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

Study at a glance

From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

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

ClinicalTrials.gov ID

NCT05127304

Acronym / sponsor ID

1237-0113

Conditions

Pulmonary Disease, Chronic Obstructive

Study type

Observational

Recruitment status

Completed

Enrolment

11,316 participants (actual)

Lead sponsor

Boehringer IngelheimIndustry (pharma, biotech, devices)

Study start

26 Feb 2021 (actual)

Primary completion

3 Feb 2022 (actual)

Study completion

3 Feb 2022 (actual)

First posted

19 Nov 2021 (actual)

Results

Posted 13 Nov 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model

Cohort

Time perspective

Retrospective

Number of arms

2

Who may qualify

Ages

40 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Study population

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

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]).

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Derived from this study: PubMed 37133429Sethi S, Palli SR, Bengtson LGS, Buysman EK, Clark B, Sargent A, Shaikh A, Ferguson GT. Clinical and economic outcomes in patients with chronic obstructive pulmonary disease initiating maintenance therapy with tiotropium bromide/olodaterol or fluticasone furoate/umeclidinium/vilanterol. J Manag Care Spec Pharm. 2023 Jul;29(7):791-806. doi: 10.18553/jmcp.2023.22373. Epub 2023 May 3.
• Related InfoLink provided by the sponsor.
• Individual participant dataSharing planned: No. 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

Related trials for Pulmonary Disease, Chronic Obstructive

• Active, not recruiting

  Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS

  COPD, Smoking

• Not yet recruitingPhase 2/3

  An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)

  Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease

• Not yet recruiting

  The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.

  COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly

• Not yet recruitingPhase 2

  Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)

  Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease

• RecruitingPhase 3

  A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease

  Chronic Graft Versus Host Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.