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
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- Registration Number
- NCT02629965
- Lead Sponsor
- Boehringer Ingelheim
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 184
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description tiotropium + olodaterol olodaterol inhalation two puffs from the RESPIMAT inhaler, once a day, in the morning tiotropium + olodaterol tiotropium inhalation two puffs from the RESPIMAT inhaler, once a day, in the morning tiotropium tiotropium inhalation two puffs from the RESPIMAT inhaler, once a day, in the morning
- Primary Outcome Measures
Name Time Method Inspiratory Capacity at Rest Measured at 60 Minutes Post-dose 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.
- Secondary Outcome Measures
Name Time Method Average Daily Duration (Minutes) of ≥ 4 Metabolic Equivalents (METs) 2 weeks prior to Week 6 per treatment 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) 2 weeks prior to Week 6 per treatment 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.
6-minute Walk Distance [Meter] Day 43, 60 minutes post-dose after 6 weeks of each treatment 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) 2 weeks prior to Week 6 per treatment 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 ≥ 2 Metabolic Equivalents (METs) 2 weeks prior to Week 6 per treatment 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 2 weeks prior to Week 6 per treatment 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) Day 43, 60 minutes post-dose after 6 weeks of each treatment 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) Day 43, 30 minutes post-dose after 6 weeks of each treatment 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) Day 43, 30 minutes post-dose after 6 weeks of each treatment 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.
Trial Locations
- Locations (43)
Tohno Chuo Clinic
🇯🇵Gifu, Mizunami, Japan
Kirigaoka Tsuda Hospital
🇯🇵Fukuoka, Kitakyushu, Japan
Nishi Fukuoka Hospital
🇯🇵Fukuoka, Fukuoka, Japan
Japan Community Health Care Organization Hokkaido Hospital
🇯🇵Hokkaido, Sapporo, Japan
National Hospital for Geriatric Medicine
🇯🇵Aichi, Obu, Japan
Shin-yurigaoka General Hospital
🇯🇵Kanagawa, Kawasaki, Japan
Yao Tokushukai General Hospital
🇯🇵Osaka, Yao, Japan
Wakayama National Hospital
🇯🇵Wakayama, Hidaka-gun, Japan
Kobe City Medical Center General Hospital
🇯🇵Hyogo, Kobe, Japan
Uji-Tokushukai Medical Center
🇯🇵Kyoto, Uji, Japan
Mazda Hospital
🇯🇵Hiroshima, Aki-gun, Japan
Hiramatsu Internal and Respiratory Medicine Clinic
🇯🇵Aichi, Komaki, Japan
Kagoshima University Medical And Dental Hospital
🇯🇵Kagoshima, Kagoshima, Japan
Tosei General Hospital
🇯🇵Aichi, Seto, Japan
Osaki Internal and Respiratory Clinic
🇯🇵Fukuoka, Kitakyushu, Japan
Kurume University Hospital
🇯🇵Fukuoka, Kurume, Japan
Teine Keijinkai Clinic
🇯🇵Hokkaido, Sapporo, Japan
KKR Sapporo Medical Center
🇯🇵Hokkaido, Sapporo, Japan
Hokkaido University Hospital
🇯🇵Hokkaido, Sapporo, Japan
Kobe City Hospital Organization Kobe City Medical Center West Hospital
🇯🇵Hyogo, Kobe, Japan
Ibarakihigashi National Hospial
🇯🇵Ibaraki, Naka-gun, Japan
Sakaide City Hospital
🇯🇵Kagawa, Sakaide, Japan
Iwate Medical University Hospital
🇯🇵Iwate, Morioka, Japan
Kokan Clinic
🇯🇵Kanagawa, Kawasaki, Japan
Showa University Fujigaoka Hospital
🇯🇵Kanagawa, Yokohama, Japan
Kyoto University Hospital
🇯🇵Kyoto, Kyoto, Japan
Rakuwakai Otowa Hospital
🇯🇵Kyoto, Kyoto, Japan
Matsusaka City Hospital
🇯🇵Mie, Matsusaka, Japan
Tohoku Rosai Hospital
🇯🇵Miyagi, Sendai, Japan
Tohoku University Hospital
🇯🇵Miyagi, Sendai, Japan
Kishiwada City Hospital
🇯🇵Osaka, Kishiwada, Japan
Kindai University Hospital
🇯🇵Osaka, Osakasayama, Japan
National Hospital Organization Toneyama National Hospital
🇯🇵Osaka, Toyonaka, Japan
Osaka City University Hospital
🇯🇵Osaka, Osaka, Japan
Tenryu Hospital
🇯🇵Shizuoka, Hamamatsu, Japan
Shimane University Hospital
🇯🇵Shimane, Izumo, Japan
Juntendo University Hospital
🇯🇵Tokyo, Bunkyo-ku, Japan
The Respiratory Care Clinic, Nippon Medical School
🇯🇵Tokyo, Chiyoda-ku, Japan
Nihonbashi Sakura Clinic
🇯🇵Tokyo, Chuo-ku, Japan
Tokyo Medical University Hachioji Medical Center
🇯🇵Tokyo, Hachioji, Japan
Showa University Hospital
🇯🇵Tokyo, Shinagawa-ku, Japan
Nihon University Itabashi Hospital
🇯🇵Tokyo, Itabashi-ku, Japan
Shinjuku Research Park Clinic
🇯🇵Tokyo, Shinjuku-ku, Japan