Clinical trial NCT05169424: 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)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2021-12-27
Enrollment: 9117
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The sample will include medical and pharmacy claim records for COPD patients included in the IQVIA database (previously named IMS Pharmetrix).

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation After Cohort Entry
timeFrame: From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days.
measure: Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation After Cohort Entry - Among Patients With no Baseline Exacerbation
timeFrame: From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days.
measure: Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation After Cohort Entry - Among Patients With 0 or 1 Baseline Exacerbation
timeFrame: From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days.
measure: Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation After Cohort Entry - Among Patients With 2 or More Baseline Exacerbations
timeFrame: From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days.
Secondary outcomes:
measure: Incidence Rate of Pneumonia Hospitalization (Diagnosis in Any Position)
timeFrame: From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days.
measure: Incidence Rate of Pneumonia Hospitalization (Diagnosis in Any Position) - Among Patients With no Baseline Exacerbation
timeFrame: From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days.
measure: Incidence Rate of Pneumonia Hospitalization (Diagnosis in Any Position) - Among Patients With 0 or 1 Baseline Exacerbation
timeFrame: From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days.
measure: Incidence Rate of Pneumonia Hospitalization (Diagnosis in Any Position) - Among Patients With 2 or More Baseline Exacerbations
timeFrame: From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days.
measure: Total Costs of COPD or Pneumonia-related Health Care Cost and Resource Utilization (HCRU)
timeFrame: From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days.
measure: Total Costs of COPD-related HCRU
timeFrame: From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days.
measure: Total Costs of Pneumonia-related HCRU
timeFrame: From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days.
measure: Total Costs of COPD or Pneumonia Attributable HCRU
timeFrame: From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days.
measure: Total Costs of All-cause HCRU
timeFrame: From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days.
Other outcomes:
Locations:
city: White Plains
country: United States
facility: eMax health
state: New York
Study officials:
References: