Trial Outcomes & Findings for A Study to Determine the Effect of Tiotropium + Olodaterol Fixed Dose Combination on Exercise Endurance Time During Constant Work Rate Cycle Ergometry Test in COPD (NCT NCT01525615)
NCT ID: NCT01525615
Last Updated: 2016-08-29
Results Overview
Primary endpoint was endurance time during constant work rate cycle ergometry to symptom limitation at 75% of maximal work capacity after 12 weeks of treatment. The endurance time in seconds was transformed using log10 scale to correct skewness in endurance time on original scale and then the MMRM model was fitted to the log10-transformed data and the least square means and SEs were obtained. To present the results in a way easier for interpretation, the least square mean from the MMRM fitted to the log10-transformed data were transformed back taking 10 to the power of the least square estimate for the log10 of geometric mean and the corresponding SE was transformed using delta method to get the corresponding SEs of the geometric mean.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
404 participants
Primary outcome timeframe
12 weeks
Results posted on
2016-08-29
Participant Flow
This was a randomised, placebo-controlled, double-blind, parallel-group comparison of once daily treatment with orally inhaled Tiotropium+Olodaterol Fixed Dose Combination (FDC) (2.5/5.0 µg; 5.0/5.0 µg) with placebo over 12 weeks.
Participant milestones
| Measure |
Placebo
once daily 2 puffs, solution for inhalation Respimat
placebo to tiotropium+olodaterol: comparator
|
Tio+Olo 2.5 / 5.0 µg
Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
|
Tio+Olo 5.0 / 5.0 µg
Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
|
|---|---|---|---|
|
Overall Study
STARTED
|
132
|
133
|
139
|
|
Overall Study
COMPLETED
|
118
|
126
|
133
|
|
Overall Study
NOT COMPLETED
|
14
|
7
|
6
|
Reasons for withdrawal
| Measure |
Placebo
once daily 2 puffs, solution for inhalation Respimat
placebo to tiotropium+olodaterol: comparator
|
Tio+Olo 2.5 / 5.0 µg
Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
|
Tio+Olo 5.0 / 5.0 µg
Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
11
|
7
|
5
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
|
Overall Study
Other reason not described above
|
1
|
0
|
1
|
Baseline Characteristics
A Study to Determine the Effect of Tiotropium + Olodaterol Fixed Dose Combination on Exercise Endurance Time During Constant Work Rate Cycle Ergometry Test in COPD
Baseline characteristics by cohort
| Measure |
Placebo
n=132 Participants
once daily 2 puffs, solution for inhalation Respimat
placebo to tiotropium+olodaterol: comparator
|
Tio+Olo 2.5 / 5.0 µg
n=133 Participants
Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
|
Tio+Olo 5.0 / 5.0 µg
n=139 Participants
Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
|
Total
n=404 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
60.8 years
STANDARD_DEVIATION 7.6 • n=99 Participants
|
61.9 years
STANDARD_DEVIATION 7.3 • n=107 Participants
|
63.1 years
STANDARD_DEVIATION 7.5 • n=206 Participants
|
62.0 years
STANDARD_DEVIATION 7.5 • n=7 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
135 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
87 Participants
n=99 Participants
|
87 Participants
n=107 Participants
|
95 Participants
n=206 Participants
|
269 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline and at least one post-baseline measurement before or at Week 12 for the primary endpoint.
Primary endpoint was endurance time during constant work rate cycle ergometry to symptom limitation at 75% of maximal work capacity after 12 weeks of treatment. The endurance time in seconds was transformed using log10 scale to correct skewness in endurance time on original scale and then the MMRM model was fitted to the log10-transformed data and the least square means and SEs were obtained. To present the results in a way easier for interpretation, the least square mean from the MMRM fitted to the log10-transformed data were transformed back taking 10 to the power of the least square estimate for the log10 of geometric mean and the corresponding SE was transformed using delta method to get the corresponding SEs of the geometric mean.
Outcome measures
| Measure |
Placebo
n=121 Participants
once daily 2 puffs, solution for inhalation Respimat
placebo to tiotropium+olodaterol: comparator
|
Tio+Olo 2.5 / 5.0 µg
n=129 Participants
Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
|
Tio+Olo 5.0 / 5.0 µg
n=135 Participants
Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
|
|---|---|---|---|
|
Adjusted Mean Endurance Time During Constant Work Rate Cycle Ergometry (CWRCE) After 12 Weeks
|
463.63 seconds
Standard Error 18.813
|
503.64 seconds
Standard Error 19.642
|
527.51 seconds
Standard Error 20.154
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Endurance shuttle walk test (ESWT) substudy set - This patient set included all patients in the Treated Set who had given informed consent for participating in the ESWT substudy and had a baseline and at least one post-baseline measurement during ESWT before or at Week 12 for the key secondary endpoint.
Key secondary endpoint was endurance time during endurance shuttle walk test to symptom limitation at 85% of predicted maximum oxygen consumption (VO2) peak after 12 weeks of treatment. The endurance time in seconds was transformed using log10 scale to correct skewness in endurance time on original scale and then the MMRM model was fitted to the log10-transformed data and the least square means and SEs were obtained. To present the results in a way easier for interpretation, the least square mean from the MMRM fitted to the log10-transformed data were transformed back taking 10 to the power of the least square estimate for the log10 of geometric mean and the corresponding SE was transformed using delta method to get the corresponding SEs of the geometric mean.
Outcome measures
| Measure |
Placebo
n=50 Participants
once daily 2 puffs, solution for inhalation Respimat
placebo to tiotropium+olodaterol: comparator
|
Tio+Olo 2.5 / 5.0 µg
n=56 Participants
Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
|
Tio+Olo 5.0 / 5.0 µg
n=59 Participants
Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
|
|---|---|---|---|
|
Adjusted Mean Endurance Time During Endurance Shuttle Walk Test (ESWT) After 12 Weeks
|
311.41 seconds
Standard Error 22.519
|
377.20 seconds
Standard Error 25.942
|
376.39 seconds
Standard Error 25.033
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline and at least one post-baseline measurement before or at Week 12 for the primary endpoint.
Secondary endpoint was pre-exercise inspiratory capacity (IC) before constant work rate cycle ergometry to symptom limitation at 75% maximal work capacity (Wcap) after 12 weeks of treatment.
Outcome measures
| Measure |
Placebo
n=119 Participants
once daily 2 puffs, solution for inhalation Respimat
placebo to tiotropium+olodaterol: comparator
|
Tio+Olo 2.5 / 5.0 µg
n=128 Participants
Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
|
Tio+Olo 5.0 / 5.0 µg
n=133 Participants
Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
|
|---|---|---|---|
|
Adjusted Mean Inspiratory Capacity at Pre-exercise After 12 Weeks
|
2.390 liters
Standard Error 0.038
|
2.597 liters
Standard Error 0.036
|
2.624 liters
Standard Error 0.035
|
SECONDARY outcome
Timeframe: 1 dayPopulation: Visit 4 Set. All randomized patients dispensed medication, were documented to have taken any dose of study medication, and had evaluable measurements of endurance time at Baseline (Visit 3) and at Visit 4 (Day 1) during CWRCE. Patients were assigned to the Visit 4 set after implementation of data handling rules that set measurements to missing.
Secondary endpoint was endurance time during constant work rate cycle ergometry to symptom limitation at 75% of maximal work capacity on Day 1. Analysis of covariance model on log10 transformation data. Adjusted means are back transformed to report in original units. Standard errors (SEs) are calculated using the delta method.
Outcome measures
| Measure |
Placebo
n=77 Participants
once daily 2 puffs, solution for inhalation Respimat
placebo to tiotropium+olodaterol: comparator
|
Tio+Olo 2.5 / 5.0 µg
n=77 Participants
Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
|
Tio+Olo 5.0 / 5.0 µg
n=80 Participants
Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
|
|---|---|---|---|
|
Adjusted Mean Endurance Time During Constant Work Rate Cycle Ergometry (CWRCE) on Day 1
|
478.59 seconds
Standard Error 17.861
|
527.69 seconds
Standard Error 19.670
|
538.76 seconds
Standard Error 19.715
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline and at least one post-baseline measurement before or at Week 12 for the primary endpoint.
Secondary endpoint was endurance time during constant work rate cycle ergometry to symptom limitation at 75% of maximal work capacity after 6 weeks of treatment.The endurance time in seconds was transformed using log10 scale to correct skewness in endurance time on original scale and then the MMRM model was fitted to the log10-transformed data and the least square means and SEs were obtained. To present the results in a way easier for interpretation, the least square mean from the MMRM fitted to the log10-transformed data were transformed back taking 10 to the power of the least square estimate for the log10 of geometric mean and the corresponding SE was transformed using delta method to get the corresponding SEs of the geometric mean.
Outcome measures
| Measure |
Placebo
n=121 Participants
once daily 2 puffs, solution for inhalation Respimat
placebo to tiotropium+olodaterol: comparator
|
Tio+Olo 2.5 / 5.0 µg
n=129 Participants
Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
|
Tio+Olo 5.0 / 5.0 µg
n=135 Participants
Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
|
|---|---|---|---|
|
Adjusted Mean Endurance Time During Constant Work Rate Cycle Ergometry (CWRCE) After 6 Weeks Treatment
|
427.74 seconds
Standard Error 17.093
|
522.26 seconds
Standard Error 20.232
|
525.62 seconds
Standard Error 19.990
|
SECONDARY outcome
Timeframe: 1 dayPopulation: Visit 4 Set. All randomized patients dispensed medication, were documented to have taken any dose of study medication, and had evaluable measurements of endurance time at Baseline (Visit 3) and at Visit 4 (Day 1) during CWRCE. Patients were assigned to the Visit 4 set after implementation of data handling rules that set measurements to missing.
Secondary endpoint was pre-exercise inspiratory capacity (IC) during constant work rate cycle ergometry to symptom limitation at 75% maximal work capacity (Wcap) on Day 1.
Outcome measures
| Measure |
Placebo
n=75 Participants
once daily 2 puffs, solution for inhalation Respimat
placebo to tiotropium+olodaterol: comparator
|
Tio+Olo 2.5 / 5.0 µg
n=77 Participants
Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
|
Tio+Olo 5.0 / 5.0 µg
n=76 Participants
Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
|
|---|---|---|---|
|
Adjusted Mean Inspiratory Capacity at Pre-exercise After 1 Day
|
2.440 liters
Standard Error 0.041
|
2.642 liters
Standard Error 0.041
|
2.605 liters
Standard Error 0.041
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline and at least one post-baseline measurement before or at Week 12 for the primary endpoint.
Secondary endpoint was pre-exercise inspiratory capacity (IC) during constant work rate cycle ergometry to symptom limitation at 75% maximal work capacity (Wcap) after 6 weeks of treatment.
Outcome measures
| Measure |
Placebo
n=119 Participants
once daily 2 puffs, solution for inhalation Respimat
placebo to tiotropium+olodaterol: comparator
|
Tio+Olo 2.5 / 5.0 µg
n=128 Participants
Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
|
Tio+Olo 5.0 / 5.0 µg
n=133 Participants
Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
|
|---|---|---|---|
|
Adjusted Mean Inspiratory Capacity at Pre-exercise After 6 Weeks
|
2.402 liters
Standard Error 0.037
|
2.589 liters
Standard Error 0.036
|
2.627 liters
Standard Error 0.035
|
SECONDARY outcome
Timeframe: 1 dayPopulation: Visit 4 Set. All randomized patients dispensed medication, were documented to have taken any dose of study medication, and had evaluable measurements of endurance time at Baseline (Visit 3) and at Visit 4 (Day 1) during CWRCE. Patients were assigned to the Visit 4 set after implementation of data handling rules that set measurements to missing.
Secondary endpoint was the slope of the intensity of breathing discomfort during constant work rate cycle ergometry to symptom limitation at 75% of maximal work capacity after 1 day of treatment. The intensity of breathing discomfort was rated on the Borg Scale with categories from 0 (nothing at all) to 10 (maximal). The slope of the intensity of breathing discomfort was defined as the Borg scale value of breathing discomfort at the end of exercise minus the Borg scale value of breathing discomfort at pre-exercise divided by the endurance time. A decrease in slope indicates slowing down in decline in breathing, i.e., favorable results.
Outcome measures
| Measure |
Placebo
n=76 Participants
once daily 2 puffs, solution for inhalation Respimat
placebo to tiotropium+olodaterol: comparator
|
Tio+Olo 2.5 / 5.0 µg
n=77 Participants
Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
|
Tio+Olo 5.0 / 5.0 µg
n=80 Participants
Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
|
|---|---|---|---|
|
Adjusted Mean Slope of the Intensity of Breathing Discomfort on Day 1
|
0.014 units / seconds
Standard Error 0.001
|
0.012 units / seconds
Standard Error 0.001
|
0.012 units / seconds
Standard Error 0.001
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline and at least one post-baseline measurement before or at Week 12 for the primary endpoint.
Secondary endpoint was the slope of the intensity of breathing discomfort during constant work rate cycle ergometry to symptom limitation at 75% of maximal work capacity after 6 weeks of treatment. The intensity of breathing discomfort was rated on the Borg Scale with categories from 0 (nothing at all) to 10 (maximal). The slope of the intensity of breathing discomfort was defined as the Borg scale value of breathing discomfort at the end of exercise minus the Borg scale value of breathing discomfort at pre-exercise divided by the endurance time. A decrease in slope indicates favorable results.
Outcome measures
| Measure |
Placebo
n=120 Participants
once daily 2 puffs, solution for inhalation Respimat
placebo to tiotropium+olodaterol: comparator
|
Tio+Olo 2.5 / 5.0 µg
n=129 Participants
Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
|
Tio+Olo 5.0 / 5.0 µg
n=135 Participants
Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
|
|---|---|---|---|
|
Adjusted Mean Slope of the Intensity of Breathing Discomfort After Week 6
|
0.016 units / seconds
Standard Error 0.001
|
0.013 units / seconds
Standard Error 0.001
|
0.013 units / seconds
Standard Error 0.001
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline and at least one post-baseline measurement before or at Week 12 for the primary endpoint.
Secondary endpoint was the slope of the intensity of breathing discomfort during constant work rate cycle ergometry to symptom limitation at 75% of maximal work capacity after 12 weeks of treatment. The intensity of breathing discomfort was rated on the Borg Scale with categories from 0 (nothing at all) to 10 (maximal). The slope of the intensity of breathing discomfort was defined as the Borg scale value of breathing discomfort at the end of exercise minus the Borg scale value of breathing discomfort at pre-exercise divided by the endurance time. A decrease in slope indicates favorable results.
Outcome measures
| Measure |
Placebo
n=120 Participants
once daily 2 puffs, solution for inhalation Respimat
placebo to tiotropium+olodaterol: comparator
|
Tio+Olo 2.5 / 5.0 µg
n=129 Participants
Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
|
Tio+Olo 5.0 / 5.0 µg
n=135 Participants
Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
|
|---|---|---|---|
|
Adjusted Mean Slope of the Intensity of Breathing Discomfort After Week 12
|
0.015 units / seconds
Standard Error 0.001
|
0.013 units / seconds
Standard Error 0.001
|
0.013 units / seconds
Standard Error 0.001
|
SECONDARY outcome
Timeframe: 1 dayPopulation: Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline and at least one post-baseline measurement before or at Week 12 for the primary endpoint.
Secondary endpoint was adjusted mean 1-hour, post-dose Forced Expiratory Volume in one second (FEV1) observed on day 1
Outcome measures
| Measure |
Placebo
n=121 Participants
once daily 2 puffs, solution for inhalation Respimat
placebo to tiotropium+olodaterol: comparator
|
Tio+Olo 2.5 / 5.0 µg
n=129 Participants
Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
|
Tio+Olo 5.0 / 5.0 µg
n=135 Participants
Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
|
|---|---|---|---|
|
Adjusted Mean 1-hour, Post-dose Forced Expiratory Volume in One Second (FEV1) on Day 1
|
1.509 liters
Standard Error 0.020
|
1.693 liters
Standard Error 0.019
|
1.679 liters
Standard Error 0.019
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline and at least one post-baseline measurement before or at Week 12 for the primary endpoint.
Secondary endpoint was adjusted mean 1-hour, post-dose Forced Expiratory Volume in one second (FEV1) observed after 6 weeks of treatment
Outcome measures
| Measure |
Placebo
n=121 Participants
once daily 2 puffs, solution for inhalation Respimat
placebo to tiotropium+olodaterol: comparator
|
Tio+Olo 2.5 / 5.0 µg
n=129 Participants
Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
|
Tio+Olo 5.0 / 5.0 µg
n=135 Participants
Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
|
|---|---|---|---|
|
Adjusted Mean 1-hour, Post-dose Forced Expiratory Volume in One Second (FEV1) After 6 Weeks
|
1.517 liters
Standard Error 0.020
|
1.790 liters
Standard Error 0.019
|
1.763 liters
Standard Error 0.019
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline and at least one post-baseline measurement before or at Week 12 for the primary endpoint.
Secondary endpoint was adjusted mean 1-hour, post-dose Forced Expiratory Volume in one second (FEV1) observed after 12 weeks of treatment
Outcome measures
| Measure |
Placebo
n=121 Participants
once daily 2 puffs, solution for inhalation Respimat
placebo to tiotropium+olodaterol: comparator
|
Tio+Olo 2.5 / 5.0 µg
n=129 Participants
Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
|
Tio+Olo 5.0 / 5.0 µg
n=135 Participants
Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
|
|---|---|---|---|
|
Adjusted Mean 1-hour, Post-dose Forced Expiratory Volume in One Second (FEV1) After 12 Weeks
|
1.527 liters
Standard Error 0.020
|
1.784 liters
Standard Error 0.019
|
1.778 liters
Standard Error 0.019
|
Adverse Events
Placebo
Serious events: 5 serious events
Other events: 25 other events
Deaths: 0 deaths
Tio+Olo 2.5 / 5.0 μg
Serious events: 9 serious events
Other events: 25 other events
Deaths: 0 deaths
Tio+Olo 5.0 / 5.0 μg
Serious events: 4 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=132 participants at risk
once daily 2 puffs, solution for inhalation Respimat placebo to tiotropium+olodaterol: comparator
|
Tio+Olo 2.5 / 5.0 μg
n=133 participants at risk
Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
|
Tio+Olo 5.0 / 5.0 μg
n=139 participants at risk
Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
|
|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/132 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
0.00%
0/133 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
0.72%
1/139 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/132 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
0.00%
0/133 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
0.72%
1/139 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/132 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
0.75%
1/133 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
0.00%
0/139 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/132 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
0.00%
0/133 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
0.72%
1/139 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/132 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
0.75%
1/133 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
0.00%
0/139 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/132 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
0.00%
0/133 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
0.72%
1/139 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/132 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
0.00%
0/133 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
0.72%
1/139 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
|
Infections and infestations
Pneumonia
|
0.76%
1/132 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
0.75%
1/133 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
0.00%
0/139 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/132 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
0.00%
0/133 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
0.72%
1/139 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/132 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
0.75%
1/133 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
0.00%
0/139 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.76%
1/132 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
0.00%
0/133 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
0.00%
0/139 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/132 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
0.75%
1/133 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
0.00%
0/139 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of unknown primary site
|
0.00%
0/132 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
0.75%
1/133 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
0.00%
0/139 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to adrenals
|
0.00%
0/132 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
0.75%
1/133 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
0.00%
0/139 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/132 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
0.75%
1/133 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
0.00%
0/139 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/132 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
0.75%
1/133 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
0.00%
0/139 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.00%
0/132 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
0.75%
1/133 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
0.00%
0/139 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.00%
0/132 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
0.75%
1/133 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
0.00%
0/139 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Paraneoplastic syndrome
|
0.00%
0/132 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
0.75%
1/133 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
0.00%
0/139 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
|
Nervous system disorders
Epilepsy
|
0.76%
1/132 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
0.00%
0/133 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
0.00%
0/139 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
|
Psychiatric disorders
Depression
|
0.76%
1/132 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
0.00%
0/133 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
0.00%
0/139 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/132 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
0.75%
1/133 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
0.00%
0/139 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.5%
2/132 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
3.8%
5/133 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
0.00%
0/139 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
Other adverse events
| Measure |
Placebo
n=132 participants at risk
once daily 2 puffs, solution for inhalation Respimat placebo to tiotropium+olodaterol: comparator
|
Tio+Olo 2.5 / 5.0 μg
n=133 participants at risk
Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
|
Tio+Olo 5.0 / 5.0 μg
n=139 participants at risk
Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
4.5%
6/132 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
6.8%
9/133 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
2.9%
4/139 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
11.4%
15/132 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
7.5%
10/133 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
7.2%
10/139 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.1%
8/132 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
6.8%
9/133 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
1.4%
2/139 • 142 days
All adverse events, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards throughout the 12 week treatment period and the 21-day follow up period) were to be collected, documented, and reported to the sponsor on the appropriate electronic case report form / serious adverse event reporting forms.
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
- Publication restrictions are in place
Restriction type: OTHER