| 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 |
|---|
| - OG000-0.007± 0.014
- OG0010.165± 0.014
- OG0020.169± 0.014
|
|
| | 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) | 0.172 | Standard Error of the Mean | 0.019 | | 95 | 0.135 | 0.209 | | | 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 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 | 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 | Olodaterol (Olo) 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olodaterol (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 | Olodaterol (Olo) 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olodaterol (Olo) 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. |
| |
| Secondary | Weekly Mean 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. | | Posted | | Mean | Standard Error | Number of puffs | | From Screening to week 48 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olodaterol (Olo) 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olodaterol (Olo) 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. |
| |
| Secondary | Weekly Mean 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. | | Posted | | Mean | Standard Error | Number of puffs | | From Screening to week 48 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olodaterol (Olo) 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olodaterol (Olo) 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. |
| |
| Secondary | Weekly Mean 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. | | Posted | | Mean | Standard Error | Number of puffs | | From Screening to week 48 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olodaterol (Olo) 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olodaterol (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 measure type is the First Quartile. | 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 | | OG003 |
|
| 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 measure type is the First Quartile. | 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 |
|
| 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. These exacerbations 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 measure type is the First Quartile. | 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 |
|
| Secondary | Number of COPD Exacerbations | 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 | Number of COPD exacerbations | | Baseline to end of study at 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 | Number of COPD Exacerbations Requiring 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. | Treated set- all patients who received at least one dose of study medication | Posted | | Mean | Standard Error | Number of COPD exacerbations | | Baseline to end of study at 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 | Number of Moderate Chronic Obstructive Pulmonary Disease (COPD) Exacerbations | 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 did not lead to hospitalization but included treatment with antibiotics and/or systemic steroids. | | Posted | | Mean | Standard Error | Number of COPD exacerbations | | Baseline to end of study at 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 | Changes in Safety Parameters Related to Treatment | Occurrence 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 |
|---|
| 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 | 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 |
|---|
| OG000 | Placebo | Matching Placebo delivered by the Respimat Inhaler. | | OG001 | Olodaterol (Olo) 5 mcg qd | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | | OG002 | Olodaterol (Olo) 10 mcg qd | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. |
| |