| Primary | Trough FEV1 Response After 4 Weeks | Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation at the end of the dosing interval. | Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint. | Posted | | Least Squares Mean | Standard Error | Liter | | Baseline and 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG003 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. | | OG004 | Olo 20 mcg qd | Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler. |
| | Units | Counts |
|---|
| Participants | - OG00053
- OG00161
- OG00259
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0000.004± 0.034
- OG0010.083± 0.032
- OG0020.090± 0.032
- 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 | Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect | 0.0754 | | Mean Difference (Final Values) | 0.080 | Standard Error of the Mean | 0.045 | | 95 | -0.008 | 0.167 | | | Olo 2 mcg qd minus Placebo | No | Superiority or Other | | | |
|
| Secondary | Weekly Mean Pre-dose Morning PEFR After 4 Weeks | Response was defined as change from baseline. Baseline peak expiratory flow response (PEFR) was defined as the mean of the morning PEFR measurements obtained during the week just prior to first dose of randomized treatment. | Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint. | Posted | | Least Squares Mean | Standard Error | Liter/minute | | Baseline and 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG003 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. | |
|
| Secondary | Trough FEV1 Response After 1 Week | Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation at the end of the dosing interval. | Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint. | Posted | | Least Squares Mean | Standard Error | Liter | | Baseline and 1 week | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG003 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. |
|
| Secondary | Trough FEV1 Response After 2 Weeks | Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation at the end of the dosing interval. | Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint. | Posted | | Least Squares Mean | Standard Error | Liter | | Baseline and 2 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG003 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. |
|
| Secondary | Trough FVC Response After 1 Week | Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation at the end of the dosing interval. | Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint. | Posted | | Least Squares Mean | Standard Error | Liter | | Baseline and 1 week | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG003 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. |
|
| Secondary | Trough FVC Response After 2 Weeks | Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation at the end of the dosing interval. | Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint. | Posted | | Least Squares Mean | Standard Error | Liter | | Baseline and 2 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG003 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. |
|
| Secondary | Trough FVC Response After 4 Weeks | Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation at the end of the dosing interval. | Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint. | Posted | | Least Squares Mean | Standard Error | Liter | | Baseline and 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG003 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. |
|
| Secondary | Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-6 h (AUC 0-6h) Response at Week 4 | Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. FEV1 AUC 0-6h was calculated from 0-6 hours post-dose using the trapezoidal rule, divided by the observation time (6h) to report in litres. | Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint. | Posted | | Least Squares Mean | Standard Error | Liter | | 1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and 30 min, 1h, 2h, 3h, 4h, 5h, 6h relative to dose at Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG003 | Olo 10 mcg qd |
|
| Secondary | Forced Vital Capacity (FVC) Area Under Curve 0-6 h (AUC 0-6h) Response at Week 4 | Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. FVC AUC 0-6h was calculated from 0-6 hours post-dose using the trapezoidal rule, divided by the observation time (6h) to report in litres. | Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint. | Posted | | Least Squares Mean | Standard Error | Liter | | 1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and 30 min, 1h, 2h, 3h, 4h, 5h, 6h relative to dose at Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG003 | Olo 10 mcg qd |
|
| Secondary | Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response at Day 1 | Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres. | Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint. | Posted | | Least Squares Mean | Standard Error | Liter | | 1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and 30 min, 1h, 2h, 3h relative to dose at Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG003 | Olo 10 mcg qd |
|
| Secondary | Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response at Week 1 | Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres. | Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint. | Posted | | Least Squares Mean | Standard Error | Liter | | 1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and 30 min, 1h, 2h, 3h relative to dose at Week 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG003 | Olo 10 mcg qd |
|
| Secondary | Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response at Week 2 | Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres. | Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint. | Posted | | Least Squares Mean | Standard Error | Liter | | 1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and 30 min, 1h, 2h, 3h relative to dose at Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG003 | Olo 10 mcg qd |
|
| Secondary | Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response at Week 4 | Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres. | Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint. | Posted | | Least Squares Mean | Standard Error | Liter | | 1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and 30 min, 1h, 2h, 3h relative to dose at Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG003 | Olo 10 mcg qd |
|
| Secondary | Peak FEV1 (0-3h) Response At Day 1 | Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. | Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint. | Posted | | Least Squares Mean | Standard Error | Liter | | 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose at day 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG003 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. |
|
| Secondary | Peak FEV1 (0-3h) Response After 1 Week | Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. | Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint. | Posted | | Least Squares Mean | Standard Error | Liter | | 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose after 1 week | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG003 | Olo 10 mcg qd | |
|
| Secondary | Peak FEV1 (0-3h) Response After 2 Weeks | Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. | Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint. | Posted | | Least Squares Mean | Standard Error | Liter | | 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG003 | Olo 10 mcg qd | |
|
| Secondary | Peak FEV1 (0-3h) Response After 4 Weeks | Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. | Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint. | Posted | | Least Squares Mean | Standard Error | Liter | | 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose after 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG003 | Olo 10 mcg qd | |
|
| Secondary | Peak FVC (0-3h) Response At Day 1 | Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. | Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint. | Posted | | Least Squares Mean | Standard Error | Liter | | 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose after 1 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG003 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. |
|
| Secondary | Peak FVC (0-3h) Response After 1 Week | Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. | Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint. | Posted | | Least Squares Mean | Standard Error | Liter | | 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose after 1 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG003 | Olo 10 mcg qd | |
|
| Secondary | Peak FVC (0-3h) Response After 2 Weeks | Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. | Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint. | Posted | | Least Squares Mean | Standard Error | Liter | | 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG003 | Olo 10 mcg qd | |
|
| Secondary | Peak FVC (0-3h) Response After 4 Weeks | Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. | Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint. | Posted | | Least Squares Mean | Standard Error | Liter | | 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose after 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG003 | Olo 10 mcg qd | |
|
| Secondary | Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 6-12 h (AUC 6-12h) Response at Week 4 | Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. FEV1 AUC 6-12h was calculated from 6-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres. | Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint. | Posted | | Least Squares Mean | Standard Error | Liter | | 1 hour (h) prior to dose on first day of randomized treatment (baseline) and 1h, 3h, 6h, 9h, 12h relative to dose at Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG003 | Olo 10 mcg qd |
|
| Secondary | Weekly Mean Evening PEFR After 4 Weeks | Response was defined as change from baseline. Baseline PEFR was defined as the mean of the evening PEFR measurements obtained during the week just prior to first dose of randomized treatment. | Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint. | Posted | | Least Squares Mean | Standard Error | Liter/minute | | Baseline and 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG003 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. | | OG004 |
|
| Secondary | PEFR Variability After 4 Weeks | PEFR variability represents the absolute difference between the highest morning PEFR value and the highest evening PEFR value of 1 day, divided by the arithmetic mean of these 2 PEFR values and expressed as a percent, weekly means. | Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint. | Posted | | Least Squares Mean | Standard Error | percentage of PEFR | | 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG003 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. | |
|
| Secondary | Weekly Mean Number of Occasions of Rescue Therapy After 4 Weeks | Weekly mean number of occasions of rescue therapy used per day (prn salbutamol [albuterol]) as assessed by the e-Diary (e-Diary incorporated in AM2+). | Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint. | Posted | | Least Squares Mean | Standard Error | Number of Puffs | | 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG003 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. | | OG004 |
|
| Secondary | Area Under Curve From 0 to 3 Hours (AUC0-3) | AUC0-3 represents the area under the concentration curve of olodaterol and olodaterol glucuronide (a metabolite of olodaterol) in plasma from 0 to time t=3 | All evaluable patients were included in the pharmacokinetic (PK) analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of PK parameters or had insufficient data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Picogram*hours/milliliter | | 30 minutes (mins) before drug administration and 5mins, 10mins, 20mins, 40mins, 1 hour (h) and 3h after drug administration | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG003 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. |
|
| Secondary | Maximum Concentration (Cmax) | Cmax represents the maximum concentration of olodaterol and olodaterol glucuronide (a metabolite of olodaterol) in plasma. | All evaluable patients were included in the pharmacokinetic (PK) analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of PK parameters or had insufficient data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Picogram/milliliter | | 30 minutes (mins) before drug administration and 5mins, 10mins, 20mins, 40mins, 1 hour (h) and 3h after drug administration | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG003 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. |
|
| Secondary | Time From Dosing to the Maximum Concentration (Tmax) | tmax represents the time from dosing to maximum concentration of olodaterol and olodaterol glucuronide (a metabolite of olodaterol) in plasma. | All evaluable patients were included in the pharmacokinetic (PK) analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of PK parameters or had insufficient data. | Posted | | Median | Full Range | hours | | 30 minutes (mins) before drug administration and 5mins, 10mins, 20mins, 40mins, 1 hour (h) and 3h after drug administration | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG003 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. |
|
| Secondary | Area Under Curve From 0 to 3 Hours at Steady State (AUC0-3,ss) | AUC0-3,ss represents the area under the concentration curve of olodaterol and olodaterol glucuronide (a metabolite of olodaterol) in plasma from 0 to time t=3 at steady state. | All evaluable patients were included in the pharmacokinetic (PK) analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of PK parameters or had insufficient data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Picogram*hours/milliliter | | 30 minutes (mins) before drug administration and 5mins, 10mins, 20mins, 40mins, 1 hour (h), 3h and 6h after drug administration | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG003 | Olo 10 mcg qd | |
|
| Secondary | Area Under Curve From 0 to 6 Hours at Steady State (AUC0-6,ss) | AUC0-6,ss represents the area under the concentration curve of olodaterol and olodaterol glucuronide (a metabolite of olodaterol) in plasma from 0 to time t=6 at steady state. | All evaluable patients were included in the pharmacokinetic (PK) analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of PK parameters or had insufficient data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Picogram*hours/milliliter | | 30 minutes (mins) before drug administration and 5mins, 10mins, 20mins, 40mins, 1 hour (h), 3h and 6h after drug administration | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG003 | Olo 10 mcg qd | |
|
| Secondary | Area Under Curve From 0 to 24 Hours at Steady State (AUC0-24,ss) | AUC0-24,ss represents the area under the concentration curve of olodaterol and olodaterol glucuronide (a metabolite of olodaterol) in plasma from 0 to time t=24 at steady state. | All evaluable patients were included in the pharmacokinetic (PK) analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of PK parameters or had insufficient data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Picogram*hours/milliliter | | 30 minutes (mins) before drug administration and 5mins, 10mins, 20mins, 40mins, 1 hour (h), 3h and 6h after drug administration | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG003 | Olo 10 mcg qd | |
|
| Secondary | Maximum Concentration at Steady State (Cmax,ss) | Cmax,ss represents the maximum concentration of olodaterol and olodaterol glucuronide (a metabolite of olodaterol) in plasma at steady state. | All evaluable patients were included in the pharmacokinetic (PK) analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of PK parameters or had insufficient data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Picogram/milliliter | | 30 minutes (mins) before drug administration and 5mins, 10mins, 20mins, 40mins, 1 hour (h), 3h and 6h after drug administration | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG003 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. |
|
| Secondary | Time From Dosing to the Maximum Concentration at Steady State (Tmax,ss) | tmax,ss represents the time from dosing to maximum concentration of olodaterol and olodaterol glucuronide (a metabolite of olodaterol) in plasma at steady state. | All evaluable patients were included in the pharmacokinetic (PK) analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of PK parameters or had insufficient data. | Posted | | Median | Full Range | hours | | 30 minutes (mins) before drug administration and 5mins, 10mins, 20mins, 40mins, 1 hour (h), 3h and 6h after drug administration | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG003 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. |
|
| Secondary | Total Score in Asthma Control Questionnaire After 4 Weeks | Adequacy of asthma control was assessed using a scale of: 0=totally controlled, to 6=Severely uncontrolled. | Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint. | Posted | | Least Squares Mean | Standard Error | units on a scale | | 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG003 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. | | OG004 | Olo 20 mcg qd |
|
| Secondary | Clinical Relevant Abnormalities for Vital Signs, ECG and Physical Examination | Clinical relevant abnormalities for vital signs, ECG and physical examination. Any new or clinically relevant worsening of baseline conditions was reported as adverse events. | | Posted | | Number | | participants | | 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG003 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. | | OG004 | Olo 20 mcg qd | |
|
| Secondary | Laboratory Testing: Average Change From Baseline of Potassium | Laboratory testing: Average change from baseline of potassium measured on test-days. Pre-dose value on test day 1 is the baseline value. | | Posted | | Geometric Mean | Inter-Quartile Range | mmol/L | | Baseline and 29 days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 2 mcg qd | Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG003 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. | | OG004 | Olo 20 mcg qd | Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler. |
|