A Retrospective rEal-life daTa Study to Assess the Incidence of exaceRbations and Change in Lung functIon Forced Expiratory Volume (FEV1) in Chronic Obstructive Pulmonary Disease ( COPD ) patiEnts receiVing Fluticasone/Salmeterol Fixed Dose Combination (FDC) Comparing to Those Εscalating in Open-triple Fluticasone/Salmeterol, Long Acting Muscarinic Antagonist (LAMA) Combination
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- FEV1
研究概览
简要总结
Inhaled corticosteroid (ICS)/long-acting β2-agonist (LABA) combination is commonly prescribed to treat COPD; we will perform a retrospective analysis on the effect of adding a long-acting muscarinic receptor antagonist (LAMA) to ICS/LABA combination in COPD.
详细描述
According to the current guidelines for the treatment of COPD, it is recommended to use combination therapies with different or complementary mechanisms of action . Data suggest that open triple therapy incorporating LAMA with ICS / LABA combination products administered through different delivery devices may be beneficial for improving pulmonary function in patients with COPD. However, there is little evidence of the effect of triple therapy on pulmonary function and the incidence of exacerbations in COPD patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（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
FEV1
时间窗: 36 months
The rate of FEV1 change in patients in both groups A and B during the recording period.
Exacerbations
时间窗: 36 months
The number of exacerbations per year of patients in both groups A and B during the recording period.
次要结局
未报告次要终点