| Primary | Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at Day 85 (12 Weeks) | Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. 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). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before Day 85 (12 weeks) for either co-primary efficacy variable. | Posted | | Mean | Standard Error | Liter | | 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Day 85 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0000.008± 0.013
- OG0010.159± 0.013
- OG0020.152± 0.013
|
|
| | 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 effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect | <0.0001 | | Mean Difference (Final Values) | 0.151 | Standard Error of the Mean | 0.017 | | 95 | 0.116 | 0.185 | | | Olo 5 mcg qd minus Placebo | No | Superiority or Other | | | |
|
| Primary | Trough FEV1 Response at Day 85 (12 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 as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. | | Posted | | Mean | Standard Error | Liter | | 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h and - 10 mins prior to study drug at Day 85. | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | 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 0-12 h (AUC 0-12h) Response at Day 85 (12 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. Means are adjusted using a non-mixed effects model with treatment (trt), tio stratum, baseline as fixed effects. 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. | Patients in FAS with spirometry data after 3 hours at Visit 5 (12-hour pulmonary function test set) | Posted | | Mean | Standard Error | Liter | | 1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and -1h and -10 min, 5 min, 15 min, 30 min, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h relative to dose at Day 85 (12 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. |
|
| Secondary | Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response At Day 1 | Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. 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. | | Posted | | Mean | Standard Error | Liter | | 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 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 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler. |
|
| Secondary | Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response After 2 Weeks | Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. 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. | | Posted | | Mean | Standard Error | Liter | | 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 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 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler. |
|
| Secondary | Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response After 6 Weeks | Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. 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. | | Posted | | Mean | Standard Error | Liter | | 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -1h, -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler. |
|
| Secondary | Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response After 24 Weeks | Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. 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. | | Posted | | Mean | Standard Error | Liter | | 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler. |
|
| Secondary | Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response After 48 Weeks | Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. 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. | | Posted | | Mean | Standard Error | Liter | | 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | 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 a -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. | | Posted | | Mean | Standard Error | Liter | | 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 2 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. |
| |
| Secondary | Trough FEV1 Response After 6 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 as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. | | Posted | | Mean | Standard Error | Liter | | 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. |
| |
| Secondary | Trough FEV1 Response After 18 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 as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. | | Posted | | Mean | Standard Error | Liter | | 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 18 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. |
| |
| Secondary | Trough FEV1 Response After 24 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 as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. | | Posted | | Mean | Standard Error | Liter | | 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. |
| |
| Secondary | Trough FEV1 Response After 32 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 as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. | | Posted | | Mean | Standard Error | Liter | | 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 32 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. |
| |
| Secondary | Trough FEV1 Response After 40 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 as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. | | Posted | | Mean | Standard Error | Liter | | 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 40 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. |
| |
| Secondary | Trough FEV1 Response After 48 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 as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. | | Posted | | Mean | Standard Error | Liter | | 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 48 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. |
| |
| Secondary | Peak FEV1 (0-3h) Response At Day 1 | Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. | | Posted | | Mean | Standard Error | Liter | | 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 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 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler. |
| |
| Secondary | Peak FEV1 (0-3h) Response After 2 Weeks | Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. | | Posted | | Mean | Standard Error | Liter | | 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 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 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. |
| |
| Secondary | Peak FEV1 (0-3h) Response After 6 Weeks | Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. | | Posted | | Mean | Standard Error | Liter | | 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. |
| |
| Secondary | Peak FEV1 (0-3h) Response After 12 Weeks | Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. | | Posted | | Mean | Standard Error | Liter | | 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. |
| |
| Secondary | Peak FEV1 (0-3h) Response After 24 Weeks | Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. | | Posted | | Mean | Standard Error | Liter | | 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. |
| |
| Secondary | Peak FEV1 (0-3h) Response After 48 Weeks | Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. | | Posted | | Mean | Standard Error | Liter | | 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. |
| |
| Secondary | Forced Vital Capacity (FVC) Area Under Curve 0-3 Hours (AUC 0-3h) Response At Day 1 | Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres. | | Posted | | Mean | Standard Error | Liter | | 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 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 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler. |
| |
| Secondary | Forced Vital Capacity (FVC) Area Under Curve 0-3 Hours (AUC 0-3h) Response After 2 Weeks | Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres. | | Posted | | Mean | Standard Error | Liter | | 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 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 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. |
| |
| Secondary | FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response After 6 Weeks | Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres. | | Posted | | Mean | Standard Error | Liter | | 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. |
| |
| Secondary | FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response After 12 Weeks | Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres. | | Posted | | Mean | Standard Error | Liter | | 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. |
| |
| Secondary | FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response After 24 Weeks | Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres. | | Posted | | Mean | Standard Error | Liter | | 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. |
| |
| Secondary | FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response After 48 Weeks | Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres. | | Posted | | Mean | Standard Error | Liter | | 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | 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 FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. | | Posted | | Mean | Standard Error | Liter | | 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 2 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. |
| |
| Secondary | Trough FVC Response After 6 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 FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. | | Posted | | Mean | Standard Error | Liter | | 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. |
| |
| Secondary | Trough FVC Response After 12 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 FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. | | Posted | | Mean | Standard Error | Liter | | 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. |
| |
| Secondary | Trough FVC Response After 18 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 FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. | | Posted | | Mean | Standard Error | Liter | | 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 18 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. |
| |
| Secondary | Trough FVC Response After 24 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 FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. | | Posted | | Mean | Standard Error | Liter | | 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. |
| |
| Secondary | Trough FVC Response After 32 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 FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. | | Posted | | Mean | Standard Error | Liter | | 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 32 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. |
| |
| Secondary | Trough FVC Response After 40 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 FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. | | Posted | | Mean | Standard Error | Liter | | 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 40 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. |
| |
| Secondary | Trough FVC Response After 48 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 FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. | | Posted | | Mean | Standard Error | Liter | | 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 48 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. |
| |
| Secondary | FVC Peak (0-3h) Response At Day 1 | Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours aftertreatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. | | Posted | | Mean | Standard Error | Liter | | 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 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 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler. |
| |
| Secondary | FVC Peak (0-3h) Response After 2 Weeks | Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. | | Posted | | Mean | Standard Error | Liter | | 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 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 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. |
| |
| Secondary | FVC Peak (0-3h) Response After 6 Weeks | Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. | | Posted | | Mean | Standard Error | Liter | | 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. |
| |
| Secondary | FVC Peak (0-3h) Response After 12 Weeks | Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. | | Posted | | Mean | Standard Error | Liter | | 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. |
| |
| Secondary | FVC Peak (0-3h) Response After 24 Weeks | Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. | | Posted | | Mean | Standard Error | Liter | | 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. |
| |
| Secondary | FVC Peak (0-3h) Response After 48 Weeks | Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. | | Posted | | Mean | Standard Error | Liter | | 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. |
| |
| Secondary | Forced Vital Capacity (FVC) Area Under Curve 0-12 h (AUC 0-12h) Response at Day 85 (12 Weeks) | 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. Means are adjusted using a non-mixed effects model with treatment (trt), tio stratum, baseline as fixed effects. FVC 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. | Patients in FAS with spirometry data after 3 hours at Visit 5 (12-hour pulmonary function test set) | Posted | | Mean | Standard Error | Liter | | 1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and -1h and -10 min, 5 min, 15 min, 30 min, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h relative to dose at Day 85 (12 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. |
|
| Secondary | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEF) | Weekly mean pre-dose morning peak expiratory flow rate (PEF) at 48 weeks. PEFR measurements recorded by means of an e-Diary on a daily basis. This e-Diary was used to record the twice daily PEFs, study drug use, and rescue salbutamol (albuterol) use. The best of three readings for each measurement was recorded. | | Posted | | Mean | Standard Error | L/min | | immediately upon arising (before drug administration) from Screening to week 48 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. |
| |
| Secondary | Weekly Mean Evening Peak Expiratory Flow Rate (PEF) | Weekly mean evening peak expiratory flow rate (PEF) at 48 weeks. PEFR measurements recorded by means of an e-Diary on a daily basis. This e-Diary was used to record the twice daily PEFs, study drug use, and rescue salbutamol (albuterol) use. The best of three readings for each measurement was recorded. | | Posted | | Mean | Standard Error | L/min | | at bedtime from Screening to week 48 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. |
| |
| Secondary | Weekly Mean of Daily Daytime Rescue Use | The patient was to record in the e-Diary the number of puffs of salbutamol (albuterol) Metered-Dose Inhaler used each day and night. The weekly mean was calculated by taking the average of the number of puffs of rescue medication used each day during week 48. | | Posted | | Mean | Standard Error | Number of puffs | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. |
| |
| Secondary | Weekly Mean of Daily Nighttime Rescue Use | The patient was to record in the e-Diary the number of puffs of salbutamol (albuterol) Metered-Dose Inhaler used each day and night. The weekly mean was calculated by taking the average of the number of puffs of rescue medication used each night during week 48. | | Posted | | Mean | Standard Error | Number of puffs | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. |
| |
| Secondary | Weekly Mean of Daily (24h) Rescue Use | The patient was to record in the e-Diary the number of puffs of salbutamol (albuterol) Metered-Dose Inhaler used each day and night. The weekly mean was calculated by taking the average of the number of puffs of rescue medication used each 24 hour period during week 48. | | Posted | | Mean | Standard Error | Number of puffs | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. |
| |
| Secondary | Patient's Global Rating at Week 6 | Patients were asked to rate their respiratory condition relative to their condition prior to the first dose of study medication. The scale is a seven point scale: 1=very much better, 2=much better,3=a little better,4=no change,5=a little worse,6=much worse,7=very much worst. | | Posted | | Mean | Standard Error | Point on scale | | Week 6 visit | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. |
| |
| Secondary | Patient's Global Rating at Week 12 | Patients were asked to rate their respiratory condition relative to their condition prior to the first dose of study medication. The scale is a seven point scale: 1=very much better, 2=much better,3=a little better,4=no change,5=a little worse,6=much worse,7=very much worst. | | Posted | | Mean | Standard Error | Point on scale | | Week 12 visit | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. |
| |
| Secondary | Patient's Global Rating at Week 24 | Patients were asked to rate their respiratory condition relative to their condition prior to the first dose of study medication. The scale is a seven point scale: 1=very much better, 2=much better,3=a little better,4=no change,5=a little worse,6=much worse,7=very much worst. | | Posted | | Mean | Standard Error | Point on scale | | Week 24 visit | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. |
| |
| Secondary | Patient's Global Rating at Week 48 | Patients were asked to rate their respiratory condition relative to their condition prior to the first dose of study medication. The scale is a seven point scale: 1=very much better, 2=much better,3=a little better,4=no change,5=a little worse,6=much worse,7=very much worst. | | Posted | | Mean | Standard Error | Point on scale | | Week 48 visit | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. |
| |
| Secondary | Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation | Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor. Due to the limited number of events some statistics were not able to be calculated and are listed as N/A or are blank. The measured values presented are actually the First Quartile and 95% confidence interval. | Treated set- all patients who received at least one dose of study medication | Posted | | Mean | 95% Confidence Interval | days | | Baseline to end of study at 48 weeks. | | | | ID | Title | Description |
|---|
| OG000 | Placebo (Tiotropium) | Matching Placebo delivered by the Respimat Inhaler - tiotropium use stratum | | OG001 | Placebo (Non-tiotropium) | Matching Placebo delivered by the Respimat Inhaler - non-tiotropium use stratum. | | OG002 | Olo 5 mcg qd (Tiotropium) | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum |
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| Secondary | Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Leading to Hospitalization | Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations required hospitalization. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor. Due to the limited number of events some statistics were not able to be calculated and are listed as N/A or are blank. The measured values presented are actually the First Quartile and 95% confidence interval. | Treated set- all patients who received at least one dose of study medication | Posted | | Mean | 95% Confidence Interval | days | | Baseline to end of study at 48 weeks. | | | | ID | Title | Description |
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| OG000 | Placebo (Tiotropium) | Matching Placebo delivered by the Respimat Inhaler - tiotropium use stratum | | OG001 | Placebo (Non-tiotropium) | Matching Placebo delivered by the Respimat Inhaler - non-tiotropium use stratum. | | OG002 | Olo 5 mcg qd (Tiotropium) | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum |
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| Secondary | Time to First Moderate Chronic Obstructive Pulmonary Disease (COPD) Exacerbation | Qualifying events of COPD were specifically pre-defined in the protocol.Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. Moderate exacerbations were defined as exacerbations which did not lead to hospitalization but included treatment with antibiotics and/or systemic steroids. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor.Due to the limited number of events some statistics were not able to be calculated and are listed as N/A or are blank. The measured values presented are actually the First Quartile and 95% confidence interval.. | Treated set- all patients who received at least one dose of study medication | Posted | | Mean | 95% Confidence Interval | days | | Baseline to end of study at 48 weeks. | | | | ID | Title | Description |
|---|
| OG000 | Placebo (Tiotropium) | Matching Placebo delivered by the Respimat Inhaler - tiotropium use stratum | | OG001 | Placebo (Non-tiotropium) | Matching Placebo delivered by the Respimat Inhaler - non-tiotropium use stratum. | | OG002 | Olo 5 mcg qd (Tiotropium) | |
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| Secondary | Number of COPD Exacerbations | Mean number of COPD exacerbations per patient years. Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. | Treated set- all patients who received at least one dose of study medication | Posted | | Mean | Standard Error | COPD exacerbations | | Baseline to end of study at week 48 visit | | | | ID | Title | Description |
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| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler. |
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| Secondary | Number of COPD Exacerbations Requiring Hospitalization | Mean number of COPD exacerbations requiring hospitalization per patient years. Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations required hospitalization. | Treated set- all patients who received at least one dose of study medication | Posted | | Mean | Standard Error | COPD exacerbations | | Baseline to end of study at week 48 visit | | | | ID | Title | Description |
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| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler. |
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| Secondary | Number of Moderate Chronic Obstructive Pulmonary Disease (COPD) Exacerbations | Mean number of moderate COPD exacerbations per patient years. Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. Moderate exacerbations were defined as exacerbations which did not lead to hospitalization but included treatment with antibiotics and/or systemic steroids. | Treated set- all patients who received at least one dose of study medication | Posted | | Mean | Standard Error | COPD exacerbations | | Baseline to end of study at 48 weeks. | | | | ID | Title | Description |
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| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler. |
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| Secondary | Changes in Safety Parameters Related to Treatment | Occurence of bronchoconstriction, cardiac disorders and investigations related to treatment. Bronchoconstriction is defined as any of the following events: Drop in trough FEV1 >= 15%, Rescue medication use within 30 min of inhaling randomized treatment on a clinic test day or Cough, wheeze, or dyspnoea AE within 30 min of inhaling randomized treatment on a clinic test day. | | Posted | | Number | | percentage of participants | | 48 weeks | | | | ID | Title | Description |
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| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. |
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| Secondary | Change From Baseline in Potassium | Laboratory testing: Average change from baseline of potassium measured. The laboratory tests at Day 1 were considered the baseline measurements. | | Posted | | Mean | Standard Deviation | mmol/L | | Day 1 and at 12, 24 and 48 weeks | | | | ID | Title | Description |
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| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olo 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olo 10 mcg qd | Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler. |
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