A Study Using US Medical and Pharmacy Claim Records to Compare the Resource Use, Cost, and Outcomes of People With COPD Who Take Either Tiotropium + Olodaterol or Fluticasone + Umeclidinium + Vilanterol

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

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).

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Device: Stiolto Respimat; Drug: Tiotropium Bromide/Olodaterol; Device: Trelegy Ellipta; Drug: Furoate/Umeclidinium/Vilanterol

• Study Type: Observational
• Enrollment (Actual): 11316

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Eden Prairie, Minnesota, United States, 55344
      • Optum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The sample will include commercial and Medicare Advantage Part D (MAPD) health plan members diagnosed with COPD

Description

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 2019. 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: Stiolto Respimat; Stiolto Respimat with Tiotropium Bromide/Olodaterol; Drug: Tiotropium Bromide/Olodaterol; 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.	Device: Trelegy Ellipta; Trelegy Ellipta with Furoate/Umeclidinium/Vilanterol; Drug: Furoate/Umeclidinium/Vilanterol; Furoate/Umeclidinium/Vilanterol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause Health Care Resource Utilization	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]).	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: 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]).	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: 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]).	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).
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]).	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).
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]).	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).
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]).	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).
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]).	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).
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]).	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).
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]).	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).
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]).	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).
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]).	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).
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]).	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).
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]).	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).
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.	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 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.	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).
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.	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).
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.	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).
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.	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).
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.	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).
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]).	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).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients With 30-day All-cause Readmission After COPD Hospitalization	Percentage of patients with 30-day all-cause readmission after Chronic Obstructive Pulmonary Disease (COPD) hospitalization is reported. Hospitalizations were classified as COPD-related if they met either of the following 2 criteria: ≥1 diagnosis of COPD in the primary position any time during the acute inpatient stay; or; ≥1 diagnosis of acute respiratory failure in the primary position and a diagnosis of acute exacerbation of COPD in a later position on the same claim during an acute inpatient stay.	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).

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2021
• Primary Completion (Actual): February 3, 2022
• Study Completion (Actual): February 3, 2022

Study Registration Dates

• First Submitted: November 12, 2021
• First Submitted That Met QC Criteria: November 12, 2021
• First Posted (Actual): November 19, 2021

Study Record Updates

• Last Update Posted (Estimated): November 13, 2023
• Last Update Submitted That Met QC Criteria: January 30, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Lung Diseases, Obstructive; Chronic Disease; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Anticonvulsants; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Tiotropium Bromide; Bromides; Olodaterol
• Other Study ID Numbers: 1237-0113

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to: https://www.mystudywindow.com/msw/datatransparency

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes