Trial Outcomes & Findings for Co-administration of Olodaterol Respimat® and Tiotropium Handihaler® (NCT NCT01694771)
NCT ID: NCT01694771
Last Updated: 2014-09-04
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
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1134 participants
Primary outcome timeframe
baseline and 12 weeks
Results posted on
2014-09-04
Participant Flow
1134 patients were entered and randomized to treatment and 1132 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
|
567
|
565
|
|
Overall Study
COMPLETED
|
527
|
525
|
|
Overall Study
NOT COMPLETED
|
40
|
40
|
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
|
18
|
16
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
|
Overall Study
Non compliance protocol
|
7
|
6
|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
|
Overall Study
Consent withdrawn
|
7
|
9
|
|
Overall Study
Other reasons
|
5
|
6
|
Baseline Characteristics
Co-administration of Olodaterol Respimat® and Tiotropium Handihaler®
Baseline characteristics by cohort
| Measure |
Olodaterol (5µg) and Tiotropium (18µg)
n=567 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=565 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=1132 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.3 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
64.8 years
STANDARD_DEVIATION 9.1 • n=7 Participants
|
64.6 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
288 Participants
n=5 Participants
|
280 Participants
n=7 Participants
|
568 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
279 Participants
n=5 Participants
|
285 Participants
n=7 Participants
|
564 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
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=564 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
|
0.313 Area Under the Curve (L)
Standard Error 0.010
|
0.196 Area Under the Curve (L)
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=548 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=551 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
|
0.195 L
Standard Error 0.009
|
0.133 L
Standard Error 0.009
|
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 changes 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=564 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
|
0.389 L
Standard Error 0.010
|
0.270 L
Standard Error 0.010
|
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.
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=564 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
|
0.438 L
Standard Error 0.017
|
0.292 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=548 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=551 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
|
0.276 L
Standard Error 0.016
|
0.213 L
Standard Error 0.016
|
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=564 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
|
0.586 L
Standard Error 0.017
|
0.433 L
Standard Error 0.017
|
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).
Outcome measures
| Measure |
Olodaterol (5µg) and Tiotropium (18µg)
n=557 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=561 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
|
54.915 percentage of days
Standard Error 1.534
|
50.774 percentage of days
Standard Error 1.528
|
|
Rescue Medication Usage - Percentage of Rescue Free Days
Week 12
|
63.353 percentage of days
Standard Error 1.553
|
54.894 percentage of days
Standard Error 1.546
|
|
Rescue Medication Usage - Percentage of Rescue Free Days
Week 1
|
52.633 percentage of days
Standard Error 1.507
|
48.606 percentage of days
Standard Error 1.502
|
|
Rescue Medication Usage - Percentage of Rescue Free Days
Week 3
|
56.562 percentage of days
Standard Error 1.565
|
50.262 percentage of days
Standard Error 1.562
|
|
Rescue Medication Usage - Percentage of Rescue Free Days
Week 4
|
60.580 percentage of days
Standard Error 1.405
|
55.577 percentage of days
Standard Error 1.399
|
|
Rescue Medication Usage - Percentage of Rescue Free Days
Week 5
|
60.405 percentage of days
Standard Error 1.581
|
52.614 percentage of days
Standard Error 1.572
|
|
Rescue Medication Usage - Percentage of Rescue Free Days
Week 6
|
57.782 percentage of days
Standard Error 1.632
|
50.547 percentage of days
Standard Error 1.625
|
|
Rescue Medication Usage - Percentage of Rescue Free Days
Week 7
|
58.642 percentage of days
Standard Error 1.625
|
50.727 percentage of days
Standard Error 1.614
|
|
Rescue Medication Usage - Percentage of Rescue Free Days
Week 8
|
58.931 percentage of days
Standard Error 1.648
|
51.618 percentage of days
Standard Error 1.636
|
|
Rescue Medication Usage - Percentage of Rescue Free Days
Week 9
|
59.350 percentage of days
Standard Error 1.652
|
51.399 percentage of days
Standard Error 1.637
|
|
Rescue Medication Usage - Percentage of Rescue Free Days
Week 10
|
59.991 percentage of days
Standard Error 1.624
|
52.535 percentage of days
Standard Error 1.615
|
|
Rescue Medication Usage - Percentage of Rescue Free Days
Week 11
|
59.543 percentage of days
Standard Error 1.651
|
50.584 percentage of days
Standard Error 1.643
|
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 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.
Outcome measures
| Measure |
Olodaterol (5µg) and Tiotropium (18µg)
n=557 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=561 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
|
1.760 usage (total daily) number of puffs
Standard Error 0.074
|
2.028 usage (total daily) number of puffs
Standard Error 0.074
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Total Daily)
Week 2
|
1.747 usage (total daily) number of puffs
Standard Error 0.079
|
2.073 usage (total daily) number of puffs
Standard Error 0.079
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Total Daily)
Week 3
|
1.699 usage (total daily) number of puffs
Standard Error 0.079
|
2.094 usage (total daily) number of puffs
Standard Error 0.078
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Total Daily)
Week 4
|
1.730 usage (total daily) number of puffs
Standard Error 0.080
|
2.057 usage (total daily) number of puffs
Standard Error 0.080
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Total Daily)
Week 5
|
1.609 usage (total daily) number of puffs
Standard Error 0.080
|
2.037 usage (total daily) number of puffs
Standard Error 0.079
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Total Daily)
Week 6
|
1.682 usage (total daily) number of puffs
Standard Error 0.085
|
2.047 usage (total daily) number of puffs
Standard Error 0.084
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Total Daily)
Week 7
|
1.657 usage (total daily) number of puffs
Standard Error 0.087
|
2.053 usage (total daily) number of puffs
Standard Error 0.086
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Total Daily)
Week 8
|
1.613 usage (total daily) number of puffs
Standard Error 0.085
|
2.042 usage (total daily) number of puffs
Standard Error 0.084
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Total Daily)
Week 9
|
1.622 usage (total daily) number of puffs
Standard Error 0.084
|
2.056 usage (total daily) number of puffs
Standard Error 0.083
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Total Daily)
Week 10
|
1.571 usage (total daily) number of puffs
Standard Error 0.084
|
2.050 usage (total daily) number of puffs
Standard Error 0.083
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Total Daily)
Week 11
|
1.533 usage (total daily) number of puffs
Standard Error 0.080
|
2.020 usage (total daily) number of puffs
Standard Error 0.079
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Total Daily)
Week 12
|
1.520 usage (total daily) number of puffs
Standard Error 0.082
|
1.998 usage (total daily) number of puffs
Standard Error 0.082
|
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.
Outcome measures
| Measure |
Olodaterol (5µg) and Tiotropium (18µg)
n=557 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=561 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 4
|
0.393 percentage of days
Standard Error 0.029
|
0.416 percentage of days
Standard Error 0.029
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Daytime)
Week 5
|
0.383 percentage of days
Standard Error 0.030
|
0.454 percentage of days
Standard Error 0.030
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Daytime)
Week 6
|
0.404 percentage of days
Standard Error 0.031
|
0.447 percentage of days
Standard Error 0.030
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Daytime)
Week 10
|
0.390 percentage of days
Standard Error 0.031
|
0.448 percentage of days
Standard Error 0.031
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Daytime)
Week 11
|
0.360 percentage of days
Standard Error 0.030
|
0.441 percentage of days
Standard Error 0.029
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Daytime)
Week 12
|
0.346 percentage of days
Standard Error 0.029
|
0.429 percentage of days
Standard Error 0.029
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Daytime)
Week 1
|
0.392 percentage of days
Standard Error 0.025
|
0.409 percentage of days
Standard Error 0.025
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Daytime)
Week 2
|
0.415 percentage of days
Standard Error 0.030
|
0.449 percentage of days
Standard Error 0.029
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Daytime)
Week 3
|
0.394 percentage of days
Standard Error 0.028
|
0.437 percentage of days
Standard Error 0.028
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Daytime)
Week 7
|
0.402 percentage of days
Standard Error 0.033
|
0.455 percentage of days
Standard Error 0.032
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Daytime)
Week 8
|
0.385 percentage of days
Standard Error 0.030
|
0.451 percentage of days
Standard Error 0.030
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Daytime)
Week 9
|
0.404 percentage of days
Standard Error 0.031
|
0.457 percentage of days
Standard Error 0.031
|
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.
Outcome measures
| Measure |
Olodaterol (5µg) and Tiotropium (18µg)
n=557 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=561 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 5
|
1.230 percentage of days
Standard Error 0.066
|
1.581 percentage of days
Standard Error 0.065
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Nighttime)
Week 6
|
1.285 percentage of days
Standard Error 0.070
|
1.596 percentage of days
Standard Error 0.069
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Nighttime)
Week 7
|
1.265 percentage of days
Standard Error 0.070
|
1.600 percentage of days
Standard Error 0.069
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Nighttime)
Week 8
|
1.237 percentage of days
Standard Error 0.070
|
1.587 percentage of days
Standard Error 0.069
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Nighttime)
Week 1
|
1.370 percentage of days
Standard Error 0.062
|
1.617 percentage of days
Standard Error 0.061
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Nighttime)
Week 2
|
1.336 percentage of days
Standard Error 0.064
|
1.620 percentage of days
Standard Error 0.064
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Nighttime)
Week 3
|
1.309 percentage of days
Standard Error 0.065
|
1.654 percentage of days
Standard Error 0.064
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Nighttime)
Week 4
|
1.340 percentage of days
Standard Error 0.065
|
1.640 percentage of days
Standard Error 0.065
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Nighttime)
Week 9
|
1.597 percentage of days
Standard Error 0.069
|
1.225 percentage of days
Standard Error 0.068
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Nighttime)
Week 10
|
1.186 percentage of days
Standard Error 0.070
|
1.600 percentage of days
Standard Error 0.069
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Nighttime)
Week 11
|
1.177 percentage of days
Standard Error 0.067
|
1.581 percentage of days
Standard Error 0.067
|
|
Rescue Medication Usage - Mean Weekly Rescue Usage (Nighttime)
Week 12
|
1.178 percentage of days
Standard Error 0.070
|
1.571 percentage of days
Standard Error 0.069
|
Adverse Events
Olodaterol (5µg) and Tiotropium (18µg)
Serious events: 40 serious events
Other events: 60 other events
Deaths: 0 deaths
Placebo and Tiotropium (18µg)
Serious events: 26 serious events
Other events: 52 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Olodaterol (5µg) and Tiotropium (18µg)
n=567 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=565 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
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.18%
1/567 • 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%
0/565 • 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
|
0.18%
1/567 • 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%
0/565 • 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%
0/567 • 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%
1/565 • 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%
2/567 • 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%
2/565 • 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
Myocardial infarction
|
0.35%
2/567 • 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%
1/565 • 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
Myocardial ischaemia
|
0.18%
1/567 • 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%
0/565 • 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
|
0.18%
1/567 • 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%
0/565 • 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
Ileus
|
0.18%
1/567 • 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%
0/565 • 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 ischaemia
|
0.18%
1/567 • 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%
0/565 • 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
|
0.00%
0/567 • 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%
1/565 • 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
Obstruction gastric
|
0.00%
0/567 • 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%
1/565 • 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
|
0.18%
1/567 • 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%
0/565 • 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
Rectal haemorrhage
|
0.00%
0/567 • 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%
1/565 • 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
Volvulus
|
0.18%
1/567 • 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%
0/565 • 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
|
0.35%
2/567 • 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%
1/565 • 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.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/567 • 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%
1/565 • 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
Bronchitis
|
0.18%
1/567 • 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%
0/565 • 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
Campylobacter gastroenteritis
|
0.18%
1/567 • 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%
0/565 • 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%
1/567 • 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%
0/565 • 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
Gastroenteritis
|
0.18%
1/567 • 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%
1/565 • 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
Groin infection
|
0.18%
1/567 • 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%
0/565 • 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
Haemophilus infection
|
0.18%
1/567 • 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%
0/565 • 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
Influenza
|
0.18%
1/567 • 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%
0/565 • 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
|
0.53%
3/567 • 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%
1/565 • 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 necrotising
|
0.00%
0/567 • 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%
1/565 • 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
Post procedural infection
|
0.00%
0/567 • 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%
1/565 • 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
Urinary tract infection
|
0.18%
1/567 • 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%
0/565 • 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
Arthropod bite
|
0.18%
1/567 • 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%
0/565 • 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
Chest injury
|
0.00%
0/567 • 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%
1/565 • 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
Post procedural haematoma
|
0.18%
1/567 • 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%
0/565 • 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
|
0.00%
0/567 • 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%
1/565 • 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
Hypokalaemia
|
0.00%
0/567 • 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%
1/565 • 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
Hyponatraemia
|
0.00%
0/567 • 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%
1/565 • 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
Muscle spasms
|
0.18%
1/567 • 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%
0/565 • 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
Osteoarthritis
|
0.18%
1/567 • 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%
0/565 • 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%
1/567 • 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%
0/565 • 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)
Intraductal proliferative breast lesion
|
0.00%
0/567 • 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%
1/565 • 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)
Lung cancer metastatic
|
0.18%
1/567 • 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%
0/565 • 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)
Oesophageal carcinoma
|
0.00%
0/567 • 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%
1/565 • 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)
Squamous cell carcinoma of skin
|
0.18%
1/567 • 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%
0/565 • 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
Haemorrhagic cerebral infarction
|
0.18%
1/567 • 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%
0/565 • 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
Loss of consciousness
|
0.18%
1/567 • 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%
0/565 • 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
Presyncope
|
0.00%
0/567 • 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%
1/565 • 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
Vascular encephalopathy
|
0.18%
1/567 • 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%
0/565 • 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.
|
|
Psychiatric disorders
Anxiety
|
0.18%
1/567 • 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%
1/565 • 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.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/567 • 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%
1/565 • 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%
0/567 • 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%
1/565 • 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
|
0.35%
2/567 • 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%
0/565 • 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
|
0.53%
3/567 • 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%
0/565 • 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
|
2.5%
14/567 • 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.
|
1.6%
9/565 • 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
Dyspnoea
|
0.00%
0/567 • 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%
1/565 • 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
Pulmonary hypertension
|
0.18%
1/567 • 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%
1/565 • 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
|
0.18%
1/567 • 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%
0/565 • 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
|
0.35%
2/567 • 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%
0/565 • 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
Arteriosclerosis
|
0.18%
1/567 • 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%
0/565 • 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
Haemorrhage
|
0.18%
1/567 • 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%
0/565 • 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
Hypertensive crisis
|
0.18%
1/567 • 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%
0/565 • 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
Peripheral arterial occlusive disease
|
0.00%
0/567 • 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%
1/565 • 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
Peripheral artery stenosis
|
0.18%
1/567 • 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%
0/565 • 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
Peripheral vascular disorder
|
0.18%
1/567 • 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%
0/565 • 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=567 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=565 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
|
10.6%
60/567 • 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.
|
9.2%
52/565 • 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