Pulmonary Disease, Chronic ObstructiveNCT02850978

Long-term Use of Spiolto Respimat in Japanese Patients With Chronic Obstructive Pulmonary Disease

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

Study to assess the long-term safety and effectiveness of Spiolto in Japanese patients with Chronic Obstructive Pulmonary Disease (COPD) in real-world setting Read more about this study

Who is it for?: Ages 15 years and older
Conditions the study is for: Pulmonary Disease, Chronic Obstructive
What is being tested?: Spiolto
How many people: 1,335 participants
Where: 1 siteJapan
Study dates: 23 Aug 2016to 30 Nov 2018
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 15 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: 1000

Who may be able to join

Patients who have been diagnosed with chronic obstructive pulmonary disease (chronic bronchitis, emphysema) by physician and need relief of various symptoms associated with Long Acting Beta2 Agonist (LABA) or Long Acting Muscarinic Antagonist (LAMA).
Patients who are prescribed Tio+Olo FDC 5µg/5µg for the first time

Who cannot join

Patients who have been registered once in this study (i.e., re-entry of patients is not allowed).
Patients who are participating in a registry or clinical trial.
Patients who have a contraindication to Tio+Olo FDC 5µg/5µg defined in the package insert for Tio+Olo FDC 5µg/5µg.

Trial locations and contacts

1 site in 1 country.

Japan1 site

Study site
Multiple Locations

Other trials in Japan

About this study

Official title: Post-marketing Surveillance (PMS) on Long-term Use of Tiotropium+Olodaterol Fixed Dose Combination (Tio+Olo FDC) 5µg/5µg in Patients With Chronic Obstructive Pulmonary Disease (Chronic Bronchitis, Emphysema) in Japan

Study to assess the long-term safety and effectiveness of Spiolto in Japanese patients with Chronic Obstructive Pulmonary Disease (COPD) in real-world setting

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: Spiolto
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.

SpioltoDrug

Study groups in NCT02850978
Study group	Role	What they receive
Spiolto		Patient with COPD to received Spiolto Receives: Drug: Spiolto

What is being measured

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

Percentage of Participants With Adverse Drug Reactions
Percentage of participants with adverse drug reactions (ADR). An adverse drug reaction (ADR) is defined as an adverse event (AE) for which either the investigator or the sponsor (or both) assess the causal relationship to Spiolto® Respimat® as "Yes".
Measured: From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.

Secondary outcomes (1)

Change of COPD Assessment Test (CAT) Score From Baseline to Week 12
The COPD Assessment Test™ (CAT) is a short 8-item questionnaire for assessment and monitoring of COPD health status in routine practice. Its scale is 0-40 (high score = poor health). The CAT questionnaire has the advantage of a reduced number of items and could be used to assess the effects of inhaled therapies. The CAT score was the sum of the values corresponding to the answers to the eight questions.
Measured: Baseline and Week 12

Timeline

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

23 Aug 201630 Nov 2018

First posted1 Aug 2016 (estimated)
Study start23 Aug 2016
Primary completion30 Oct 2018
Study completion30 Nov 2018

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.
Publications (1)Papers the sponsor has linked to this study.
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: Prospective
Enrolment: 1,335 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02850978
Sponsor's protocol ID: 1237.34
Status last verified: Nov 2019
First submitted: 28 Jul 2016
Last updated: 6 Dec 2019
Results posted: Yes, on ClinicalTrials.gov

Publications

Sato A, Miyazaki A, Nakamura S. Effectiveness of Tiotropium/Olodaterol in the Real World: A Post Hoc Subgroup Analysis After the First Year of Use. Adv Ther. 2022 Oct;39(10):4692-4706. doi: 10.1007/s12325-022-02268-1. Epub 2022 Aug 10.
PubMed 35948844

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 6 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post-marketing Surveillance (PMS) on Long-term Use of Tiotropium+Olodaterol Fixed Dose Combination (Tio+Olo FDC) 5µg/5µg in Patients With Chronic Obstructive Pulmonary Disease (Chronic Bronchitis, Emphysema) in Japan
ClinicalTrials.gov ID: NCT02850978
Acronym / sponsor ID: 1237.34
Conditions: Pulmonary Disease, Chronic Obstructive
Study type: Observational
Recruitment status: Completed
Enrolment: 1,335 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 23 Aug 2016 (actual)
Primary completion: 30 Oct 2018 (actual)
Study completion: 30 Nov 2018 (actual)
First posted: 1 Aug 2016 (estimated)
Results: Posted 6 Dec 2019

Clinical summary

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

Study to assess the long-term safety and effectiveness of Spiolto in Japanese patients with Chronic Obstructive Pulmonary Disease (COPD) in real-world setting

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Spiolto	–	Drug: SpioltoPatient with COPD to received Spiolto

Who may qualify

Ages: 15 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: 1000

Key inclusion criteria (2 listed)

Patients who have been diagnosed with chronic obstructive pulmonary disease (chronic bronchitis, emphysema) by physician and need relief of various symptoms associated with Long Acting Beta2 Agonist (LABA) or Long Acting Muscarinic Antagonist (LAMA).
Patients who are prescribed Tio+Olo FDC 5µg/5µg for the first time

Key exclusion criteria (3 listed)

Patients who have been registered once in this study (i.e., re-entry of patients is not allowed).
Patients who are participating in a registry or clinical trial.
Patients who have a contraindication to Tio+Olo FDC 5µg/5µg defined in the package insert for Tio+Olo FDC 5µg/5µg.

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
Spiolto	Drug	Spiolto

Primary outcome

Percentage of Participants With Adverse Drug Reactions
Time frame: From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
Percentage of participants with adverse drug reactions (ADR). An adverse drug reaction (ADR) is defined as an adverse event (AE) for which either the investigator or the sponsor (or both) assess the causal relationship to Spiolto® Respimat® as "Yes".

1 secondary outcome

Change of COPD Assessment Test (CAT) Score From Baseline to Week 12
Time frame: Baseline and Week 12

Results and safety

Results posted to the registry on 6 Dec 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Spiolto®	1,335	909

Primary outcome: Percentage of Participants With Adverse Drug Reactions

Time frame: From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.. Number. Unit: Percentage of participants (%)

Measure	Spiolto® n = 1273
Value	3.93

Population analysed: Safety set: This patient set includes all patients who were documented to have taken at least one dose of Spiolto® Respimat® excluding no visit after Spiolto® Respimat® administration.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Spiolto®	94 of 1,273 (7.4%)	0 of 1,273 (0%)	38 of 1,273

Limitations and caveats (from the sponsor): The study was conducted in an unblinded manner and without controls. The explanatory power of the study results was limited and the study results should be interpreted with the necessary caution.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35948844Sato A, Miyazaki A, Nakamura S. Effectiveness of Tiotropium/Olodaterol in the Real World: A Post Hoc Subgroup Analysis After the First Year of Use. Adv Ther. 2022 Oct;39(10):4692-4706. doi: 10.1007/s12325-022-02268-1. Epub 2022 Aug 10.
Related InfoLink provided by the sponsor.

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Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
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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.

Boehringer Ingelheim study chair

Boehringer Ingelheim

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 2 inclusion and 3 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 6 Dec 2019. 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 6 Dec 2019). 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?

Percentage of Participants With Adverse Drug Reactions (time frame: From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.). 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 NCT02850978, which also lists 1 linked publication.

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 6 Dec 2019.