The primary objective of this trial is to investigate the effect of 6 weeks treatment with tiotropium + olodaterol fixed dose combination inhalation solution on lung hyperinflation and exercise tolerance in patients with COPD
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
295
placebo matching tiotropium + olodaterol FDC
Tiotropium 5 mcg once daily
Olodaterol 5 mcg once daily
Inspiratory Capacity at Rest Before Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap
Inspiratory capacity (IC) at rest before constant work rate cycle ergometry to symptom limitation at 75% maximal work capacity (Wcap). Wcap was defined as the maximum work rate achieved for at least 30 seconds during the incremental cycle ergometry performed at Visit 1. The presented means are adjusted means from the MMRM (Mixed Effects Model Repeated Measures) model.
Time frame: 6 weeks
Endurance Time During Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap
Endurance time during constant work rate cycle ergometry (CWRCE) to symptom limitation at 75% work capacity (Wcap). Wcap was defined as the maximum work rate achieved for at least 30 seconds during the incremental cycle ergometry performed at Visit 1. The presented means are adjusted mean from the MMRM model.
Time frame: 6 weeks
Slope of the Intensity of Breathing Discomfort During Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Work Capacity
Slope of the intensity of breathing discomfort during Constant Work Rate Cycle Ergometry (CWRCE) to symptom limitation at 75% Work capacity (Wcap). The intensity of breathing discomfort was rated using the modified Borg scale with ratings from 0 (nothing at all) to 10 (maximal). Slope of breathing discomfort is defined as: (intensity of breathing discomfort at the end of exercise minus intensity of breathing discomfort at rest) / endurance time. A decrease in slope indicates improvement. The presented means are adjusted means from MMRM model.
Time frame: 6 weeks
Forced Expiratory Volume in 1 Second (One Hour Post-dose)
Forced Expiratory Volume in 1 Second (FEV1) (one hour post-dose) The presented means are adjusted means from MMRM model.
Time frame: 6 weeks
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tiotropium + olodaterol 5 mcg once daily
Tiotropium 2.5 mcg + Olodaterol 5 mcg once daily
Respimat inhaler
1237.13.01302 Boehringer Ingelheim Investigational Site
Torrance, California, United States
1237.13.01308 Boehringer Ingelheim Investigational Site
Hartford, Connecticut, United States
1237.13.01304 Boehringer Ingelheim Investigational Site
Livonia, Michigan, United States
1237.13.01307 Boehringer Ingelheim Investigational Site
Pittsburgh, Pennsylvania, United States
1237.13.01305 Boehringer Ingelheim Investigational Site
Easley, South Carolina, United States
1237.13.01301 Boehringer Ingelheim Investigational Site
Greenville, South Carolina, United States
1237.13.01303 Boehringer Ingelheim Investigational Site
Spartanburg, South Carolina, United States
1237.13.01306 Boehringer Ingelheim Investigational Site
Richmond, Virginia, United States
1237.13.54301 Boehringer Ingelheim Investigational Site
Capital Federal, Argentina
1237.13.54302 Boehringer Ingelheim Investigational Site
Mar del Plata, Argentina
...and 34 more locations