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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05169424
Other study ID # 1237-0121
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 17, 2021
Est. completion date December 27, 2021

Study information

Verified date December 2022
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 9117
Est. completion date December 27, 2021
Est. primary completion date December 27, 2021
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States eMax health White Plains New York

Sponsors (1)

Lead Sponsor Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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.
Primary 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.
Primary 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 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
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