| Primary | Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-24 Hours (AUC 0-24h) Response at the End of Each Treatment 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. | 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. | Posted | | Mean | Standard Error | Liter | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer). | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG003 | Olo 10 mcg qd | Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG004 | Olo 20 mcg qd | Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG005 | Form 12 mcg Bid | Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler. |
| | Units | Counts |
|---|
| Participants | - OG000122
- OG001119
- OG002126
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-0.004± 0.025
- OG0010.135± 0.025
- OG0020.178± 0.025
- OG003
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Mixed Models Analysis | Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect. | <0.0001 | | Mean Difference (Final Values) | 0.140 | Standard Error of the Mean | 0.022 | | 95 | 0.097 | 0.182 | | | Olo 2 mcg qd minus Placebo | No | Superiority or Other | | | |
|
| Secondary | FEV1 Area Under Curve 0-12 h (AUC 0-12h) Response at the End of Each Treatment 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 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres. | | Posted | | Mean | Standard Error | Liter | | 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 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer). | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG003 | Olo 10 mcg qd |
|
| Secondary | FEV1 Area Under Curve 12-24 h (AUC 12-24h) Response at the End of Each Treatment 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 12-24h was calculated from 12-24 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres. | | Posted | | Mean | Standard Error | Liter | | 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 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer). | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG003 |
|
| Secondary | Peak FEV1 Within 24 Hours Post-dose Response | 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. | | Posted | | Mean | Standard Error | Liter | | 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 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer). | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG003 |
|
| Secondary | Trough FEV1 Response | 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. | | Posted | | Mean | Standard Error | Liter | | 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 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer). | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG003 | Olo 10 mcg qd |
|
| Secondary | Forced Vital Capacity (FVC) Area Under Curve 0-12 Hours (AUC 0-12h) Response | 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. | | Posted | | Mean | Standard Error | Liter | | 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 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer). | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG003 | Olo 10 mcg qd |
|
| Secondary | FVC Area Under Curve 12-24 Hours (AUC 12-24h) Response | 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. | | Posted | | Mean | Standard Error | Liter | | 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 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer). | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG003 | Olo 10 mcg qd |
|
| Secondary | FVC Area Under Curve 0-24 Hours (AUC 0-24h) Response | 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. | | Posted | | Mean | Standard Error | Liter | | 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 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer). | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG003 |
|
| Secondary | Peak FVC Within 24 Hours Post-dose Response | 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. | | Posted | | Mean | Standard Error | Liter | | 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 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer). | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG003 |
|
| Secondary | Trough FVC Response | 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. | | Posted | | Mean | Standard Error | Liter | | 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 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer). | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG003 | Olo 10 mcg qd |
|
| Secondary | Peak Expiratory Flow (PEF) Area Under Curve 0-12 Hours (AUC 0-12h) Response | 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. | | Posted | | Mean | Standard Error | Liter/sec | | 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 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer). | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG003 | Olo 10 mcg qd |
|
| Secondary | PEF Area Under Curve 12-24 Hours (AUC 12-24h) Response | 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. | | Posted | | Mean | Standard Error | Liter/sec | | 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 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer). | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG003 | Olo 10 mcg qd |
|
| Secondary | Peak Expiratory Flow (PEF) Area Under Curve 0-24 Hours (AUC 0-24h) Response | 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. | | Posted | | Mean | Standard Error | Liter/sec | | 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 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer). | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG003 |
|
| Secondary | Peak PEF Within 24 Hours Post-dose Response | 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. | | Posted | | Mean | Standard Error | Liter/sec | | 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 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer). | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG003 |
|
| Secondary | Trough PEF Response | 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. | | Posted | | Mean | Standard Error | Liter/sec | | 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 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer). | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG003 | Olo 10 mcg qd |
|
| Secondary | Mean Pre-dose Morning PEF (PEF a.m.) | 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. | FAS including all patients who contributed data for this endpoint. | Posted | | Mean | Standard Error | Liter/min | | 2-4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer). | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG003 | Olo 10 mcg qd | Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. |
|
| Secondary | Mean Pre-dose Evening PEF (PEF p.m.) | 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. | FAS including all patients who contributed data for this endpoint. | Posted | | Mean | Standard Error | Liter/min | | 2-4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer). | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG003 | Olo 10 mcg qd | Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. |
|
| Secondary | PEF Daily Variability | 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. | FAS including all patients who contributed data for this endpoint. | Posted | | Mean | Standard Error | Percentage | | 2-4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer). | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG003 | Olo 10 mcg qd | |
|
| Secondary | Mean Pre-dose Morning FEV1 (FEV1 a.m.) | 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. | FAS including all patients who contributed data for this endpoint. | Posted | | Mean | Standard Error | L | | 2-4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer). | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG003 | Olo 10 mcg qd | Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. |
|
| Secondary | Mean Pre-dose Evening FEV1 (FEV1 p.m.) | 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. | FAS including all patients who contributed data for this endpoint. | Posted | | Mean | Standard Error | L | | 2-4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer). | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG003 | Olo 10 mcg qd | Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. |
|
| Secondary | Mean Number of Puffs of Rescue Medication During the Whole Day | 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. | FAS including all patients who contributed data for this endpoint. | Posted | | Mean | Standard Error | Number of Puffs | | 2-4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer). | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG003 | Olo 10 mcg qd | Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. |
|
| Secondary | Percentage of Asthma Symptom Free Days | 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. | FAS including all patients who contributed data for this endpoint. | Posted | | Mean | Standard Error | Percentage of asthma symptom free days | | 2-4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer). | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. |
|
| Secondary | Number of Patients Categorized by Highest Number of Night Time Awakenings (Overall) | Assessed by patients at home using the AM2+ device after the first 2 weeks of each period of randomised treatment. | FAS including all patients who contributed data for this endpoint. | Posted | | Number | | Number of patients | | 2-4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer). | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG003 | Olo 10 mcg qd | Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG004 |
|
| Secondary | Number of Patients Categorized by Worst Asthma Daytime Symptoms (Overall) | Assessed by patients at home using the AM2+ device after the first 2 weeks of each period of randomised treatment. | FAS including all patients who contributed data for this endpoint. | Posted | | Number | | Number of patients | | 2-4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer). | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG003 | Olo 10 mcg qd | Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG004 |
|
| Secondary | Number of Patients Categorized by Worst Asthma Nighttime Symptoms (Overall) | Assessed by patients at home using the AM2+ device after the first 2 weeks of each period of randomised treatment. | FAS including all patients who contributed data for this endpoint. | Posted | | Number | | Number of patients | | 2-4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer). | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG003 | Olo 10 mcg qd | Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG004 |
|
| Secondary | Total Asthma Quality of Life Questionnaire (AQLQ(s)) Score | 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. | FAS including all patients who contributed data for this endpoint. | Posted | | Mean | Standard Error | units on a scale | | 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer). | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG003 | Olo 10 mcg qd | Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. |
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| Secondary | Total Asthma Control Questionnaire (ACQ) Score | 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. | FAS including all patients who contributed data for this endpoint. | Posted | | Mean | Standard Error | units on a scale | | 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer). | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG003 | Olo 10 mcg qd | Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. |
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| Secondary | Potassium 1 Hour Pre-dose | 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. | | Posted | | Geometric Mean | 95% Confidence Interval | mmol/L | | 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer). | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG003 | Olo 10 mcg qd | Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG004 | Olo 20 mcg qd |
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| Secondary | Potassium 1 Hour Post-dose | 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. | | Posted | | Geometric Mean | 95% Confidence Interval | mmol/L | | 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer). | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG003 | Olo 10 mcg qd | Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG004 | Olo 20 mcg qd |
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| Secondary | Potassium 3 Hours Post-dose | 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. | | Posted | | Geometric Mean | 95% Confidence Interval | mmol/L | | 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer). | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG003 | Olo 10 mcg qd | Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG004 | Olo 20 mcg qd |
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| Secondary | Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG | 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. | | Posted | | Number | | Participants | | 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer). | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG003 | Olo 10 mcg qd | Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler. | | OG004 |
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