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
1,137
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. AUC was standardized by dividing by time unit.
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
Saint George Respiratory Questionnaire - (Total Score) Based on Combined 1222.51 and 1222.52 Data
The Saint George Respiratory Questionnaire (SGRQ) is designed to measure health impairment in patients with asthma and chronic obstructive pulmonary disease (COPD). It is divided into two parts. Part I produces the Symptoms score (several scales), and Part II the Activity and Impacts scores \[dichotomous (true/false) except last question (4-point Likert scale)\]. A Total score is also produced with scores ranging from 0 to 100, with higher scores indicating more limitations. Since the SGRQ analysis is based on the combined data from both this study and protocol 1222.51 (NCT01694771), only combined SGRQ results will be included in the latest clinical trial report. Hence there will only be one SGRQ analysis from both studies, which will not appear in the first clinical trial report. For this same reason, another covariate - study - will also be included in the MMRM for SGRQ analysis. The combined data for this outcome measure was pre-specified in both protocols.
Time frame: 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 change from baseline. All p-values for these measures are only descriptive.
Time frame: baseline and 12 weeks
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one dose
1222.52.02090 Boehringer Ingelheim Investigational Site
Anniston, Alabama, United States
1222.52.02046 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
1222.52.02014 Boehringer Ingelheim Investigational Site
Mobile, Alabama, United States
1222.52.02017 Boehringer Ingelheim Investigational Site
Montgomery, Alabama, United States
1222.52.02092 Boehringer Ingelheim Investigational Site
Anchorage, Alaska, United States
1222.52.02072 Boehringer Ingelheim Investigational Site
Chandler, Arizona, United States
1222.52.02063 Boehringer Ingelheim Investigational Site
Glendale, Arizona, United States
1222.52.02088 Boehringer Ingelheim Investigational Site
Peoria, Arizona, United States
1222.52.02012 Boehringer Ingelheim Investigational Site
Phoenix, Arizona, United States
1222.52.02006 Boehringer Ingelheim Investigational Site
Huntington Beach, California, United States
...and 84 more locations
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. AUC was standardized by dividing by time unit.
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
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
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). Results are from non-MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline. Number of patients contributing to models: Tio+Placebo (559), Tio+Olo 5ug (552)
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 metered dose inhaler (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. Results are from non-MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline. Number of patients contributing to models: Tio+Placebo (559), Tio+Olo 5ug (555)
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. Results are from non-MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline. Number of patients contributing to models: Tio+Placebo (559), Tio+Olo 5ug (555)
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. Results are from non-MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline. Number of patients contributing to models: Tio+Placebo (559), Tio+Olo 5ug (555)
Time frame: over 12 weeks