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)

Sponsor

Boehringer Ingelheim (Industry)

Overall Status

Completed

CT.gov ID

NCT05169424

Collaborator

(none)

51,224

Enrollment

Location

Actual Duration (Days)

155913.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Disease, Chronic Obstructive	Device: Trelegy Ellipta Device: Stiolto Respimat Drug: Tiotropium + Olodaterol (5/5 mcg) Drug: Fluticasone Furoate + Umeclidinium + Vilanterol (100/62.5/25 mcg)

Study Design

Study Type:

Observational

Actual Enrollment :

51224 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Dec 17, 2021

Actual Primary Completion Date :

Dec 27, 2021

Actual Study Completion Date :

Dec 27, 2021

Arms and Interventions

Arm	Intervention/Treatment
Stiolto initiators Chronic obstructive pulmonary disease (COPD) patients who initiated with Stiolto Respimat (Tiotropium + Olodaterol (5/5 micrograms (mcg)) between 15 September 2017 and 31st March 2020.	Device: Stiolto Respimat Stiolto Respimat Drug: Tiotropium + Olodaterol (5/5 mcg) Tiotropium + Olodaterol (5/5 mcg)
Trelegy initiators COPD patients who initiated with Trelegy Ellipta (Fluticasone Furoate + Umeclidinium + Vilanterol (100/62.5/25 mcg) between 15 September 2017 and 31st March 2020.	Device: Trelegy Ellipta Trelegy Ellipta Drug: Fluticasone Furoate + Umeclidinium + Vilanterol (100/62.5/25 mcg) Fluticasone Furoate + Umeclidinium + Vilanterol (100/62.5/25 mcg)

Arm

Intervention/Treatment

Stiolto initiators

Chronic obstructive pulmonary disease (COPD) patients who initiated with Stiolto Respimat (Tiotropium + Olodaterol (5/5 micrograms (mcg)) between 15 September 2017 and 31st March 2020.

Device: Stiolto Respimat

Stiolto Respimat

Drug: Tiotropium + Olodaterol (5/5 mcg)

Tiotropium + Olodaterol (5/5 mcg)

Trelegy initiators

COPD patients who initiated with Trelegy Ellipta (Fluticasone Furoate + Umeclidinium + Vilanterol (100/62.5/25 mcg) between 15 September 2017 and 31st March 2020.

Device: Trelegy Ellipta

Trelegy Ellipta

Drug: Fluticasone Furoate + Umeclidinium + Vilanterol (100/62.5/25 mcg)

Fluticasone Furoate + Umeclidinium + Vilanterol (100/62.5/25 mcg)

Outcome Measures

Primary Outcome Measures

Time to first chronic obstructive pulmonary disease (COPD) exacerbation after cohort entry [up to 30 months and 16 days]

Secondary Outcome Measures

Time to first hospitalization for community-acquired pneumonia (serious pneumonia) [up to 30 months and 16 days]
Total costs of COPD and/or pneumonia-related health care cost and resource utilization (HCRU) [up to 30 months and 16 days]
Total costs of COPD-related HCRU [up to 30 months and 16 days]
Total costs of pneumonia-related HCRU [up to 30 months and 16 days]
Total costs of COPD-attributable HCRU [Total costs of up to 30 months and 16 days]
Total costs of all-cause HCRU [up to 30 months and 16 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.