Trial Outcomes & Findings for Co-administration of Olodaterol Respimat® and Tiotropium Handihaler® (NCT NCT01696058)
NCT ID: NCT01696058
Last Updated: 2014-11-25
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1137 participants
Primary outcome timeframe
baseline and 12 weeks
Results posted on
2014-11-25
Participant Flow
1137 patients were entered and randomized to treatment and 1135 patients were treated with study medication.
Participant milestones
| Measure |
Olodaterol (5μg) and Tiotropium (18μg)
2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Olodaterol: One dose
Tiotropium: Marketed dose
|
Placebo and Tiotropium (18μg)
2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning
Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning
|
|---|---|---|
|
Overall Study
STARTED
|
566
|
569
|
|
Overall Study
COMPLETED
|
523
|
538
|
|
Overall Study
NOT COMPLETED
|
43
|
31
|
Reasons for withdrawal
| Measure |
Olodaterol (5μg) and Tiotropium (18μg)
2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Olodaterol: One dose
Tiotropium: Marketed dose
|
Placebo and Tiotropium (18μg)
2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning
Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning
|
|---|---|---|
|
Overall Study
Adverse Event
|
21
|
11
|
|
Overall Study
Lack of Efficacy
|
2
|
3
|
|
Overall Study
Protocol Violation
|
9
|
3
|
|
Overall Study
Lost to Follow-up
|
2
|
5
|
|
Overall Study
Withdrawal by Subject
|
4
|
6
|
|
Overall Study
Other reason prematurely discontinued
|
5
|
3
|
Baseline Characteristics
Co-administration of Olodaterol Respimat® and Tiotropium Handihaler®
Baseline characteristics by cohort
| Measure |
Olodaterol (5μg) and Tiotropium (18μg)
n=566 Participants
2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Olodaterol: One dose
Tiotropium: Marketed dose
|
Placebo and Tiotropium (18μg)
n=569 Participants
2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning
Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning
|
Total
n=1135 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.6 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
63.6 years
STANDARD_DEVIATION 8.9 • n=7 Participants
|
64.1 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
261 Participants
n=5 Participants
|
266 Participants
n=7 Participants
|
527 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
305 Participants
n=5 Participants
|
303 Participants
n=7 Participants
|
608 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and 12 weeksPopulation: Full analysis set (FAS) with last observation carried forward (LOCF) imputation at 12 weeks. FAS included all patients in the treated set who had both baseline and at least one post-baseline measurement at or before 12 weeks for any of the co-primary efficacy variables
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.
Outcome measures
| Measure |
Olodaterol (5μg) and Tiotropium (18μg)
n=563 Participants
2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Olodaterol: One dose, 2 inhalations once daily in the morning
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning
|
Placebo and Tiotropium (18μg)
n=566 Participants
2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning
Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning
|
|---|---|---|
|
FEV1 AUC0-3h Response at 12 Weeks; Defined as Change From Baseline to Week 12
|
0.297 Area Under the Curve (L) (standardized)
Standard Error 0.010
|
0.191 Area Under the Curve (L) (standardized)
Standard Error 0.010
|
PRIMARY outcome
Timeframe: baseline and 12 weeksPopulation: Full Analysis set (FAS) with last observation carried forward (LOCF) imputation at 12 weeks.
Trough FEV1 (Forced expiratory volume in 1 second) response at 12 weeks; defined as change from baseline to Week 12
Outcome measures
| Measure |
Olodaterol (5μg) and Tiotropium (18μg)
n=550 Participants
2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Olodaterol: One dose, 2 inhalations once daily in the morning
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning
|
Placebo and Tiotropium (18μg)
n=555 Participants
2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning
Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning
|
|---|---|---|
|
Trough FEV1 Response at 12 Weeks; Defined as Change From Baseline to Week 12
|
0.175 L
Standard Error 0.009
|
0.135 L
Standard Error 0.009
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: FAS with last observation carried forward (LOCF) imputation (combined data from twin studies 1222.51 and 1222.52). Number of patients contributing to models: Tio+Placebo (1055), Tio+Olo 5ug (1039).
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.
Outcome measures
| Measure |
Olodaterol (5μg) and Tiotropium (18μg)
n=1039 Participants
2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Olodaterol: One dose, 2 inhalations once daily in the morning
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning
|
Placebo and Tiotropium (18μg)
n=1055 Participants
2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning
Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning
|
|---|---|---|
|
Saint George Respiratory Questionnaire - (Total Score) Based on Combined 1222.51 and 1222.52 Data
|
41.204 units on a scale (total score)
Standard Error 0.327
|
43.059 units on a scale (total score)
Standard Error 0.325
|
SECONDARY outcome
Timeframe: baseline and 12 weeksPopulation: Full analysis set (FAS) with last observation carried forward (LOCF) imputation at 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.
Outcome measures
| Measure |
Olodaterol (5μg) and Tiotropium (18μg)
n=563 Participants
2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Olodaterol: One dose, 2 inhalations once daily in the morning
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning
|
Placebo and Tiotropium (18μg)
n=566 Participants
2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning
Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning
|
|---|---|---|
|
Peak FEV1 Response at 12 Weeks - Defined as Change From Baseline
|
0.371 L
Standard Error 0.011
|
0.271 L
Standard Error 0.011
|
SECONDARY outcome
Timeframe: baseline and 12 WeeksPopulation: Full analysis set (FAS) with last observation carried forward (LOCF) imputation at 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.
Outcome measures
| Measure |
Olodaterol (5μg) and Tiotropium (18μg)
n=563 Participants
2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Olodaterol: One dose, 2 inhalations once daily in the morning
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning
|
Placebo and Tiotropium (18μg)
n=566 Participants
2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning
Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning
|
|---|---|---|
|
FVC AUC0-3h Response at 12 Weeks; Defined as Change From Baseline
|
0.424 L
Standard Error 0.017
|
0.306 L
Standard Error 0.017
|
SECONDARY outcome
Timeframe: baseline and 12 weeksPopulation: Full analysis set (FAS) with last observation carried forward (LOCF) imputation at 12 weeks.
Peak FVC response at 12 weeks - defined as change from baseline.
Outcome measures
| Measure |
Olodaterol (5μg) and Tiotropium (18μg)
n=563 Participants
2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Olodaterol: One dose, 2 inhalations once daily in the morning
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning
|
Placebo and Tiotropium (18μg)
n=566 Participants
2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning
Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning
|
|---|---|---|
|
Peak FVC Response at 12 Weeks; Defined as Change From Baseline
|
0.562 L
Standard Error 0.017
|
0.457 L
Standard Error 0.017
|
SECONDARY outcome
Timeframe: baseline and 12 weeksPopulation: Full analysis set (FAS) with last observation carried forward (LOCF) imputation
Trough Forced Vital Capacity (FVC) response at 12 weeks- defined as change from baseline.
Outcome measures
| Measure |
Olodaterol (5μg) and Tiotropium (18μg)
n=550 Participants
2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Olodaterol: One dose, 2 inhalations once daily in the morning
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning
|
Placebo and Tiotropium (18μg)
n=555 Participants
2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning
Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning
|
|---|---|---|
|
Trough FVC Response at 12 Weeks; Defined as Change From Baseline
|
0.269 L
Standard Error 0.015
|
0.235 L
Standard Error 0.015
|
SECONDARY outcome
Timeframe: over 12 weeksPopulation: Full analysis set (FAS) with last observation carried forward (LOCF) imputation
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)
Outcome measures
| Measure |
Olodaterol (5μg) and Tiotropium (18μg)
n=552 Participants
2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Olodaterol: One dose, 2 inhalations once daily in the morning
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning
|
Placebo and Tiotropium (18μg)
n=559 Participants
2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning
Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning
|
|---|---|---|
|
Rescue Medication Usage - Percentage of Rescue Free Days
Week 2
|
54.249 percentage of days
Standard Error 48.640
|
48.640 percentage of days
Standard Error 1.477
|
|
Rescue Medication Usage - Percentage of Rescue Free Days
Week 3
|
54.820 percentage of days
Standard Error 1.536
|
49.865 percentage of days
Standard Error 1.528
|
|
Rescue Medication Usage - Percentage of Rescue Free Days
Week 4
|
60.761 percentage of days
Standard Error 1.388
|
55.969 percentage of days
Standard Error 1.378
|
|
Rescue Medication Usage - Percentage of Rescue Free Days
Week 5
|
60.154 percentage of days
Standard Error 1.550
|
51.840 percentage of days
Standard Error 1.549
|
|
Rescue Medication Usage - Percentage of Rescue Free Days
Week 7
|
59.493 percentage of days
Standard Error 1.598
|
50.164 percentage of days
Standard Error 1.594
|
|
Rescue Medication Usage - Percentage of Rescue Free Days
Week 9
|
60.524 percentage of days
Standard Error 1.636
|
51.273 percentage of days
Standard Error 1.620
|
|
Rescue Medication Usage - Percentage of Rescue Free Days
Week 10
|
60.216 percentage of days
Standard Error 1.636
|
51.634 percentage of days
Standard Error 1.616
|
|
Rescue Medication Usage - Percentage of Rescue Free Days
Week 12
|
62.327 percentage of days
Standard Error 1.525
|
55.090 percentage of days
Standard Error 1.508
|
|
Rescue Medication Usage - Percentage of Rescue Free Days
Week 1
|
53.207 percentage of days
Standard Error 1.481
|
48.583 percentage of days
Standard Error 1.472
|
|
Rescue Medication Usage - Percentage of Rescue Free Days
Week 6
|
59.707 percentage of days
Standard Error 1.572
|
49.001 percentage of days
Standard Error 1.568
|
|
Rescue Medication Usage - Percentage of Rescue Free Days
Week 8
|
59.021 percentage of days
Standard Error 1.634
|
51.017 percentage of days
Standard Error 1.626
|
|
Rescue Medication Usage - Percentage of Rescue Free Days
Week 11
|
59.650 percentage of days
Standard Error 1.636
|
51.604 percentage of days
Standard Error 1.616
|
SECONDARY outcome
Timeframe: over 12 weeksPopulation: Full analysis set (FAS) with last observation carried forward (LOCF) imputation
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)
Outcome measures
| Measure |
Olodaterol (5μg) and Tiotropium (18μg)
n=555 Participants
2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Olodaterol: One dose, 2 inhalations once daily in the morning
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning
|
Placebo and Tiotropium (18μg)
n=559 Participants
2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning
Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning
|
|---|---|---|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Total Daily)
Week 1
|
1.627 usage (total daily) number of puffs
Standard Error 0.066
|
2.072 usage (total daily) number of puffs
Standard Error 0.066
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Total Daily)
Week 2
|
1.652 usage (total daily) number of puffs
Standard Error 0.072
|
2.145 usage (total daily) number of puffs
Standard Error 0.072
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Total Daily)
Week 3
|
1.635 usage (total daily) number of puffs
Standard Error 0.078
|
2.167 usage (total daily) number of puffs
Standard Error 0.078
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Total Daily)
Week 4
|
1.647 usage (total daily) number of puffs
Standard Error 0.081
|
2.189 usage (total daily) number of puffs
Standard Error 0.080
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Total Daily)
Week 6
|
1.523 usage (total daily) number of puffs
Standard Error 0.081
|
2.179 usage (total daily) number of puffs
Standard Error 0.080
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Total Daily)
Week 7
|
1.540 usage (total daily) number of puffs
Standard Error 0.083
|
2.138 usage (total daily) number of puffs
Standard Error 0.082
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Total Daily)
Week 8
|
1.586 usage (total daily) number of puffs
Standard Error 0.085
|
2.107 usage (total daily) number of puffs
Standard Error 0.084
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Total Daily)
Week 9
|
1.519 usage (total daily) number of puffs
Standard Error 0.083
|
2.121 usage (total daily) number of puffs
Standard Error 0.082
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Total Daily)
Week 10
|
1.499 usage (total daily) number of puffs
Standard Error 0.082
|
2.103 usage (total daily) number of puffs
Standard Error 0.081
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Total Daily)
Week 11
|
1.484 usage (total daily) number of puffs
Standard Error 0.083
|
2.107 usage (total daily) number of puffs
Standard Error 0.082
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Total Daily)
Week 12
|
1.535 usage (total daily) number of puffs
Standard Error 0.084
|
2.103 usage (total daily) number of puffs
Standard Error 0.083
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Total Daily)
Week 5
|
1.551 usage (total daily) number of puffs
Standard Error 0.081
|
2.183 usage (total daily) number of puffs
Standard Error 0.080
|
SECONDARY outcome
Timeframe: over 12 weeksPopulation: Full analysis set (FAS) with last observation carried forward (LOCF) imputation
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)
Outcome measures
| Measure |
Olodaterol (5μg) and Tiotropium (18μg)
n=555 Participants
2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Olodaterol: One dose, 2 inhalations once daily in the morning
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning
|
Placebo and Tiotropium (18μg)
n=559 Participants
2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning
Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning
|
|---|---|---|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Daytime)
Week 3
|
0.407 number of puffs
Standard Error 0.030
|
0.459 number of puffs
Standard Error 0.030
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Daytime)
Week 4
|
0.408 number of puffs
Standard Error 0.031
|
0.479 number of puffs
Standard Error 0.031
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Daytime)
Week 5
|
0.375 number of puffs
Standard Error 0.030
|
0.479 number of puffs
Standard Error 0.030
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Daytime)
Week 6
|
0.378 number of puffs
Standard Error 0.030
|
0.491 number of puffs
Standard Error 0.030
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Daytime)
Week 7
|
0.403 number of puffs
Standard Error 0.033
|
0.499 number of puffs
Standard Error 0.032
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Daytime)
Week 8
|
0.417 number of puffs
Standard Error 0.033
|
0.482 number of puffs
Standard Error 0.033
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Daytime)
Week 9
|
0.396 number of puffs
Standard Error 0.033
|
0.487 number of puffs
Standard Error 0.032
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Daytime)
Week 10
|
0.392 number of puffs
Standard Error 0.032
|
0.480 number of puffs
Standard Error 0.031
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Daytime)
Week 11
|
0.383 number of puffs
Standard Error 0.031
|
0.482 number of puffs
Standard Error 0.031
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Daytime)
Week 12
|
0.393 number of puffs
Standard Error 0.032
|
0.483 number of puffs
Standard Error 0.032
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Daytime)
Week 1
|
0.406 number of puffs
Standard Error 0.025
|
0.437 number of puffs
Standard Error 0.025
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Daytime)
Week 2
|
0.421 number of puffs
Standard Error 0.027
|
0.466 number of puffs
Standard Error 0.027
|
SECONDARY outcome
Timeframe: over 12 weeksPopulation: Full analysis set (FAS) with last observation carried forward (LOCF) imputation
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)
Outcome measures
| Measure |
Olodaterol (5μg) and Tiotropium (18μg)
n=555 Participants
2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Olodaterol: One dose, 2 inhalations once daily in the morning
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning
|
Placebo and Tiotropium (18μg)
n=559 Participants
2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning
Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning
|
|---|---|---|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Nighttime)
Week 1
|
1.222 number of puffs
Standard Error 0.055
|
1.633 number of puffs
Standard Error 0.055
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Nighttime)
Week 2
|
1.232 number of puffs
Standard Error 0.058
|
1.677 number of puffs
Standard Error 0.058
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Nighttime)
Week 3
|
1.229 number of puffs
Standard Error 0.062
|
1.707 number of puffs
Standard Error 0.062
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Nighttime)
Week 4
|
1.239 number of puffs
Standard Error 0.064
|
1.709 number of puffs
Standard Error 0.064
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Nighttime)
Week 5
|
1.177 number of puffs
Standard Error 0.065
|
1.710 number of puffs
Standard Error 0.064
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Nighttime)
Week 6
|
1.148 number of puffs
Standard Error 0.065
|
1.692 number of puffs
Standard Error 0.064
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Nighttime)
Week 8
|
1.173 number of puffs
Standard Error 0.067
|
1.628 number of puffs
Standard Error 0.066
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Nighttime)
Week 9
|
1.125 number of puffs
Standard Error 0.065
|
1.636 number of puffs
Standard Error 0.065
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Nighttime)
Week 10
|
1.108 number of puffs
Standard Error 0.066
|
1.630 number of puffs
Standard Error 0.065
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Nighttime)
Week 11
|
1.104 number of puffs
Standard Error 0.067
|
1.630 number of puffs
Standard Error 0.066
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Nighttime)
Week 12
|
1.143 number of puffs
Standard Error 0.067
|
1.625 number of puffs
Standard Error 0.066
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Nighttime)
Week 7
|
1.139 number of puffs
Standard Error 0.065
|
1.641 number of puffs
Standard Error 0.064
|
Adverse Events
Olodaterol (5μg) and Tiotropium (18μg)
Serious events: 24 serious events
Other events: 48 other events
Deaths: 0 deaths
Placebo and Tiotropium (18μg)
Serious events: 27 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Olodaterol (5μg) and Tiotropium (18μg)
n=566 participants at risk
2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Olodaterol: One dose, 2 inhalations once daily in the morning
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning
|
Placebo and Tiotropium (18μg)
n=569 participants at risk
2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning
Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.18%
1/566 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
0.00%
0/569 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/566 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
0.35%
2/569 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
|
Cardiac disorders
Angina unstable
|
0.18%
1/566 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
0.00%
0/569 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
|
Cardiac disorders
Atrial fibrillation
|
0.35%
2/566 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
0.00%
0/569 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/566 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
0.18%
1/569 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
|
Cardiac disorders
Cardiac arrest
|
0.18%
1/566 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
0.00%
0/569 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.35%
2/566 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
0.18%
1/569 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/566 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
0.18%
1/569 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.18%
1/566 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
0.00%
0/569 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.18%
1/566 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
0.00%
0/569 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/566 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
0.18%
1/569 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.18%
1/566 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
0.00%
0/569 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.18%
1/566 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
0.00%
0/569 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.18%
1/566 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
0.00%
0/569 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/566 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
0.18%
1/569 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/566 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
0.18%
1/569 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
|
General disorders
Chest pain
|
0.18%
1/566 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
0.18%
1/569 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
|
General disorders
Death
|
0.00%
0/566 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
0.18%
1/569 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
|
General disorders
Sudden death
|
0.18%
1/566 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
0.00%
0/569 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/566 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
0.18%
1/569 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
|
Infections and infestations
Cellulitis
|
0.18%
1/566 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
0.00%
0/569 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/566 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
0.70%
4/569 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
|
Infections and infestations
Sepsis
|
0.00%
0/566 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
0.18%
1/569 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.18%
1/566 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
0.00%
0/569 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
|
Injury, poisoning and procedural complications
Postoperative renal failure
|
0.00%
0/566 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
0.18%
1/569 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.18%
1/566 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
0.00%
0/569 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.18%
1/566 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
0.00%
0/569 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.18%
1/566 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
0.00%
0/569 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.18%
1/566 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
0.00%
0/569 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/566 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
0.18%
1/569 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.18%
1/566 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
0.00%
0/569 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.18%
1/566 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
0.00%
0/569 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.18%
1/566 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
0.00%
0/569 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/566 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
0.18%
1/569 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
|
Nervous system disorders
Syncope
|
0.00%
0/566 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
0.18%
1/569 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/566 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
0.18%
1/569 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.18%
1/566 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
0.00%
0/569 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/566 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
0.18%
1/569 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/566 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
0.18%
1/569 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/566 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
0.18%
1/569 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.35%
2/566 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
0.00%
0/569 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.71%
4/566 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
1.9%
11/569 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.18%
1/566 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
0.00%
0/569 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/566 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
0.18%
1/569 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/566 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
0.18%
1/569 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/566 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
0.18%
1/569 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
|
Vascular disorders
Hypotension
|
0.18%
1/566 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
0.00%
0/569 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
Other adverse events
| Measure |
Olodaterol (5μg) and Tiotropium (18μg)
n=566 participants at risk
2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Olodaterol: One dose, 2 inhalations once daily in the morning
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning
|
Placebo and Tiotropium (18μg)
n=569 participants at risk
2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning
Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
8.5%
48/566 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
7.7%
44/569 • Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER