The overall objective of this study is to assess efficacy and safety of 12 weeks, once daily, orally inhaled co-administration of olodaterol 5 µg (delivered by the Respimat® Inhaler) and tiotropium (delivered by the Handihaler® as Spiriva Handihaler®), compared to tiotropium (Spiriva Handihaler®) monotherapy on lung function in patients with COPD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,134
FEV1 AUC0-3h Response at 12 Weeks; Defined as Change From Baseline to Week 12
FEV1 (Forced expiratory volume in 1 second) AUC0-3h (area under the curve) response at 12 weeks; defined as change from baseline to Week 12
Time frame: baseline and 12 weeks
Trough FEV1 Response at 12 Weeks; Defined as Change From Baseline to Week 12
Trough FEV1 (Forced expiratory volume in 1 second) response at 12 weeks; defined as change from baseline to Week 12
Time frame: baseline and 12 weeks
Peak FEV1 Response at 12 Weeks - Defined as Change From Baseline
Peak FEV1 (Forced Expiratory Volume in 1 second) response at 12 Weeks - defined as changes from baseline
Time frame: baseline and 12 weeks
FVC AUC0-3h Response at 12 Weeks - Defined as Change From Baseline
Forced Vital Capacity (FVC) AUC0-3h response at 12 weeks - defined as change from baseline.
Time frame: baseline and 12 weeks
Trough FVC Response at 12 Weeks- Defined as Change From Baseline
Trough Forced Vital Capacity (FVC) response at 12 weeks- defined as change from baseline.
Time frame: baseline and 12 weeks
Peak FVC Response at 12 Weeks - Defined as Change From Baseline
Peak FVC response at 12 weeks - defined as change from baseline.
Time frame: baseline and 12 weeks
Rescue Medication Usage - Percentage of Rescue Free Days
Rescue medication usage - the percentage of rescue free days. The percentage of rescue free days is defined as: number of rescue free days divided by total exposure, multiplied by 100%. The baseline for the number of rescue-free days was defined as the number of rescue-free days observed during the last week of the baseline period (i.e., the 7 days prior to administration of the first dose of randomized treatment).
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Marketed dose
1222.51.01055 Boehringer Ingelheim Investigational Site
Florence, Alabama, United States
1222.51.01087 Boehringer Ingelheim Investigational Site
Jasper, Alabama, United States
1222.51.01066 Boehringer Ingelheim Investigational Site
Phoenix, Arizona, United States
1222.51.01069 Boehringer Ingelheim Investigational Site
Scottsdale, Arizona, United States
1222.51.01040 Boehringer Ingelheim Investigational Site
Anaheim, California, United States
1222.51.01064 Boehringer Ingelheim Investigational Site
Encinitas, California, United States
1222.51.01060 Boehringer Ingelheim Investigational Site
Fullerton, California, United States
1222.51.01084 Boehringer Ingelheim Investigational Site
Lincoln, California, United States
1222.51.01041 Boehringer Ingelheim Investigational Site
San Diego, California, United States
1222.51.01094 Boehringer Ingelheim Investigational Site
San Diego, California, United States
...and 80 more locations
Time frame: over 12 weeks
Rescue Medication Usage - Mean Weekly Rescue Usage (Total Daily)
Rescue medication usage - mean weekly rescue usage (total daily). The baseline for the rescue use was the mean of the observations during the last week of the baseline period. Administration of rescue medication could occur at any point during the trial as deemed necessary by the patient or the investigator. Open label albuterol MDI (100 μg per puff) was provided as rescue medication . Daily, between clinic visits, patients recorded the number of puffs of albuterol in a paper diary.
Time frame: over 12 weeks
Rescue Medication Usage - Mean Weekly Rescue Usage (Daytime)
Rescue medication usage - Mean weekly rescue usage during daytime hours. Administration of rescue medication could occur at any point during the trial as deemed necessary by the patient or the investigator. Open label albuterol MDI (100 μg per puff) was provided as rescue medication by BI, and only the albuterol MDI provided by BI was allowed for rescue medication use. Daily, between clinic visits, patients recorded the number of puffs of albuterol in a paper diary.
Time frame: over 12 weeks
Rescue Medication Usage - Mean Weekly Rescue Usage (Nighttime)
Rescue medication usage - Mean weekly rescue usage during nighttime hours. Administration of rescue medication could occur at any point during the trial as deemed necessary by the patient or the investigator. Open label albuterol MDI (100 μg per puff) was provided as rescue medication by BI, and only the albuterol MDI provided by BI was allowed for rescue medication use. Daily, between clinic visits, patients recorded the number of puffs of albuterol in a paper diary.
Time frame: over 12 weeks