A Study in the US Based on Pharmacy and Medical Claims That Compares How Well Stiolto® and Trelegy® Work in People With Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Device: Trelegy Ellipta
* Device: Stiolto Respimat
* Drug: Tiotropium + Olodaterol (5/5 mcg)
* Drug: Fluticasone Furoate + Umeclidinium + Vilanterol (100/62.5/25 mcg)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥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). Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Stiolto initiators<br>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). | Device: Stiolto Respimat<br>* Stiolto Respimat<br>Drug: Tiotropium + Olodaterol (5/5 mcg)<br>* Tiotropium + Olodaterol (5/5 mcg)<br>|
| Trelegy initiators<br>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). | Device: Trelegy Ellipta<br>* Trelegy Ellipta<br>Drug: Fluticasone Furoate + Umeclidinium + Vilanterol (100/62.5/25 mcg)<br>* Fluticasone Furoate + Umeclidinium + Vilanterol (100/62.5/25 mcg)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation After Cohort Entry | 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. | 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 | 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. | 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 | 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. | 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 | 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. | From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence Rate of Pneumonia Hospitalization (Diagnosis in Any Position) | The incidence rates of pneumonia (pneu.) hospitalization (diagnosis in any position) were reported. The incidence rate was calculated as totaling the number of pneumonia hospitalization for all patients / total follow-up in days * 365. | 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 no Baseline Exacerbation | The incidence rates of pneumonia (pneu.) hospitalization (diagnosis in any position) among patients with no baseline exacerbation were reported. The incidence rate was calculated as totaling the number of pneumonia hospitalization for all patients / total follow-up in days * 365. | 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 | The incidence rates of pneumonia (pneu.) hospitalization (diagnosis in any position) among patients with 0 or 1 baseline exacerbation were reported. The incidence rate was calculated as totaling the number of pneumonia hospitalization for all patients / total follow-up in days * 365. | 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 | The incidence rates of pneumonia (pneu.) hospitalization (diagnosis in any position) among patients with 2 or more baseline exacerbations were reported. The incidence rate was calculated as totaling the number of pneumonia hospitalization for all patients / total follow-up in days * 365. | 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) | The total annualized costs of COPD or pneumonia-related health care cost and resource utilization (HCRU) were calculated for each cohort by totaling the costs for all patients divided by the total follow-up in days, multiplied by 365. | 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 | The total annualized costs of COPD-related HCRU were calculated for each cohort by totaling the costs for all patients divided by the total follow-up in days, multiplied by 365. | 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 | The total annualized costs of pneumonia-related HCRU were calculated for each cohort by totaling the costs for all patients divided by the total follow-up in days, multiplied by 365. | 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 | The total annualized costs of COPD or pneumonia attributable HCRU were calculated for each cohort by totaling the costs for all patients divided by the total follow-up in days, multiplied by 365. | 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 | The total annualized costs of all-cause HCRU were calculated for each cohort by totaling the costs for all patients divided by the total follow-up in days, multiplied by 365. | From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days. |