Clinical Trials/NCT05127304

NCT05127304

Completed

Not Applicable

Health Care Resource Utilization, Cost and Other Outcomes of Patients Diagnosed With COPD Initiating Tiotropium Bromide/Olodaterol Versus Fluticasone Furoate/Umeclidinium/Vilanterol

Boehringer Ingelheim1 site in 1 country11,316 target enrollmentFebruary 26, 2021

ConditionsPulmonary Disease, Chronic Obstructive

InterventionsStiolto Respimat Tiotropium Bromide/Olodaterol Trelegy Ellipta Furoate/Umeclidinium/Vilanterol

DrugsFuroate/Umeclidinium/Vilanterol Tiotropium Bromide/Olodaterol

Overview

Phase: Not Applicable
Intervention: Stiolto Respimat
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Enrollment: 11316
Locations: 1
Primary Endpoint: All-cause Health Care Resource Utilization
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to estimate disease-related and all-cause burden and clinical outcomes of interest following initiation of chronic obstructive lung disease (COPD) maintenance therapy with Tiotropium Bromide/Olodaterol (TIO/OLO) or Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI).

Registry

clinicaltrials.gov

Start Date

February 26, 2021

End Date

February 3, 2022

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Boehringer Ingelheim

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•≥30 consecutive days with Tiotropium Bromide/Olodaterol (TIO/OLO) or Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) initiated during the patient identification period of 01 June 2015 to 30 November
•The index date will be the date of the TIO/OLO or FF/UMEC/VI pharmacy claim that starts the ≥30 consecutive days with the medication.
•\>1 facility claim with a diagnosis of chronic obstructive lung disease (COPD) in the primary position or ≥2 professional claims with a diagnosis code for COPD in any position on separate dates of service during the study period
•≥40 years of age as of the year of the index date
•Continuous enrollment with medical and pharmacy coverage for 12 months prior to and including the index date (baseline period)
•Continuous enrollment with medical and pharmacy coverage for ≥30 days following the index date and without discontinuation of the index medication or switch to a non-index regimen (follow-up period); discontinuation and switch as defined in the protocol.

Exclusion Criteria

•≥2 medical claims with a diagnosis code for asthma, cystic fibrosis, lung cancer, or interstitial lung disease in any position on separate dates of service during the baseline period
•Pharmacy claims for both TIO/OLO and FF/UMEC/VI on the index date
•A pharmacy claim for any non-index COPD maintenance medication on the index date, defined as: long-acting muscarinic antagonists (LAMA) monotherapy; long-acting beta2 agonists (LABA) monotherapy; inhaled corticosteroids (ICS) monotherapy; fixed-dose combination (FDC) ICS/LABA, or FDC LAMA/LABA
•Free or fixed dose LAMA+LABA maintenance therapy defined as ≥7 consecutive days of overlapping days' supply with a LAMA and LABA during a 6-month pre-index period, excluding the index date
•- Flags will be created to identify patients excluded for baseline LAMA/LABA use overall and specifically for each FDC LAMA/LABA medication
•Free or fixed dose triple therapy (TT) defined as ≥7 consecutive days of overlapping days' supply with an ICS, LABA, and LAMA during a 6-month pre-index period, excluding the index date
•≥1 medical claim with a procedure code for lung volume reduction during the study period
•Unknown age, gender, or business line, or unknown/other geographic region

Arms & Interventions

Tiotropium bromide/Olodaterol (TIO/OLO)

Chronic Obstructive Pulmonary Disease (COPD) patients with ≥30 consecutive days with TIO/OLO initiated during the patient identification period of 01 June 2015 to 30 November 2019 and ≥40 years of age as of the year of the index date. The index date was the date of the TIO/OLO pharmacy claim that started the ≥30 consecutive days with the medication.

Intervention: Stiolto Respimat

Tiotropium bromide/Olodaterol (TIO/OLO)

Intervention: Tiotropium Bromide/Olodaterol

Fluticasone furoate/Umeclidinium/Vilanterol (FF/UMEC/VI)

Chronic Obstructive Pulmonary Disease (COPD) patients with ≥30 consecutive days with FF/UMEC/VI initiated during the patient identification period of 01 June 2015 to 30 November 2019 and ≥40 years of age as of the year of the index date. The index date was the date of the FF/UMEC/VI pharmacy claim that started the ≥30 consecutive days with the medication.

Intervention: Trelegy Ellipta

Fluticasone furoate/Umeclidinium/Vilanterol (FF/UMEC/VI)

Intervention: Furoate/Umeclidinium/Vilanterol

Outcomes

Primary Outcomes

All-cause Health Care Resource Utilization

Time Frame: Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).

All-cause health care resource utilization. Annualized population averages of visits for each of the following categories is reported: * Ambulatory visits * Office visits * Outpatient visits * Emergency room visits * Inpatient visits * Other medical visits (included services like independent laboratory, home health, durable medical equipment, etc.) Annualized population averages of visits were calculated as: (\[sum of all visits for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]).

COPD and/or Pneumonia-related Health Care Resource Utilization

Chronic Obstructive Pulmonary Disease (COPD) and/or pneumonia-related health care resource utilization (medical claims with a diagnosis for COPD, pneumonia, or acute bronchitis/bronchiolitis in any position and pharmacy claims for a COPD-related treatment, including COPD-guideline recommended antibiotics). Population annualized averages of visits in each of the following categories is reported: * Ambulatory visits * Office visits * Outpatient visits * Emergency room visits * Inpatient visits * Other medical visits (independent laboratory, home health, durable medical equipment, etc.) Population annualized averages of visits were calculated as: (\[sum of all visits for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]).

Pneumonia-related Health Care Resource Utilization

Pneumonia-related health care resource utilization: This utilization was calculated for medical claims with a diagnosis for pneumonia in any position. Population annualized averages of visits in each of the following categories is reported: * Ambulatory visits * Office visits * Outpatient visits * Emergency room visits * Inpatient visits * Other medical visits (independent laboratory, home health, durable medical equipment, etc.) Population annualized averages of visits were calculated as: (\[sum of all visits for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]).

Pneumonia-related Health Care Resource Utilization: Inpatient Days

Pneumonia-related health care resource utilization: This utilization was calculated for medical claims with a diagnosis for pneumonia in any position. Population annualized averages of inpatient days is reported. Population annualized averages of inpatient days were calculated as: (\[sum of all inpatient days for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]).

COPD or Pneumonia-attributable Health Care Resource Utilization

COPD or pneumonia-attributable health care resource utilization: This utilization was calculated for medical claims with a diagnosis for COPD, pneumonia, or acute bronchitis/bronchiolitis in the primary position or a diagnosis for acute respiratory failure in the primary position and a diagnosis for COPD, pneumonia, or acute bronchitis/bronchiolitis in a non-primary position and pharmacy claims for a COPD-related treatment, including COPD-guideline recommended antibiotics. Population annualized averages of visits in each of the following categories is reported: * Ambulatory visits * Office visits * Outpatient visits * Emergency room visits * Inpatient visits * Other medical visits (independent laboratory, home health, durable medical equipment, etc.) Population annualized averages of visits were calculated as: (\[sum of all visits for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]).

All-cause Health Care Resource Utilization: Inpatient Days

All-cause health care resource utilization: Inpatient days. Annualized population averages of inpatient days is reported. Annualized population averages of inpatient days were calculated as: (\[sum of all inpatient days for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]).

All-cause Health Care Resource Utilization: Pharmacy Fills

All-cause health care resource utilization: Pharmacy fills. Annualized population averages for pharmacy fills is reported. Annualized population averages of pharmacy fills were calculated as:(\[sum of all pharmacy fills for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]).

COPD-related Health Care Resource Utilization

Chronic Obstructive Pulmonary Disease (COPD)-related (medical claims with a diagnosis for COPD in any position and pharmacy claims for a COPD-related treatment, including COPD-guideline recommended antibiotics) health care resource utilization. Population annualized averages of visits for each of the following categories is reported: * Ambulatory visits * Office visits * Outpatient visits * Emergency room visits * Inpatient visits * Other medical visits (included services like independent laboratory, home health, durable medical equipment, etc.). Annualized population averages of visits were calculated as: (\[sum of all visits for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]).

COPD-related Health Care Resource Utilization: Inpatient Days

Chronic Obstructive Pulmonary Disease (COPD)-related (medical claims with a diagnosis for COPD in any position and pharmacy claims for a COPD-related treatment, including COPD-guideline recommended antibiotics) health care resource utilization: Inpatient days. Population annualized averages of inpatient days is reported. Annualized population averages of inpatient days were calculated as: (\[sum of all inpatient days for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]).

COPD-related Health Care Resource Utilization: Pharmacy Fills

Chronic Obstructive Pulmonary Disease (COPD)-related (medical claims with a diagnosis for COPD in any position and pharmacy claims for a COPD-related treatment, including COPD-guideline recommended antibiotics) health care resource utilization. Population annualized averages for pharmacy fills is reported. Annualized population averages of pharmacy fills were calculated as: (\[sum of all pharmacy fills for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]).

COPD and/or Pneumonia-related Health Care Resource Utilization: Inpatient Days

Chronic Obstructive Pulmonary Disease (COPD) and/or pneumonia-related health care resource utilization (medical claims with a diagnosis for COPD, pneumonia, or acute bronchitis/bronchiolitis in any position and pharmacy claims for a COPD-related treatment, including COPD-guideline recommended antibiotics). Population annualized averages of inpatient days is reported. Population annualized averages of inpatient days were calculated as: (\[sum of all inpatient days for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]).

COPD and/or Pneumonia-related Health Care Resource Utilization: Pharmacy Fills

Chronic Obstructive Pulmonary Disease (COPD) and/or pneumonia-related health care resource utilization (medical claims with a diagnosis for COPD, pneumonia, or acute bronchitis/bronchiolitis in any position and pharmacy claims for a COPD-related treatment, including COPD-guideline recommended antibiotics). Population annualized averages of pharmacy fills is reported. Population annualized averages of pharmacy fills were calculated as: (\[sum of all pharmacy fills for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]).

COPD or Pneumonia-attributable Health Care Resource Utilization: Inpatient Days

COPD or pneumonia-attributable health care resource utilization: This utilization was calculated for medical claims with a diagnosis for COPD, pneumonia, or acute bronchitis/bronchiolitis in the primary position or a diagnosis for acute respiratory failure in the primary position and a diagnosis for COPD, pneumonia, or acute bronchitis/bronchiolitis in a non-primary position and pharmacy claims for a COPD-related treatment, including COPD-guideline recommended antibiotics. Population annualized averages of inpatient days is reported. Population annualized averages of inpatient days were calculated as: (\[sum of all inpatient days for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]).

COPD or Pneumonia-attributable Health Care Resource Utilization: Pharmacy Fills

COPD or pneumonia-attributable health care resource utilization: This utilization was calculated for medical claims with a diagnosis for COPD, pneumonia, or acute bronchitis/bronchiolitis in the primary position or a diagnosis for acute respiratory failure in the primary position and a diagnosis for COPD, pneumonia, or acute bronchitis/bronchiolitis in a non-primary position and pharmacy claims for a COPD-related treatment, including COPD-guideline recommended antibiotics. Annualized population averages for pharmacy claims are calculated as the (\[sum of all pharmacy fills for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]). Wald 95% confidence limits for this ratio used the Taylor expansion to estimate the standard error.

All-cause Health Care Costs (Insurer + Patient Paid Amounts)

All-cause health care costs were computed from the payer and patient perspective together. Annualized population averages of all-cause health care costs in each of the following categories is reported: * Medical costs (includes physician office costs, hospital outpatient costs, emergency services costs, inpatient costs, and other costs) * Ambulatory * Office visits * Outpatient visits * Emergency room visits * Inpatient stay * Other medical costs * Pharmacy costs * Total (medical + pharmacy) costs. Annualized population averages of costs were calculated as: (\[sum of all costs for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]). Costs were adjusted to 2020 dollars using the most recent year of the medical care component of the Consumer Price Index (CPI) to reflect inflation between the date of the claim and 2020.

COPD-related Health Care Costs (Insurer + Patient Paid Amounts)

COPD-related health care costs (HCC) cover the costs for medical claims with a diagnosis for COPD in any position and pharmacy claims for a COPD-related treatment, including COPD-guideline recommended antibiotics. Annualized population averages of COPD-related HCC for the categories below are reported: * Medical costs (includes physician office costs, hospital outpatient costs, emergency services costs, inpatient costs, and other costs) * Ambulatory * Office visits * Outpatient visits * Emergency room visits * Inpatient stay * Other medical costs * Pharmacy costs * Total (medical + pharmacy) costs. Annualized population averages of costs = (\[sum of all costs for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]). Costs are adjusted to 2020 dollars using the most recent year of the medical care component of the Consumer Price Index (CPI) to reflect inflation between the claim date and 2020.

COPD and/or Pneumonia-related Health Care Costs (Insurer + Patient Paid Amounts)

These costs were calculated for medical claims with a diagnosis for COPD, pneumonia, or acute bronchitis/bronchiolitis in any position and pharmacy claims for a COPD-related treatment, including COPD-guideline recommended antibiotics. Annualized population averages of costs for categories below is reported: * Medical costs (includes physician office costs, hospital outpatient costs, emergency services costs, inpatient costs, and other costs) * Ambulatory * Office visits * Outpatient visits * Emergency room visits * Inpatient stay * Other medical costs * Pharmacy costs * Total (medical + pharmacy) costs. Annualized population averages=(\[sum of all costs for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]). Costs were adjusted to 2020 dollars using the most recent year of the medical care component of the Consumer Price Index (CPI) to reflect inflation between the claim date and 2020.

Pneumonia-related Health Care Costs (Insurer + Patient Paid Amounts)

These costs were calculated for medical claims with a diagnosis for pneumonia in any position. Annualized population averages of pneumonia-related health care costs for the categories below is reported: * Medical costs (includes physician office costs, hospital outpatient costs, emergency services costs, inpatient costs, and other costs) * Ambulatory * Office visits * Outpatient visits * Emergency room visits * Inpatient stay * Other medical costs * Pharmacy costs * Total (medical + pharmacy) costs. Annualized population averages=(\[sum of all costs for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]). Costs were adjusted to 2020 dollars using the most recent year of the medical care component of the Consumer Price Index (CPI) to reflect inflation between the claim date and 2020.

COPD or Pneumonia-attributable Health Care Costs (Insurer + Patient Paid Amounts)

These costs were calculated for medical claims with a diagnosis for COPD, pneumonia, or acute bronchitis/bronchiolitis in the primary position or a diagnosis for acute respiratory failure in the primary position and a diagnosis for COPD, pneumonia, or acute bronchitis/bronchiolitis in a non-primary position, or pharmacy claims for a COPD-related treatment, including COPD-guideline recommended antibiotics. Annualized population averages are reported and were calculated as=(\[sum of all costs for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]). Costs were adjusted to 2020 dollars using the most recent year of the medical care component of the Consumer Price Index (CPI) to reflect inflation between the claim date and 2020.

Chronic Obstructive Pulmonary Disease (COPD) Exacerbations

Annualized population averages of COPD exacerbations for the categories below are reported: * Any COPD exacerbation * Severe COPD exacerbation (defined as an inpatient admission or an emergency room (ER) visit with a COPD diagnosis code in the primary position; or an inpatient admission or an ER visit with a diagnosis code for acute respiratory failure in the primary position and a COPD diagnosis code in any position; or an inpatient admission or an ER visit with a diagnosis code for acute respiratory failure in the primary position + an inpatient admission or an ER visit within ±7 days with a COPD diagnosis code in any position). Annualized population averages= (\[sum of all exacerbations for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]).

Secondary Outcomes

Percentage of Patients With 30-day All-cause Readmission After COPD Hospitalization(Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).)