NCT04011475已完成不适用
Taiwan Outcomes and Real-world Treatment Options for Chronic Obstructive Pulmonary Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,617
- 试验地点
- 12
- 主要终点
- Number of Participants With Moderate-to-severe Acute Exacerbation
研究概览
简要总结
Study to collect the data on Chronic Obstructive Pulmonary Disease (COPD) patients who were administered with Long-Acting Beta-Agonist/ Long-Acting Muscarinic Antagonist (LABA/LAMA) (Fixed-dose Combination (FDC) or free combo) or LAMA treatment
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Patients who fulfil ALL the following criteria are included.
- •Patients who diagnosed with COPD who were prescribed with LABA/LABA (FDC or free combo) as a new initiation or switching from other therapy (i.e., single/dual/triple), or newly receiving LAMA treatment for 3 months at least prior to 30 June 2018
- •Male or female patients ≥ 40 years of age
排除标准
- •Patients who meet the following criterion are not included.
- •Patients with documented diagnosis of bronchial asthma, asthma-COPD overlap syndrome (ACOS), bronchiectasis, cystic fibrosis, or lung cancer
研究组 & 干预措施
Subjects with Tiotropium and Olodaterol
干预措施: Tiotropium + Olodaterol (Drug)
Subjects treated with other LABA/LAMA therapy
干预措施: Other LABA/LAMA (Drug)
Subjects treated with LAMA therapy
干预措施: LAMA (Drug)
结局指标
主要结局
Number of Participants With Moderate-to-severe Acute Exacerbation
时间窗: Up to 1 year after the index date (Baseline).
Number of participants with moderate-to-severe acute exacerbation within 1 year after the index date was reported.
次要结局
- Annualized Rate of Severe Exacerbation(Up to 1 year after the index date (Baseline).)
- Incidence of Patients Escalating Therapy (From Single/Dual to Dual/Triple Therapy)(Up to 1 year after the index date (Baseline).)
- Change From Baseline in Pulmonary Function After LABA+LAMA or LAMA Initiation Evaluating by Post-bronchodilator Forced Volume Vital Capacity (Post-FVC) at 12 Months After Index Date(At index date (Baseline) and at 12 months after index date.)
- Annualized Rate of Moderate Exacerbation(Up to 1 year after the index date (Baseline).)
- Percentage of Patients Using Rescue Medications(Up to 1 year after index date (Baseline).)
- Annualized Rate of Moderate-to-severe Exacerbation(Up to 1 year after the index date (Baseline).)
- Annualized Rate of Mild Exacerbation(Up to 1 year after the index date (Baseline).)
- Percentage of Patients Receiving Dual Therapy Escalated to Triple Therapy or LAMA Escalated to Dual Therapy(Up to 1 year after index date (Baseline).)
- Change From Baseline in Pulmonary Function After LABA+LAMA or LAMA Initiation Evaluating by Post-bronchodilator Forced Expiratory Volume in One Second (Post-FEV1) at 12 Months After Index Date(At index date (Baseline) and at 12 months after index date.)
- Change From Baseline in Pulmonary Function After LABA+LAMA or LAMA Initiation Evaluating by Modified Medical Research Council Dyspnea Scale (mMRC) at 12 Months After Index Date(At index date (baseline) and at 12 months after index date)
- Change From Baseline in Pulmonary Function After LABA+LAMA or LAMA Initiation Evaluating by COPD Assessment Test (CAT) Score at 12 Months After Index Date(At index date (Baseline) and at 12 months after index date.)
研究者
研究点 (12)
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