Pulmonary Disease, Chronic ObstructiveNCT05402020

Effectiveness of Tiotropium + Olodaterol Versus Inhaled Corticosteroids (ICS) + Long-acting β2-agonists (LABA) Among COPD Patients in Taiwan

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 real world study aims to assess effectiveness and safety profile between tiotropium/olodaterol (Tio/Olo) and inhaled corticosteroids(ICS) / Long-acting β2-agonists (LABA) in patients with chronic obstructive pulmonary disease (COPD) in Taiwan. 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 (Tio), Inhaled corticosteroids (ICS) and Olodaterol (Olo)
How many people: 17,018 participants
Where: 1 siteChina
Study dates: 30 Sep 2022to 13 Feb 2023
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: Patients with chronic obstructive pulmonary disease, included in the NHI database between 2014 and 2019, who received either Tiotropium + Olodaterol or Inhaled Corticosteroids + Long-acting ß2 agonist.

Who may be able to join

At least one prescriptions for Tiotropium/Olodaterol (Tio/Olo) combined inhaler or Long-acting ß2 agonist / Inhaled Corticosteroids (LABA/ICS) combined inhaler between 1st January 2014 and 31st December 2019.
The first dispensing of either Tio/Olo or LABA/ICS combined inhaler will be defined as the index date;
For the main analyses, only fixed dose combination (FDC) inhalers will be included.
Aged ≥ 40 years on the index date (in a sensitivity analysis we will only include patients aged ≥ 55 years on the index date);
At least one diagnosis of chronic obstructive pulmonary disease (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, ICS/LABA, or ICS/LABA/ Long-acting muscarinic antagonists (LAMA) 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 (in a sensitivity analysis we will include patients with asthma);

Trial locations and contacts

1 site in 1 country.

China1 site

National Tawain University Hospital
Taipei, 100225

Other trials in China

About this study

Official title: Effectiveness of Maintenance Treatment With Tiotropium + Olodaterol in Comparison to Inhaled Corticosteroids + Long-acting β2 Agonists in COPD Patients in Taiwan: a Non-interventional Study Based on the Taiwan National Health Insurance (NHI) Data

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: Tiotropium (Tio), Inhaled corticosteroids (ICS), Olodaterol (Olo), Long-acting β2-agonists (LABA)
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 (Tio)Drug
Tiotropium (Tio)
Inhaled corticosteroids (ICS)Drug
Inhaled corticosteroids (ICS)
Olodaterol (Olo)Drug
Olodaterol (Olo)
Long-acting β2-agonists (LABA)Drug
Long-acting β2-agonists (LABA)

Study groups in NCT05402020
Study group	Role	What they receive
Tiotropium + Olodaterol cohort		Subjects who initiated Tiotropium + Olodaterol between 1st January 2014 and 31st December 2019 according to data from the Taiwan National Health Insurance (NHI), Taiwan Cancer Registry (TCR) and Taiwan Mortality Data. Receives: Drug: Tiotropium (Tio); Drug: Olodaterol (Olo)
Inhaled Corticosteroids (ICS) + Long-acting ß2 agonists (LABA) cohort		Subjects who initiated Inhaled Corticosteroids (ICS) + Long-acting ß2 agonists (LABA) between 1st January 2014 and 31st December 2019 according to data from the Taiwan National Health Insurance (NHI), Taiwan Cancer Registry (TCR) and Taiwan Mortality Data. Receives: Drug: Inhaled corticosteroids (ICS); Drug: Long-acting β2-agonists (LABA)

What is being measured

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

Number of Subjects With Event First Moderate or Severe COPD Exacerbations After Index Date
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
Measured: From the index date (the first dispensing of either Tio/Olo or ICS/LABA combined inhaler) until first event, up to 6 years.

Secondary outcomes (5)

Number of Subjects With Event Triple Therapy Escalation After Index Date
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.
Measured: 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
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).
Measured: 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 Hospitalization for Community-acquired Pneumonia After Entry
Number of subjects with event the first hospitalization for community-acquired pneumonia after initiation of study drug.
Measured: 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
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).
Measured: 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 COPD Exacerbations After Index Date
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.
Measured: From the index date (The first dispensing of either Tio/Olo or ICS/LABA combined inhaler) until first event, up to 6 years.

Timeline

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

30 Sep 202213 Feb 2023

First posted2 Jun 2022
Study start30 Sep 2022
Primary completion13 Feb 2023
Study completion13 Feb 2023

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: 17,018 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05402020
Sponsor's protocol ID: 1237-0110
Status last verified: Aug 2024
First submitted: 30 May 2022
Last updated: 9 Aug 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?

See locations

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All Pulmonary Disease, Chronic Obstructive trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of Maintenance Treatment With Tiotropium + Olodaterol in Comparison to Inhaled Corticosteroids + Long-acting β2 Agonists in COPD Patients in Taiwan: a Non-interventional Study Based on the Taiwan National Health Insurance (NHI) Data
ClinicalTrials.gov ID: NCT05402020
Acronym / sponsor ID: 1237-0110
Conditions: Pulmonary Disease, Chronic Obstructive
Study type: Observational
Recruitment status: Completed
Enrolment: 17,018 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 30 Sep 2022 (actual)
Primary completion: 13 Feb 2023 (actual)
Study completion: 13 Feb 2023 (actual)
First posted: 2 Jun 2022 (actual)
Results: Posted 9 Aug 2024

Clinical summary

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

Study design

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

Arm	Type	Receives
Tiotropium + Olodaterol cohort	–	Drug: Tiotropium (Tio), Drug: Olodaterol (Olo)Subjects who initiated Tiotropium + Olodaterol between 1st January 2014 and 31st December 2019 according to data from the Taiwan National Health Insurance (NHI), Taiwan Cancer Registry (TCR) and Taiwan Mortality Data.
Inhaled Corticosteroids (ICS) + Long-acting ß2 agonists (LABA) cohort	–	Drug: Inhaled corticosteroids (ICS), Drug: Long-acting β2-agonists (LABA)Subjects who initiated Inhaled Corticosteroids (ICS) + Long-acting ß2 agonists (LABA) between 1st January 2014 and 31st December 2019 according to data from the Taiwan National Health Insurance (NHI), Taiwan Cancer Registry (TCR) and Taiwan Mortality Data.

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with chronic obstructive pulmonary disease, included in the NHI database between 2014 and 2019, who received either Tiotropium + Olodaterol or Inhaled Corticosteroids + Long-acting ß2 agonist.

Key inclusion criteria (7 listed)

At least one prescriptions for Tiotropium/Olodaterol (Tio/Olo) combined inhaler or Long-acting ß2 agonist / Inhaled Corticosteroids (LABA/ICS) combined inhaler between 1st January 2014 and 31st December 2019.
Aged ≥ 40 years on the index date (in a sensitivity analysis we will only include patients aged ≥ 55 years on the index date);
At least one diagnosis of chronic obstructive pulmonary disease (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 (2 listed)

Any use of Tio/Olo, ICS/LABA, or ICS/LABA/ Long-acting muscarinic antagonists (LAMA) 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 (in a sensitivity analysis we will include patients with asthma);

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 (Tio)Tiotropium (Tio)	Drug	Tiotropium + Olodaterol cohort
Inhaled corticosteroids (ICS)Inhaled corticosteroids (ICS)	Drug	Inhaled Corticosteroids (ICS) + Long-acting ß2 agonists (LABA) cohort
Olodaterol (Olo)Olodaterol (Olo)	Drug	Tiotropium + Olodaterol cohort
Long-acting β2-agonists (LABA)Long-acting β2-agonists (LABA)	Drug	Inhaled Corticosteroids (ICS) + Long-acting ß2 agonists (LABA) cohort

Primary outcome

Number of Subjects With Event First Moderate or Severe COPD Exacerbations After Index Date
Time frame: 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

5 secondary outcomes

Number of Subjects With Event Triple Therapy Escalation After Index Date
Time frame: 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
Time frame: 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 Hospitalization for Community-acquired Pneumonia After Entry
Time frame: 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
Time frame: 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 COPD Exacerbations After Index Date
Time frame: From the index date (The first dispensing of either Tio/Olo or ICS/LABA combined inhaler) until first event, up to 6 years.

Results and safety

Results posted to the registry on 9 Aug 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 Cohort	3,815	3,815
Inhaled Corticosteroids (ICS) + Long-acting ß2 Agonists (LABA) Cohort	13,203	13,203

Primary outcome: Number of Subjects With Event First Moderate or Severe COPD Exacerbations After Index Date

Time frame: From the index date (the first dispensing of either Tio/Olo or ICS/LABA combined inhaler) until first event, up to 6 years.. Count of participants. Unit: Participants

Measure	Tiotropium + Olodaterol Cohort - Propensity Score Matched n = 3752	Inhaled Corticosteroids (ICS) + Long-acting ß2 Agonists (LABA) Cohort - Propensity Score Matched n = 3752
Value	424	375

Tiotropium + Olodaterol Cohort - Propensity Score Matched vs Inhaled Corticosteroids (ICS) + Long-acting ß2 Agonists (LABA) Cohort - Propensity Score Matched: Hazard Ratio (HR): 1.00 (95% CI 0.87 to 1.15)

Population analysed: 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.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event information was not applicable for this study.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tiotropium + Olodaterol Cohort	0 of 0	0 of 0	0
Inhaled Corticosteroids (ICS) + Long-acting ß2 Agonists (LABA) Cohort	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 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 7 inclusion and 2 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 9 Aug 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 9 Aug 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?

Number of Subjects With Event First Moderate or Severe COPD Exacerbations After Index Date (time frame: From the index date (the first dispensing of either Tio/Olo or ICS/LABA combined inhaler) until first event, up to 6 years.). 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 NCT05402020.

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 9 Aug 2024; AzTrials last refreshed its copy on 8 Nov 2026.