A Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Determine the Effect of 12 Weeks Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination (2.5/5 µg and 5/5 µg) Delivered by the Respimat® Inhaler, on Exercise Endurance Time During Constant Work Rate Cycle Ergometry in Patients With Chronic Obstructive Pulmonary Disease (COPD)[Torracto (TM)]
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 404
- Locations
- 60
- Primary Endpoint
- Adjusted Mean Endurance Time During Constant Work Rate Cycle Ergometry (CWRCE) After 12 Weeks
Study Overview
Brief Summary
The primary objective of this study is to compare the effects of orally inhaled tiotropium + olodaterol fixed dose combination (2.5/5 µg; 5/5 µg) with placebo on exercise tolerance after 12 weeks of treatment in patients with COPD.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 40 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
tiotropium+olodaterol low dose
once daily 2 puffs, fixed dose combination (FDC) solution for inhalation Respimat
Intervention: Respimat inhaler (Device)
tiotropium+olodaterol low dose
once daily 2 puffs, fixed dose combination (FDC) solution for inhalation Respimat
Intervention: tiotropium+olodaterol (low dose) (Drug)
tiotropium+olodaterol high dose
once daily 2 puffs, FDC solution for inhalation Respimat
Intervention: tiotropium + olodaterol (high dose) (Drug)
tiotropium+olodaterol high dose
once daily 2 puffs, FDC solution for inhalation Respimat
Intervention: Respimat inhaler (Device)
placebo
once daily 2 puffs, solution for inhalation Respimat
Intervention: Respimat inhaler (Device)
placebo
once daily 2 puffs, solution for inhalation Respimat
Intervention: placebo to tiotropium+olodaterol (Drug)
Outcomes
Primary Outcomes
Adjusted Mean Endurance Time During Constant Work Rate Cycle Ergometry (CWRCE) After 12 Weeks
Time Frame: 12 weeks
Primary endpoint was endurance time during constant work rate cycle ergometry to symptom limitation at 75% of maximal work capacity after 12 weeks of treatment. The endurance time in seconds was transformed using log10 scale to correct skewness in endurance time on original scale and then the MMRM model was fitted to the log10-transformed data and the least square means and SEs were obtained. To present the results in a way easier for interpretation, the least square mean from the MMRM fitted to the log10-transformed data were transformed back taking 10 to the power of the least square estimate for the log10 of geometric mean and the corresponding SE was transformed using delta method to get the corresponding SEs of the geometric mean.
Secondary Outcomes
- Adjusted Mean Inspiratory Capacity at Pre-exercise After 6 Weeks(6 weeks)
- Adjusted Mean Slope of the Intensity of Breathing Discomfort After Week 6(6 weeks)
- Adjusted Mean 1-hour, Post-dose Forced Expiratory Volume in One Second (FEV1) After 6 Weeks(6 weeks)
- Adjusted Mean Inspiratory Capacity at Pre-exercise After 12 Weeks(12 weeks)
- Adjusted Mean Endurance Time During Constant Work Rate Cycle Ergometry (CWRCE) on Day 1(1 day)
- Adjusted Mean Endurance Time During Constant Work Rate Cycle Ergometry (CWRCE) After 6 Weeks Treatment(6 weeks)
- Adjusted Mean Slope of the Intensity of Breathing Discomfort After Week 12(12 weeks)
- Adjusted Mean Endurance Time During Endurance Shuttle Walk Test (ESWT) After 12 Weeks(12 weeks)
- Adjusted Mean Inspiratory Capacity at Pre-exercise After 1 Day(1 day)
- Adjusted Mean Slope of the Intensity of Breathing Discomfort on Day 1(1 day)
- Adjusted Mean 1-hour, Post-dose Forced Expiratory Volume in One Second (FEV1) on Day 1(1 day)
- Adjusted Mean 1-hour, Post-dose Forced Expiratory Volume in One Second (FEV1) After 12 Weeks(12 weeks)