Effectiveness and Safety of Maintenance Treatment With Combination of Tiotropium and Olodaterol in Comparison to Maintenance Treatment With a Combination of Inhaled Corticosteroids and Long-acting β2 Agonists in COPD Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42,953
- 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
The primary objective is to compare the effectiveness of maintenance therapy initiation with the combination treatment Tiotropium and Olodaterol (Olo+Tio) compared with LABA/ICS combination in COPD as the time to the first COPD exacerbation.
Secondary objectives are to compare patients treated with Tio+Olo and patients treated with LABA/ ICS combination.
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 prescription for Tio+Olo combined inhaler or a LABA/ICS combined inhaler between 1 January 2013 and 31 March
- •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. Sensitivity analyses will also accept free combinations of LABA/ICS.
- •At least one diagnosis of COPD at any time prior to the index date.
- •At least one year of continuous medical and pharmacy health plan eligibility prior to the index date will be required to allow a baseline period for the covariates and identification of new use of the study drugs.
排除标准
- •To increase the likelihood of a true diagnosis of COPD, we will exclude:
- •All patients less than 40 years of age on the index date, and
- •All patients with a diagnosis of asthma in the year prior to the index date
- •To limit the population to those without severe lung compromise outside of COPD, we will exclude individuals with lung cancer, interstitial lung disease, or lung transplant identified at any time prior to the index date
- •To restrict the cohort to new users of Tio+Olo or LABA/ICS, we will exclude any individual with use of either Tio+Olo, LABA/ICS, or LABA/LAMA/ICS combination therapy in free or fixed form for at least one year prior to the index date.
研究组 & 干预措施
Patients initiating Tiotropium+Olodaterol therapy
干预措施: Tiotropium bromide + Olodaterol (Drug)
Patients initiating Long-acting beta agonist/inhaled corticosteroid therapy
干预措施: LABA/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 one year after cohort entry.
Incidence rate of Chronic Obstructive Pulmonary Disease (COPD) exacerbation after cohort entry. The event was defined as follows: Severe exacerbation: Hospitalization with a principal discharge diagnosis of COPD. or Moderate exacerbation: An emergency department (ED) visit with a discharge diagnosis of COPD, or, an antibiotic for a respiratory condition dispensed the same day as an oral corticosteroid.
次要结局
- Incidence Rate of First Hospitalization for Community-acquired Pneumonia(From cohort entry (index date) until the occurrence of first hospitalization for community-acquired pneumonia (serious pneumonia). Up to one year after cohort entry.)
- Incidence Rate of the First Date of a Pharmacy Dispensing Indicating Escalation (Original Case Definition) to Triple Therapy(From cohort entry (index date) until the escalation, up to one year after cohort entry.)
- Incidence Rate of the First Date of a Pharmacy Dispensing Indicating Escalation (Alternative Case Definition) to Triple Therapy(From cohort entry (index date) until the escalation, up to one year after cohort entry.)
- Incidence Rate of Any Element of a Composite Outcome Including Exacerbation, Hospitalization for Pneumonia, or Escalation (Original Case Definition) to Triple Therapy(From cohort entry (index date) until exacerbation, hospitalization (for community-acquired pneumonia) or escalation, up to one year after cohort entry.)
- Incidence Rate of Any Element of a Composite Outcome Including Exacerbation, Hospitalization for Pneumonia, or Escalation (Alternative Case Definition) to Triple Therapy(From cohort entry (index date) until exacerbation, hospitalization (for community-acquired pneumonia) or escalation, up to one year after cohort entry.)