations rates and improve lung function parameters which may result in a better health-related quality of life and an improved long-term management of COPD.
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. Evaluation is based on two COPD specific questionnaires to assess the patient's health status over six months. During the study, socio-demographic data and cost-of-illness data will be recorded. 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
DINO
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
- Evaluation of tolerability(after 6 months)
- Evaluation of symptom reduction of sputum and cough(after 6 months)
- Effectiveness during treatment(after 6 months)
- Evaluation of cost-of-illness data(before treatment)
- Evaluation of sociodemographic data(before treatment)