Effect on Exercise Endurance and Lung Hyperinflation of Tiotropium + Olodaterol in COPD Patients.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- Registration Number
- NCT01533935
- 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
- 291
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Tiotropium 5 mcg QD Respimat patient will receive tiotropium 5 mcg once daily Tiotropium + olodaterol high dose Respimat patient will receive tiotropium 5 mcg + olodaterol 5 mcg in fixed dose combination once daily Olodaterol 5 mcg QD Respimat patient will receive olodaterol 5 mcg once daily Placebo QD Placebo placebo comparator for tiotropium + olodaterol Placebo QD Respimat placebo comparator for tiotropium + olodaterol Tiotropium + olodaterol low dose QD tiotropium + Olodaterol patient will receive tiotropium 2.5 mcg + olodaterol 5 mcg in fixed dose combination once daily Tiotropium + olodaterol low dose QD Respimat patient will receive tiotropium 2.5 mcg + olodaterol 5 mcg in fixed dose combination once daily Tiotropium + olodaterol high dose tiotropium + Olodaterol patient will receive tiotropium 5 mcg + olodaterol 5 mcg in fixed dose combination once daily Olodaterol 5 mcg QD Olodaterol patient will receive olodaterol 5 mcg once daily Tiotropium 5 mcg QD Tiotropium patient will receive tiotropium 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% Work Capacity 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% 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 (Borg Scale) During Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap 6 weeks 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.FEV1 (1 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 (33)
1237.14.11404 Boehringer Ingelheim Investigational Site
🇨🇦Vancouver, British Columbia, Canada
1237.14.43402 Boehringer Ingelheim Investigational Site
🇦🇹Grieskirchen, Austria
1237.14.43401 Boehringer Ingelheim Investigational Site
🇦🇹Neumarkt am Wallersee, Austria
1237.14.01408 Boehringer Ingelheim Investigational Site
🇺🇸St. Charles, Missouri, United States
1237.14.01403 Boehringer Ingelheim Investigational Site
🇺🇸Spartanburg, South Carolina, United States
1237.14.01404 Boehringer Ingelheim Investigational Site
🇺🇸Phoenix, Arizona, United States
1237.14.01414 Boehringer Ingelheim Investigational Site
🇺🇸Austell, Georgia, United States
1237.14.01418 Boehringer Ingelheim Investigational Site
🇺🇸Rochester, Minnesota, United States
1237.14.01417 Boehringer Ingelheim Investigational Site
🇺🇸Baltimore, Maryland, 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
1237.14.01401 Boehringer Ingelheim Investigational Site
🇺🇸Union, South Carolina, United States
1237.14.01412 Boehringer Ingelheim Investigational Site
🇺🇸Dallas, Texas, United States
1237.14.54402 Boehringer Ingelheim Investigational Site
🇦🇷Buenos Aires, Argentina
1237.14.49401 Boehringer Ingelheim Investigational Site
🇩🇪Großhansdorf, Germany
1237.14.11402 Boehringer Ingelheim Investigational Site
🇨🇦Montreal, Quebec, Canada
1237.14.11401 Boehringer Ingelheim Investigational Site
🇨🇦Ste-Foy, Quebec, Canada
1237.14.49404 Boehringer Ingelheim Investigational Site
🇩🇪Bochum, Germany
1237.14.49405 Boehringer Ingelheim Investigational Site
🇩🇪Hamburg, Germany
1237.14.31004 Boehringer Ingelheim Investigational Site
🇳🇱Hoorn, Netherlands
1237.14.31005 Boehringer Ingelheim Investigational Site
🇳🇱Hoofddorp, Netherlands
1237.14.31001 Boehringer Ingelheim Investigational Site
🇳🇱Heerlen, Netherlands
1237.14.31006 Medisch Centrum Leeuwarden
🇳🇱Leeuwarden, Netherlands
1237.14.31007 Boehringer Ingelheim Investigational Site
🇳🇱Leiden, Netherlands
1237.14.70402 Boehringer Ingelheim Investigational Site
🇷🇺St. Petersburg, Russian Federation
1237.14.70401 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
1237.14.46001 Boehringer Ingelheim Investigational Site
🇸🇪Lund, Sweden
1237.14.11403 Boehringer Ingelheim Investigational Site
🇨🇦Toronto, Ontario, Canada
1237.14.49402 Boehringer Ingelheim Investigational Site
🇩🇪Kiel, Germany
1237.14.49406 Boehringer Ingelheim Investigational Site
🇩🇪Bamberg, Germany
1237.14.49403 Boehringer Ingelheim Investigational Site
🇩🇪Hannover, Germany
1237.14.01410 Boehringer Ingelheim Investigational Site
🇺🇸Seattle, Washington, United States
1237.14.54401 Boehringer Ingelheim Investigational Site
🇦🇷Mendoza, Argentina