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)
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 184
- Locations
- 43
- Primary Endpoint
- Inspiratory Capacity at Rest Measured at 60 Minutes Post-dose
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
tiotropium + olodaterol
inhalation two puffs from the RESPIMAT inhaler, once a day, in the morning
Intervention: tiotropium (Drug)
tiotropium + olodaterol
inhalation two puffs from the RESPIMAT inhaler, once a day, in the morning
Intervention: olodaterol (Drug)
tiotropium
inhalation two puffs from the RESPIMAT inhaler, once a day, in the morning
Intervention: tiotropium (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 6-minute Walk Distance [Meter](Day 43, 60 minutes post-dose after 6 weeks of each treatment)
- Average Number of Step Per Day (Step/Day)(2 weeks prior to Week 6 per treatment)
- Average Daily Duration (Minutes) of ≥ 4 Metabolic Equivalents (METs)(2 weeks prior to Week 6 per treatment)
- Average Daily Duration (Minutes) of ≥ 3 Metabolic Equivalents (METs)(2 weeks prior to Week 6 per treatment)
- Average Daily Duration (Minutes) of ≥ 2 Metabolic Equivalents (METs)(2 weeks prior to Week 6 per treatment)
- Average Daily Active Strength (Metabolic Equivalents*Minutes) of ≥ 3 METs(2 weeks prior to Week 6 per treatment)
- 60 Minutes Post-dose Slow Vital Capacity (SVC) (in Litre)(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)(Day 43, 30 minutes post-dose after 6 weeks of each treatment)
- 30 Minutes Post-dose Forced Vital Capacity (FVC) (in Litre)(Day 43, 30 minutes post-dose after 6 weeks of each treatment)