Trial · NCT05393245
Safety of Tiotropium + Olodaterol in Chronic Obstructive Pulmonary Disease (COPD) Patients in Taiwan: a Non-interventional Study Based on the Taiwan National Health Insurance (NHI) Data
NCT05393245, Completed, Boehringer Ingelheim; results first posted 2024-12-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety of Tiotropium + Olodaterol in Chronic Obstructive Pulmonary Disease (COPD) Patients in Taiwan: a Non-interventional Study Based on the Taiwan National Health Insurance (NHI) Data. Trials, record NCT05393245. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05393245
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety of Tiotropium + Olodaterol in Chronic Obstructive Pulmonary Disease (COPD) Patients in Taiwan: a Non-interventional Study Based on the Taiwan National Health Insurance (NHI) Data
- NCT number
- NCT05393245
- Status
- Completed
- Enrollment
- 19,467 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- Tiotropium+Olodaterol, Spiolto Respimat, Long-acting muscarinic antagonists (LAMAs), Long-acting β2-agonists (LABAs)
- First posted
- 2022-05-26
- Last updated
- 2024-12-04
- Results first posted
- 2024-12-04
- Limitations and caveats
According to Boehringer Ingelheim's internal policy, no document date is required in the title page of the Statistical and Epidemiological Analysis Plan.~A direct comparison of the incidence of AEs in similar studies should take into account that the cohorts in the current study were not matched, and, as a consequence, patients treated with Tiotropium/Olodaterol or Other LABA/LAMA presented different baseline characteristics.
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Potentially Recurrent Events | From index date between 1st January 2014 until 31st December 2019. Up to 2160 days. | Incidence rate of adverse events in patients with COPD treated with Tiotropium+Olodaterol (Tio+Olo) per number of person-years is reported. From the index date until the earliest: Outcome of interest, disenrollment, the end of the study period, death, discontinuation of the index drug, addition of Inhaled corticosteroids mono on top of Tio/Olo. The incidence rate was reported as (Total number of patients in the Tio+Olo cohort experiencing an event of interest for the 1st time during the given time period) / (Total person-time at risk from current use of Tio+Olo during the given period). Urinary tract infection: (1): Diagnosis codes were primary inpatient diagnosis associated with a hospitalization. (2): Diagnosis codes were primary or secondary diagnosis associated with a hospitalization.(3): Diagnosis codes were primary or secondary diagnosis associated with a hospitalization OR associated with at least 2 outpatient/emergency visits within 30 days of each other. |
| Primary | Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Incident Events | From index date between 1st January 2014 until 31st December 2019. Up to 2160 days. | Incidence rate of Adverse Events (AEs) in patients with COPD treated with Tiotropium+Olodaterol (Tio+Olo) per number of person-years is reported. From index date until the earliest: Outcome of interest, disenrollment, end of the study period, death, discontinuation, use of Inhaled corticosteroids. Incident events. The incidence rate was reported as (Total number of patients in the Tio+Olo cohort experiencing an event of interest for the 1st time during the given time period) / (Total person-time at risk from current use of Tio+Olo during the given period). Urinary tract infection: (1): Diagnosis codes were primary inpatient diagnosis associated with a hospitalization. (2): Diagnosis codes were primary or secondary diagnosis associated with a hospitalization.(3): Diagnosis codes were primary or secondary diagnosis associated with a hospitalization OR associated with at least 2 outpatient/emergency visits within 30 days of each other. |
| Secondary | Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Sex | At index date between 2014-2019. Up to 2160 days. | Number of patients by sex according to whether they started Tio+Olo or another LAMA/LABA |
| Secondary | Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Age | At index date between 2014-2019 | Number of patients by age groups according to whether they started Tio+Olo or another LAMA/LABA. The reported age groups are: 40-59, 60-79 and 80+. |
| Secondary | Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Calendar Year of Cohort Entry | At index date between 2014-2019 | Number of patients by Calendar year of cohort entry according to whether they started Tio+Olo or another LAMA/LABA. The reported year groups are: 2014, 2015, 2016, 2017, 2018 and 2019. |
| Secondary | Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Season of Cohort Entry Date | At index date between 2014-2019 | Number of patients by season of cohort entry date according to whether they started Tio+Olo or another LAMA/LABA. The reported seasons are: Spring (Mar-May), Summer (Jun-Aug), Fall (Sep-Nov) and Winter (Dec-Feb). |
| Secondary | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Specific Previous COPD Treatment | Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days. | Number of patients by specific previous COPD treatment during the 1 year pre-index baseline period according to whether they started Tio+Olo or another LAMA/LABA is reported. The treatments were: Long-acting muscarinic antagonists (LAMA) monotherapy, Long-acting β2-agonists (LABA) monotherapy, Inhaled corticosteroids (ICS) monotherapy, ICS containing therapy and LAMA+LABA free combinations. |
| Secondary | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Use of Other Respiratory Drugs | Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days. | Number of patients by use of other respiratory drugs during the 1 year pre-index baseline period according to whether they started Tio+Olo or another LAMA/LABA is reported. The treatments were: Mucolytics, Theophylline, Short-acting beta-agonists and Short-acting muscarinic antagonists. |
| Secondary | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Moderate COPD Exacerbation in 1 Year Prior to Index Date | Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days. | Number of patients by moderate Chronic Obstructive Pulmonary Disease (COPD) exacerbation in 1 year prior to index date according to whether they started Tio+Olo or another LAMA/LABA is reported. Categorized as 0, 1, or 2+ according to the frequency of previous acute COPD exacerbation in 1 year for each patient. |
| Secondary | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Severe COPD Exacerbation in 1 Year Prior to Index Date | Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days. | Number of patients by severe Chronic Obstructive Pulmonary Disease (COPD) exacerbation in 1 year prior to index date according to whether they started Tio+Olo or another LAMA/LABA is reported. Categorized as 0, 1, or 2+. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Potentially Recurrent Events | From index date between 1st January 2014 until 31st December 2019. Up to 2160 days. | Eligible Patients set: All patients who met the criteria and who were treated with Tio/Olo were included in the analysis dataset. | Events per 100 person-years | NUMBER |
| PRIMARY | Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Incident Events | From index date between 1st January 2014 until 31st December 2019. Up to 2160 days. | Eligible Patients set: All patients who met the criteria and who were treated with Tio/Olo were included in the analysis dataset. | Events per 100 person-years | NUMBER |
| SECONDARY | Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Sex | At index date between 2014-2019. Up to 2160 days. | Eligible Patients set: All patients who met the criteria were included in the analysis dataset. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Age | At index date between 2014-2019 | Eligible Patients set: All patients who met the criteria were included in the analysis dataset. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Calendar Year of Cohort Entry | At index date between 2014-2019 | Eligible Patients set: All patients who met the criteria were included in the analysis dataset. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Season of Cohort Entry Date | At index date between 2014-2019 | Eligible Patients set: All patients who met the criteria were included in the analysis dataset. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Specific Previous COPD Treatment | Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days. | Eligible Patients set: All patients who met the criteria were included in the analysis dataset. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Use of Other Respiratory Drugs | Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days. | Eligible Patients set: All patients who met the criteria were included in the analysis dataset. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Moderate COPD Exacerbation in 1 Year Prior to Index Date | Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days. | Eligible Patients set: All patients who met the criteria were included in the analysis dataset. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Severe COPD Exacerbation in 1 Year Prior to Index Date | Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days. | Eligible Patients set: All patients who met the criteria were included in the analysis dataset. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group156
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Potentially Recurrent Events | Tiotropium/Olodaterol (Tio/Olo) | Nasopharyngitis | 10.63 | 95% Confidence Interval 9.45 to 11.96 | Events per 100 person-years |
| Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Potentially Recurrent Events | Tiotropium/Olodaterol (Tio/Olo) | Pneumonia- Diagnosis codes were primary inpatient diagnosis associated with a hospitalization | 0.55 | 95% Confidence Interval 0.33 to 0.91 | Events per 100 person-years |
| Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Potentially Recurrent Events | Tiotropium/Olodaterol (Tio/Olo) | Pneumonia-Diagnosis codes were primary or secondary diagnosis associated with a hospitalization | 0.84 | 95% Confidence Interval 0.56 to 1.26 | Events per 100 person-years |
| Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Potentially Recurrent Events | Tiotropium/Olodaterol (Tio/Olo) | Moderate COPD exacerbation | 19.71 | 95% Confidence Interval 18.05 to 21.52 | Events per 100 person-years |
| Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Potentially Recurrent Events | Tiotropium/Olodaterol (Tio/Olo) | Severe COPD exacerbation | 15.66 | 95% Confidence Interval 14.21 to 17.26 | Events per 100 person-years |
| Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Potentially Recurrent Events | Tiotropium/Olodaterol (Tio/Olo) | Constipation | 17.06 | 95% Confidence Interval 15.53 to 18.74 | Events per 100 person-years |
| Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Potentially Recurrent Events | Tiotropium/Olodaterol (Tio/Olo) | Diarrhoea | 1.58 | 95% Confidence Interval 1.17 to 2.13 | Events per 100 person-years |
| Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Potentially Recurrent Events | Tiotropium/Olodaterol (Tio/Olo) | Urinary retention | 6.17 | 95% Confidence Interval 5.30 to 7.19 | Events per 100 person-years |
| Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Potentially Recurrent Events | Tiotropium/Olodaterol (Tio/Olo) | Urinary tract infection (1) | 2.53 | 95% Confidence Interval 2.00 to 3.21 | Events per 100 person-years |
| Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Potentially Recurrent Events | Tiotropium/Olodaterol (Tio/Olo) | Urinary tract infection (2) | 9.44 | 95% Confidence Interval 8.34 to 10.68 | Events per 100 person-years |
1 to 10 of 156Source ClinicalTrials.gov
See all 156 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 (Tio/Olo) | 5,820 | |
| Overall Study | STARTED | Other LABA/LAMA | 13,647 | |
| Overall Study | COMPLETED | Tiotropium/Olodaterol (Tio/Olo) | 5,820 | |
| Overall Study | COMPLETED | Other LABA/LAMA | 13,647 | |
| Overall Study | NOT COMPLETED | Tiotropium/Olodaterol (Tio/Olo) | 0 | |
| Overall Study | NOT COMPLETED | Other LABA/LAMA | 0 |
Source ClinicalTrials.gov
Adverse events3
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Tiotropium/Olodaterol (Tio/Olo) | 904 | 5,820 | |
| other | Constipation | Gastrointestinal disorders | Tiotropium/Olodaterol (Tio/Olo) | 435 | 5,820 | |
| other | Urinary tract infection | Infections and infestations | Tiotropium/Olodaterol (Tio/Olo) | 675 | 5,820 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tiotropium/Olodaterol (Tio/Olo) | 526 | 5,820 |
| Total, other adverse events | Tiotropium/Olodaterol (Tio/Olo) | 2,014 | 5,820 |
| Total, serious adverse events | Tiotropium/Olodaterol (Tio/Olo) | 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/NCT05393245
GET https://conductscience.org/api/trials/v1/NCT05393245/results?page=2