Trial Outcomes & Findings for Effect on Exercise Endurance and Lung Hyperinflation of Tiotropium + Olodaterol in COPD Patients. (NCT NCT01533935)
NCT ID: NCT01533935
Last Updated: 2015-09-15
Results Overview
Inspiratory capacity (IC) at rest before constant work rate cycle ergometry to symptom limitation at 75% maximal work capacity (Wcap). Wcap was defined as the maximum work rate achieved for at least 30 seconds during the incremental cycle ergometry performed at Visit 1. The presented means are adjusted means from the MMRM (Mixed Effects Model Repeated Measures) model.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
291 participants
Primary outcome timeframe
6 weeks
Results posted on
2015-09-15
Participant Flow
This was a randomised, 4-period incomplete block cross-over trial. 291 patients were randomized to one of five treatments sequences and treated. It was a double-blind trial in which each treatment period lasted 6 weeks with a washout period of 21 days between each.
Participant milestones
| Measure |
Tio+Olo 2.5/5 / Tio+Olo 5/5 / Tio / Olo
Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered, by oral inhalation delivered once daily in the morning, via the respimat inhaler, were
* Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg.
* Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg
* Tiotropium fixed dose 5 µg
* Olodaterol fixed dose 5 µg
|
Tio+Olo 5/5 / Tio / Olo / Placebo
Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered, by oral inhalation delivered once daily in the morning, via the respimat inhaler, were
* Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg
* Tiotropium fixed dose 5 µg
* Olodaterol fixed dose 5 µg
* Oral inhalation of placebo
|
Tio / Olo / Placebo / Tio+Olo 2.5/5
Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered, by oral inhalation delivered once daily in the morning, via the respimat inhaler, were
* Tiotropium fixed dose 5 µg
* Olodaterol fixed dose 5 µg
* Oral inhalation of placebo
* Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg
|
Olo / Placebo / Tio+Olo 2.5/5 / Tio+Olo 5/5
Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered, by oral inhalation delivered once daily in the morning, via the respimat inhaler, were
* Olodaterol fixed dose 5 µg
* Oral inhalation of placebo
* Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg
* Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg
|
Placebo / Tio+Olo 2.5/5 / Tio+Olo 5/5 / Tio
Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered, by oral inhalation delivered once daily in the morning, via the respimat inhaler, were
* Oral inhalation of placebo
* Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg
* Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg
* Tiotropium fixed dose 5 µg
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
58
|
58
|
58
|
59
|
58
|
|
Overall Study
Received Placebo
|
0
|
47
|
52
|
57
|
58
|
|
Overall Study
Received Olo 5
|
52
|
52
|
55
|
59
|
0
|
|
Overall Study
Received Tio 5
|
54
|
54
|
58
|
0
|
52
|
|
Overall Study
Received Tio+Olo 2.5/5
|
58
|
0
|
49
|
56
|
56
|
|
Overall Study
Received Tio+Olo 5/5
|
56
|
58
|
1
|
54
|
55
|
|
Overall Study
COMPLETED
|
52
|
45
|
50
|
52
|
50
|
|
Overall Study
NOT COMPLETED
|
6
|
13
|
8
|
7
|
8
|
Reasons for withdrawal
| Measure |
Tio+Olo 2.5/5 / Tio+Olo 5/5 / Tio / Olo
Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered, by oral inhalation delivered once daily in the morning, via the respimat inhaler, were
* Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg.
* Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg
* Tiotropium fixed dose 5 µg
* Olodaterol fixed dose 5 µg
|
Tio+Olo 5/5 / Tio / Olo / Placebo
Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered, by oral inhalation delivered once daily in the morning, via the respimat inhaler, were
* Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg
* Tiotropium fixed dose 5 µg
* Olodaterol fixed dose 5 µg
* Oral inhalation of placebo
|
Tio / Olo / Placebo / Tio+Olo 2.5/5
Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered, by oral inhalation delivered once daily in the morning, via the respimat inhaler, were
* Tiotropium fixed dose 5 µg
* Olodaterol fixed dose 5 µg
* Oral inhalation of placebo
* Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg
|
Olo / Placebo / Tio+Olo 2.5/5 / Tio+Olo 5/5
Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered, by oral inhalation delivered once daily in the morning, via the respimat inhaler, were
* Olodaterol fixed dose 5 µg
* Oral inhalation of placebo
* Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg
* Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg
|
Placebo / Tio+Olo 2.5/5 / Tio+Olo 5/5 / Tio
Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered, by oral inhalation delivered once daily in the morning, via the respimat inhaler, were
* Oral inhalation of placebo
* Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg
* Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg
* Tiotropium fixed dose 5 µg
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
5
|
7
|
1
|
5
|
3
|
|
Overall Study
Protocol Violation
|
0
|
2
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
4
|
5
|
2
|
4
|
|
Overall Study
Other reason not defined above
|
1
|
0
|
1
|
0
|
1
|
Baseline Characteristics
Effect on Exercise Endurance and Lung Hyperinflation of Tiotropium + Olodaterol in COPD Patients.
Baseline characteristics by cohort
| Measure |
Overall Study
n=291 Participants
A randomised, double-blind, placebo controlled, 5 treatment, 4-period, incomplete, crossover study. Each treatment period was separated by a washout period of 21 days. The treatments administered, by oral inhalation delivered once daily in the morning, via the respimat inhaler, were:
* Oral inhalation of placebo
* Tiotropium fixed dose 5 µg
* Olodaterol fixed dose 5 µg
* Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg
* Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg
Treatment sequence is not considered as a factor which may affect the treatment effect due to sufficient washout period added between treatment cycles. As a result, we only display baseline characteristics as a whole population, but not by treatment sequence
|
|---|---|
|
Age, Continuous
|
61.2 years
STANDARD_DEVIATION 7.9 • n=39 Participants
|
|
Sex: Female, Male
Female
|
87 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
204 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Full Analysis Set (FAS) : This patient set included all patients in the TS who had the study baseline and at least 1 evaluable post-dose measurement for 1 of the primary endpoints. Assignment to the FAS was done after implementation of any data handling rules,which set measurements to missing.
Inspiratory capacity (IC) at rest before constant work rate cycle ergometry to symptom limitation at 75% maximal work capacity (Wcap). Wcap was defined as the maximum work rate achieved for at least 30 seconds during the incremental cycle ergometry performed at Visit 1. The presented means are adjusted means from the MMRM (Mixed Effects Model Repeated Measures) model.
Outcome measures
| Measure |
Placebo
n=202 Participants
Oral inhalation of placebo, 2 puffs from the Respimat inhaler, once daily, in the morning.
|
Olodaterol 5 µg
n=208 Participants
Oral inhalation of Olodaterol fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
Tiotropium 5 µg
n=208 Participants
Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
Tiotropium + Olodaterol 2.5/5
n=212 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.
|
Tiotropium + Olodaterol 5/5
n=218 Participants
Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
|---|---|---|---|---|---|
|
Inspiratory Capacity at Rest Before Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Work Capacity
|
2.502 Litres
Standard Error 0.026
|
2.687 Litres
Standard Error 0.025
|
2.679 Litres
Standard Error 0.025
|
2.776 Litres
Standard Error 0.025
|
2.767 Litres
Standard Error 0.025
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: FAS
Endurance time during constant work rate cycle ergometry (CWRCE) to symptom limitation at 75% Wcap Wcap was defined as the maximum work rate achieved for at least 30 seconds during the incremental cycle ergometry performed at Visit 1. The presented means are adjusted mean from the MMRM model.
Outcome measures
| Measure |
Placebo
n=205 Participants
Oral inhalation of placebo, 2 puffs from the Respimat inhaler, once daily, in the morning.
|
Olodaterol 5 µg
n=207 Participants
Oral inhalation of Olodaterol fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
Tiotropium 5 µg
n=209 Participants
Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
Tiotropium + Olodaterol 2.5/5
n=212 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.
|
Tiotropium + Olodaterol 5/5
n=216 Participants
Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
|---|---|---|---|---|---|
|
Endurance Time During Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap
|
410.77 seconds
Standard Error 12.009
|
419.06 seconds
Standard Error 12.207
|
446.50 seconds
Standard Error 12.958
|
460.66 seconds
Standard Error 13.310
|
465.68 seconds
Standard Error 13.359
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: FAS
Slope of the intensity of breathing discomfort (Borg Scale) during CWRCE to symptom limitation at 75% Wcap. The intensity of breathing discomfort was rated using the modified Borg scale with ratings from 0 (nothing at all) to 10 (maximal). Slope is defined as : (intensity of breathing discomfort at the end of exercise minus intensity of breathing discomfort at rest) / endurance time. A decrease in slope indicates improvement. The presented means are adjusted means from MMRM model.
Outcome measures
| Measure |
Placebo
n=205 Participants
Oral inhalation of placebo, 2 puffs from the Respimat inhaler, once daily, in the morning.
|
Olodaterol 5 µg
n=207 Participants
Oral inhalation of Olodaterol fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
Tiotropium 5 µg
n=208 Participants
Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
Tiotropium + Olodaterol 2.5/5
n=212 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.
|
Tiotropium + Olodaterol 5/5
n=216 Participants
Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
|---|---|---|---|---|---|
|
Slope of the Intensity of Breathing Discomfort (Borg Scale) During Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap
|
0.018 units on a scale / s
Standard Error 0.001
|
0.017 units on a scale / s
Standard Error 0.001
|
0.015 units on a scale / s
Standard Error 0.001
|
0.014 units on a scale / s
Standard Error 0.001
|
0.015 units on a scale / s
Standard Error 0.001
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: All patients in FAS with available FEV1 data at baseline and week 6 are included in the analysis.
Forced Expiratory Volume in 1 Second (FEV1) (one hour post-dose). The presented means are adjusted means from MMRM model.
Outcome measures
| Measure |
Placebo
n=210 Participants
Oral inhalation of placebo, 2 puffs from the Respimat inhaler, once daily, in the morning.
|
Olodaterol 5 µg
n=215 Participants
Oral inhalation of Olodaterol fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
Tiotropium 5 µg
n=211 Participants
Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
Tiotropium + Olodaterol 2.5/5
n=215 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.
|
Tiotropium + Olodaterol 5/5
n=219 Participants
Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
|---|---|---|---|---|---|
|
FEV1 (1 Hour Post-dose)
|
1.548 Litres
Standard Error 0.016
|
1.742 Litres
Standard Error 0.016
|
1.741 Litres
Standard Error 0.016
|
1.852 Litres
Standard Error 0.016
|
1.876 Litres
Standard Error 0.016
|
Adverse Events
Placebo
Serious events: 3 serious events
Other events: 41 other events
Deaths: 0 deaths
Olodaterol 5 µg
Serious events: 3 serious events
Other events: 42 other events
Deaths: 0 deaths
Tiotropium 5 µg
Serious events: 8 serious events
Other events: 48 other events
Deaths: 0 deaths
Tiotropium + Olodaterol 2.5/5
Serious events: 3 serious events
Other events: 36 other events
Deaths: 0 deaths
Tiotropium + Olodaterol 5/5
Serious events: 4 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=214 participants at risk
Oral inhalation of placebo, 2 puffs from the Respimat inhaler, once daily, in the morning.
|
Olodaterol 5 µg
n=218 participants at risk
Oral inhalation of Olodaterol fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
Tiotropium 5 µg
n=218 participants at risk
Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
Tiotropium + Olodaterol 2.5/5
n=219 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.
|
Tiotropium + Olodaterol 5/5
n=224 participants at risk
Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/214 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.46%
1/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/219 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/224 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
|
Cardiac disorders
Sick sinus syndrome
|
0.00%
0/214 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.46%
1/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/219 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/224 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/214 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.46%
1/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/219 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/224 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/214 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.46%
1/219 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/224 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/214 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/219 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.45%
1/224 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/214 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/219 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.45%
1/224 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/214 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/219 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.45%
1/224 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
|
General disorders
Death
|
0.00%
0/214 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.46%
1/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/219 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/224 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
|
General disorders
Pain
|
0.00%
0/214 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.46%
1/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/219 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/224 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
|
Infections and infestations
Acute tonsillitis
|
0.47%
1/214 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/219 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/224 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
|
Infections and infestations
Cellulitis gangrenous
|
0.00%
0/214 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.46%
1/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/219 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/224 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.00%
0/214 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.46%
1/219 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/224 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/214 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.46%
1/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/219 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/224 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/214 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.46%
1/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/219 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/224 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/214 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/219 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.45%
1/224 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/214 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/219 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.45%
1/224 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/214 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/219 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.45%
1/224 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/214 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/219 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.45%
1/224 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric neoplasm
|
0.00%
0/214 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.46%
1/219 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/224 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/214 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.46%
1/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/219 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/224 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/214 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.46%
1/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/219 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/224 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/214 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/219 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.45%
1/224 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/214 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.46%
1/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/219 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.45%
1/224 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/214 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/219 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.45%
1/224 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.93%
2/214 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.92%
2/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/219 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.45%
1/224 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/214 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.46%
1/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/219 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/224 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/214 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/219 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.45%
1/224 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/214 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.46%
1/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/219 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
0.00%
0/224 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
Other adverse events
| Measure |
Placebo
n=214 participants at risk
Oral inhalation of placebo, 2 puffs from the Respimat inhaler, once daily, in the morning.
|
Olodaterol 5 µg
n=218 participants at risk
Oral inhalation of Olodaterol fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
Tiotropium 5 µg
n=218 participants at risk
Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
Tiotropium + Olodaterol 2.5/5
n=219 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.
|
Tiotropium + Olodaterol 5/5
n=224 participants at risk
Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
4.7%
10/214 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
6.4%
14/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
6.0%
13/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
8.2%
18/219 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
7.1%
16/224 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
7.5%
16/214 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
11.0%
24/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
8.7%
19/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
6.8%
15/219 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
8.9%
20/224 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.1%
11/214 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
2.3%
5/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
3.7%
8/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
1.8%
4/219 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
1.3%
3/224 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.6%
12/214 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
2.8%
6/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
6.0%
13/218 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
2.7%
6/219 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
2.7%
6/224 • From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
|
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 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