Co-administration of Olodaterol Respimat® and Tiotropium Handihaler®
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- Registration Number
- NCT01696058
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1137
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo and Tiotropium Placebo matching Olodaterol 2 puffs placebo inhalation solution from Respimat and one capsule Tiotropium by Handihaler once daily in am, co-administered Olodaterol andTiotropium Tiotropium 2 puffs Olodaterol from Respimat and one capsule Tiotropium by Handihaler once daily in am, co-administered Olodaterol andTiotropium Olodaterol 2 puffs Olodaterol from Respimat and one capsule Tiotropium by Handihaler once daily in am, co-administered Placebo and Tiotropium Tiotropium 2 puffs placebo inhalation solution from Respimat and one capsule Tiotropium by Handihaler once daily in am, co-administered
- Primary Outcome Measures
Name Time Method FEV1 AUC0-3h Response at 12 Weeks; Defined as Change From Baseline to Week 12 baseline and 12 weeks 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.
Trough FEV1 Response at 12 Weeks; Defined as Change From Baseline to Week 12 baseline and 12 weeks Trough FEV1 (Forced expiratory volume in 1 second) response at 12 weeks; defined as change from baseline to Week 12
- Secondary Outcome Measures
Name Time Method Trough FVC Response at 12 Weeks; Defined as Change From Baseline baseline and 12 weeks Trough Forced Vital Capacity (FVC) response at 12 weeks- defined as change from baseline.
Rescue Medication Usage - Percentage of Rescue Free Days over 12 weeks 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)Rescue Medication Usage - Mean Weekly Rescue Usage (Nighttime) over 12 weeks 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)Rescue Medication Usage - Mean Weekly Rescue Usage (Daytime) over 12 weeks 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)Saint George Respiratory Questionnaire - (Total Score) Based on Combined 1222.51 and 1222.52 Data 12 weeks 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.
Rescue Medication Usage - Mean Weekly Rescue Usage (Total Daily) over 12 weeks 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)Peak FEV1 Response at 12 Weeks - Defined as Change From Baseline baseline and 12 weeks 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.
FVC AUC0-3h Response at 12 Weeks; Defined as Change From Baseline baseline and 12 Weeks Forced Vital Capacity (FVC) AUC0-3h response at 12 weeks - defined as change from baseline. AUC was standardized by dividing by time unit.
Peak FVC Response at 12 Weeks; Defined as Change From Baseline baseline and 12 weeks Peak FVC response at 12 weeks - defined as change from baseline.
Trial Locations
- Locations (94)
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
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