Patient Registry of Roflumilast In Real Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 1,950
- 主要终点
- Number of observed exacerbations
研究概览
简要总结
A patient registry to capture real life data and demonstrate the performance of roflumilast (Daxas®) in a standard clinical practice.
详细描述
The drug being tested in this observational study design is called roflumilast, but not as an therapeutic intervention. Roflumilast is approved for and marketed globally for maintenance treatment of severe Chronic Obstructive Pulmonary Disease (COPD) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add on to bronchodilator treatment.
This study will capture real life data and demonstrate the performance of roflumilast in a standard clinical practice. The study will enroll approximately 1350 (EU)+600(North Asia) patients. This multi-centre trial will be conducted in at least 4 EU and 2 North Asian countries.
The overall time to participate in this study is 12 months. No visits, diagnostic procedures or monitoring will take place, which would not happen had the patient not been included in the study.
Participants will be followed according to usual practice and data recorded approximately at 6 months and at 12 months of roflumilast treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Signed informed consent to the data collection
- •Roflumilast (Daxas®) treatment initiated in Roflumilast (Daxas®) naïve patients at the time of registry
排除标准
- •There are no exclusion criteria per se. However it is expected that patients are treated according to locally approved marketing authorisation.
结局指标
主要结局
Number of observed exacerbations
时间窗: 12 months
Number of exacerbations observed during the study period and per patient per year
次要结局
- Change from Baseline in blood oxygen saturation(Baseline and Month 12)
- Changes in concomitant administration of COPD maintenance treatments(12 months)
- Severity of exacerbations(12 months)
- Number of hospitalizations due to COPD exacerbations(12 months)
- Change from Baseline in lung function parameters (FEV1 and FEV1/FVC)(Baseline and Month 12)
- Percentage of compliance to treatment(12 months)
- Number of Participants with adverse Drug Reactions (ADRs)(12 months)
- Change from Baseline in breathlessness(Baseline and Month 12)
- Seasonal variation of exacerbation(12 months)
- Health status using the COPD Assessment Questionnaire (CAT)(Baseline, Month 6 and Month 12)