Pulmonary Disease, Chronic ObstructivePhase 3NCT01536262

Japan Long-term Safety for Tiotropium Plus Olodaterol

A Phase 3 study testing Tiotropium + Olodaterol, Respimat and Olodaterol in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 24 sites in Japan.

Completed

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

Official record

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Trial summary

The primary objective of this study is to assess the safety of 52 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC and olodaterol (delivered by the RESPIMAT Inhaler) in Japanese patients with Chronic Obstructive Pulmonary Disease (COPD). 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, Respimat and Olodaterol
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 122 participants
Where: 24 sitesJapan
Study dates: Feb 2012to Sep 2013
Phase: Phase 3
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

Who may be able to join

Diagnosis of chronic obstructive pulmonary disease.
Relatively stable airway obstruction with post FEV1< 80% predicted normal and post FEV1/FVC <70%.
Male or female Japanese patients, 40 years of age or older.
Smoking history of more than 10 pack years.

Who cannot join

Significant disease other than COPD
Clinically relevant abnormal lab values.
History of asthma.
Diagnosis of thyrotoxicosis
Diagnosis of paroxysmal tachycardia
History of myocardial infarction within 1 year of screening visit

Show all 25Show fewer

Unstable or life-threatening cardiac arrhythmia.
Hospitalization for heart failure within the past year.
Known active tuberculosis.
Malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years
History of life-threatening pulmonary obstruction.
History of cystic fibrosis.
Clinically evident bronchiectasis.
History of significant alcohol or drug abuse.
Thoracotomy with pulmonary resection
Oral ß-adrenergics.
Oral corticosteroid medication at unstable doses
Regular use of daytime oxygen therapy for more than one hour per day
Pulmonary rehabilitation program in the six weeks prior to the screening visit
Investigational drug within one month or six half lives (whichever is greater) prior to screening visit
Known hypersensitivity to ß-adrenergic drugs, anticholinergics, BAC, EDTA
Pregnant or nursing women.
Women of childbearing potential not using a highly effective method of birth control
Patients who are unable to comply with pulmonary medication restrictions
Patients with narrow-angle glaucoma or micturition disorder due to prostatic hyperplasia etc.

Trial locations and contacts

24 sites in 1 country.

City, postcode or hospital

24 sites in 1 country

Japan24 sites

1237.22.81015 Boehringer Ingelheim Investigational Site
Chiyoda-ku, Tokyo
1237.22.81023 Boehringer Ingelheim Investigational Site
Chuo-ku, Tokyo
1237.22.81009 Boehringer Ingelheim Investigational Site
Hamamatu, Shizuoka
1237.22.81011 Boehringer Ingelheim Investigational Site
Kishiwada, Osaka
1237.22.81007 Boehringer Ingelheim Investigational Site
Komatsu, Ishikawa
1237.22.81028 Boehringer Ingelheim Investigational Site
Koriyama, Fukushima
1237.22.81019 Boehringer Ingelheim Investigational Site
Koto-ku,Tokyo
1237.22.81021 Boehringer Ingelheim Investigational Site
Kyoto, Kyoto
1237.22.81014 Boehringer Ingelheim Investigational Site
Minami-ku, Kumamoto, Kumamoto
1237.22.81017 Boehringer Ingelheim Investigational Site
Morioka, Iwate
1237.22.81004 Boehringer Ingelheim Investigational Site
Nagaoka, Niigata
1237.22.81029 Boehringer Ingelheim Investigational Site
Nagasaki, Nagasaki
1237.22.81027 Boehringer Ingelheim Investigational Site
Osakasayama, Osaka
1237.22.81008 Boehringer Ingelheim Investigational Site
Saku, Nagano-ken
1237.22.81001 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido
1237.22.81016 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido
1237.22.81022 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido
1237.22.81025 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido
1237.22.81018 Boehringer Ingelheim Investigational Site
Setagaya-ku, Tokyo
1237.22.81026 Boehringer Ingelheim Investigational Site
Tagajyo,Miyagi
1237.22.81010 Boehringer Ingelheim Investigational Site
Takatsuki, Osaka
1237.22.81020 Boehringer Ingelheim Investigational Site
Toyohashi, Aichi
1237.22.81030 Boehringer Ingelheim Investigational Site
Unzen, Nagasaki
1237.22.81003 Boehringer Ingelheim Investigational Site
Yokohama,Kanagawa

Other trials in Japan

About this study

Official title: A Randomised, Double-blind, Parallel-group Study to Assess the Safety and Efficacy of 52 Weeks of Once Daily Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed-dose Combination (2.5µg / 5µg, 5µg / 5µg ) and Olodaterol (5 µg) Delivered by the RESPIMAT Inhaler in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: Tiotropium + Olodaterol, Respimat, Olodaterol
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 and Olodaterol FDC once daily inhalation
RespimatDevice
Respimat inhaler
Tiotropium + OlodaterolDrug
Tiotropium and Olodaterol FDC once daily inhalation
OlodaterolDrug
Olodaterol once daily inhalation
RespimatDevice
Respimat inhaler
RespimatDevice
Respimat inhaler

Study groups in NCT01536262
Study group	Role	What they receive
Tiotropium + Olodaterol (high dose)	Other	Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT Receives: Drug: Tiotropium + Olodaterol; Device: Respimat
Olodaterol	Other	Olodaterol solution for inhalation - RESPIMAT Receives: Drug: Olodaterol; Device: Respimat
Tiotropium + Olodaterol (low dose)	Other	Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT Receives: Drug: Tiotropium + Olodaterol; Device: Respimat

What is being measured

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

Number (%) of Patients With Drug-related AEs
Number (%) of patients with drug-related Adverse Events (AEs).
Measured: From first drug administration until 21 days after the last administration, upto 392 days

Secondary outcomes (2)

FEV1 AUC0-3h Response
Forced Expiratory Volume in 1 second Area Under Curve (AUC0-3h) response. FEV1 AUC0-3h was calculated using the trapezoidal rule, divided by the duration (3 h) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.
Note: The Mean presented is the unadjusted mean.
Measured: Baseline and 1 h, 10 min pre-dose and 30 min, 1 h, 2 h, 3 h post-dose after 52 weeks
Trough FEV1 Response
Trough Forced Expiratory Volume in 1 second Response. The trough was defined as the mean of the 1 h pre-dose and 10 min pre-dose measurements after 52 weeks. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.
Note: The Mean presented is the unadjusted mean.
Measured: Baseline and 1 h, 10 min pre-dose after 52 weeks

Timeline

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

Feb 2012Sep 2013

First posted22 Feb 2012 (estimated)
Study startFeb 2012
Primary completionSep 2013
Study completionSep 2013

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: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 122 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01536262
Sponsor's protocol ID: 1237.22
Status last verified: Jun 2015
First submitted: 16 Feb 2012
Last updated: 15 Jul 2015
Results posted: Yes, on ClinicalTrials.gov

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 15 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Double-blind, Parallel-group Study to Assess the Safety and Efficacy of 52 Weeks of Once Daily Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed-dose Combination (2.5µg / 5µg, 5µg / 5µg ) and Olodaterol (5 µg) Delivered by the RESPIMAT Inhaler in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)
ClinicalTrials.gov ID: NCT01536262
Acronym / sponsor ID: 1237.22
Conditions: Pulmonary Disease, Chronic Obstructive
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 122 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Feb 2012
Primary completion: Sep 2013 (actual)
Study completion: Sep 2013 (actual)
First posted: 22 Feb 2012 (estimated)
Results: Posted 15 Jul 2015

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 3

Arm	Type	Receives
Tiotropium + Olodaterol (high dose)	Other	Drug: Tiotropium + Olodaterol, Device: RespimatTiotropium and Olodaterol FDC solution for inhalation - RESPIMAT
Olodaterol	Other	Drug: Olodaterol, Device: RespimatOlodaterol solution for inhalation - RESPIMAT
Tiotropium + Olodaterol (low dose)	Other	Drug: Tiotropium + Olodaterol, Device: RespimatTiotropium and Olodaterol FDC solution for inhalation - RESPIMAT

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Diagnosis of chronic obstructive pulmonary disease.
Relatively stable airway obstruction with post FEV1< 80% predicted normal and post FEV1/FVC <70%.
Male or female Japanese patients, 40 years of age or older.
Smoking history of more than 10 pack years.

Key exclusion criteria (25 listed)

Significant disease other than COPD
Clinically relevant abnormal lab values.
History of asthma.
Diagnosis of thyrotoxicosis
Diagnosis of paroxysmal tachycardia

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 and Olodaterol FDC once daily inhalation	Drug	Tiotropium + Olodaterol (low dose)
RespimatRespimat inhaler	Device	Tiotropium + Olodaterol (low dose)
Tiotropium + OlodaterolTiotropium and Olodaterol FDC once daily inhalation	Drug	Tiotropium + Olodaterol (high dose)
OlodaterolOlodaterol once daily inhalation	Drug	Olodaterol
RespimatRespimat inhaler	Device	Tiotropium + Olodaterol (high dose)
RespimatRespimat inhaler	Device	Olodaterol

Primary outcome

Number (%) of Patients With Drug-related AEs
Time frame: From first drug administration until 21 days after the last administration, upto 392 days
Number (%) of patients with drug-related Adverse Events (AEs).

2 secondary outcomes

FEV1 AUC0-3h Response
Time frame: Baseline and 1 h, 10 min pre-dose and 30 min, 1 h, 2 h, 3 h post-dose after 52 weeks
Trough FEV1 Response
Time frame: Baseline and 1 h, 10 min pre-dose after 52 weeks

Results and safety

Results posted to the registry on 15 Jul 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Olodaterol (5 μg)	41	33
Tiotropium + Olodaterol (2.5 / 5 μg)	40	38
Tiotropium + Olodaterol (5 / 5 μg)	41	39

Primary outcome: Number (%) of Patients With Drug-related AEs

Time frame: From first drug administration until 21 days after the last administration, upto 392 days. Number. Unit: percentage of participants

Measure	Olodaterol (5 μg) n = 41	Tiotropium + Olodaterol (2.5 / 5 μg) n = 40	Tiotropium + Olodaterol (5 / 5 μg) n = 41
Value	4.9	5.0	7.3

Population analysed: Treated set: This patient set included all patients who received at least 1 dose of treatment.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first drug administration until 21 days after the last administration, upto 392 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Olodaterol (5 μg)	5 of 41 (12.2%)	21 of 41 (51.2%)	Not reported
Tiotropium + Olodaterol (2.5 / 5 μg)	6 of 40 (15%)	20 of 40 (50%)	Not reported
Tiotropium + Olodaterol (5 / 5 μg)	3 of 41 (7.3%)	24 of 41 (58.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

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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

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tiotropium + Olodaterol, Respimat and Olodaterol in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 24 sites 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 4 inclusion and 25 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 15 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jul 2015). 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 Patients With Drug-related AEs (time frame: From first drug administration until 21 days after the last administration, upto 392 days). 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 NCT01536262.

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 15 Jul 2015.