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OpenTrials
Completed

NCT Number: NCT05127304

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

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).

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Optum

Eden Prairie, Minnesota, 55344, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trelegy Ellipta

Device

Trelegy Ellipta with Furoate/Umeclidinium/Vilanterol

Stiolto Respimat

Device

Stiolto Respimat with Tiotropium Bromide/Olodaterol

Furoate/Umeclidinium/Vilanterol

Drug

Furoate/Umeclidinium/Vilanterol

Tiotropium Bromide/Olodaterol

Drug

Tiotropium Bromide/Olodaterol

Primary outcomes

  1. 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]).

  2. All-cause Health Care Resource Utilization: Inpatient Days

    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: 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]).

  3. All-cause Health Care Resource Utilization: Pharmacy Fills

    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: 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]).

  4. COPD-related 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).

    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]).

  5. COPD-related Health Care Resource Utilization: Inpatient Days

    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).

    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]).

  6. COPD-related Health Care Resource Utilization: Pharmacy Fills

    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).

    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]).

  7. COPD and/or Pneumonia-related 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).

    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]).

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

    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).

    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]).

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

    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).

    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]).

  10. Pneumonia-related 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).

    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]).

  11. Pneumonia-related Health Care Resource Utilization: Inpatient Days

    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).

    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]).

  12. COPD or Pneumonia-attributable 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).

    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]).

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

    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).

    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]).

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

    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).

    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.

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

    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 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.

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

    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).

    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.

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

    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).

    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.

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

    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).

    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.

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

    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).

    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.

  20. Chronic Obstructive Pulmonary Disease (COPD) Exacerbations

    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).

    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

  1. Percentage of Patients With 30-day All-cause Readmission After COPD Hospitalization

    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).

    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.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 19, 2021
Registry last updated
Nov 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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