Effectiveness and Safety of Maintenance Treatment With Combination of Tiotropium and Olodaterol in Comparison to Maintenance Treatment With a Combination of Inhaled Corticosteroids, Long-acting β2 Agonists and Long-acting Muscarinic Antagonists in COPD Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27,190
- 试验地点
- 1
- 主要终点
- Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
研究概览
简要总结
To assess the comparative effectiveness of combination Tiotropium and Olodaterol (Tio+Olo) (FDC) compared to combination LAMA/LABA and ICS (fixed or open), and to explore whether this varies across COPD sub populations defined by exacerbation risk
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
- •New users of Tio+Olo on the same date or of LABA, LAMA and ICS, either as a fixed-dose combination (LABA/LAMA/ICS) or free combination (LABA/ICS + LAMA, etc), on the same date between January 2013 and March
- •Diagnosis of COPD prior to first maintenance inhaler and age ≥ 40 years at index date
排除标准
- •Less than one year of medical history information prior to the date of combined treatment initiation (index date)
- •Lung cancer, interstitial lung disease, or lung transplantation at any time prior to the index date
- •Asthma diagnosis within one year prior to the index date
研究组 & 干预措施
Subjects initiated with Tiotropium and Olodaterol (Tio+Olo)
干预措施: Tiotropium and Olodaterol (Tio+Olo) (Drug)
Subjets initiated with LABA/LAMA/ICS
Long-acting beta2/ Long-acting muscarinic antagonists/Inhaled corticosteriods
干预措施: Long-acting beta2-agonist and Inhaled corticosteroids (LABA and ICS) (Drug)
结局指标
主要结局
Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
时间窗: From cohort entry (index date) until the occurrence of a hospitalization for COPD (severe exacerbation), ED visit for COPD or prescription of an antibiotic and oral corticosteroid on the same day (moderate exacerbation). Up to 1 year after cohort entry.
Incidence rate of Chronic Obstructive Pulmonary Disease (COPD) exacerbation was reported. Time to the first Chronic obstructive pulmonary disease (COPD) exacerbation will be measured from cohort entry until the occurrence of a hospitalization for COPD (severe exacerbation) or Emergency Department (ED) visit for COPD with the prescription of an antibiotic and/or an oral corticosteroid on the same day (moderate exacerbation).
Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation - Without Exacerbation Within 30 Days Prior to Cohort Entry
时间窗: From cohort entry (index date) until the occurrence of a hospitalization for COPD (severe exacerbation), ED visit for COPD or prescription of an antibiotic and oral corticosteroid on the same day (moderate exacerbation). Up to 1 year after cohort entry.
Incidence rate of Chronic Obstructive Pulmonary Disease (COPD) exacerbation excluding participants who had exacerbation within 30 days prior to cohort entry, was reported. Time to the first Chronic obstructive pulmonary disease (COPD) exacerbation will be measured from cohort entry until the occurrenceof a hospitalization for COPD (severe exacerbation) or Emergency Department (ED) visit for COPD with the prescription of an antibiotic and/or an oral corticosteroid on the same day (moderate exacerbation).
次要结局
- Overall Incidence Rate of Hospitalization for Community-acquired Pneumonia (Serious Pneumonia)(From cohort entry (index date) until the occurrence of hospitalization for community-acquired pneumonia (serious pneumonia). Up to 1 year after cohort entry.)