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 Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

9117 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-17

Study Completion Date

2021-12-27

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.

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Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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).

Stiolto Respimat

Intervention Type DEVICE

Stiolto Respimat

Tiotropium + Olodaterol (5/5 mcg)

Intervention Type DRUG

Tiotropium + Olodaterol (5/5 mcg)

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).

Trelegy Ellipta

Intervention Type DEVICE

Trelegy Ellipta

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

Intervention Type DRUG

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

Interventions

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Trelegy Ellipta

Intervention Type DEVICE

Stiolto Respimat

Intervention Type DEVICE

Tiotropium + Olodaterol (5/5 mcg)

Intervention Type DRUG

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

Intervention Type DRUG

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.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No