Pulmonary Disease, Chronic ObstructiveNCT05393245

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

An observational study of Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The aim of this real world study is to assess the safety profile of tiotropium/olodaterol (Tio/Olo). Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Pulmonary Disease, Chronic Obstructive
What is being tested?: Tiotropium+Olodaterol, Spiolto Respimat and Long-acting muscarinic antagonists (LAMAs)
Type of treatment: Medical device
How many people: 19,467 participants
Where: 1 siteChina
Study dates: 30 Sep 2022to 7 Dec 2022
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Chinese patients with chronic obstructive pulmonary disease (COPD) in routine clinical practice in Taiwan.

Who may be able to join

At least one prescription for Tio+Olo (fixed dose combination (FDC) or free combination) as a new initiation between 1st January 2014 and 31st December 2019.
Aged ≥ 40 years on the index date.
At least one diagnosis of COPD at any time prior to or on the index date.
At least one year of continuous medical and health insurance plan prior to the index date will be required to allow for a look-back period for the covariates and identification of new use of the study drugs.
At least one record in the health insurance system database.
At least one prescription for LAMA+LABA (FDC or free combination) other than Tio/Olo as a new initiation between 1st January 2014 and 31st December 2019.

Show all 10Show fewer

Aged ≥ 40 years on the index date.
At least one diagnosis of COPD at any time prior to or on the index date-
At least one year of continuous medical and health insurance plan prior to the index date will be required to allow for a look-back period for the covariates and identification of new use of the study drugs.
At least one record in the health insurance system database.

Who cannot join

Any use of Tio+Olo in free or fixed form within one year prior to the index date.
Individuals with asthma, allergic rhinitis, lung cancer, interstitial lung disease, or lung transplant identified at any time prior to the index date.
Patients using other Long-acting β2-agonists/Long-acting muscarinic antagonists (LAMA/LABAs):
Any use of LAMA+LABA in free or fixed form for one year prior to the index date.
Individuals with asthma, allergic rhinitis, lung cancer, interstitial lung disease, or lung transplant identified at any time prior to the index date.

Trial locations and contacts

1 site in 1 country.

China1 site

Health Data Research Center, National Taiwan University
Taiwan, 10617

Other trials in China

About this study

Official title: Safety Profile of Tiotropium + Olodaterol Used as Maintenance Treatment in COPD Patients in Taiwan: a Non-interventional Study Based on the Taiwan National Health Insurance (NHI) Data

The aim of this real world study is to assess the safety profile of tiotropium/olodaterol (Tio/Olo).

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: Tiotropium+Olodaterol, Spiolto Respimat, Long-acting muscarinic antagonists (LAMAs), Long-acting β2-agonists (LABAs)
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tiotropium+OlodaterolDrug
Tiotropium+Olodaterol
Spiolto RespimatDevice
Spiolto Respimat Inhaler device
Long-acting muscarinic antagonists (LAMAs)Drug
Long-acting muscarinic antagonists (LAMAs)
Long-acting β2-agonists (LABAs)Drug
Long-acting β2-agonists (LABAs)

Study groups in NCT05393245
Study group	Role	What they receive
COPD patients treated with tiotropium and olodaterol (Tio+Olo)		Not described Receives: Drug: Tiotropium+Olodaterol; Device: Spiolto Respimat
COPD patients using other Long-acting muscarinic antagonists/Long-acting β2-agonists (LAMA/LABAs)		Not described Receives: Drug: Long-acting muscarinic antagonists (LAMAs); Drug: Long-acting β2-agonists (LABAs)

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Potentially Recurrent Events
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.
Measured: 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 Tio+Olo: Incident Events
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.
Measured: From index date between 1st January 2014 until 31st December 2019. Up to 2160 days.

Secondary outcomes (17)

Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Sex
Number of patients by sex according to whether they started Tio+Olo or another LAMA/LABA
Measured: At index date between 2014-2019. Up to 2160 days.
Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Age
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+.
Measured: At index date between 2014-2019
Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Calendar Year of Cohort Entry
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.
Measured: At index date between 2014-2019
Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Season of Cohort Entry Date
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).
Measured: At index date between 2014-2019
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Specific Previous COPD Treatment
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.
Measured: Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days.
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Use of Other Respiratory Drugs
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.
Measured: Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days.
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
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.
Measured: Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days.
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
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+.
Measured: Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days.
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: All COPD Exacerbation in 1 Year Prior to Index Date
Number of patients by Chronic Obstructive Pulmonary Disease (COPD) exacerbations 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+.
Measured: Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days.
Baseline Period: Characteristics Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Moderate COPD Exacerbation 30 Days Prior to Index Date
Number of patients by moderate Chronic Obstructive Pulmonary Disease (COPD) exacerbation in 30 days prior to index date according to whether they started Tio+Olo or another LAMA/LABA is reported. Categorized as 0, 1, or 2+.
Measured: Baseline period: 30 consecutive days ending the day before the index date. Up to 30 days.
Baseline Period: Characteristics Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Severe COPD Exacerbation 30 Days Prior to Index Date
Number of patients by severe Chronic Obstructive Pulmonary Disease (COPD) exacerbation in 30 days prior to index date according to whether they started Tio+Olo or another LAMA/LABA is reported. Categorized as 0, 1, or 2+.
Measured: Baseline period: 30 consecutive days ending the day before the index date. Up to 30 days.
Baseline Period: Characteristics Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: All COPD Exacerbation 30 Days Prior to Index Date
Number of patients by Chronic Obstructive Pulmonary Disease (COPD) exacerbations in 30 days prior to index date according to whether they started Tio+Olo or another LAMA/LABA is reported. Categorized as 0, 1, or 2+.
Measured: Baseline period: 30 consecutive days ending the day before the index date. Up to 30 days.
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Hospitalizations Caused by Exacerbation of COPD in 1 Year Prior to Index Date
Number of hospitalizations caused by Chronic Obstructive Pulmonary Disease (COPD) exacerbations 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+.
Measured: Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days.
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: All-cause Hospitalizations in 1 Year Prior to Index Date
Number of all-cause hospitalizations 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+.
Measured: Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days.
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Comorbidities in 1 Year Prior to Index Date
Number of participants with comorbidities in 1 year prior to index date according to whether they started Tio+Olo or another LAMA/LABA is reported. The following comorbidities are reported: Cardiovascular disease, Cerebrovascular disease, Diabetes, Chronic kidney disease, Pneumonia, Cancer and Cirrhosis.
Measured: Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days.
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Charlson Comorbidity Index (CCI) in 1 Year Prior to Index Date
Charlson Comorbidity Index (CCI) according to whether they started Tio+Olo or another LAMA/LABA is reported.
The CCI (using Deyo version) is a comorbidity index used to evaluate survival rate in patients with multiple comorbidities. 17 comorbidities were assessed with different weights, and the total score was determined by adding the scores of each comorbidity. The total score goes from 0 to 37, with higher values predicting a higher mortality rate.
Measured: Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days.
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: History of Medications Dispensed in 1 Year Prior to Index Date
Number of participants with history of medications dispensed in 1 year prior to index date according to whether they started Tio+Olo or another LAMA/LABA is reported. The following medications are reported: Antihypertensives, Antiarrhythmics, Nitrates, Heart failure medications, Lipid-lowering medications, Blood glucose-lowering medications, Anticoagulants and antiplatelet agents, Antibiotics and Antineoplastic agents.
Measured: Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Sep 20227 Dec 2022

First posted26 May 2022
Study start30 Sep 2022
Primary completion7 Dec 2022
Study completion7 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 19,467 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05393245
Sponsor's protocol ID: 1237-0109
Status last verified: Oct 2024
First submitted: 23 May 2022
Last updated: 4 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety Profile of Tiotropium + Olodaterol Used as Maintenance Treatment in COPD Patients in Taiwan: a Non-interventional Study Based on the Taiwan National Health Insurance (NHI) Data
ClinicalTrials.gov ID: NCT05393245
Acronym / sponsor ID: 1237-0109
Conditions: Pulmonary Disease, Chronic Obstructive
Study type: Observational
Recruitment status: Completed
Enrolment: 19,467 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 30 Sep 2022 (actual)
Primary completion: 7 Dec 2022 (actual)
Study completion: 7 Dec 2022 (actual)
First posted: 26 May 2022 (actual)
Results: Posted 4 Dec 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The aim of this real world study is to assess the safety profile of tiotropium/olodaterol (Tio/Olo).

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
COPD patients treated with tiotropium and olodaterol (Tio+Olo)	–	Drug: Tiotropium+Olodaterol, Device: Spiolto Respimat
COPD patients using other Long-acting muscarinic antagonists/Long-acting β2-agonists (LAMA/LABAs)	–	Drug: Long-acting muscarinic antagonists (LAMAs), Drug: Long-acting β2-agonists (LABAs)

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Chinese patients with chronic obstructive pulmonary disease (COPD) in routine clinical practice in Taiwan.

Key inclusion criteria (10 listed)

At least one prescription for Tio+Olo (fixed dose combination (FDC) or free combination) as a new initiation between 1st January 2014 and 31st December 2019.
Aged ≥ 40 years on the index date.
At least one diagnosis of COPD at any time prior to or on the index date.
At least one year of continuous medical and health insurance plan prior to the index date will be required to allow for a look-back period for the covariates and identification of new use of the study drugs.
At least one record in the health insurance system database.

Key exclusion criteria (5 listed)

Any use of Tio+Olo in free or fixed form within one year prior to the index date.
Individuals with asthma, allergic rhinitis, lung cancer, interstitial lung disease, or lung transplant identified at any time prior to the index date.
Patients using other Long-acting β2-agonists/Long-acting muscarinic antagonists (LAMA/LABAs):
Any use of LAMA+LABA in free or fixed form for one year prior to the index date.
Individuals with asthma, allergic rhinitis, lung cancer, interstitial lung disease, or lung transplant identified at any time prior to the index date.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tiotropium+OlodaterolTiotropium+Olodaterol	Drug	COPD patients treated with tiotropium and olodaterol (Tio+Olo)
Spiolto RespimatSpiolto Respimat Inhaler device	Device	COPD patients treated with tiotropium and olodaterol (Tio+Olo)
Long-acting muscarinic antagonists (LAMAs)Long-acting muscarinic antagonists (LAMAs)	Drug	COPD patients using other Long-acting muscarinic antagonists/Long-acting β2-agonists (LAMA/LABAs)
Long-acting β2-agonists (LABAs)Long-acting β2-agonists (LABAs)	Drug	COPD patients using other Long-acting muscarinic antagonists/Long-acting β2-agonists (LAMA/LABAs)

Primary outcome

Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Potentially Recurrent Events
Time frame: 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.
Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Incident Events
Time frame: 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.

17 secondary outcomes

Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Sex
Time frame: At index date between 2014-2019. Up to 2160 days.
Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Age
Time frame: At index date between 2014-2019
Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Calendar Year of Cohort Entry
Time frame: At index date between 2014-2019
Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Season of Cohort Entry Date
Time frame: At index date between 2014-2019
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Specific Previous COPD Treatment
Time frame: Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days.
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Use of Other Respiratory Drugs
Time frame: Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days.
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
Time frame: Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days.
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
Time frame: Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days.
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: All COPD Exacerbation in 1 Year Prior to Index Date
Time frame: Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days.
Baseline Period: Characteristics Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Moderate COPD Exacerbation 30 Days Prior to Index Date
Time frame: Baseline period: 30 consecutive days ending the day before the index date. Up to 30 days.
Baseline Period: Characteristics Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Severe COPD Exacerbation 30 Days Prior to Index Date
Time frame: Baseline period: 30 consecutive days ending the day before the index date. Up to 30 days.
Baseline Period: Characteristics Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: All COPD Exacerbation 30 Days Prior to Index Date
Time frame: Baseline period: 30 consecutive days ending the day before the index date. Up to 30 days.
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Hospitalizations Caused by Exacerbation of COPD in 1 Year Prior to Index Date
Time frame: Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days.
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: All-cause Hospitalizations in 1 Year Prior to Index Date
Time frame: Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days.
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Comorbidities in 1 Year Prior to Index Date
Time frame: Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days.
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Charlson Comorbidity Index (CCI) in 1 Year Prior to Index Date
Time frame: Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days.
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: History of Medications Dispensed in 1 Year Prior to Index Date
Time frame: Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days.

Results and safety

Results posted to the registry on 4 Dec 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tiotropium/Olodaterol (Tio/Olo)	5,820	5,820
Other LABA/LAMA	13,647	13,647

Primary outcome: Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Potentially Recurrent Events

Time frame: From index date between 1st January 2014 until 31st December 2019. Up to 2160 days.. Number (95% Confidence Interval). Unit: Events per 100 person-years

Measure	Tiotropium/Olodaterol (Tio/Olo) n = 5820
Nasopharyngitis	10.63 (9.45 to 11.96)
Pneumonia- Diagnosis codes were primary inpatient diagnosis associated with a hospitalization	0.55 (0.33 to 0.91)
Pneumonia-Diagnosis codes were primary or secondary diagnosis associated with a hospitalization	0.84 (0.56 to 1.26)
Moderate COPD exacerbation	19.71 (18.05 to 21.52)
Severe COPD exacerbation	15.66 (14.21 to 17.26)
Constipation	17.06 (15.53 to 18.74)
Diarrhoea	1.58 (1.17 to 2.13)
Urinary retention	6.17 (5.30 to 7.19)

Population analysed: Eligible Patients set: All patients who met the criteria and who were treated with Tio/Olo were included in the analysis dataset.

Primary outcome: Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Incident Events

Time frame: From index date between 1st January 2014 until 31st December 2019. Up to 2160 days.. Number (95% Confidence Interval). Unit: Events per 100 person-years

Measure	Tiotropium/Olodaterol (Tio/Olo) n = 5820
Arrhythmia	6.80 (5.83 to 7.94)
Myocardial ischemia	4.02 (3.31 to 4.90)
Supraventricular tachycardia	0.33 (0.17 to 0.63)
Glaucoma	1.13 (0.79 to 1.62)
Nonfatal myocardial infarction (1)	0.59 (0.36 to 0.96)
Nonfatal myocardial infarction (2)	1.11 (0.78 to 1.59)
Nonfatal hemorrhagic stroke (1)	0.18 (0.08 to 0.44)
Nonfatal hemorrhagic stroke (2)	0.66 (0.42 to 1.05)

Population analysed: Eligible Patients set: All patients who met the criteria and who were treated with Tio/Olo were included in the analysis dataset.

17 secondary outcomes are reported in the full results.

Adverse events

Time frame: From index date between 1st January 2014 until 31st December 2019. Up to 2160 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tiotropium/Olodaterol (Tio/Olo)	0 of 0	2,014 of 5,820 (34.6%)	526 of 5,820

Limitations and caveats (from the sponsor): 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.

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Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Potentially Recurrent Events (time frame: From index date between 1st January 2014 until 31st December 2019. Up to 2160 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05393245.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.