Trial Outcomes & Findings for A Study of the Safety and Efficacy of 4 Doses of BI 1744 CL Delivered Via the Respimat in Patients With Asthma. (NCT NCT01013753)
NCT ID: NCT01013753
Last Updated: 2014-06-27
Results Overview
Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FEV1 AUC 0-24h was calculated from 0-24 hours post-dose using the trapezoidal rule, divided by the observation time (24h) to report in litres.
COMPLETED
PHASE2
198 participants
1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks
2014-06-27
Participant Flow
Participant milestones
| Measure |
Study Total
This was a randomised, double-blind, double dummy, placebo- and active-controlled, 6 treatment, 4 period incomplete crossover trial. 198 patients were assigned randomly to one of 30 treatment sequences, each sequence comprising 4 out of the 6 treatments listed: one of four doses (20 microgram (mcg), 10 mcg, 5 mcg or 2 mcg) of Olodaterol (Olo) once daily (qd) delivered via the Respimat inhaler or Foradil (Form) 12 mcg twice daily (bid) delivered via the Aerolizer inhaler or equivalent placebo. The duration of each treatment period was 4 weeks with no washout periods between treatments.
|
|---|---|
|
Overall Study
STARTED
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198
|
|
Overall Study
Received Placebo
|
125
|
|
Overall Study
Received Olo 2 mcg qd
|
121
|
|
Overall Study
Received Olo 5 mcg qd
|
130
|
|
Overall Study
Received Olo 10 mcg qd
|
127
|
|
Overall Study
Received Olo 20 mcg qd
|
124
|
|
Overall Study
Received Form 12 mcg Bid
|
125
|
|
Overall Study
COMPLETED
|
182
|
|
Overall Study
NOT COMPLETED
|
16
|
Reasons for withdrawal
| Measure |
Study Total
This was a randomised, double-blind, double dummy, placebo- and active-controlled, 6 treatment, 4 period incomplete crossover trial. 198 patients were assigned randomly to one of 30 treatment sequences, each sequence comprising 4 out of the 6 treatments listed: one of four doses (20 microgram (mcg), 10 mcg, 5 mcg or 2 mcg) of Olodaterol (Olo) once daily (qd) delivered via the Respimat inhaler or Foradil (Form) 12 mcg twice daily (bid) delivered via the Aerolizer inhaler or equivalent placebo. The duration of each treatment period was 4 weeks with no washout periods between treatments.
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|---|---|
|
Overall Study
Adverse Event
|
8
|
|
Overall Study
Protocol Violation
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Other
|
2
|
Baseline Characteristics
A Study of the Safety and Efficacy of 4 Doses of BI 1744 CL Delivered Via the Respimat in Patients With Asthma.
Baseline characteristics by cohort
| Measure |
Study Total
n=198 Participants
This was a randomised, double-blind, double dummy, placebo- and active-controlled, 6 treatment, 4 period incomplete crossover trial. 198 patients were assigned randomly to one of 30 treatment sequences, each sequence comprising 4 out of the 6 treatments listed: one of four doses (20 microgram (mcg), 10 mcg, 5 mcg or 2 mcg) of Olodaterol (Olo) once daily (qd) delivered via the Respimat inhaler or Foradil (Form) 12 mcg twice daily (bid) delivered via the Aerolizer inhaler or equivalent placebo. The duration of each treatment period was 4 weeks with no washout periods between treatments.
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|---|---|
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Age, Continuous
|
45.0 years
STANDARD_DEVIATION 11.8 • n=99 Participants
|
|
Sex: Female, Male
Female
|
112 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
86 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeksPopulation: Full analysis set (FAS). FAS is defined as all patients in the treated set for whom the baseline (pre-dose) value is available, and who have a value for the primary endpoint for at least one crossover period.
Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FEV1 AUC 0-24h was calculated from 0-24 hours post-dose using the trapezoidal rule, divided by the observation time (24h) to report in litres.
Outcome measures
| Measure |
Placebo
n=122 Participants
Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
|
Olo 2 mcg qd
n=119 Participants
Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=126 Participants
Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=121 Participants
Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=119 Participants
Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Form 12 mcg Bid
n=122 Participants
Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
|
|---|---|---|---|---|---|---|
|
Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-24 Hours (AUC 0-24h) Response at the End of Each Treatment Period
|
-0.004 Liter
Standard Error 0.025
|
0.135 Liter
Standard Error 0.025
|
0.178 Liter
Standard Error 0.025
|
0.201 Liter
Standard Error 0.025
|
0.225 Liter
Standard Error 0.025
|
0.164 Liter
Standard Error 0.025
|
SECONDARY outcome
Timeframe: 1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min related to evening dose after 4 weeksPopulation: FAS
Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FEV1 AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.
Outcome measures
| Measure |
Placebo
n=122 Participants
Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
|
Olo 2 mcg qd
n=119 Participants
Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=126 Participants
Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=121 Participants
Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=119 Participants
Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Form 12 mcg Bid
n=122 Participants
Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
|
|---|---|---|---|---|---|---|
|
FEV1 Area Under Curve 0-12 h (AUC 0-12h) Response at the End of Each Treatment Period
|
-0.039 Liter
Standard Error 0.026
|
0.124 Liter
Standard Error 0.026
|
0.173 Liter
Standard Error 0.026
|
0.194 Liter
Standard Error 0.026
|
0.211 Liter
Standard Error 0.026
|
0.145 Liter
Standard Error 0.026
|
SECONDARY outcome
Timeframe: 1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeksPopulation: FAS
Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FEV1 AUC 12-24h was calculated from 12-24 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.
Outcome measures
| Measure |
Placebo
n=122 Participants
Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
|
Olo 2 mcg qd
n=119 Participants
Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=126 Participants
Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=121 Participants
Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=119 Participants
Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Form 12 mcg Bid
n=122 Participants
Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
|
|---|---|---|---|---|---|---|
|
FEV1 Area Under Curve 12-24 h (AUC 12-24h) Response at the End of Each Treatment Period
|
0.031 Liter
Standard Error 0.026
|
0.147 Liter
Standard Error 0.026
|
0.183 Liter
Standard Error 0.025
|
0.208 Liter
Standard Error 0.026
|
0.238 Liter
Standard Error 0.026
|
0.183 Liter
Standard Error 0.026
|
SECONDARY outcome
Timeframe: 1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeksPopulation: FAS
Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Peak FEV1 within 24 hours post dose measured following the evening trial drug inhalation at the end of each 4 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.
Outcome measures
| Measure |
Placebo
n=122 Participants
Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
|
Olo 2 mcg qd
n=119 Participants
Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=126 Participants
Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=121 Participants
Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=119 Participants
Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Form 12 mcg Bid
n=122 Participants
Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
|
|---|---|---|---|---|---|---|
|
Peak FEV1 Within 24 Hours Post-dose Response
|
0.224 Liter
Standard Error 0.026
|
0.326 Liter
Standard Error 0.027
|
0.359 Liter
Standard Error 0.026
|
0.385 Liter
Standard Error 0.027
|
0.404 Liter
Standard Error 0.027
|
0.390 Liter
Standard Error 0.026
|
SECONDARY outcome
Timeframe: 1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 23 h, and 23 h 50 min related to evening dose after 4 weeksPopulation: FAS
Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Trough values were defined as the mean of 2 FEV1 values performed at the planned timepoints 23h and 23h 50min related to evening trial-drug inhalation at the end of each 4 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.
Outcome measures
| Measure |
Placebo
n=122 Participants
Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
|
Olo 2 mcg qd
n=119 Participants
Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=126 Participants
Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=121 Participants
Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=119 Participants
Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Form 12 mcg Bid
n=122 Participants
Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
|
|---|---|---|---|---|---|---|
|
Trough FEV1 Response
|
0.013 Liter
Standard Error 0.026
|
0.116 Liter
Standard Error 0.026
|
0.146 Liter
Standard Error 0.026
|
0.182 Liter
Standard Error 0.026
|
0.211 Liter
Standard Error 0.026
|
0.115 Liter
Standard Error 0.026
|
SECONDARY outcome
Timeframe: 1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h , 3 h, 4 h, 11 h 50 min related to evening dose after 4 weeksPopulation: FAS
Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FVC AUC 0-12h was calculated using the trapezoidal rule, divided by the observation time to report in litres.
Outcome measures
| Measure |
Placebo
n=122 Participants
Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
|
Olo 2 mcg qd
n=119 Participants
Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=126 Participants
Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=121 Participants
Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=119 Participants
Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Form 12 mcg Bid
n=122 Participants
Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
|
|---|---|---|---|---|---|---|
|
Forced Vital Capacity (FVC) Area Under Curve 0-12 Hours (AUC 0-12h) Response
|
-0.047 Liter
Standard Error 0.029
|
0.056 Liter
Standard Error 0.029
|
0.109 Liter
Standard Error 0.029
|
0.094 Liter
Standard Error 0.029
|
0.122 Liter
Standard Error 0.029
|
0.055 Liter
Standard Error 0.029
|
SECONDARY outcome
Timeframe: 1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeksPopulation: FAS
Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FVC AUC 12-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.
Outcome measures
| Measure |
Placebo
n=122 Participants
Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
|
Olo 2 mcg qd
n=119 Participants
Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=126 Participants
Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=121 Participants
Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=119 Participants
Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Form 12 mcg Bid
n=122 Participants
Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
|
|---|---|---|---|---|---|---|
|
FVC Area Under Curve 12-24 Hours (AUC 12-24h) Response
|
-0.005 Liter
Standard Error 0.029
|
0.055 Liter
Standard Error 0.029
|
0.109 Liter
Standard Error 0.028
|
0.110 Liter
Standard Error 0.029
|
0.139 Liter
Standard Error 0.029
|
0.085 Liter
Standard Error 0.029
|
SECONDARY outcome
Timeframe: 1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 min, 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeksPopulation: FAS
Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FVC AUC 0-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.
Outcome measures
| Measure |
Placebo
n=122 Participants
Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
|
Olo 2 mcg qd
n=119 Participants
Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=126 Participants
Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=121 Participants
Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=119 Participants
Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Form 12 mcg Bid
n=122 Participants
Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
|
|---|---|---|---|---|---|---|
|
FVC Area Under Curve 0-24 Hours (AUC 0-24h) Response
|
-0.026 Liter
Standard Error 0.028
|
0.056 Liter
Standard Error 0.028
|
0.109 Liter
Standard Error 0.028
|
0.102 Liter
Standard Error 0.028
|
0.131 Liter
Standard Error 0.028
|
0.070 Liter
Standard Error 0.028
|
SECONDARY outcome
Timeframe: 1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeksPopulation: FAS
Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Peak FVC within 24 hours post dose measured following the trial drug inhalation at the end of each 4 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.
Outcome measures
| Measure |
Placebo
n=122 Participants
Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
|
Olo 2 mcg qd
n=119 Participants
Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=126 Participants
Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=121 Participants
Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=119 Participants
Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Form 12 mcg Bid
n=122 Participants
Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
|
|---|---|---|---|---|---|---|
|
Peak FVC Within 24 Hours Post-dose Response
|
0.253 Liter
Standard Error 0.031
|
0.300 Liter
Standard Error 0.031
|
0.356 Liter
Standard Error 0.031
|
0.342 Liter
Standard Error 0.031
|
0.380 Liter
Standard Error 0.031
|
0.326 Liter
Standard Error 0.031
|
SECONDARY outcome
Timeframe: 1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 23 h, and 23 h 50 min related to evening dose after 4 weeksPopulation: FAS
Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Trough values were defined as the mean of 2 FEV1 values performed at the planned timepoints 23h and 23h 50min related to evening trial-drug inhalation at the end of each 4 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.
Outcome measures
| Measure |
Placebo
n=122 Participants
Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
|
Olo 2 mcg qd
n=119 Participants
Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=126 Participants
Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=121 Participants
Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=119 Participants
Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Form 12 mcg Bid
n=122 Participants
Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
|
|---|---|---|---|---|---|---|
|
Trough FVC Response
|
-0.022 Liter
Standard Error 0.029
|
0.015 Liter
Standard Error 0.029
|
0.069 Liter
Standard Error 0.029
|
0.088 Liter
Standard Error 0.029
|
0.107 Liter
Standard Error 0.029
|
0.029 Liter
Standard Error 0.029
|
SECONDARY outcome
Timeframe: 1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min related to evening dose after 4 weeksPopulation: FAS
Response was defined as change from baseline. Study baseline PEF was defined as the mean of the available pre-dose PEF values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. PEF AUC 0-12h was calculated using the trapezoidal rule, divided by the observation time to report in litres/seconds.
Outcome measures
| Measure |
Placebo
n=122 Participants
Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
|
Olo 2 mcg qd
n=119 Participants
Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=126 Participants
Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=121 Participants
Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=119 Participants
Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Form 12 mcg Bid
n=122 Participants
Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
|
|---|---|---|---|---|---|---|
|
Peak Expiratory Flow (PEF) Area Under Curve 0-12 Hours (AUC 0-12h) Response
|
-0.117 Liter/sec
Standard Error 0.076
|
0.291 Liter/sec
Standard Error 0.077
|
0.449 Liter/sec
Standard Error 0.076
|
0.495 Liter/sec
Standard Error 0.077
|
0.553 Liter/sec
Standard Error 0.077
|
0.471 Liter/sec
Standard Error 0.076
|
SECONDARY outcome
Timeframe: 1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeksPopulation: FAS
Response was defined as change from baseline. Study baseline PEF was defined as the mean of the available pre-dose PEF values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. PEF AUC 12-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres/seconds.
Outcome measures
| Measure |
Placebo
n=122 Participants
Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
|
Olo 2 mcg qd
n=119 Participants
Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=126 Participants
Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=121 Participants
Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=119 Participants
Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Form 12 mcg Bid
n=122 Participants
Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
|
|---|---|---|---|---|---|---|
|
PEF Area Under Curve 12-24 Hours (AUC 12-24h) Response
|
0.043 Liter/sec
Standard Error 0.075
|
0.380 Liter/sec
Standard Error 0.075
|
0.528 Liter/sec
Standard Error 0.075
|
0.575 Liter/sec
Standard Error 0.075
|
0.692 Liter/sec
Standard Error 0.075
|
0.594 Liter/sec
Standard Error 0.075
|
SECONDARY outcome
Timeframe: 1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeksPopulation: FAS
Response was defined as change from baseline. Study baseline PEF was defined as the mean of the available pre-dose PEF values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. PEF AUC 0-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres/seconds.
Outcome measures
| Measure |
Placebo
n=122 Participants
Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
|
Olo 2 mcg qd
n=119 Participants
Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=126 Participants
Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=121 Participants
Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=119 Participants
Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Form 12 mcg Bid
n=122 Participants
Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
|
|---|---|---|---|---|---|---|
|
Peak Expiratory Flow (PEF) Area Under Curve 0-24 Hours (AUC 0-24h) Response
|
-0.038 Liter/sec
Standard Error 0.074
|
0.336 Liter/sec
Standard Error 0.074
|
0.489 Liter/sec
Standard Error 0.074
|
0.534 Liter/sec
Standard Error 0.074
|
0.623 Liter/sec
Standard Error 0.074
|
0.532 Liter/sec
Standard Error 0.074
|
SECONDARY outcome
Timeframe: 1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeksPopulation: FAS
Response was defined as change from baseline. Study baseline PEF was defined as the mean of the available pre-dose PEF values at the randomisation visit. Peak PEF within 24 hours post-dose measured following the evening trial drug inhalation at the end of each 4 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.
Outcome measures
| Measure |
Placebo
n=122 Participants
Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
|
Olo 2 mcg qd
n=119 Participants
Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=126 Participants
Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=121 Participants
Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=119 Participants
Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Form 12 mcg Bid
n=122 Participants
Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
|
|---|---|---|---|---|---|---|
|
Peak PEF Within 24 Hours Post-dose Response
|
0.664 Liter/sec
Standard Error 0.079
|
0.966 Liter/sec
Standard Error 0.079
|
1.093 Liter/sec
Standard Error 0.078
|
1.130 Liter/sec
Standard Error 0.079
|
1.198 Liter/sec
Standard Error 0.079
|
1.168 Liter/sec
Standard Error 0.079
|
SECONDARY outcome
Timeframe: 1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 23 h, and 23 h 50 min related to evening dose after 4 weeksPopulation: FAS
Response was defined as change from baseline. Study baseline PEF was defined as the mean of the available pre-dose PEF values at the randomisation visit. Trough values were defined as the mean of 2 FEV1 values performed at the planned timepoints 23h and 23h 50min related to evening trial-drug inhalation at the end of each 4 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.
Outcome measures
| Measure |
Placebo
n=122 Participants
Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
|
Olo 2 mcg qd
n=119 Participants
Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=126 Participants
Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=121 Participants
Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=119 Participants
Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Form 12 mcg Bid
n=122 Participants
Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
|
|---|---|---|---|---|---|---|
|
Trough PEF Response
|
0.031 Liter/sec
Standard Error 0.078
|
0.295 Liter/sec
Standard Error 0.078
|
0.499 Liter/sec
Standard Error 0.077
|
0.515 Liter/sec
Standard Error 0.078
|
0.655 Liter/sec
Standard Error 0.078
|
0.478 Liter/sec
Standard Error 0.078
|
SECONDARY outcome
Timeframe: 2-4 weeksPopulation: FAS including all patients who contributed data for this endpoint.
PEF a.m. was measured by patients at home using the AM2+ device (overall means obtained during each period of randomised treatment excluding the data of the first 2 weeks will be compared). Means are adjusted for treatment, period, patient and study baseline.
Outcome measures
| Measure |
Placebo
n=122 Participants
Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
|
Olo 2 mcg qd
n=119 Participants
Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=126 Participants
Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=123 Participants
Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=120 Participants
Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Form 12 mcg Bid
n=123 Participants
Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
|
|---|---|---|---|---|---|---|
|
Mean Pre-dose Morning PEF (PEF a.m.)
|
361.89 Liter/min
Standard Error 4.548
|
383.90 Liter/min
Standard Error 4.567
|
390.91 Liter/min
Standard Error 4.519
|
389.78 Liter/min
Standard Error 4.539
|
394.82 Liter/min
Standard Error 4.560
|
385.42 Liter/min
Standard Error 4.539
|
SECONDARY outcome
Timeframe: 2-4 weeksPopulation: FAS including all patients who contributed data for this endpoint.
PEF p.m. was measured by patients at home using the AM2+ device (overall means obtained during each period of randomised treatment excluding the data of the first 2 weeks will be compared). Means are adjusted for treatment, period, patient and study baseline.
Outcome measures
| Measure |
Placebo
n=122 Participants
Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
|
Olo 2 mcg qd
n=119 Participants
Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=126 Participants
Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=123 Participants
Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=120 Participants
Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Form 12 mcg Bid
n=123 Participants
Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
|
|---|---|---|---|---|---|---|
|
Mean Pre-dose Evening PEF (PEF p.m.)
|
379.44 Liter/min
Standard Error 4.398
|
394.36 Liter/min
Standard Error 4.418
|
404.28 Liter/min
Standard Error 4.368
|
403.06 Liter/min
Standard Error 4.389
|
407.89 Liter/min
Standard Error 4.410
|
399.88 Liter/min
Standard Error 4.389
|
SECONDARY outcome
Timeframe: 2-4 weeksPopulation: FAS including all patients who contributed data for this endpoint.
PEF daily variability was assessed by patients at home using the AM2+ device (overall means obtained during each period of randomised treatment excluding the data of the first 2 weeks will be compared). PEF daily variability is the absolute difference between the morning and the evening PEF value divided by the mean of these two values, expressed as a percent. Means are adjusted for treatment, period, patient and study baseline.
Outcome measures
| Measure |
Placebo
n=122 Participants
Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
|
Olo 2 mcg qd
n=119 Participants
Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=126 Participants
Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=122 Participants
Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=120 Participants
Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Form 12 mcg Bid
n=123 Participants
Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
|
|---|---|---|---|---|---|---|
|
PEF Daily Variability
|
11.688 Percentage
Standard Error 0.480
|
9.694 Percentage
Standard Error 0.484
|
9.593 Percentage
Standard Error 0.475
|
9.851 Percentage
Standard Error 0.480
|
9.899 Percentage
Standard Error 0.483
|
10.417 Percentage
Standard Error 0.479
|
SECONDARY outcome
Timeframe: 2-4 weeksPopulation: FAS including all patients who contributed data for this endpoint.
FEV1 a.m. was measured by patients at home using the AM2+ device (overall means obtained during each period of randomised treatment excluding the data of the first 2 weeks will be compared). Means are adjusted for treatment, period, patient and study baseline.
Outcome measures
| Measure |
Placebo
n=122 Participants
Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
|
Olo 2 mcg qd
n=119 Participants
Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=126 Participants
Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=123 Participants
Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=120 Participants
Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Form 12 mcg Bid
n=123 Participants
Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
|
|---|---|---|---|---|---|---|
|
Mean Pre-dose Morning FEV1 (FEV1 a.m.)
|
2.309 L
Standard Error 0.028
|
2.402 L
Standard Error 0.028
|
2.438 L
Standard Error 0.028
|
2.445 L
Standard Error 0.028
|
2.479 L
Standard Error 0.028
|
2.403 L
Standard Error 0.028
|
SECONDARY outcome
Timeframe: 2-4 weeksPopulation: FAS including all patients who contributed data for this endpoint.
FEV1 p.m. was measured by patients at home using the AM2+ device (overall means obtained during each period of randomised treatment excluding the data of the first 2 weeks will be compared). Means are adjusted for treatment, period, patient and study baseline.
Outcome measures
| Measure |
Placebo
n=122 Participants
Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
|
Olo 2 mcg qd
n=119 Participants
Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=126 Participants
Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=123 Participants
Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=120 Participants
Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Form 12 mcg Bid
n=123 Participants
Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
|
|---|---|---|---|---|---|---|
|
Mean Pre-dose Evening FEV1 (FEV1 p.m.)
|
2.378 L
Standard Error 0.027
|
2.428 L
Standard Error 0.027
|
2.460 L
Standard Error 0.027
|
2.467 L
Standard Error 0.027
|
2.495 L
Standard Error 0.027
|
2.457 L
Standard Error 0.027
|
SECONDARY outcome
Timeframe: 2-4 weeksPopulation: FAS including all patients who contributed data for this endpoint.
Mean of daily use of salbutamol (albuterol) rescue medication as needed during the entire study period. Assessed by patients at home using the AM2+ device (overall means obtained during each period of randomised treatment excluding the data of the first 2 weeks will be compared). Means are adjusted for treatment, period, patient and study baseline.
Outcome measures
| Measure |
Placebo
n=122 Participants
Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
|
Olo 2 mcg qd
n=119 Participants
Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=126 Participants
Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=123 Participants
Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=120 Participants
Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Form 12 mcg Bid
n=123 Participants
Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
|
|---|---|---|---|---|---|---|
|
Mean Number of Puffs of Rescue Medication During the Whole Day
|
1.749 Number of Puffs
Standard Error 0.130
|
1.222 Number of Puffs
Standard Error 0.130
|
1.317 Number of Puffs
Standard Error 0.128
|
1.271 Number of Puffs
Standard Error 0.129
|
1.092 Number of Puffs
Standard Error 0.130
|
1.300 Number of Puffs
Standard Error 0.129
|
SECONDARY outcome
Timeframe: 2-4 weeksPopulation: FAS including all patients who contributed data for this endpoint.
Percentage of asthma-symptom free days after the first 2 weeks of each treatment period was calculated as the number of symptom-free days divided by the number of days on treatment multiplied by 100. A symptom-free day was defined as a day in which no asthma symptoms were recorded, no rescue medication was recorded, activities during the day were not at all limited due to asthma, no shortness of breath during the day was recorded, no wheezing or coughing during the day and no night-time awakenings due to asthma were recorded. Assessed by patients at home using the AM2+ device.
Outcome measures
| Measure |
Placebo
n=123 Participants
Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
|
Olo 2 mcg qd
n=119 Participants
Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=126 Participants
Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=123 Participants
Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=120 Participants
Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Form 12 mcg Bid
n=123 Participants
Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
|
|---|---|---|---|---|---|---|
|
Percentage of Asthma Symptom Free Days
|
18.502 Percentage of asthma symptom free days
Standard Error 2.494
|
26.430 Percentage of asthma symptom free days
Standard Error 2.973
|
22.348 Percentage of asthma symptom free days
Standard Error 2.835
|
23.624 Percentage of asthma symptom free days
Standard Error 2.951
|
21.326 Percentage of asthma symptom free days
Standard Error 2.803
|
23.664 Percentage of asthma symptom free days
Standard Error 2.797
|
SECONDARY outcome
Timeframe: 2-4 weeksPopulation: FAS including all patients who contributed data for this endpoint.
Assessed by patients at home using the AM2+ device after the first 2 weeks of each period of randomised treatment.
Outcome measures
| Measure |
Placebo
n=122 Participants
Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
|
Olo 2 mcg qd
n=119 Participants
Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=126 Participants
Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=123 Participants
Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=120 Participants
Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Form 12 mcg Bid
n=123 Participants
Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
|
|---|---|---|---|---|---|---|
|
Number of Patients Categorized by Highest Number of Night Time Awakenings (Overall)
Did not wake up
|
55 Number of patients
|
60 Number of patients
|
58 Number of patients
|
56 Number of patients
|
63 Number of patients
|
59 Number of patients
|
|
Number of Patients Categorized by Highest Number of Night Time Awakenings (Overall)
Woke up once
|
37 Number of patients
|
36 Number of patients
|
34 Number of patients
|
34 Number of patients
|
34 Number of patients
|
29 Number of patients
|
|
Number of Patients Categorized by Highest Number of Night Time Awakenings (Overall)
Woke up 2-5 times
|
26 Number of patients
|
17 Number of patients
|
30 Number of patients
|
30 Number of patients
|
20 Number of patients
|
33 Number of patients
|
|
Number of Patients Categorized by Highest Number of Night Time Awakenings (Overall)
Woke up > 5 times
|
3 Number of patients
|
5 Number of patients
|
2 Number of patients
|
1 Number of patients
|
2 Number of patients
|
2 Number of patients
|
|
Number of Patients Categorized by Highest Number of Night Time Awakenings (Overall)
Was awake all night
|
1 Number of patients
|
1 Number of patients
|
2 Number of patients
|
2 Number of patients
|
1 Number of patients
|
0 Number of patients
|
SECONDARY outcome
Timeframe: 2-4 weeksPopulation: FAS including all patients who contributed data for this endpoint.
Assessed by patients at home using the AM2+ device after the first 2 weeks of each period of randomised treatment.
Outcome measures
| Measure |
Placebo
n=122 Participants
Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
|
Olo 2 mcg qd
n=119 Participants
Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=126 Participants
Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=123 Participants
Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=120 Participants
Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Form 12 mcg Bid
n=123 Participants
Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
|
|---|---|---|---|---|---|---|
|
Number of Patients Categorized by Worst Asthma Daytime Symptoms (Overall)
No asthma symptoms
|
20 Number of patients
|
26 Number of patients
|
29 Number of patients
|
23 Number of patients
|
21 Number of patients
|
24 Number of patients
|
|
Number of Patients Categorized by Worst Asthma Daytime Symptoms (Overall)
Mild asthma symptoms
|
31 Number of patients
|
46 Number of patients
|
29 Number of patients
|
37 Number of patients
|
38 Number of patients
|
37 Number of patients
|
|
Number of Patients Categorized by Worst Asthma Daytime Symptoms (Overall)
Moderate asthma symptoms
|
56 Number of patients
|
37 Number of patients
|
51 Number of patients
|
52 Number of patients
|
54 Number of patients
|
49 Number of patients
|
|
Number of Patients Categorized by Worst Asthma Daytime Symptoms (Overall)
Severe asthma symptoms
|
15 Number of patients
|
10 Number of patients
|
12 Number of patients
|
10 Number of patients
|
6 Number of patients
|
12 Number of patients
|
|
Number of Patients Categorized by Worst Asthma Daytime Symptoms (Overall)
Very severe asthma symptoms
|
0 Number of patients
|
0 Number of patients
|
5 Number of patients
|
1 Number of patients
|
1 Number of patients
|
1 Number of patients
|
SECONDARY outcome
Timeframe: 2-4 weeksPopulation: FAS including all patients who contributed data for this endpoint.
Assessed by patients at home using the AM2+ device after the first 2 weeks of each period of randomised treatment.
Outcome measures
| Measure |
Placebo
n=122 Participants
Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
|
Olo 2 mcg qd
n=119 Participants
Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=126 Participants
Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=123 Participants
Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=120 Participants
Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Form 12 mcg Bid
n=123 Participants
Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
|
|---|---|---|---|---|---|---|
|
Number of Patients Categorized by Worst Asthma Nighttime Symptoms (Overall)
No asthma symptoms
|
27 Number of patients
|
31 Number of patients
|
22 Number of patients
|
25 Number of patients
|
27 Number of patients
|
26 Number of patients
|
|
Number of Patients Categorized by Worst Asthma Nighttime Symptoms (Overall)
Mild asthma symptoms
|
32 Number of patients
|
47 Number of patients
|
48 Number of patients
|
40 Number of patients
|
45 Number of patients
|
39 Number of patients
|
|
Number of Patients Categorized by Worst Asthma Nighttime Symptoms (Overall)
Moderate asthma symptoms
|
49 Number of patients
|
29 Number of patients
|
45 Number of patients
|
46 Number of patients
|
43 Number of patients
|
46 Number of patients
|
|
Number of Patients Categorized by Worst Asthma Nighttime Symptoms (Overall)
Severe asthma symptoms
|
14 Number of patients
|
10 Number of patients
|
11 Number of patients
|
10 Number of patients
|
5 Number of patients
|
10 Number of patients
|
|
Number of Patients Categorized by Worst Asthma Nighttime Symptoms (Overall)
Very severe asthma symptoms
|
0 Number of patients
|
2 Number of patients
|
0 Number of patients
|
2 Number of patients
|
0 Number of patients
|
2 Number of patients
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: FAS including all patients who contributed data for this endpoint.
Total score from the Standardised Asthma Quality of Life Questionnaire (AQLQ (s)) at the end of each 4 week treatment period. The AQLQ(s) contains 32 questions, each question has a 7 point scale from 1 (highest intensity) till 7 (no symptoms). Total score was defined as the sum of all items divided by the number of items.
Outcome measures
| Measure |
Placebo
n=122 Participants
Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
|
Olo 2 mcg qd
n=119 Participants
Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=125 Participants
Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=121 Participants
Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=118 Participants
Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Form 12 mcg Bid
n=122 Participants
Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
|
|---|---|---|---|---|---|---|
|
Total Asthma Quality of Life Questionnaire (AQLQ(s)) Score
|
5.174 units on a scale
Standard Error 0.063
|
5.463 units on a scale
Standard Error 0.064
|
5.383 units on a scale
Standard Error 0.063
|
5.437 units on a scale
Standard Error 0.063
|
5.491 units on a scale
Standard Error 0.064
|
5.489 units on a scale
Standard Error 0.063
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: FAS including all patients who contributed data for this endpoint.
Control of asthma as assessed by the ACQ at the end of each 4-week treatment period.The ACQ contains 7 questions, each question has a 7 point scale from 0 (no symptoms) till 6 (highest intensity). Total score was defined as the sum of all items divided by the number of items.
Outcome measures
| Measure |
Placebo
n=123 Participants
Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
|
Olo 2 mcg qd
n=119 Participants
Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=126 Participants
Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=122 Participants
Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=119 Participants
Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Form 12 mcg Bid
n=122 Participants
Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
|
|---|---|---|---|---|---|---|
|
Total Asthma Control Questionnaire (ACQ) Score
|
1.882 units on a scale
Standard Error 0.058
|
1.561 units on a scale
Standard Error 0.058
|
1.589 units on a scale
Standard Error 0.057
|
1.556 units on a scale
Standard Error 0.058
|
1.488 units on a scale
Standard Error 0.058
|
1.536 units on a scale
Standard Error 0.058
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: Treated set
Effect on potassium evaluated 1 hour pre-dose. Analysis is based on the log of the potassium values. For the geometric means, the results were back-transformed to the original scale.
Outcome measures
| Measure |
Placebo
n=119 Participants
Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
|
Olo 2 mcg qd
n=118 Participants
Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=122 Participants
Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=117 Participants
Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=117 Participants
Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Form 12 mcg Bid
n=119 Participants
Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
|
|---|---|---|---|---|---|---|
|
Potassium 1 Hour Pre-dose
|
4.067 mmol/L
Interval 4.019 to 4.114
|
4.051 mmol/L
Interval 4.004 to 4.099
|
4.051 mmol/L
Interval 4.005 to 4.097
|
4.061 mmol/L
Interval 4.014 to 4.109
|
4.057 mmol/L
Interval 4.01 to 4.105
|
4.080 mmol/L
Interval 4.032 to 4.128
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: Treated set
Effect on potassium evaluated 1 hour post-dose. Analysis is based on the log of the potassium values. For the geometric means, the results were back-transformed to the original scale.
Outcome measures
| Measure |
Placebo
n=115 Participants
Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
|
Olo 2 mcg qd
n=113 Participants
Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=118 Participants
Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=114 Participants
Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=109 Participants
Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Form 12 mcg Bid
n=114 Participants
Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
|
|---|---|---|---|---|---|---|
|
Potassium 1 Hour Post-dose
|
4.097 mmol/L
Interval 4.04 to 4.155
|
4.069 mmol/L
Interval 4.012 to 4.126
|
4.013 mmol/L
Interval 3.958 to 4.069
|
4.004 mmol/L
Interval 3.948 to 4.06
|
4.015 mmol/L
Interval 3.957 to 4.073
|
4.059 mmol/L
Interval 4.003 to 4.117
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: Treated set
Effect on potassium evaluated 3 hours post-dose. Analysis is based on the log of the potassium values. For the geometric means, the results were back-transformed to the original scale.
Outcome measures
| Measure |
Placebo
n=113 Participants
Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
|
Olo 2 mcg qd
n=110 Participants
Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=119 Participants
Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=114 Participants
Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=105 Participants
Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Form 12 mcg Bid
n=114 Participants
Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
|
|---|---|---|---|---|---|---|
|
Potassium 3 Hours Post-dose
|
4.029 mmol/L
Interval 3.98 to 4.079
|
4.026 mmol/L
Interval 3.976 to 4.076
|
3.997 mmol/L
Interval 3.95 to 4.045
|
3.979 mmol/L
Interval 3.931 to 4.027
|
3.992 mmol/L
Interval 3.942 to 4.043
|
4.007 mmol/L
Interval 3.959 to 4.056
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: Treated Set
Clinical relevant abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.
Outcome measures
| Measure |
Placebo
n=125 Participants
Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
|
Olo 2 mcg qd
n=121 Participants
Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=130 Participants
Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=127 Participants
Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=124 Participants
Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Form 12 mcg Bid
n=125 Participants
Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
|
|---|---|---|---|---|---|---|
|
Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG
Atrioventricular block first degree
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG
Blood creatine phosphokinase MB increased
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG
Blood creatine phosphokinase increased
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG
Blood pressure increased
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG
Hypothyroidism
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG
Hypertension
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
Placebo
Olo 2 mcg
Olo 5 mcg
Olo 10 mcg
Olo 20 mcg
Form 12 mcg
Serious adverse events
| Measure |
Placebo
n=125 participants at risk
Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
|
Olo 2 mcg
n=121 participants at risk
Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg
n=130 participants at risk
Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg
n=127 participants at risk
Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg
n=124 participants at risk
Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
|
Form 12 mcg
n=125 participants at risk
Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/125 • 4 weeks
|
0.00%
0/121 • 4 weeks
|
0.00%
0/130 • 4 weeks
|
0.79%
1/127 • 4 weeks
|
0.00%
0/124 • 4 weeks
|
0.00%
0/125 • 4 weeks
|
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
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
- Publication restrictions are in place
Restriction type: OTHER