Observational Study for the Evaluation of Clinical Effectiveness in Routine Practice of Daxas® (Roflumilast), in Approximately 2700 Patients With Severe and Very Severe COPD (Chronic Obstructive Pulmonary Disease) in Greece
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 2,577
- 主要终点
- Change From Baseline in Ratio of Forced Expiratory Volume After 1 Second to Forced Vital Capacity (FEV1/FVC) at Month 6
研究概览
简要总结
The purpose of this study was to examine the characteristics of patients selected for treatment with roflumilast and the effectiveness and safety of roflumilast in patients with severe or very severe COPD treated in Hospital and outpatient specialist ward settings in Greece.
详细描述
The drug being observed in this study is called roflumilast. Roflumilast is used to treat people who have chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis with a history of worsening symptoms. This study looked at side effects and the lung function of people who take roflumilast. The study enrolled 2577 patients who were already prescribed roflumilast as an add on to bronchiodilator treatment by their healthcare provider. This multi-centre trial was conducted in Greece. The overall time to participate in this study was up to 6 months. Participants were evaluated during routine appointments with their healthcare provider.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change From Baseline in Ratio of Forced Expiratory Volume After 1 Second to Forced Vital Capacity (FEV1/FVC) at Month 6
时间窗: Baseline and Month 6
The FEV1/FVC ratio represents the percentage of vital capacity expelled from the lungs during the first second of a forced exhalation.
Change From Baseline in Forced Vital Capacity (FVC) at Month 6
时间窗: Baseline and Month 6
Vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.
Change from Baseline in Forced Expiratory Volume in First Second (FEV1) at Month 6
时间窗: Baseline and Month 6
FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.
次要结局
- Percentage of Participants with Chronic Obstructive Pulmonary Disease (COPD) Exacerbations(Month 3 and Month 6)
- Percentage of Participants requiring Hospitalizations due to Exacerbations of COPD(Up to Month 6)
- Physician's Satisfaction with Roflumilast(Baseline and Months 3 and 6)
- Patient's Satisfaction with Roflumilast(Baseline and Months 3 and 6)
- Number of participants with adverse drug reactions (ADR)(6 months)
- Concomitant administration of inhaled bronchodilators and corticosteroids(6 months)
- Change from Baseline in Forced Expiratory Volume in First Second (FEV1) at Month 6(Baseline and Month 6)
- Change from Baseline in Clinical COPD Questionnaire (CCQ) Total Score(Baseline and Months 3 and 6)
- Change From Baseline in Ratio of Forced Expiratory Volume After 1 Second to Forced Vital Capacity (FEV1/FVC) at Month 3(Baseline and Month 3)
- Compliance to treatment(6 months)
- Change from Baseline in MRC Dyspnea Scale(Baseline and Months 3 and 6)
- Change From Baseline in Forced Vital Capacity (FVC) at Month 3(Baseline and Month 3)