Trial · NCT04138758
Comparative Effectiveness and Safety of Tiotropium and Olodaterol in Comparison to LABA/ICS
NCT04138758, Completed, Boehringer Ingelheim; results first posted 2020-11-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Comparative Effectiveness and Safety of Tiotropium and Olodaterol in Comparison to LABA/ICS. Trials, record NCT04138758. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04138758
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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 LABA/ICS
- NCT number
- NCT04138758
- Status
- Completed
- Enrollment
- 42,953 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- COPD
- Interventions
- Tiotropium bromide + Olodaterol, LABA/ICS
- First posted
- 2019-10-24
- Last updated
- 2021-11-15
- Results first posted
- 2020-11-30
Source ClinicalTrials.gov
Registered outcomes6
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 one year after cohort entry. | Incidence rate of Chronic Obstructive Pulmonary Disease (COPD) exacerbation after cohort entry. The event was defined as follows: Severe exacerbation: Hospitalization with a principal discharge diagnosis of COPD. or Moderate exacerbation: An emergency department (ED) visit with a discharge diagnosis of COPD, or, an antibiotic for a respiratory condition dispensed the same day as an oral corticosteroid. |
| Secondary | Incidence Rate of First Hospitalization for Community-acquired Pneumonia | From cohort entry (index date) until the occurrence of first hospitalization for community-acquired pneumonia (serious pneumonia). Up to one year after cohort entry. | Incidence rate of first hospitalization for community-acquired pneumonia (serious pneumonia). Pneumonia was defined using ICD-9-CM diagnoses and ICD-10 diagnosis codes. |
| Secondary | Incidence Rate of the First Date of a Pharmacy Dispensing Indicating Escalation (Original Case Definition) to Triple Therapy | From cohort entry (index date) until the escalation, up to one year after cohort entry. | Incidence rate of the first date of a pharmacy dispensing indicating escalation to triple therapy, (i.e., addition of Inhaled Corticosteroids to Tiotropium and Olodaterol or a Long-acting Muscarinic Antagonists to long-acting beta agonist / inhaled corticosteroid therapy). |
| Secondary | Incidence Rate of the First Date of a Pharmacy Dispensing Indicating Escalation (Alternative Case Definition) to Triple Therapy | From cohort entry (index date) until the escalation, up to one year after cohort entry. | Incidence rate of the first date of a pharmacy dispensing indicating escalation to triple therapy. Based on feedback from clinical experts during review of study results, an alternative post-hoc definition was also assessed in which initiation of any treatment including simultaneous LABA (long-acting beta agonist) /LAMA (Long-acting Muscarinic Antagonists) /ICS (inhaled corticosteroid therapy) use in free or fixed combination was counted as an outcome. |
| Secondary | Incidence Rate of Any Element of a Composite Outcome Including Exacerbation, Hospitalization for Pneumonia, or Escalation (Original Case Definition) to Triple Therapy | From cohort entry (index date) until exacerbation, hospitalization (for community-acquired pneumonia) or escalation, up to one year after cohort entry. | Incidence rate of any element of a composite outcome including exacerbation, hospitalization for pneumonia, or escalation (original case definition) to triple therapy. Exacerbation was defined as follows: Severe exacerbation: Hospitalization with a principal discharge diagnosis of COPD. Moderate exacerbation: An emergency department (ED) visit with a discharge diagnosis of COPD, or, an antibiotic for a respiratory condition dispensed the same day as an oral corticosteroid. Pneumonia was defined using ICD-9-CM diagnoses and ICD-10 diagnosis codes. Escalation was defined as the addition of Inhaled Corticosteroids to Tiotropium and Olodaterol or a Long-acting Muscarinic Antagonists to long-acting beta agonist / inhaled corticosteroid therapy. |
| Secondary | Incidence Rate of Any Element of a Composite Outcome Including Exacerbation, Hospitalization for Pneumonia, or Escalation (Alternative Case Definition) to Triple Therapy | From cohort entry (index date) until exacerbation, hospitalization (for community-acquired pneumonia) or escalation, up to one year after cohort entry. | Incidence rate of any element of a composite outcome including exacerbation, hospitalization for pneumonia, or escalation (alternative case definition) to triple therapy. Exacerbation was defined as follows: Severe exacerbation: Hospitalization with a principal discharge diagnosis of COPD. Moderate exacerbation: An emergency department (ED) visit with a discharge diagnosis of COPD, or, an antibiotic for a respiratory condition dispensed the same day as an oral corticosteroid. Pneumonia was defined using ICD-9-CM diagnoses and ICD-10 diagnosis codes. Escalation was defined as the initiation of any treatment including simultaneous LABA (long-acting beta agonist) /LAMA (Long-acting Muscarinic Antagonists) /ICS (inhaled corticosteroid therapy) use in free or fixed combination. |
Source ClinicalTrials.gov
Outcomes6
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 one year after cohort entry. | Propensity score weighted populations of patients with Chronic Obstructive Pulmonary Disease (COPD) derived from the HealthCore Integrated Research Database (HIRD, January 2013 - March 2019), who initiated fixed dose combination (FDC) inhaler treatment of Tiotropium and Olodaterol or long-acting beta agonist / inhaled corticosteroid therapy. | Events per 1,000 Person-days | NUMBER |
| SECONDARY | Incidence Rate of First Hospitalization for Community-acquired Pneumonia | From cohort entry (index date) until the occurrence of first hospitalization for community-acquired pneumonia (serious pneumonia). Up to one year after cohort entry. | Propensity score weighted populations of patients with Chronic Obstructive Pulmonary Disease (COPD) derived from the HealthCore Integrated Research Database (HIRD, January 2013 - March 2019), who initiated fixed dose combination (FDC) inhaler treatment of Tiotropium and Olodaterol or long-acting beta agonist / inhaled corticosteroid therapy. | events per 1,000 Person-days | NUMBER |
| SECONDARY | Incidence Rate of the First Date of a Pharmacy Dispensing Indicating Escalation (Original Case Definition) to Triple Therapy | From cohort entry (index date) until the escalation, up to one year after cohort entry. | Propensity score weighted populations of patients with Chronic Obstructive Pulmonary Disease (COPD) derived from the HealthCore Integrated Research Database (HIRD, January 2013 - March 2019), who initiated fixed dose combination (FDC) inhaler treatment of Tiotropium and Olodaterol or long-acting beta agonist / inhaled corticosteroid therapy. | events per 1,000 Person-days | NUMBER |
| SECONDARY | Incidence Rate of the First Date of a Pharmacy Dispensing Indicating Escalation (Alternative Case Definition) to Triple Therapy | From cohort entry (index date) until the escalation, up to one year after cohort entry. | Propensity score weighted populations of patients with Chronic Obstructive Pulmonary Disease (COPD) derived from the HealthCore Integrated Research Database (HIRD, January 2013 - March 2019), who initiated fixed dose combination (FDC) inhaler treatment of Tiotropium and Olodaterol or long-acting beta agonist / inhaled corticosteroid therapy. | events per 1,000 Person-days | NUMBER |
| SECONDARY | Incidence Rate of Any Element of a Composite Outcome Including Exacerbation, Hospitalization for Pneumonia, or Escalation (Original Case Definition) to Triple Therapy | From cohort entry (index date) until exacerbation, hospitalization (for community-acquired pneumonia) or escalation, up to one year after cohort entry. | Propensity score weighted populations of patients with Chronic Obstructive Pulmonary Disease (COPD) derived from the HealthCore Integrated Research Database (HIRD, January 2013 - March 2019), who initiated fixed dose combination (FDC) inhaler treatment of Tiotropium and Olodaterol or long-acting beta agonist / inhaled corticosteroid therapy. | events per 1,000 Person-days | NUMBER |
| SECONDARY | Incidence Rate of Any Element of a Composite Outcome Including Exacerbation, Hospitalization for Pneumonia, or Escalation (Alternative Case Definition) to Triple Therapy | From cohort entry (index date) until exacerbation, hospitalization (for community-acquired pneumonia) or escalation, up to one year after cohort entry. | Propensity score weighted populations of patients with Chronic Obstructive Pulmonary Disease (COPD) derived from the HealthCore Integrated Research Database (HIRD, January 2013 - March 2019), who initiated fixed dose combination (FDC) inhaler treatment of Tiotropium and Olodaterol or long-acting beta agonist / inhaled corticosteroid therapy. | events per 1,000 Person-days | NUMBER |
Source ClinicalTrials.gov
Results by group12
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 | 1.63 | 95% Confidence Interval 1.47 to 1.81 | Events per 1,000 Person-days | |
| Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation | Long-acting Beta Agonist / Inhaled Corticosteroid Therapy | 2.43 | 95% Confidence Interval 2.37 to 2.49 | Events per 1,000 Person-days | |
| Incidence Rate of First Hospitalization for Community-acquired Pneumonia | Tiotropium + Olodaterol | 0.23 | 95% Confidence Interval 0.18 to 0.30 | events per 1,000 Person-days | |
| Incidence Rate of First Hospitalization for Community-acquired Pneumonia | Long-acting Beta Agonist / Inhaled Corticosteroid Therapy | 0.34 | 95% Confidence Interval 0.32 to 0.37 | events per 1,000 Person-days | |
| Incidence Rate of the First Date of a Pharmacy Dispensing Indicating Escalation (Original Case Definition) to Triple Therapy | Tiotropium + Olodaterol | 0.54 | 95% Confidence Interval 0.46 to 0.64 | events per 1,000 Person-days | |
| Incidence Rate of the First Date of a Pharmacy Dispensing Indicating Escalation (Original Case Definition) to Triple Therapy | Long-acting Beta Agonist / Inhaled Corticosteroid Therapy | 2.90 | 95% Confidence Interval 2.84 to 2.97 | events per 1,000 Person-days | |
| Incidence Rate of the First Date of a Pharmacy Dispensing Indicating Escalation (Alternative Case Definition) to Triple Therapy | Tiotropium + Olodaterol | 0.57 | 95% Confidence Interval 0.48 to 0.67 | events per 1,000 Person-days | |
| Incidence Rate of the First Date of a Pharmacy Dispensing Indicating Escalation (Alternative Case Definition) to Triple Therapy | Long-acting Beta Agonist / Inhaled Corticosteroid Therapy | 3.14 | 95% Confidence Interval 3.08 to 3.21 | events per 1,000 Person-days | |
| Incidence Rate of Any Element of a Composite Outcome Including Exacerbation, Hospitalization for Pneumonia, or Escalation (Original Case Definition) to Triple Therapy | Tiotropium + Olodaterol | 2.14 | 95% Confidence Interval 1.96 to 2.34 | events per 1,000 Person-days | |
| Incidence Rate of Any Element of a Composite Outcome Including Exacerbation, Hospitalization for Pneumonia, or Escalation (Original Case Definition) to Triple Therapy | Long-acting Beta Agonist / Inhaled Corticosteroid Therapy | 5.45 | 95% Confidence Interval 5.36 to 5.54 | events per 1,000 Person-days |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 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 + Olodaterol | 2,600 | |
| Overall Study | STARTED | Long-acting Beta Agonist / Inhaled Corticosteroid Therapy | 40,353 | |
| Overall Study | COMPLETED | Tiotropium + Olodaterol | 2,600 | |
| Overall Study | COMPLETED | Long-acting Beta Agonist / Inhaled Corticosteroid Therapy | 40,353 | |
| Overall Study | NOT COMPLETED | Tiotropium + Olodaterol | 0 | |
| Overall Study | NOT COMPLETED | Long-acting Beta Agonist / Inhaled Corticosteroid Therapy | 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 | Long-acting Beta Agonist / Inhaled Corticosteroid Therapy | 0 | 0 |
| Total, other adverse events | Tiotropium + Olodaterol | 0 | 0 |
| Total, other adverse events | Long-acting Beta Agonist / Inhaled Corticosteroid Therapy | 0 | 0 |
| Total, serious adverse events | Tiotropium + Olodaterol | 0 | 0 |
| Total, serious adverse events | Long-acting Beta Agonist / Inhaled Corticosteroid Therapy | 0 | 0 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33721209 | 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.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04138758
GET https://conductscience.org/api/trials/v1/NCT04138758/registered