Effect on Exercise Endurance and Lung Hyperinflation of Tiotropium + Olodaterol in COPD Patients
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- Registration Number
- NCT01533922
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 295
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Tiotropium + olodaterol High dose QD Tiotropium + Olodaterol patient will receive tiotropium 5 mcg + olodaterol 5 mcg in a fixed dose combination once daily Tiotropium + olodaterol High dose QD Respimat patient will receive tiotropium 5 mcg + olodaterol 5 mcg in a fixed dose combination once daily Tiotropium + olodaterol Low dose QD Tiotropium + Olodaterol patient will receive tiotropium 2.5 mcg + olodaterol 5 mcg in a fixed dose combination once daily Tiotropium + olodaterol Low dose QD Respimat patient will receive tiotropium 2.5 mcg + olodaterol 5 mcg in a fixed dose combination once daily Tiotropium 5 mcg QD Respimat patient will receive tiotropium 5 mcg once daily Olodaterol 5 mcg QD Respimat patient will receive olodaterol 5 mcg once daily Placebo QD Placebo - Placebo QD Respimat - Tiotropium 5 mcg QD Tiotropium patient will receive tiotropium 5 mcg once daily Olodaterol 5 mcg QD Olodaterol patient will receive olodaterol 5 mcg once daily
- Primary Outcome Measures
Name Time Method Inspiratory Capacity at Rest Before Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap 6 weeks 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.Endurance Time During Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap 6 weeks 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.
- Secondary Outcome Measures
Name Time Method Slope of the Intensity of Breathing Discomfort During Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Work Capacity 6 weeks 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.Forced Expiratory Volume in 1 Second (One Hour Post-dose) 6 weeks Forced Expiratory Volume in 1 Second (FEV1) (one hour post-dose)
The presented means are adjusted means from MMRM model.
Trial Locations
- Locations (44)
1237.13.01307 Boehringer Ingelheim Investigational Site
🇺🇸Pittsburgh, Pennsylvania, United States
1237.13.01305 Boehringer Ingelheim Investigational Site
🇺🇸Easley, South Carolina, United States
1237.13.43303 Boehringer Ingelheim Investigational Site
🇦🇹Linz, Austria
1237.13.32303 Boehringer Ingelheim Investigational Site
🇧🇪Edegem, Belgium
1237.13.43301 Boehringer Ingelheim Investigational Site
🇦🇹Thalheim bei Wels, Austria
1237.13.32302 Boehringer Ingelheim Investigational Site
🇧🇪Brussel, Belgium
1237.13.32301 Boehringer Ingelheim Investigational Site
🇧🇪Leuven, Belgium
1237.13.32305 Boehringer Ingelheim Investigational Site
🇧🇪Jambes, Belgium
1237.13.56302 Boehringer Ingelheim Investigational Site
🇨🇱Santiago de Chile, Chile
1237.13.32304 Boehringer Ingelheim Investigational Site
🇧🇪Lanaken, Belgium
1237.13.01304 Boehringer Ingelheim Investigational Site
🇺🇸Livonia, Michigan, United States
1237.13.54301 Boehringer Ingelheim Investigational Site
🇦🇷Capital Federal, Argentina
1237.13.61301 Boehringer Ingelheim Investigational Site
🇦🇺Daw Park, South Australia, Australia
1237.13.01302 Boehringer Ingelheim Investigational Site
🇺🇸Torrance, California, United States
1237.13.61304 Boehringer Ingelheim Investigational Site
🇦🇺Footscray, Victoria, Australia
1237.13.01303 Boehringer Ingelheim Investigational Site
🇺🇸Spartanburg, South Carolina, United States
1237.13.54302 Boehringer Ingelheim Investigational Site
🇦🇷Mar del Plata, Argentina
1237.13.49303 Boehringer Ingelheim Investigational Site
🇩🇪Hannover, Germany
1237.13.39305 Boehringer Ingelheim Investigational Site
🇮🇹Pavullo Nel Frignano (mo), Italy
1237.13.39304 Boehringer Ingelheim Investigational Site
🇮🇹Parma, Italy
1237.13.39310 Boehringer Ingelheim Investigational Site
🇮🇹Roma, Italy
1237.13.61302 Boehringer Ingelheim Investigational Site
🇦🇺Prahran, Victoria, Australia
1237.13.01308 Boehringer Ingelheim Investigational Site
🇺🇸Hartford, Connecticut, United States
1237.13.01301 Boehringer Ingelheim Investigational Site
🇺🇸Greenville, South Carolina, United States
1237.13.01306 Boehringer Ingelheim Investigational Site
🇺🇸Richmond, Virginia, United States
1237.13.61306 Boehringer Ingelheim Investigational Site
🇦🇺Concord, New South Wales, Australia
1237.13.61305 Boehringer Ingelheim Investigational Site
🇦🇺Toorak Gardens, South Australia, Australia
1237.13.11302 Boehringer Ingelheim Investigational Site
🇨🇦Hamilton, Ontario, Canada
1237.13.11304 Boehringer Ingelheim Investigational Site
🇨🇦Saskatoon, Saskatchewan, Canada
1237.13.56301 Boehringer Ingelheim Investigational Site
🇨🇱Chile, Chile
1237.13.11303 Boehringer Ingelheim Investigational Site
🇨🇦Kingston, Ontario, Canada
1237.13.49307 Boehringer Ingelheim Investigational Site
🇩🇪Dortmund, Germany
1237.13.49301 Boehringer Ingelheim Investigational Site
🇩🇪Halle, Germany
1237.13.49302 Boehringer Ingelheim Investigational Site
🇩🇪Berlin, Germany
1237.13.49304 Boehringer Ingelheim Investigational Site
🇩🇪Frankfurt, Germany
1237.13.39303 Boehringer Ingelheim Investigational Site
🇮🇹Pavia, Italy
1237.13.49305 Boehringer Ingelheim Investigational Site
🇩🇪Lübeck, Germany
1237.13.39302 Boehringer Ingelheim Investigational Site
🇮🇹Genova, Italy
1237.13.39301 Boehringer Ingelheim Investigational Site
🇮🇹Pisa, Italy
1237.13.39308 Boehringer Ingelheim Investigational Site
🇮🇹Sesto S. Giovanni (mi), Italy
1237.13.39312 Boehringer Ingelheim Investigational Site
🇮🇹Pisa, Italy
1237.13.39306 Boehringer Ingelheim Investigational Site
🇮🇹Trieste, Italy
1237.13.64302 Boehringer Ingelheim Investigational Site
🇳🇿Christchurch, New Zealand
1237.13.64301 Boehringer Ingelheim Investigational Site
🇳🇿Greenlane East Auckland NZ, New Zealand