Trial · NCT05402020
Effectiveness of Tiotropium + Olodaterol Versus Inhaled Corticosteroids (ICS) + Long-acting β2-agonists (LABA) Among COPD Patients in Taiwan
NCT05402020, Completed, Boehringer Ingelheim; results first posted 2024-08-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Effectiveness of Tiotropium + Olodaterol Versus Inhaled Corticosteroids (ICS) + Long-acting β2-agonists (LABA) Among COPD Patients in Taiwan. Trials, record NCT05402020. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05402020
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effectiveness of Tiotropium + Olodaterol Versus Inhaled Corticosteroids (ICS) + Long-acting β2-agonists (LABA) Among COPD Patients in Taiwan
- NCT number
- NCT05402020
- Status
- Completed
- Enrollment
- 17,018 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- Tiotropium (Tio), Inhaled corticosteroids (ICS), Olodaterol (Olo), Long-acting β2-agonists (LABA)
- First posted
- 2022-06-02
- Last updated
- 2024-08-09
- Results first posted
- 2024-08-09
- Limitations and caveats
Clinically important parameters and reasons for using medications were not available. Anticipated is that a certain level of misclassification of disease conditions occurred. Not accounting for such confounders may have resulted in biased findings. Follow-up was censored resulting in limited follow-up time. This may have compromised statistical power, but was not likely to contribute substantial bias in the comparisons. SEAP template does not contain a document date as per internal SOP.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects With Event First Moderate or Severe COPD Exacerbations After Index Date | From the index date (the first dispensing of either Tio/Olo or ICS/LABA combined inhaler) until first event, up to 6 years. | Number of subjects with event first moderate or severe COPD exacerbations after index date. The first dispensing of either Tio/Olo or ICS/LABA combined inhaler was defined as the index date. Definition of moderate or severe COPD exacerbation: 1. Moderate exacerbation was defined as an outpatient visit with a diagnosis code for COPD in any field and a prescription for an oral corticosteroid or an antibiotic for respiratory infections 2. Severe exacerbation was defined as a hospitalization or emergency room visit with a primary diagnosis for COPD |
| Secondary | Number of Subjects With Event Triple Therapy Escalation After Index Date | From the index date (The first dispensing of either Tio/Olo or ICS/LABA combined inhaler) until first event, up to 6 years. | Number of subjects with event triple therapy escalation, defined as any LAMA/ICS/LABA fixed dose combination or any concurrent use for 30 consecutive days of the following: 1. any LAMA/LABA fixed dose combination + any ICS single formulation 2. any LAMA single formulation + any ICS/LABA fixed dose combination 3. any LAMA single formulation + any LABA single formulation + any ICS single formulation The event date was the 30th day after initiation of triple therapy. |
| Secondary | Incidence Rate of Triple Therapy Initiation | From the index date (The first dispensing of either Tio/Olo or ICS/LABA combined inhaler) until first event, up to 6 years. | Incidence rate of triple therapy initiation (first event per patient). Triple therapy escalation, defined as any LAMA/ICS/LABA fixed dose combination or any concurrent use for 30 consecutive days of the following: 1. any LAMA/LABA fixed dose combination + any ICS single formulation 2. any LAMA single formulation + any ICS/LABA fixed dose combination 3. any LAMA single formulation + any LABA single formulation + any ICS single formulation Incidence rate calculated as (total number of patients in the cohort experiencing an event of interest for the first time during the given time period) / (total person-time at risk from current use of treatment of cohort during the given period). |
| Secondary | Number of Subjects With Event First Hospitalization for Community-acquired Pneumonia After Entry | From the index date (The first dispensing of either Tio/Olo or ICS/LABA combined inhaler) until first event, up to 6 years. | Number of subjects with event the first hospitalization for community-acquired pneumonia after initiation of study drug. |
| Secondary | Annualized Rate of Prescriptions of Rescue Medications After the Index Date | From the index date (The first dispensing of either Tio/Olo or ICS/LABA combined inhaler) until first event, up to 6 years. | Annualized rate of prescriptions of rescue medications after the index date. Rescue medications were defined as free or combination use of short-acting beta-agonist (SABA) or short-acting muscarinic antagonist (SAMA) or SABA/SAMA. Annualized rates were calculated for each cohort as follows: (total number of events in the cohort during the given time period) / (total person-year at risk from current use of treatment of cohort during the given period). |
| Secondary | Annualized Rate of COPD Exacerbations After Index Date | From the index date (The first dispensing of either Tio/Olo or ICS/LABA combined inhaler) until first event, up to 6 years. | Annualized rate of moderate or severe COPD exacerbation after the index date. Annualized rate is calculated as follows: number of moderate or severe COPD exacerbations/total patient year at risk=number of exacerbations per patient year. Definitions of moderate or severe COPD exacerbation were: 1. Moderate exacerbation was defined as an outpatient visit with a diagnosis code for COPD in any field + a prescription for an oral corticosteroid or an antibiotic for respiratory infections, prescriptions within 30 days of each other were considered as continuation of the initial exacerbation. 2. Severe exacerbation was defined as a hospitalization or emergency room visit with a primary diagnosis for COPD; hospitalizations or emergency room visits within 30 days of each other were considered as continuation of the initial exacerbation. |
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 | Number of Subjects With Event First Moderate or Severe COPD Exacerbations After Index Date | From the index date (the first dispensing of either Tio/Olo or ICS/LABA combined inhaler) until first event, up to 6 years. | Propensity score matched cohorts: Subjects were 1:1 propensity score matched between cohorts. The two groups were comparable with regards to year of treatment initiation, season of treatment initiation, prior treatment for Chronic Obstructive Pulmonary Disease (COPD), use of respiratory drugs of interest, frequency and severity of COPD exacerbation, prevalence of major comorbidity, Charlson Comorbidity Index, and concomitant medications. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Event Triple Therapy Escalation After Index Date | From the index date (The first dispensing of either Tio/Olo or ICS/LABA combined inhaler) until first event, up to 6 years. | Propensity score matched cohorts: Subjects were 1:1 propensity score matched between cohorts. The two groups were comparable with regards to year of treatment initiation, season of treatment initiation, prior treatment for Chronic Obstructive Pulmonary Disease (COPD), use of respiratory drugs of interest, frequency and severity of COPD exacerbation, prevalence of major comorbidity, Charlson Comorbidity Index, and concomitant medications. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Incidence Rate of Triple Therapy Initiation | From the index date (The first dispensing of either Tio/Olo or ICS/LABA combined inhaler) until first event, up to 6 years. | Propensity score matched cohorts: Subjects were 1:1 propensity score matched between cohorts. The two groups were comparable with regards to year of treatment initiation, season of treatment initiation, prior treatment for Chronic Obstructive Pulmonary Disease (COPD), use of respiratory drugs of interest, frequency and severity of COPD exacerbation, prevalence of major comorbidity, Charlson Comorbidity Index, and concomitant medications. | Events(escalations per 1000 person years | NUMBER |
| SECONDARY | Number of Subjects With Event First Hospitalization for Community-acquired Pneumonia After Entry | From the index date (The first dispensing of either Tio/Olo or ICS/LABA combined inhaler) until first event, up to 6 years. | Propensity score matched cohorts: Subjects were 1:1 propensity score matched between cohorts. The two groups were comparable with regards to year of treatment initiation, season of treatment initiation, prior treatment for Chronic Obstructive Pulmonary Disease (COPD), use of respiratory drugs of interest, frequency and severity of COPD exacerbation, prevalence of major comorbidity, Charlson Comorbidity Index, and concomitant medications. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Annualized Rate of Prescriptions of Rescue Medications After the Index Date | From the index date (The first dispensing of either Tio/Olo or ICS/LABA combined inhaler) until first event, up to 6 years. | Propensity score matched cohorts: Subjects were 1:1 propensity score matched between cohorts. The two groups were comparable with regards to year of treatment initiation, season of treatment initiation, prior treatment for Chronic Obstructive Pulmonary Disease (COPD), use of respiratory drugs of interest, frequency and severity of COPD exacerbation, prevalence of major comorbidity, Charlson Comorbidity Index, and concomitant medications. | Events (prescriptions) per Person-year | NUMBER |
| SECONDARY | Annualized Rate of COPD Exacerbations After Index Date | From the index date (The first dispensing of either Tio/Olo or ICS/LABA combined inhaler) until first event, up to 6 years. | Propensity score matched cohorts: Subjects were 1:1 propensity score matched between cohorts. The two groups were comparable with regards to year of treatment initiation, season of treatment initiation, prior treatment for Chronic Obstructive Pulmonary Disease (COPD), use of respiratory drugs of interest, frequency and severity of COPD exacerbation, prevalence of major comorbidity, Charlson Comorbidity Index, and concomitant medications. | Events (exacerbations) per Person-year | 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 |
|---|---|---|---|---|---|
| Number of Subjects With Event First Moderate or Severe COPD Exacerbations After Index Date | Tiotropium + Olodaterol Cohort - Propensity Score Matched | 424 | Participants | ||
| Number of Subjects With Event First Moderate or Severe COPD Exacerbations After Index Date | Inhaled Corticosteroids (ICS) + Long-acting ß2 Agonists (LABA) Cohort - Propensity Score Matched | 375 | Participants | ||
| Number of Subjects With Event Triple Therapy Escalation After Index Date | Tiotropium + Olodaterol Cohort - Propensity Score Matched | 122 | Participants | ||
| Number of Subjects With Event Triple Therapy Escalation After Index Date | Inhaled Corticosteroids (ICS) + Long-acting ß2 Agonists (LABA) Cohort - Propensity Score Matched | 153 | Participants | ||
| Incidence Rate of Triple Therapy Initiation | Tiotropium + Olodaterol Cohort - Propensity Score Matched | 76.2 | 95% Confidence Interval 74.5 to 77.9 | Events(escalations per 1000 person years | |
| Incidence Rate of Triple Therapy Initiation | Inhaled Corticosteroids (ICS) + Long-acting ß2 Agonists (LABA) Cohort - Propensity Score Matched | 114.2 | 95% Confidence Interval 112.1 to 116.3 | Events(escalations per 1000 person years | |
| Number of Subjects With Event First Hospitalization for Community-acquired Pneumonia After Entry | Tiotropium + Olodaterol Cohort - Propensity Score Matched | 11 | Participants | ||
| Number of Subjects With Event First Hospitalization for Community-acquired Pneumonia After Entry | Inhaled Corticosteroids (ICS) + Long-acting ß2 Agonists (LABA) Cohort - Propensity Score Matched | 11 | Participants | ||
| Annualized Rate of Prescriptions of Rescue Medications After the Index Date | Tiotropium + Olodaterol Cohort - Propensity Score Matched | 0.86 | 95% Confidence Interval 0.01 to 5.33 | Events (prescriptions) per Person-year | |
| Annualized Rate of Prescriptions of Rescue Medications After the Index Date | Inhaled Corticosteroids (ICS) + Long-acting ß2 Agonists (LABA) Cohort - Propensity Score Matched | 1.03 | 95% Confidence Interval 0.03 to 5.62 | Events (prescriptions) per Person-year |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tiotropium + Olodaterol Cohort | 3,815 | |
| Overall Study | STARTED | Inhaled Corticosteroids (ICS) + Long-acting ß2 Agonists (LABA) Cohort | 13,203 | |
| Overall Study | Propensity Score-matched Cohorts | Tiotropium + Olodaterol Cohort | 3,752 | |
| Overall Study | Propensity Score-matched Cohorts | Inhaled Corticosteroids (ICS) + Long-acting ß2 Agonists (LABA) Cohort | 3,752 | |
| Overall Study | COMPLETED | Tiotropium + Olodaterol Cohort | 3,815 | |
| Overall Study | COMPLETED | Inhaled Corticosteroids (ICS) + Long-acting ß2 Agonists (LABA) Cohort | 13,203 | |
| Overall Study | NOT COMPLETED | Tiotropium + Olodaterol Cohort | 0 | |
| Overall Study | NOT COMPLETED | Inhaled Corticosteroids (ICS) + Long-acting ß2 Agonists (LABA) Cohort | 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 Cohort | 0 | 0 |
| Total, all-cause mortality | Inhaled Corticosteroids (ICS) + Long-acting ß2 Agonists (LABA) Cohort | 0 | 0 |
| Total, other adverse events | Tiotropium + Olodaterol Cohort | 0 | 0 |
| Total, other adverse events | Inhaled Corticosteroids (ICS) + Long-acting ß2 Agonists (LABA) Cohort | 0 | 0 |
| Total, serious adverse events | Tiotropium + Olodaterol Cohort | 0 | 0 |
| Total, serious adverse events | Inhaled Corticosteroids (ICS) + Long-acting ß2 Agonists (LABA) Cohort | 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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Tiotropium + Olodaterol Cohort - Propensity Score Matched vs Inhaled Corticosteroids (ICS) + Long-acting ß2 Agonists (LABA) Cohort - Propensity Score Matched: Number of Subjects With Event First Moderate or Severe COPD Exacerbations After Index Date | Trial comparisons |
Tiotropium + Olodaterol Cohort - Propensity Score Matched vs Inhaled Corticosteroids (ICS) + Long-acting ß2 Agonists (LABA) Cohort - Propensity Score Matched: Number of Subjects With Event First Hospitalization for Community-acquired Pneumonia After Entry | Trial comparisons |
Tiotropium + Olodaterol Cohort - Propensity Score Matched vs Inhaled Corticosteroids (ICS) + Long-acting ß2 Agonists (LABA) Cohort - Propensity Score Matched: Number of Subjects With Event Triple Therapy Escalation After Index Date | Trial comparisons |
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/NCT05402020
GET https://conductscience.org/api/trials/v1/NCT05402020/registered