Comparison of Exacerbation Risk and Health Outcomes in Maintenance Treatment naïve Chronic Obstructive Pulmonary Disease (COPD) Patients Using Stiolto Versus Trelegy, a Real-World Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9,117
- 试验地点
- 1
- 主要终点
- Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation After Cohort Entry
研究概览
简要总结
This study looks at data from people with chronic obstructive pulmonary disease (COPD). Some used Stiolto Respimat and the others Trelegy Ellipta as their first treatment for COPD.
The purpose of this study is to find out how well the treatments worked. Researchers compare the time to first COPD flare-up (exacerbation) between the 2 treatments.
The study analyses anonymous data from pharmacy claims collected over 3.5 years.
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
- •≥40 years of age as of the year of the index date
- •At least one pharmacy claim for Stiolto Respimat or Trelegy Ellipta.
- •For Stiolto Respimat users, the first pharmacy claim of Fixed Dose Combination (FDC) of Tiotropium + Olodaterol (5/5 micrograms (mcg)) will be defined as the index date.
- •For Trelegy Ellipta users, the first pharmacy claim of FDC of Fluticasone Furoate + Umeclidinium + Vilanterol (100/62.5/25 mcg), will be defined as the index date.
- •Two medical claims (at least one claim on index date or before in the baseline period) with an International Statistical Classification of Diseases and Related Health Problems (ICD)-9/10 diagnosis code(s) for chronic obstructive pulmonary disease (COPD) in any position during the study period (baseline ± post index date).
- •At least one year of continuous medical and pharmacy health plan eligibility prior to the index date is required (to allow a baseline period for the covariates and characterizing the study population).
排除标准
- •To increase the likelihood of a true diagnosis of COPD, we will exclude all patients with two medical claims of asthma, cystic fibrosis, lung cancer, or interstitial lung disease in any position on separate dates of service during the study period.
- •To restrict the cohort to first line maintenance therapy of Stiolto Respimat or first line maintenance therapy of Trelegy Ellipta we will exclude: patients on long-acting muscarinic antagonists (LAMA) monotherapy; long-acting beta2 agonists (LABA) monotherapy; inhaled corticosteroids (ICS) monotherapy; free or FDC of: ICS+LABA, LAMA+LABA, ICS+LABA+LAMA therapy within six months prior to index date.
- •Pharmacy claims for multiple index medications on the index date.
- •Pharmacy claims for non-index COPD maintenance medications on the index date.
研究组 & 干预措施
Stiolto initiators
Chronic obstructive pulmonary disease (COPD) patients who initiated with Stiolto Respimat (Tiotropium + Olodaterol (5/5 micrograms (mcg)) in the existing real-world data from the Commercial Insurance and Medicare beneficiaries data using administrative claims between 15 September 2016 and 31st March 2020.
All participants had enrolled 1 year before the index date (starting from 15 September 2017).
干预措施: Stiolto Respimat (Device)
Stiolto initiators
Chronic obstructive pulmonary disease (COPD) patients who initiated with Stiolto Respimat (Tiotropium + Olodaterol (5/5 micrograms (mcg)) in the existing real-world data from the Commercial Insurance and Medicare beneficiaries data using administrative claims between 15 September 2016 and 31st March 2020.
All participants had enrolled 1 year before the index date (starting from 15 September 2017).
干预措施: Tiotropium + Olodaterol (5/5 mcg) (Drug)
Trelegy initiators
COPD patients who initiated with Trelegy Ellipta (Fluticasone Furoate + Umeclidinium + Vilanterol (100/62.5/25 mcg) in the existing real-world data from the Commercial Insurance and Medicare beneficiaries data using administrative claims between 15 September 2016 and 31st March 2020.
All participants had enrolled 1 year before the index date (starting from 15 September 2017).
干预措施: Trelegy Ellipta (Device)
Trelegy initiators
COPD patients who initiated with Trelegy Ellipta (Fluticasone Furoate + Umeclidinium + Vilanterol (100/62.5/25 mcg) in the existing real-world data from the Commercial Insurance and Medicare beneficiaries data using administrative claims between 15 September 2016 and 31st March 2020.
All participants had enrolled 1 year before the index date (starting from 15 September 2017).
干预措施: Fluticasone Furoate + Umeclidinium + Vilanterol (100/62.5/25 mcg) (Drug)
结局指标
主要结局
Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation After Cohort Entry
时间窗: From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days.
Incidence rate of chronic obstructive pulmonary disease (COPD) exacerbation after cohort entry were reported. The incidence rate was calculated as totaling the number of exacerbation for all patients / total follow-up in days \* 365.
Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation After Cohort Entry - Among Patients With no Baseline Exacerbation
时间窗: From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days.
Incidence rate of chronic obstructive pulmonary disease (COPD) exacerbation after cohort entry among patients with no baseline exacerbation were reported. The incidence rate was calculated as totaling the number of exacerbation for all patients / total follow-up in days \* 365.
Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation After Cohort Entry - Among Patients With 0 or 1 Baseline Exacerbation
时间窗: From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days.
Incidence rate of chronic obstructive pulmonary disease (COPD) exacerbation after cohort entry among patients with 0 or 1 baseline exacerbation were reported. The incidence rate was calculated as totaling the number of exacerbation for all patients / total follow-up in days \* 365.
Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation After Cohort Entry - Among Patients With 2 or More Baseline Exacerbations
时间窗: From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days.
Incidence rate of chronic obstructive pulmonary disease (COPD) exacerbation after cohort entry among patients with 2 or more baseline exacerbations were reported. The incidence rate was calculated as totaling the number of exacerbation for all patients / total follow-up in days \* 365.
次要结局
- Incidence Rate of Pneumonia Hospitalization (Diagnosis in Any Position) - Among Patients With no Baseline Exacerbation(From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days.)
- Incidence Rate of Pneumonia Hospitalization (Diagnosis in Any Position) - Among Patients With 0 or 1 Baseline Exacerbation(From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days.)
- Total Costs of COPD-related HCRU(From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days.)
- Total Costs of Pneumonia-related HCRU(From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days.)
- Incidence Rate of Pneumonia Hospitalization (Diagnosis in Any Position)(From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days.)
- Incidence Rate of Pneumonia Hospitalization (Diagnosis in Any Position) - Among Patients With 2 or More Baseline Exacerbations(From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days.)
- Total Costs of COPD or Pneumonia-related Health Care Cost and Resource Utilization (HCRU)(From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days.)
- Total Costs of COPD or Pneumonia Attributable HCRU(From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days.)
- Total Costs of All-cause HCRU(From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days.)