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
291
placebo matching tiotropium + olodaterol
Tiotropium 2.5 mcg + olodaterol 5 mcg once daily
tiotropium 5 mcg + olodaterol 5 mcg once daily
Inspiratory Capacity at Rest Before Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Work Capacity
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% 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 (Borg Scale) During Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap
Slope of the intensity of breathing discomfort (Borg Scale) during CWRCE to symptom limitation at 75% Wcap. The intensity of breathing discomfort was rated using the modified Borg scale with ratings from 0 (nothing at all) to 10 (maximal). Slope 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
FEV1 (1 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
tiotropium
Olodaterol 5 mcg once daily
Respimat inhaler
1237.14.01404 Boehringer Ingelheim Investigational Site
Phoenix, Arizona, United States
1237.14.01414 Boehringer Ingelheim Investigational Site
Austell, Georgia, United States
1237.14.01417 Boehringer Ingelheim Investigational Site
Baltimore, Maryland, United States
1237.14.01418 Boehringer Ingelheim Investigational Site
Rochester, Minnesota, United States
1237.14.01408 Boehringer Ingelheim Investigational Site
Saint Charles, Missouri, United States
1237.14.01409 Boehringer Ingelheim Investigational Site
Charlotte, North Carolina, United States
1237.14.01407 Boehringer Ingelheim Investigational Site
Greenville, South Carolina, United States
1237.14.01403 Boehringer Ingelheim Investigational Site
Spartanburg, South Carolina, United States
1237.14.01401 Boehringer Ingelheim Investigational Site
Union, South Carolina, United States
1237.14.01412 Boehringer Ingelheim Investigational Site
Dallas, Texas, United States
...and 23 more locations