Pulmonary Disease, Chronic ObstructivePhase 3NCT02629965
Comparing the Efficacy of Tiotropium + Olodaterol Fixed Dose Combination (FDC) Over Tiotropium in Improvement of Lung Hyperinflation, Exercise Capacity and Physical Activity in Japanese COPD Patients
A Phase 3 study testing tiotropium and olodaterol in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 43 sites in Japan.
Trial summary
This is a multi-centre, randomised, double-blinded, active-controlled, 2-way cross over trial to assess the effects of once daily administration of orally inhaled tiotropium + olodaterol FDC or tiotropium (both delivered by the RESPIMAT Inhaler) on pulmonary function (lung hyperinflation), exercise capacity (6-minute… 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 and olodaterol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 43 sitesJapan
- Study dates
- 12 Feb 2016to 17 Apr 2017
- 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
- All patients must sign an informed consent consistent with International Conference on Harmonization - Good Clinical Practice (ICH-GCP) guidelines prior to participation in the trial, which includes medication washout and restrictions.
- All patients must have a diagnosis of chronic obstructive pulmonary disease (COPD) and must meet the following spirometric criteria:
- Patients must have relatively stable airway obstruction with a post-bronchodilator Forced expiratory volume in one second (FEV1) < 80% of predicted normal and post-bronchodilator FEV1/forced vital capacity (FVC) < 70% at Visit 1.
- Male or female patients, aged >= 40 years.
- Patients must be current or ex-smokers with a smoking history of more than 10 pack years. Patients who have never smoked cigarettes must be excluded.
- Patients with score on the modified Medical Research Council (mMRC) >= 1.
Show all 9Show fewer
- Patients who walk < 400 meters of 6MWT and have a score on the modified Borg >= 4 at the end of 6 minute walk test (6MWT) at Visit 2.
- Patients must be able to perform technically acceptable pulmonary function tests (spirometry), to use the physical activity monitor and must be able to complete 6MWT during the study period as required in the protocol.
- Patients must be able to inhale medication in a competent manner from the RESPIMAT Inhaler and from a metered dose inhaler.
Who cannot join
- Patients with a significant disease other than COPD; a significant disease is defined as a disease which, in the opinion of the investigator, may put the patient at risk because of participation in the study, influence the results of the study and cause concern regarding the patient's ability to participate in the study.
- Patients with clinically relevant abnormal baseline haematology, blood chemistry,urinalysis or creatinine > x2 upper limit of normal (ULN) will be excluded regardless of clinical condition (a repeat laboratory evaluation can be conducted if deemed necessary by the investigator).
- Patients with a current documented diagnosis of asthma. For patients with allergic rhinitis or atopy, source documentation is required to verify that the patient does not have asthma.
- Further exclusion criteria apply
Trial locations and contacts
43 sites in 1 country.
43 sites in 1 country
Japan43 sites
Hiramatsu Internal and Respiratory Medicine Clinic
Aichi, Komaki, 485-0041
National Hospital for Geriatric Medicine
Aichi, Obu, 474-8511
Tosei General Hospital
Aichi, Seto, 489-8642
Nishi Fukuoka Hospital
Fukuoka, Fukuoka, 819-8555
Kirigaoka Tsuda Hospital
Fukuoka, Kitakyushu, 802-0052
Osaki Internal and Respiratory Clinic
Fukuoka, Kitakyushu, 802-0083
Kurume University Hospital
Fukuoka, Kurume, 830-0011
Tohno Chuo Clinic
Gifu, Mizunami, 509-6134
Mazda Hospital
Hiroshima, Aki-gun, 735-8585
Teine Keijinkai Clinic
Hokkaido, Sapporo, 006-0811
Hokkaido University Hospital
Hokkaido, Sapporo, 060-8648
KKR Sapporo Medical Center
Hokkaido, Sapporo, 062-0931
Japan Community Health Care Organization Hokkaido Hospital
Hokkaido, Sapporo, 062-8618
Kobe City Medical Center General Hospital
Hyogo, Kobe, 650-0047
Kobe City Hospital Organization Kobe City Medical Center West Hospital
Hyogo, Kobe, 653-0013
Ibarakihigashi National Hospial
Ibaraki, Naka-gun, 319-1113
Iwate Medical University Hospital
Iwate, Morioka, 020-8505
Sakaide City Hospital
Kagawa, Sakaide, 762-8550
Kagoshima University Medical And Dental Hospital
Kagoshima, Kagoshima, 890-8520
Kokan Clinic
Kanagawa, Kawasaki, 210-0852
Shin-yurigaoka General Hospital
Kanagawa, Kawasaki, 215-0026
Showa University Fujigaoka Hospital
Kanagawa, Yokohama, 227-8501
Kyoto University Hospital
Kyoto, Kyoto, 606-8507
Rakuwakai Otowa Hospital
Kyoto, Kyoto, 607-8062
Uji-Tokushukai Medical Center
Kyoto, Uji, 611-0041
Matsusaka City Hospital
Mie, Matsusaka, 515-8544
Tohoku University Hospital
Miyagi, Sendai, 980-8574
Tohoku Rosai Hospital
Miyagi, Sendai, 981-8563
Kishiwada City Hospital
Osaka, Kishiwada, 596-8501
Osaka City University Hospital
Osaka, Osaka, 545-8586
Kindai University Hospital
Osaka, Osakasayama, 589-8511
National Hospital Organization Toneyama National Hospital
Osaka, Toyonaka, 560-8552
Yao Tokushukai General Hospital
Osaka, Yao, 581-0011
Shimane University Hospital
Shimane, Izumo, 693-8501
Tenryu Hospital
Shizuoka, Hamamatsu, 434-8511
Juntendo University Hospital
Tokyo, Bunkyo-ku, 113-8431
The Respiratory Care Clinic, Nippon Medical School
Tokyo, Chiyoda-ku, 102-0074
Nihonbashi Sakura Clinic
Tokyo, Chuo-ku, 103-0025
Tokyo Medical University Hachioji Medical Center
Tokyo, Hachioji, 193-0998
Nihon University Itabashi Hospital
Tokyo, Itabashi-ku, 173-8610
Showa University Hospital
Tokyo, Shinagawa-ku, 142-8666
Shinjuku Research Park Clinic
Tokyo, Shinjuku-ku, 169-0073
Wakayama National Hospital
Wakayama, Hidaka-gun, 644-0044
About this study
Official title: A Randomised, Double-blinded, Active-controlled 2-way Cross Over Trial to Assess the Effects of 6 Weeks Treatment of Once Daily Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination Delivered by RESPIMAT Inhaler Compared With Tiotropium Delivered by RESPIMAT Inhaler on Lung Hyperinflation, Exercise Capacity and Physical Activity in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)
This is a multi-centre, randomised, double-blinded, active-controlled, 2-way cross over trial to assess the effects of once daily administration of orally inhaled tiotropium + olodaterol FDC or tiotropium (both delivered by the RESPIMAT Inhaler) on pulmonary function (lung hyperinflation), exercise capacity (6-minute walk distance) and physical activities after 6 weeks of treatment in Japanese patients with Chronic Obstructive Pulmonary Disease.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- tiotropium, 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.
tiotropiumDrug
fixed dose combination
olodaterolDrug
fixed dose combination
tiotropiumDrug
| Study group | Role | What they receive |
|---|---|---|
| tiotropium + olodaterol | Experimental | inhalation two puffs from the RESPIMAT inhaler, once a day, in the morning Receives: Drug: tiotropium; Drug: olodaterol |
| tiotropium | Active comparator | inhalation two puffs from the RESPIMAT inhaler, once a day, in the morning Receives: Drug: tiotropium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inspiratory Capacity at Rest Measured at 60 Minutes Post-dose
At day 43 inspiratory capacity at rest measured at 60 minutes post-dose, after 6 weeks of each treatment. Adjusted mean was entered instead of mean in statistical analysis.
Measured: Day 43, 60 minutes post-dose after 6 weeks of each treatment
Secondary outcomes (9)
6-minute Walk Distance [Meter]
6-minute walk distance [Meter] treatment comparisons after 6 weeks of each treatment. Adjusted mean was entered instead of mean in statistical analysis.
Measured: Day 43, 60 minutes post-dose after 6 weeks of each treatment
Average Number of Step Per Day (Step/Day)
At day 43 adjusted mean (SE) of average number of step per day [step/day] treatment comparisons in measured by the activity monitor in 2 weeks prior to Week 6 of each treatment. Adjusted mean was entered instead of mean in statistical analysis.
Measured: 2 weeks prior to Week 6 per treatment
Average Daily Duration (Minutes) of ≥ 4 Metabolic Equivalents (METs)
At day 43 adjusted mean (SE) of average daily duration [minute] of ≥ 4 METs treatment comparisons measured by the activity monitor in the 2 weeks prior to week 6 of each treatment. Adjusted mean was entered instead of mean in statistical analysis.
Measured: 2 weeks prior to Week 6 per treatment
Average Daily Duration (Minutes) of ≥ 3 Metabolic Equivalents (METs)
At day 43 adjusted mean (SE) of average daily duration [minute] of ≥ 3 METs treatment comparisons measured by the activity monitor in 2 weeks prior to Week 6 of each treatment. Adjusted mean was entered instead of mean in statistical analysis.
Measured: 2 weeks prior to Week 6 per treatment
Average Daily Duration (Minutes) of ≥ 2 Metabolic Equivalents (METs)
At day 43 adjusted mean (SE) of average daily duration [minute] of ≥ 2 METs treatment comparison measured by the activity monitor in 2 weeks prior to Week 6 of each treatment. Adjusted mean was entered instead of mean in statistical analysis.
Measured: 2 weeks prior to Week 6 per treatment
Average Daily Active Strength (Metabolic Equivalents*Minutes) of ≥ 3 METs
At day 43 adjusted mean (SE) of average daily active strength [METs x minute] of >=3 METs treatment comparisons measured by the activity monitor in 2 weeks prior to Week 6 of each treatment. Adjusted mean was entered instead of mean in statistical analysis.
Measured: 2 weeks prior to Week 6 per treatment
60 Minutes Post-dose Slow Vital Capacity (SVC) (in Litre)
At day 43 adjusted mean (SE) of 60 minute post-dose slow vital capacity [Litre] treatment comparisons after 6 weeks of each treatment. Adjusted mean was entered instead of mean in statistical analysis.
Measured: Day 43, 60 minutes post-dose after 6 weeks of each treatment
30 Minutes Post-dose Forced Expiratory Volume in One Second (FEV1) (in Litre)
At day 43 adjusted mean (SE) of 30 minute post-dose forced expiratory volume in one second (FEV1) [Litre] treatment comparisons after 6 weeks of each treatment. Adjusted mean was entered instead of mean in statistical analysis.
Measured: Day 43, 30 minutes post-dose after 6 weeks of each treatment
30 Minutes Post-dose Forced Vital Capacity (FVC) (in Litre)
At day 43 adjusted mean (SE) of 30 minute post-dose forced vital capacity (FVC) [Litre] treatment comparisons after 6 weeks of each treatment. Adjusted mean was entered instead of mean in statistical analysis.
Measured: Day 43, 30 minutes post-dose after 6 weeks of each treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2015 (estimated)
- Study start12 Feb 2016
- Primary completion24 Mar 2017
- Study completion17 Apr 2017
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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02629965
- Sponsor's protocol ID
- 1237.33
- Status last verified
- Oct 2018
- First submitted
- 1 Dec 2015
- Last updated
- 6 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Minakata Y, Motegi T, Ueki J, Gon Y, Nakamura S, Anzai T, Hirata K, Ichinose M. Effect of tiotropium/olodaterol on sedentary and active time in patients with COPD: post hoc analysis of the VESUTO(R) study. Int J Chron Obstruct Pulmon Dis. 2019 Aug 7;14:1789-1801. doi: 10.2147/COPD.S208081. eCollection 2019.
PubMed 31496678
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blinded, Active-controlled 2-way Cross Over Trial to Assess the Effects of 6 Weeks Treatment of Once Daily Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination Delivered by RESPIMAT Inhaler Compared With Tiotropium Delivered by RESPIMAT Inhaler on Lung Hyperinflation, Exercise Capacity and Physical Activity in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT02629965
- Acronym / sponsor ID
- 1237.33
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 12 Feb 2016 (actual)
- Primary completion
- 24 Mar 2017 (actual)
- Study completion
- 17 Apr 2017 (actual)
- First posted
- 15 Dec 2015 (estimated)
- Results
- Posted 6 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-centre, randomised, double-blinded, active-controlled, 2-way cross over trial to assess the effects of once daily administration of orally inhaled tiotropium + olodaterol FDC or tiotropium (both delivered by the RESPIMAT Inhaler) on pulmonary function (lung hyperinflation), exercise capacity (6-minute walk distance) and physical activities after 6 weeks of treatment in Japanese patients with Chronic Obstructive Pulmonary Disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tiotropium + olodaterol | Experimental | Drug: tiotropium, Drug: olodaterolinhalation two puffs from the RESPIMAT inhaler, once a day, in the morning |
| tiotropium | Active comparator | Drug: tiotropiuminhalation two puffs from the RESPIMAT inhaler, once a day, in the morning |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- All patients must sign an informed consent consistent with International Conference on Harmonization - Good Clinical Practice (ICH-GCP) guidelines prior to participation in the trial, which includes medication washout and restrictions.
- All patients must have a diagnosis of chronic obstructive pulmonary disease (COPD) and must meet the following spirometric criteria:
- Patients must have relatively stable airway obstruction with a post-bronchodilator Forced expiratory volume in one second (FEV1) < 80% of predicted normal and post-bronchodilator FEV1/forced vital capacity (FVC) < 70% at Visit 1.
- Male or female patients, aged >= 40 years.
- Patients must be current or ex-smokers with a smoking history of more than 10 pack years. Patients who have never smoked cigarettes must be excluded.
Key exclusion criteria (4 listed)
- Patients with a significant disease other than COPD; a significant disease is defined as a disease which, in the opinion of the investigator, may put the patient at risk because of participation in the study, influence the results of the study and cause concern regarding the patient's ability to participate in the study.
- Patients with clinically relevant abnormal baseline haematology, blood chemistry,urinalysis or creatinine > x2 upper limit of normal (ULN) will be excluded regardless of clinical condition (a repeat laboratory evaluation can be conducted if deemed necessary by the investigator).
- Patients with a current documented diagnosis of asthma. For patients with allergic rhinitis or atopy, source documentation is required to verify that the patient does not have asthma.
- Further exclusion criteria apply
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 |
|---|---|---|
| tiotropiumfixed dose combination | Drug | tiotropium + olodaterol |
| olodaterolfixed dose combination | Drug | tiotropium + olodaterol |
| tiotropium | Drug | tiotropium |
Primary outcome
Inspiratory Capacity at Rest Measured at 60 Minutes Post-dose
Time frame: Day 43, 60 minutes post-dose after 6 weeks of each treatment
At day 43 inspiratory capacity at rest measured at 60 minutes post-dose, after 6 weeks of each treatment. Adjusted mean was entered instead of mean in statistical analysis.
9 secondary outcomes
6-minute Walk Distance [Meter]
Time frame: Day 43, 60 minutes post-dose after 6 weeks of each treatment
Average Number of Step Per Day (Step/Day)
Time frame: 2 weeks prior to Week 6 per treatment
Average Daily Duration (Minutes) of ≥ 4 Metabolic Equivalents (METs)
Time frame: 2 weeks prior to Week 6 per treatment
Average Daily Duration (Minutes) of ≥ 3 Metabolic Equivalents (METs)
Time frame: 2 weeks prior to Week 6 per treatment
Average Daily Duration (Minutes) of ≥ 2 Metabolic Equivalents (METs)
Time frame: 2 weeks prior to Week 6 per treatment
Average Daily Active Strength (Metabolic Equivalents*Minutes) of ≥ 3 METs
Time frame: 2 weeks prior to Week 6 per treatment
60 Minutes Post-dose Slow Vital Capacity (SVC) (in Litre)
Time frame: Day 43, 60 minutes post-dose after 6 weeks of each treatment
30 Minutes Post-dose Forced Expiratory Volume in One Second (FEV1) (in Litre)
Time frame: Day 43, 30 minutes post-dose after 6 weeks of each treatment
30 Minutes Post-dose Forced Vital Capacity (FVC) (in Litre)
Time frame: Day 43, 30 minutes post-dose after 6 weeks of each treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31496678Minakata Y, Motegi T, Ueki J, Gon Y, Nakamura S, Anzai T, Hirata K, Ichinose M. Effect of tiotropium/olodaterol on sedentary and active time in patients with COPD: post hoc analysis of the VESUTO(R) study. Int J Chron Obstruct Pulmon Dis. 2019 Aug 7;14:1789-1801. doi: 10.2147/COPD.S208081. eCollection 2019.
- 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
43 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 and olodaterol in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 43 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 9 inclusion and 4 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 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 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 6 Jun 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?
Inspiratory Capacity at Rest Measured at 60 Minutes Post-dose (time frame: Day 43, 60 minutes post-dose after 6 weeks of each treatment). 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 NCT02629965, 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 Jun 2019.