Effectiveness of Maintenance Treatment With Tiotropium + Olodaterol in Comparison to Inhaled Corticosteroids + Long-acting β2 Agonists in COPD Patients in Taiwan: a Non-interventional Study Based on the Taiwan National Health Insurance (NHI) Data
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17,018
- 试验地点
- 1
- 主要终点
- Number of Subjects With Event First Moderate or Severe COPD Exacerbations After Index Date
研究概览
简要总结
The real world study aims to assess effectiveness and safety profile between tiotropium/olodaterol (Tio/Olo) and inhaled corticosteroids(ICS) / Long-acting β2-agonists (LABA) in patients with chronic obstructive pulmonary disease (COPD) in Taiwan. The data used in this study will come from the Taiwan National Health Insurance (NHI) claims data between 2014 and 2019.
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
- •At least one prescriptions for Tiotropium/Olodaterol (Tio/Olo) combined inhaler or Long-acting ß2 agonist / Inhaled Corticosteroids (LABA/ICS) combined inhaler between 1st January 2014 and 31st December
- •The first dispensing of either Tio/Olo or LABA/ICS combined inhaler will be defined as the index date;
- •For the main analyses, only fixed dose combination (FDC) inhalers will be included.
- •Aged ≥ 40 years on the index date (in a sensitivity analysis we will only include patients aged ≥ 55 years on the index date);
- •At least one diagnosis of chronic obstructive pulmonary disease (COPD) at any time prior to or on the index date;
- •At least one year of continuous medical and health insurance plan prior to the index date will be required to allow for a look-back period for the covariates and identification of new use of the study drugs;
- •At least one record in the health insurance system database
排除标准
- •Any use of Tio/Olo, ICS/LABA, or ICS/LABA/ Long-acting muscarinic antagonists (LAMA) in free or fixed form for one year prior to the index date;
- •Individuals with asthma, allergic rhinitis, lung cancer, interstitial lung disease, or lung transplant identified at any time prior to the index date (in a sensitivity analysis we will include patients with asthma);
研究组 & 干预措施
Tiotropium + Olodaterol cohort
Subjects who initiated Tiotropium + Olodaterol between 1st January 2014 and 31st December 2019 according to data from the Taiwan National Health Insurance (NHI), Taiwan Cancer Registry (TCR) and Taiwan Mortality Data.
干预措施: Tiotropium (Tio) (Drug)
Tiotropium + Olodaterol cohort
Subjects who initiated Tiotropium + Olodaterol between 1st January 2014 and 31st December 2019 according to data from the Taiwan National Health Insurance (NHI), Taiwan Cancer Registry (TCR) and Taiwan Mortality Data.
干预措施: Olodaterol (Olo) (Drug)
Inhaled Corticosteroids (ICS) + Long-acting ß2 agonists (LABA) cohort
Subjects who initiated Inhaled Corticosteroids (ICS) + Long-acting ß2 agonists (LABA) between 1st January 2014 and 31st December 2019 according to data from the Taiwan National Health Insurance (NHI), Taiwan Cancer Registry (TCR) and Taiwan Mortality Data.
干预措施: Inhaled corticosteroids (ICS) (Drug)
Inhaled Corticosteroids (ICS) + Long-acting ß2 agonists (LABA) cohort
Subjects who initiated Inhaled Corticosteroids (ICS) + Long-acting ß2 agonists (LABA) between 1st January 2014 and 31st December 2019 according to data from the Taiwan National Health Insurance (NHI), Taiwan Cancer Registry (TCR) and Taiwan Mortality Data.
干预措施: Long-acting β2-agonists (LABA) (Drug)
结局指标
主要结局
Number of Subjects With Event First Moderate or Severe COPD Exacerbations After Index Date
时间窗: From the index date (the first dispensing of either Tio/Olo or ICS/LABA combined inhaler) until first event, up to 6 years.
Number of subjects with event first moderate or severe COPD exacerbations after index date. The first dispensing of either Tio/Olo or ICS/LABA combined inhaler was defined as the index date. Definition of moderate or severe COPD exacerbation: 1. Moderate exacerbation was defined as an outpatient visit with a diagnosis code for COPD in any field and a prescription for an oral corticosteroid or an antibiotic for respiratory infections 2. Severe exacerbation was defined as a hospitalization or emergency room visit with a primary diagnosis for COPD
次要结局
- Incidence Rate of Triple Therapy Initiation(From the index date (The first dispensing of either Tio/Olo or ICS/LABA combined inhaler) until first event, up to 6 years.)
- Number of Subjects With Event Triple Therapy Escalation After Index Date(From the index date (The first dispensing of either Tio/Olo or ICS/LABA combined inhaler) until first event, up to 6 years.)
- Number of Subjects With Event First Hospitalization for Community-acquired Pneumonia After Entry(From the index date (The first dispensing of either Tio/Olo or ICS/LABA combined inhaler) until first event, up to 6 years.)
- Annualized Rate of Prescriptions of Rescue Medications After the Index Date(From the index date (The first dispensing of either Tio/Olo or ICS/LABA combined inhaler) until first event, up to 6 years.)
- Annualized Rate of COPD Exacerbations After Index Date(From the index date (The first dispensing of either Tio/Olo or ICS/LABA combined inhaler) until first event, up to 6 years.)