Trial Outcomes & Findings for 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 (NCT NCT05127304)

This was a non-interventional study using existing data from commercial and Medicare Advantage Part D (MAPD) beneficiaries, using administrative claims data for the period of 01 June 2015 through 30 November 2019.

Only subjects that met all inclusion and none of the exclusion criteria were included.

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

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: (\[sum of all visits for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]).

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

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: (\[sum of all visits for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]).

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: (\[sum of all inpatient days for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]).

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: (\[sum of all pharmacy fills for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]).

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: (\[sum of all visits for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]).

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: (\[sum of all inpatient days for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]).

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: (\[sum of all pharmacy fills for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]).

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: 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: 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: (\[sum of all visits for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]).

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: 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 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 (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.

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.

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.

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.

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= (\[sum of all exacerbations for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]).

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.