Pulmonary Disease, Chronic ObstructiveNCT04249310

Early Intervention Efficacy in COPD

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

Completed

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

Trial summary

This study aims to evaluate the time to escalation to triple therapy among the Japanese Chronic obstructive pulmonary disease (COPD) patients newly initiating therapy with a combination of Olodaterol and Tiotropium (herein referred to as Tio/Olo) using real world data. 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 and Tiotropium
How many people: 6,788 participants
Where: 1 siteJapan
Study dates: 27 Mar 2020to 12 Aug 2020
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: The study cohort will include all patients who initiate Tiotropium/Olodaterol (Tio/Olo) or Tiotropium (Tio) during the patient selection period. Initiation (new use) will be determined based on no prescription claims for Tio/Olo or Tio during the baseline period or during all available data prior to cohort entry date. All patients will additionally be required to have a second claim for the index medication within 60 days after cohort entry to ensure primary adherence of index therapy.

Who may be able to join

The study cohort will include all patients who initiate Tiotropium/ Olodaterol (Tio/Olo) or Tiotropium (Tio) during the patient selection period.

Who cannot join

The following exclusion criteria will then be applied to generate the unmatched cohort:
Aged <40 years on cohort entry.
Any LAMA, LABA, or ICS maintenance therapy (alone or in combination) during the 180-day baseline period prior to cohort entry for maintenance treatment and duration >30 days, or any prescription within the 30 days prior to cohort entry.
Patients without continuous enrolment (days since first inpatient/ outpatient encounter in the data) during the baseline period.
No prior diagnosis of COPD [International Classification of Diseases (ICD)-10: J41*, J43*, J44* and doubt (UTAGAIFLG) = 0 (no)]
Patients without a second prescription claim of their index medication within 60 days after the cohort entry date.

Show all 10Show fewer

Diagnosis of asthma [ICD-10: J45* and doubt (UTAGAIFLG) = 0 (no)] during the baseline period.
Diagnosis of lung cancer [ICD-10: C34*, D02.2, Z80.1, Z85.1 and doubt (UTALAIFLG) = 0 (no)] or lung transplant (Health claim code: 150317670, 150322510, 150322610, 150336510, 150336610, 150336710, 150399270) prior to the cohort entry date using all available data.
Patients who initiate both Tio/Olo and Tio simultaneously on the cohort entry date.
Any use of triple therapy (LAMA + LABA + ICS) during the baseline period or between the cohort entry date and 1 day prior to the start of follow-up.

Trial locations and contacts

1 site in 1 country.

Japan1 site

Nara Medical University
Nara, 634-8522

Other trials in Japan

About this study

Official title: Early Intervention Effectiveness of Tiotropium / Olodaterol Compared to Tiotropium in COPD

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: Tiotropium/Olodaterol, Tiotropium
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
Also called Spiolto®
Soft Mist Inhaler product
TiotropiumDrug
Also called Spiriva®
Soft Mist Inhaler product

Study groups in NCT04249310
Study group	Role	What they receive
Tiotropium/Olodaterol		Combination of Tiotropium and Olodaterol Receives: Drug: Tiotropium/Olodaterol
Tiotropium		Not described Receives: Drug: Tiotropium

What is being measured

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

Time to Triple Therapy Initiation
Time to triple therapy initiation (first event per patient) defined as any fixed dose combination of Long-acting muscarinic antagonists (LAMA) / Long-acting beta agonist (LABA) / Inhaled Corticosteroid (ICS) or any concurrent use for 30 consecutive days of the following:
- any LAMA/LABA fixed dose combination + any ICS single formulation
- any LAMA single formulation + any LABA/ICS fixed dose combination
- any LAMA single formulation + any LABA single formulation + any ICS single formulation.
Patients will be censored if they had an occurrence of any of the following: outcome (initiation of triple therapy), death, or end of data. The analysis will use an intention-to-treat censoring approach, which does not account for treatment change.
Measured: From index date (cohort entry date) until first occurence of event, up to 42 months.

Secondary outcomes (2)

Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
Time to First Moderate or Severe COPD Exacerbation. Moderate exacerbation is defined as an outpatient visit with a diagnosed code for COPD in any field + a prescription for an oral corticosteroid or an antibiotic for respiratory infections. Severe exacerbations will be defined as a hospitalization with a primary diagnosis for COPD.
Patients will be censored if they had an occurrence of any of the following: outcome (initiation of triple therapy), death, or end of data. The analysis will use an intention-to-treat censoring approach, which does not account for treatment change.
Measured: From index date until first occurence of event, up to 42 months.
Number of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
Number of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations.
Moderate exacerbation is defined as an outpatient visit with a diagnosed code for COPD in any field + a prescription for an oral corticosteroid or an antibiotic for respiratory infections. Severe exacerbations will be defined as a hospitalization with a primary diagnosis for COPD.
Patients will be censored if they had an occurrence of any of the following: outcome (initiation of triple therapy), death, or end of data. The analysis will use an intention-to-treat censoring approach, which does not account for treatment change.
Measured: From index date until first occurence of event, up to 42 months.

Timeline

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

27 Mar 202012 Aug 2020

First posted30 Jan 2020
Study start27 Mar 2020
Primary completion12 Aug 2020
Study completion12 Aug 2020

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: 6,788 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04249310
Sponsor's protocol ID: 1237-0100
Status last verified: May 2022
First submitted: 29 Jan 2020
Last updated: 14 Jun 2022
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
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

RecruitingPhase 2
PRA-216 COPD Safety and Biomarker Study
Chronic Obstructive Pulmonary Disease (COPD)
RecruitingPhase 2
Phase 2b Efficacy and Safety Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients
COPD, Chronic Obstructive Pulmonary Disease (COPD)
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 2
A Study to Evaluate Solrikitug in Participants With COPD (ZION)
COPD
RecruitingPhase 2
To Evaluate the Effect of EXPD-101/FXS7553 Compared With Placebo in Patients With COPD Over 52 Weeks of Treatment
Chronic Obstructive Pulmonary Disease (COPD)

All Pulmonary Disease, Chronic Obstructive trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Early Intervention Effectiveness of Tiotropium / Olodaterol Compared to Tiotropium in COPD
ClinicalTrials.gov ID: NCT04249310
Acronym / sponsor ID: 1237-0100
Conditions: Pulmonary Disease, Chronic Obstructive
Study type: Observational
Recruitment status: Completed
Enrolment: 6,788 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 27 Mar 2020 (actual)
Primary completion: 12 Aug 2020 (actual)
Study completion: 12 Aug 2020 (actual)
First posted: 30 Jan 2020 (actual)
Results: Posted 30 Aug 2021

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	–	Drug: Tiotropium/OlodaterolCombination of Tiotropium and Olodaterol
Tiotropium	–	Drug: Tiotropium

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The study cohort will include all patients who initiate Tiotropium/Olodaterol (Tio/Olo) or Tiotropium (Tio) during the patient selection period. Initiation (new use) will be determined based on no prescription claims for Tio/Olo or Tio during the baseline period or during all available data prior to cohort entry date. All patients will additionally be required to have a second claim for the index medication within 60 days after cohort entry to ensure primary adherence of index therapy.

Key inclusion criteria (1 listed)

The study cohort will include all patients who initiate Tiotropium/ Olodaterol (Tio/Olo) or Tiotropium (Tio) during the patient selection period.

Key exclusion criteria (10 listed)

Aged <40 years on cohort entry.
Any LAMA, LABA, or ICS maintenance therapy (alone or in combination) during the 180-day baseline period prior to cohort entry for maintenance treatment and duration >30 days, or any prescription within the 30 days prior to cohort entry.
Patients without continuous enrolment (days since first inpatient/ outpatient encounter in the data) during the baseline period.
No prior diagnosis of COPD [International Classification of Diseases (ICD)-10: J41*, J43*, J44* and doubt (UTAGAIFLG) = 0 (no)]
Patients without a second prescription claim of their index medication within 60 days after the cohort entry 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/OlodaterolAlso: Spiolto®Soft Mist Inhaler product	Drug	Tiotropium/Olodaterol
TiotropiumAlso: Spiriva®Soft Mist Inhaler product	Drug	Tiotropium

Primary outcome

Time to Triple Therapy Initiation
Time frame: From index date (cohort entry date) until first occurence of event, up to 42 months.
Time to triple therapy initiation (first event per patient) defined as any fixed dose combination of Long-acting muscarinic antagonists (LAMA) / Long-acting beta agonist (LABA) / Inhaled Corticosteroid (ICS) or any concurrent use for 30 consecutive days of the following: * any LAMA/LABA fixed dose combination + any ICS single formulation * any LAMA single formulation + any LABA/ICS fixed dose combination * any LAMA single formulation + any LABA single formulation + any ICS single formulation. Patients will be censored if they had an occurrence of any of the following: outcome (initiation of triple therapy), death, or end of data. The analysis will use an intention-to-treat censoring approach, which does not account for treatment change.

2 secondary outcomes

Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
Time frame: From index date until first occurence of event, up to 42 months.
Number of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
Time frame: From index date until first occurence of event, up to 42 months.

Results and safety

Results posted to the registry on 30 Aug 2021, 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 (Spiolto®)	1,436	1,436
Tiotropium (Spiriva®)	5,352	5,352

Primary outcome: Time to Triple Therapy Initiation

Time frame: From index date (cohort entry date) until first occurence of event, up to 42 months.. Mean (Standard Deviation). Unit: Days

Measure	Tiotropium/Olodaterol (Spiolto®) n = 1302	Tiotropium (Spiriva®) n = 1302
Value	195.0 (123.2)	89.5 (112.3)

Tiotropium/Olodaterol (Spiolto®) vs Tiotropium (Spiriva®): Hazard Ratio (HR): 0.89 (95% CI 0.32 to 2.46)

Population analysed: All patients included on the Japanese electronic, record based health care database (MDV) between September 2015 and December 2019 using either a combination of tiotropium/olodaterol or tiotropium alone - High dimensional propensity score (hdPS) matched cohort.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tiotropium/Olodaterol (Spiolto®)	0 of 0	0 of 0	0
Tiotropium (Spiriva®)	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
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

Related trials for Pulmonary Disease, Chronic Obstructive

RecruitingPhase 2
PRA-216 COPD Safety and Biomarker Study
Chronic Obstructive Pulmonary Disease (COPD)
RecruitingPhase 2
Phase 2b Efficacy and Safety Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients
COPD, Chronic Obstructive Pulmonary Disease (COPD)
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 2
A Study to Evaluate Solrikitug in Participants With COPD (ZION)
COPD
RecruitingPhase 2
To Evaluate the Effect of EXPD-101/FXS7553 Compared With Placebo in Patients With COPD Over 52 Weeks of Treatment
Chronic Obstructive Pulmonary Disease (COPD)

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 Japan.

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 1 inclusion and 10 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 14 Jun 2022. 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 Japan. 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 30 Aug 2021). 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?

Time to Triple Therapy Initiation (time frame: From index date (cohort entry date) until first occurence of event, up to 42 months.). 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 NCT04249310.

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 14 Jun 2022.