Early Intervention Effectiveness of Tiotropium / Olodaterol Compared to Tiotropium in COPD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6,788
- 试验地点
- 1
- 主要终点
- Time to Triple Therapy Initiation
研究概览
简要总结
This study aims to evaluate the time to escalation to triple therapy among the Japanese Chronic obstructive pulmonary disease (COPD) patients newly initiating therapy with a combination of Olodaterol and Tiotropium (herein referred to as Tio/Olo) using real world data.
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
- •The study cohort will include all patients who initiate Tiotropium/ Olodaterol (Tio/Olo) or Tiotropium (Tio) during the patient selection period.
排除标准
- •The following exclusion criteria will then be applied to generate the unmatched cohort:
- •Aged <40 years on cohort entry.
- •Any LAMA, LABA, or ICS maintenance therapy (alone or in combination) during the 180-day baseline period prior to cohort entry for maintenance treatment and duration >30 days, or any prescription within the 30 days prior to cohort entry.
- •Patients without continuous enrolment (days since first inpatient/ outpatient encounter in the data) during the baseline period.
- •No prior diagnosis of COPD [International Classification of Diseases (ICD)-10: J41*, J43*, J44* and doubt (UTAGAIFLG) = 0 (no)]
- •Patients without a second prescription claim of their index medication within 60 days after the cohort entry date.
- •Diagnosis of asthma [ICD-10: J45* and doubt (UTAGAIFLG) = 0 (no)] during the baseline period.
- •Diagnosis of lung cancer [ICD-10: C34*, D02.2, Z80.1, Z85.1 and doubt (UTALAIFLG) = 0 (no)] or lung transplant (Health claim code: 150317670, 150322510, 150322610, 150336510, 150336610, 150336710, 150399270) prior to the cohort entry date using all available data.
- •Patients who initiate both Tio/Olo and Tio simultaneously on the cohort entry date.
- •Any use of triple therapy (LAMA + LABA + ICS) during the baseline period or between the cohort entry date and 1 day prior to the start of follow-up.
研究组 & 干预措施
Tiotropium/Olodaterol
Combination of Tiotropium and Olodaterol
干预措施: Tiotropium/Olodaterol (Drug)
Tiotropium
干预措施: Tiotropium (Drug)
结局指标
主要结局
Time to Triple Therapy Initiation
时间窗: From index date (cohort entry date) until first occurence of event, up to 42 months.
Time to triple therapy initiation (first event per patient) defined as any fixed dose combination of Long-acting muscarinic antagonists (LAMA) / Long-acting beta agonist (LABA) / Inhaled Corticosteroid (ICS) or any concurrent use for 30 consecutive days of the following: * any LAMA/LABA fixed dose combination + any ICS single formulation * any LAMA single formulation + any LABA/ICS fixed dose combination * any LAMA single formulation + any LABA single formulation + any ICS single formulation. Patients will be censored if they had an occurrence of any of the following: outcome (initiation of triple therapy), death, or end of data. The analysis will use an intention-to-treat censoring approach, which does not account for treatment change.
次要结局
- Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation(From index date until first occurence of event, up to 42 months.)
- Number of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations(From index date until first occurence of event, up to 42 months.)