Back to resultsComparing 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
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
tiotropium
olodaterol
tiotropium
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive
Eligibility Criteria
Inclusion criteria:
- 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.
- 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.
Exclusion criteria:
- 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
Sites / Locations
- Hiramatsu Internal and Respiratory Medicine Clinic
- National Hospital for Geriatric Medicine
- Tosei General Hospital
- Nishi Fukuoka Hospital
- Kirigaoka Tsuda Hospital
- Osaki Internal and Respiratory Clinic
- Kurume University Hospital
- Tohno Chuo Clinic
- Mazda Hospital
- Teine Keijinkai Clinic
- Hokkaido University Hospital
- KKR Sapporo Medical Center
- Japan Community Health Care Organization Hokkaido Hospital
- Kobe City Medical Center General Hospital
- Kobe City Hospital Organization Kobe City Medical Center West Hospital
- Ibarakihigashi National Hospial
- Iwate Medical University Hospital
- Sakaide City Hospital
- Kagoshima University Medical And Dental Hospital
- Kokan Clinic
- Shin-yurigaoka General Hospital
- Showa University Fujigaoka Hospital
- Kyoto University Hospital
- Rakuwakai Otowa Hospital
- Uji-Tokushukai Medical Center
- Matsusaka City Hospital
- Tohoku University Hospital
- Tohoku Rosai Hospital
- Kishiwada City Hospital
- Kindai University Hospital
- Osaka City University Hospital
- National Hospital Organization Toneyama National Hospital
- Yao Tokushukai General Hospital
- Shimane University Hospital
- Tenryu Hospital
- Juntendo University Hospital
- The Respiratory Care Clinic, Nippon Medical School
- Nihonbashi Sakura Clinic
- Tokyo Medical University Hachioji Medical Center
- Nihon University Itabashi Hospital
- Showa University Hospital
- Shinjuku Research Park Clinic
- Wakayama National Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
tiotropium + olodaterol
tiotropium
Arm Description
inhalation two puffs from the RESPIMAT inhaler, once a day, in the morning
inhalation two puffs from the RESPIMAT inhaler, once a day, in the morning
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02629965
Brief Title
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
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)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
February 12, 2016 (Actual)
Primary Completion Date
March 24, 2017 (Actual)
Study Completion Date
April 17, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
Brief 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 walk distance) and physical activities after 6 weeks of treatment in Japanese patients with Chronic Obstructive Pulmonary Disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
184 (Actual)
8. Arms, Groups, and Interventions
Arm Title
tiotropium + olodaterol
Arm Type
Experimental
Arm Description
inhalation two puffs from the RESPIMAT inhaler, once a day, in the morning
Arm Title
tiotropium
Arm Type
Active Comparator
Arm Description
inhalation two puffs from the RESPIMAT inhaler, once a day, in the morning
Intervention Type
Drug
Intervention Name(s)
tiotropium
Intervention Description
fixed dose combination
Intervention Type
Drug
Intervention Name(s)
olodaterol
Intervention Description
fixed dose combination
Intervention Type
Drug
Intervention Name(s)
tiotropium
Primary Outcome Measure Information:
Title
Inspiratory Capacity at Rest Measured at 60 Minutes Post-dose
Description
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.
Time Frame
Day 43, 60 minutes post-dose after 6 weeks of each treatment
Secondary Outcome Measure Information:
Title
6-minute Walk Distance [Meter]
Description
6-minute walk distance [Meter] treatment comparisons after 6 weeks of each treatment. Adjusted mean was entered instead of mean in statistical analysis.
Time Frame
Day 43, 60 minutes post-dose after 6 weeks of each treatment
Title
Average Number of Step Per Day (Step/Day)
Description
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.
Time Frame
2 weeks prior to Week 6 per treatment
Title
Average Daily Duration (Minutes) of ≥ 4 Metabolic Equivalents (METs)
Description
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.
Time Frame
2 weeks prior to Week 6 per treatment
Title
Average Daily Duration (Minutes) of ≥ 3 Metabolic Equivalents (METs)
Description
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.
Time Frame
2 weeks prior to Week 6 per treatment
Title
Average Daily Duration (Minutes) of ≥ 2 Metabolic Equivalents (METs)
Description
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.
Time Frame
2 weeks prior to Week 6 per treatment
Title
Average Daily Active Strength (Metabolic Equivalents*Minutes) of ≥ 3 METs
Description
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.
Time Frame
2 weeks prior to Week 6 per treatment
Title
60 Minutes Post-dose Slow Vital Capacity (SVC) (in Litre)
Description
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.
Time Frame
Day 43, 60 minutes post-dose after 6 weeks of each treatment
Title
30 Minutes Post-dose Forced Expiratory Volume in One Second (FEV1) (in Litre)
Description
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.
Time Frame
Day 43, 30 minutes post-dose after 6 weeks of each treatment
Title
30 Minutes Post-dose Forced Vital Capacity (FVC) (in Litre)
Description
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.
Time Frame
Day 43, 30 minutes post-dose after 6 weeks of each treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
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.
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.
Exclusion criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
Hiramatsu Internal and Respiratory Medicine Clinic
City
Aichi, Komaki
ZIP/Postal Code
485-0041
Country
Japan
Facility Name
National Hospital for Geriatric Medicine
City
Aichi, Obu
ZIP/Postal Code
474-8511
Country
Japan
Facility Name
Tosei General Hospital
City
Aichi, Seto
ZIP/Postal Code
489-8642
Country
Japan
Facility Name
Nishi Fukuoka Hospital
City
Fukuoka, Fukuoka
ZIP/Postal Code
819-8555
Country
Japan
Facility Name
Kirigaoka Tsuda Hospital
City
Fukuoka, Kitakyushu
ZIP/Postal Code
802-0052
Country
Japan
Facility Name
Osaki Internal and Respiratory Clinic
City
Fukuoka, Kitakyushu
ZIP/Postal Code
802-0083
Country
Japan
Facility Name
Kurume University Hospital
City
Fukuoka, Kurume
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Tohno Chuo Clinic
City
Gifu, Mizunami
ZIP/Postal Code
509-6134
Country
Japan
Facility Name
Mazda Hospital
City
Hiroshima, Aki-gun
ZIP/Postal Code
735-8585
Country
Japan
Facility Name
Teine Keijinkai Clinic
City
Hokkaido, Sapporo
ZIP/Postal Code
006-0811
Country
Japan
Facility Name
Hokkaido University Hospital
City
Hokkaido, Sapporo
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
KKR Sapporo Medical Center
City
Hokkaido, Sapporo
ZIP/Postal Code
062-0931
Country
Japan
Facility Name
Japan Community Health Care Organization Hokkaido Hospital
City
Hokkaido, Sapporo
ZIP/Postal Code
062-8618
Country
Japan
Facility Name
Kobe City Medical Center General Hospital
City
Hyogo, Kobe
ZIP/Postal Code
650-0047
Country
Japan
Facility Name
Kobe City Hospital Organization Kobe City Medical Center West Hospital
City
Hyogo, Kobe
ZIP/Postal Code
653-0013
Country
Japan
Facility Name
Ibarakihigashi National Hospial
City
Ibaraki, Naka-gun
ZIP/Postal Code
319-1113
Country
Japan
Facility Name
Iwate Medical University Hospital
City
Iwate, Morioka
ZIP/Postal Code
020-8505
Country
Japan
Facility Name
Sakaide City Hospital
City
Kagawa, Sakaide
ZIP/Postal Code
762-8550
Country
Japan
Facility Name
Kagoshima University Medical And Dental Hospital
City
Kagoshima, Kagoshima
ZIP/Postal Code
890-8520
Country
Japan
Facility Name
Kokan Clinic
City
Kanagawa, Kawasaki
ZIP/Postal Code
210-0852
Country
Japan
Facility Name
Shin-yurigaoka General Hospital
City
Kanagawa, Kawasaki
ZIP/Postal Code
215-0026
Country
Japan
Facility Name
Showa University Fujigaoka Hospital
City
Kanagawa, Yokohama
ZIP/Postal Code
227-8501
Country
Japan
Facility Name
Kyoto University Hospital
City
Kyoto, Kyoto
ZIP/Postal Code
606-8507
Country
Japan
Facility Name
Rakuwakai Otowa Hospital
City
Kyoto, Kyoto
ZIP/Postal Code
607-8062
Country
Japan
Facility Name
Uji-Tokushukai Medical Center
City
Kyoto, Uji
ZIP/Postal Code
611-0041
Country
Japan
Facility Name
Matsusaka City Hospital
City
Mie, Matsusaka
ZIP/Postal Code
515-8544
Country
Japan
Facility Name
Tohoku University Hospital
City
Miyagi, Sendai
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Tohoku Rosai Hospital
City
Miyagi, Sendai
ZIP/Postal Code
981-8563
Country
Japan
Facility Name
Kishiwada City Hospital
City
Osaka, Kishiwada
ZIP/Postal Code
596-8501
Country
Japan
Facility Name
Kindai University Hospital
City
Osaka, Osakasayama
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Osaka City University Hospital
City
Osaka, Osaka
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
National Hospital Organization Toneyama National Hospital
City
Osaka, Toyonaka
ZIP/Postal Code
560-8552
Country
Japan
Facility Name
Yao Tokushukai General Hospital
City
Osaka, Yao
ZIP/Postal Code
581-0011
Country
Japan
Facility Name
Shimane University Hospital
City
Shimane, Izumo
ZIP/Postal Code
693-8501
Country
Japan
Facility Name
Tenryu Hospital
City
Shizuoka, Hamamatsu
ZIP/Postal Code
434-8511
Country
Japan
Facility Name
Juntendo University Hospital
City
Tokyo, Bunkyo-ku
ZIP/Postal Code
113-8431
Country
Japan
Facility Name
The Respiratory Care Clinic, Nippon Medical School
City
Tokyo, Chiyoda-ku
ZIP/Postal Code
102-0074
Country
Japan
Facility Name
Nihonbashi Sakura Clinic
City
Tokyo, Chuo-ku
ZIP/Postal Code
103-0025
Country
Japan
Facility Name
Tokyo Medical University Hachioji Medical Center
City
Tokyo, Hachioji
ZIP/Postal Code
193-0998
Country
Japan
Facility Name
Nihon University Itabashi Hospital
City
Tokyo, Itabashi-ku
ZIP/Postal Code
173-8610
Country
Japan
Facility Name
Showa University Hospital
City
Tokyo, Shinagawa-ku
ZIP/Postal Code
142-8666
Country
Japan
Facility Name
Shinjuku Research Park Clinic
City
Tokyo, Shinjuku-ku
ZIP/Postal Code
169-0073
Country
Japan
Facility Name
Wakayama National Hospital
City
Wakayama, Hidaka-gun
ZIP/Postal Code
644-0044
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
31496678
Citation
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. Erratum In: Int J Chron Obstruct Pulmon Dis. 2019 Sep 03;14:2061-2064.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com/
Description
Related Info
Learn more about this trial
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
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