Trial · NCT04184297
Comparative Effectiveness and Safety of Tiotropium and Olodaterol in Comparison to Triple Therapy
NCT04184297, Completed, Boehringer Ingelheim; results first posted 2020-11-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Comparative Effectiveness and Safety of Tiotropium and Olodaterol in Comparison to Triple Therapy. Trials, record NCT04184297. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04184297
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparative Effectiveness and Safety of Tiotropium and Olodaterol in Comparison to Triple Therapy
- NCT number
- NCT04184297
- Status
- Completed
- Enrollment
- 27,190 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- Tiotropium and Olodaterol (Tio+Olo), Long-acting beta2-agonist and Inhaled corticosteroids (LABA and ICS)
- First posted
- 2019-12-03
- Last updated
- 2021-11-15
- Results first posted
- 2020-11-30
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation | From cohort entry (index date) until the occurrence of a hospitalization for COPD (severe exacerbation), ED visit for COPD or prescription of an antibiotic and oral corticosteroid on the same day (moderate exacerbation). Up to 1 year after cohort entry. | Incidence rate of Chronic Obstructive Pulmonary Disease (COPD) exacerbation was reported. Time to the first Chronic obstructive pulmonary disease (COPD) exacerbation will be measured from cohort entry until the occurrence of a hospitalization for COPD (severe exacerbation) or Emergency Department (ED) visit for COPD with the prescription of an antibiotic and/or an oral corticosteroid on the same day (moderate exacerbation). |
| Primary | Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation - Without Exacerbation Within 30 Days Prior to Cohort Entry | From cohort entry (index date) until the occurrence of a hospitalization for COPD (severe exacerbation), ED visit for COPD or prescription of an antibiotic and oral corticosteroid on the same day (moderate exacerbation). Up to 1 year after cohort entry. | Incidence rate of Chronic Obstructive Pulmonary Disease (COPD) exacerbation excluding participants who had exacerbation within 30 days prior to cohort entry, was reported. Time to the first Chronic obstructive pulmonary disease (COPD) exacerbation will be measured from cohort entry until the occurrenceof a hospitalization for COPD (severe exacerbation) or Emergency Department (ED) visit for COPD with the prescription of an antibiotic and/or an oral corticosteroid on the same day (moderate exacerbation). |
| Secondary | Overall Incidence Rate of Hospitalization for Community-acquired Pneumonia (Serious Pneumonia) | From cohort entry (index date) until the occurrence of hospitalization for community-acquired pneumonia (serious pneumonia). Up to 1 year after cohort entry. | Overall incidence rate of first hospitalization for community-acquired pneumonia (serious pneumonia). |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation | From cohort entry (index date) until the occurrence of a hospitalization for COPD (severe exacerbation), ED visit for COPD or prescription of an antibiotic and oral corticosteroid on the same day (moderate exacerbation). Up to 1 year after cohort entry. | Patients with Chronic Obstructive Pulmonary Disease (COPD) from HealthCore Integrated Research Database (January 2013 - March 2019) that meet all inclusion criteria, with laboratory result data available and non-missing endpoint outcomes. | Events per 1000 person-days | NUMBER |
| SECONDARY | Overall Incidence Rate of Hospitalization for Community-acquired Pneumonia (Serious Pneumonia) | From cohort entry (index date) until the occurrence of hospitalization for community-acquired pneumonia (serious pneumonia). Up to 1 year after cohort entry. | Patients with Chronic Obstructive Pulmonary Disease (COPD) from HealthCore Integrated Research Database (January 2013 - March 2019) that meet all inclusion criteria, with laboratory result data available and non-missing endpoint outcomes. | Events per 1000 person-days | NUMBER |
| PRIMARY | Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation - Without Exacerbation Within 30 Days Prior to Cohort Entry | From cohort entry (index date) until the occurrence of a hospitalization for COPD (severe exacerbation), ED visit for COPD or prescription of an antibiotic and oral corticosteroid on the same day (moderate exacerbation). Up to 1 year after cohort entry. | Patients with Chronic Obstructive Pulmonary Disease (COPD) from HealthCore Integrated Research Database (January 2013 - March 2019) that meet all inclusion criteria, and non-missing endpoint outcomes. Participants with exacerbation within 30 days prior to cohort entry were excluded. | Events per 1000 person-days | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation | Tiotropium+Olodaterol | 1.32 | 95% Confidence Interval 1.19 to 1.48 | Events per 1000 person-days | |
| Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation | LABA/LAMA/ICS | 1.14 | 95% Confidence Interval 1.10 to 1.18 | Events per 1000 person-days | |
| Overall Incidence Rate of Hospitalization for Community-acquired Pneumonia (Serious Pneumonia) | Tiotropium+Olodaterol | 0.25 | 95% Confidence Interval 0.20 to 0.32 | Events per 1000 person-days | |
| Overall Incidence Rate of Hospitalization for Community-acquired Pneumonia (Serious Pneumonia) | LABA/LAMA/ICS | 0.24 | 95% Confidence Interval 0.22 to 0.25 | Events per 1000 person-days | |
| Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation - Without Exacerbation Within 30 Days Prior to Cohort Entry | Tiotropium+Olodaterol | 1.18 | 95% Confidence Interval 1.05 to 1.33 | Events per 1000 person-days | |
| Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation - Without Exacerbation Within 30 Days Prior to Cohort Entry | LABA/LAMA/ICS | 0.99 | 95% Confidence Interval 0.95 to 1.03 | Events per 1000 person-days |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tiotropium+Olodaterol | 2,864 | |
| Overall Study | STARTED | LABA/LAMA/ICS | 24,326 | |
| Overall Study | COMPLETED | Tiotropium+Olodaterol | 2,864 | |
| Overall Study | COMPLETED | LABA/LAMA/ICS | 24,326 | |
| Overall Study | NOT COMPLETED | Tiotropium+Olodaterol | 0 | |
| Overall Study | NOT COMPLETED | LABA/LAMA/ICS | 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+Olodaterol | 0 | 0 |
| Total, all-cause mortality | LABA/LAMA/ICS | 0 | 0 |
| Total, other adverse events | Tiotropium+Olodaterol | 0 | 0 |
| Total, other adverse events | LABA/LAMA/ICS | 0 | 0 |
| Total, serious adverse events | Tiotropium+Olodaterol | 0 | 0 |
| Total, serious adverse events | LABA/LAMA/ICS | 0 | 0 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04184297
GET https://conductscience.org/api/trials/v1/NCT04184297/registered