Trial · 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
NCT05127304, Completed, Boehringer Ingelheim; results first posted 2023-11-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT05127304. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05127304
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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 number
- NCT05127304
- Status
- Completed
- Enrollment
- 11,316 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- Trelegy Ellipta, Stiolto Respimat, Furoate/Umeclidinium/Vilanterol, Tiotropium Bromide/Olodaterol
- First posted
- 2021-11-19
- Last updated
- 2023-11-13
- Results first posted
- 2023-11-13
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | All-cause Health Care Resource Utilization | 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: (\[sum of all visits for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]). |
| Primary | All-cause Health Care Resource Utilization: Inpatient Days | 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: (\[sum of all inpatient days for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]). |
| Primary | All-cause Health Care Resource Utilization: Pharmacy Fills | 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:(\[sum of all pharmacy fills for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]). |
| Primary | COPD-related Health Care Resource Utilization | 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: (\[sum of all visits for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]). |
| Primary | COPD-related Health Care Resource Utilization: Inpatient Days | 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: (\[sum of all inpatient days for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]). |
| Primary | COPD-related Health Care Resource Utilization: Pharmacy Fills | 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: (\[sum of all pharmacy fills for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]). |
| Primary | COPD and/or Pneumonia-related Health Care Resource Utilization | 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: (\[sum of all visits for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]). |
| Primary | COPD and/or Pneumonia-related Health Care Resource Utilization: Inpatient Days | 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: (\[sum of all inpatient days for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]). |
| Primary | COPD and/or Pneumonia-related Health Care Resource Utilization: Pharmacy Fills | 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: (\[sum of all pharmacy fills for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]). |
| Primary | Pneumonia-related Health Care Resource Utilization | 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: (\[sum of all visits for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]). |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | All-cause Health Care Resource Utilization | 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). | Matched Overall Population: Stratified propensity score matching (PSM), using an exact match on some variables and a propensity score match on the others, was used to control for possible confounding of the association between the outcomes and treatment with TIO/OLO or FF/UMEC/VI. Patients were matched in a 1:1 ratio of TIO/OLO to FF/UMEC/VI. | visits/year | MEAN |
| PRIMARY | All-cause Health Care Resource Utilization: Inpatient Days | 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). | Matched Overall Population: Stratified propensity score matching (PSM), using an exact match on some variables and a propensity score match on the others, was used to control for possible confounding of the association between the outcomes and treatment with TIO/OLO or FF/UMEC/VI. Patients were matched in a 1:1 ratio of TIO/OLO to FF/UMEC/VI. | inpatient days/year | MEAN |
| PRIMARY | All-cause Health Care Resource Utilization: Pharmacy Fills | 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). | Matched Overall Population: Stratified propensity score matching (PSM), using an exact match on some variables and a propensity score match on the others, was used to control for possible confounding of the association between the outcomes and treatment with TIO/OLO or FF/UMEC/VI. Patients were matched in a 1:1 ratio of TIO/OLO to FF/UMEC/VI. | pharmacy fills/year | MEAN |
| PRIMARY | COPD-related Health Care Resource Utilization | 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). | Matched Overall Population: Stratified propensity score matching (PSM), using an exact match on some variables and a propensity score match on the others, was used to control for possible confounding of the association between the outcomes and treatment with TIO/OLO or FF/UMEC/VI. Patients were matched in a 1:1 ratio of TIO/OLO to FF/UMEC/VI. | visits/year | MEAN |
| PRIMARY | COPD-related Health Care Resource Utilization: Inpatient Days | 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). | Matched Overall Population: Stratified propensity score matching (PSM), using an exact match on some variables and a propensity score match on the others, was used to control for possible confounding of the association between the outcomes and treatment with TIO/OLO or FF/UMEC/VI. Patients were matched in a 1:1 ratio of TIO/OLO to FF/UMEC/VI. | inpatient days/year | MEAN |
| PRIMARY | COPD-related Health Care Resource Utilization: Pharmacy Fills | 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). | Matched Overall Population: Stratified propensity score matching (PSM), using an exact match on some variables and a propensity score match on the others, was used to control for possible confounding of the association between the outcomes and treatment with TIO/OLO or FF/UMEC/VI. Patients were matched in a 1:1 ratio of TIO/OLO to FF/UMEC/VI. | pharmacy fills/year | MEAN |
| PRIMARY | COPD and/or Pneumonia-related Health Care Resource Utilization | 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). | Matched Overall Population: Stratified propensity score matching (PSM), using an exact match on some variables and a propensity score match on the others, was used to control for possible confounding of the association between the outcomes and treatment with TIO/OLO or FF/UMEC/VI. Patients were matched in a 1:1 ratio of TIO/OLO to FF/UMEC/VI. | visits/year | MEAN |
| PRIMARY | COPD and/or Pneumonia-related Health Care Resource Utilization: Inpatient Days | 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). | Matched Overall Population: Stratified propensity score matching (PSM), using an exact match on some variables and a propensity score match on the others, was used to control for possible confounding of the association between the outcomes and treatment with TIO/OLO or FF/UMEC/VI. Patients were matched in a 1:1 ratio of TIO/OLO to FF/UMEC/VI. | inpatient days/year | MEAN |
| PRIMARY | COPD and/or Pneumonia-related Health Care Resource Utilization: Pharmacy Fills | 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). | Matched Overall Population: Stratified propensity score matching (PSM), using an exact match on some variables and a propensity score match on the others, was used to control for possible confounding of the association between the outcomes and treatment with TIO/OLO or FF/UMEC/VI. Patients were matched in a 1:1 ratio of TIO/OLO to FF/UMEC/VI. | pharmacy fills/year | MEAN |
| PRIMARY | Pneumonia-related Health Care Resource Utilization | 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). | Matched Overall Population: Stratified propensity score matching (PSM), using an exact match on some variables and a propensity score match on the others, was used to control for possible confounding of the association between the outcomes and treatment with TIO/OLO or FF/UMEC/VI. Patients were matched in a 1:1 ratio of TIO/OLO to FF/UMEC/VI. | visits/year | MEAN |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group172
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| All-cause Health Care Resource Utilization | Tiotropium Bromide/Olodaterol (TIO/OLO) | Ambulatory visits | 32.54 | 95% Confidence Interval 31.44 to 33.64 | visits/year |
| All-cause Health Care Resource Utilization | Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | Ambulatory visits | 32.91 | 95% Confidence Interval 31.84 to 33.97 | visits/year |
| All-cause Health Care Resource Utilization | Tiotropium Bromide/Olodaterol (TIO/OLO) | Office visits | 17.80 | 95% Confidence Interval 17.25 to 18.35 | visits/year |
| All-cause Health Care Resource Utilization | Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | Office visits | 17.57 | 95% Confidence Interval 17.08 to 18.06 | visits/year |
| All-cause Health Care Resource Utilization | Tiotropium Bromide/Olodaterol (TIO/OLO) | Outpatient visits | 14.82 | 95% Confidence Interval 13.95 to 15.69 | visits/year |
| All-cause Health Care Resource Utilization | Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | Outpatient visits | 15.42 | 95% Confidence Interval 14.55 to 16.28 | visits/year |
| All-cause Health Care Resource Utilization | Tiotropium Bromide/Olodaterol (TIO/OLO) | Emergency room visits | 1.26 | 95% Confidence Interval 1.17 to 1.35 | visits/year |
| All-cause Health Care Resource Utilization | Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | Emergency room visits | 1.39 | 95% Confidence Interval 1.29 to 1.50 | visits/year |
| All-cause Health Care Resource Utilization | Tiotropium Bromide/Olodaterol (TIO/OLO) | Inpatient visits | 0.45 | 95% Confidence Interval 0.41 to 0.48 | visits/year |
| All-cause Health Care Resource Utilization | Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | Inpatient visits | 0.48 | 95% Confidence Interval 0.44 to 0.52 | visits/year |
1 to 10 of 172Source ClinicalTrials.gov
See all 172 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tiotropium Bromide/Olodaterol (TIO/OLO) | 5,658 | |
| Overall Study | STARTED | Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | 5,658 | |
| Overall Study | COMPLETED | Tiotropium Bromide/Olodaterol (TIO/OLO) | 5,658 | |
| Overall Study | COMPLETED | Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | 5,658 | |
| Overall Study | NOT COMPLETED | Tiotropium Bromide/Olodaterol (TIO/OLO) | 0 | |
| Overall Study | NOT COMPLETED | Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tiotropium Bromide/Olodaterol (TIO/OLO) | 0 | 0 |
| Total, all-cause mortality | Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | 0 | 0 |
| Total, other adverse events | Tiotropium Bromide/Olodaterol (TIO/OLO) | 0 | 0 |
| Total, other adverse events | Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | 0 | 0 |
| Total, serious adverse events | Tiotropium Bromide/Olodaterol (TIO/OLO) | 0 | 0 |
| Total, serious adverse events | Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | 0 | 0 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37133429 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
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GET https://conductscience.org/api/trials/v1/NCT05127304
GET https://conductscience.org/api/trials/v1/NCT05127304/registered?page=2