| Primary | Change From Baseline in Lung Function as Measured by the Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve From 0-3h (AUC0-3h) | Change = Week 24 Value - Baseline Value | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Least Squares Mean | Standard Error | litres * hours | | baseline, week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-0.06± 0.02
- OG0010.16± 0.02
|
|
| | 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 |
|---|
| | ANCOVA | The analysis of covariance model included treatment, site, and trough forced expiratory volume in 1 second at baseline in the model. | <0.001 | There was only one primary endpoint and the p-value was not adjusted for multiple comparisons. Mean Difference (Final Values) means difference in LS-Means | Mean Difference (Final Values) | 0.23 | | | | 95 | 0.18 | 0.27 | | | | No | Superiority or Other | | |
|
| Secondary | Trough Forced Expiratory Volume in 1 Second (FEV1)(Baseline) | Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication. | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Mean | Standard Deviation | litres | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 8) | Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication. | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Mean | Standard Deviation | litres | | Baseline, week 8 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 16) | Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication. | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Mean | Standard Deviation | litres | | Baseline, week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 24) | Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication. | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Least Squares Mean | Standard Error | litres | | Baseline, week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Peak Forced Expiratory Volume in 1 Second (Baseline) | Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Mean | Standard Deviation | litres | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 8) | Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit. | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Mean | Standard Deviation | litres | | Baseline, week 8 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16) | Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit. | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Mean | Standard Deviation | litres | | Baseline, week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24) | Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit. | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Least Squares Mean | Standard Error | litres | | Baseline, week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Forced Expiratory Volume in 1 Second (Baseline, Pre-dose) | Forced expiratory volume in 1 second (baseline, pre-dose) | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Mean | Standard Deviation | litres | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Forced Expiratory Volume in 1 Second (Baseline, 30 Minutes) | Forced expiratory volume in 1 second (baseline, 30 minutes) | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Mean | Standard Deviation | litres | | baseline, 30 minutes | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Forced Expiratory Volume in 1 Second (Baseline, 60 Minutes) | Forced expiratory volume in 1 second (baseline, 60 minutes) | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Mean | Standard Deviation | litres | | baseline, 60 minutes | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Forced Expiratory Volume in 1 Second (Baseline, 120 Minutes) | Forced expiratory volume in 1 second (baseline, 120 minutes) | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Mean | Standard Deviation | litres | | Baseline, 120 minutes | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Forced Expiratory Volume in 1 Second (Baseline, 180 Minutes) | Forced expiratory volume in 1 second (baseline, 180 minutes) | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Mean | Standard Deviation | litres | | Baseline, 180 minutes | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, Pre-dose) | Change from baseline in forced expiratory volume in 1 second (at week 8, pre-dose) | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Mean | Standard Deviation | litres | | baseline, week 8, pre-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 30 Minutes) | Change from baseline in forced expiratory volume in 1 second (at week 8, 30 minutes) | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Mean | Standard Deviation | litres | | Baseline, week 8, 30 minutes | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 60 Minutes) | Change from baseline in forced expiratory volume in 1 second (at week 8, 60 minutes) | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Mean | Standard Deviation | litres | | baseline, week 8, 60 minutes | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 120 Minutes) | Change from baseline in forced expiratory volume in 1 second (at week 8, 120 minutes) | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Mean | Standard Deviation | litres | | baseline, week 8, 120 minutes | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 180 Minutes) | Change from baseline in forced expiratory volume in 1 second (at week 8, 180 minutes) | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Mean | Standard Deviation | litres | | baseline, week 8, 180 minutes | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 16, Pre-dose) | Change from baseline in forced expiratory volume in 1 second (at week 16, pre-dose) | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Mean | Standard Deviation | litres | | baseline, week 16, pre-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 30 Minutes) | Change from baseline in peak forced expiratory volume in 1 second (at week 16, 30 minutes) | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Mean | Standard Deviation | litres | | Baseline, week 16, 30 minutes | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 60 Minutes) | Change from baseline in peak forced expiratory volume in 1 second (at week 16, 60 minutes) | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Mean | Standard Deviation | litres | | baseline, week 16, 60 minutes | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 120 Minutes) | Change from baseline in peak forced expiratory volume in 1 second (at week 16, 120 minutes) | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Mean | Standard Deviation | litres | | baseline, week 16, 120 minutes | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 180 Minutes) | Change from baseline in peak forced expiratory volume in 1 second (at week 16, 180 minutes) | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Mean | Standard Deviation | litres | | baseline, week 16, 180 minutes | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, Pre-dose) | Change from baseline in peak forced expiratory volume in 1 second (at week 24, pre-dose) | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Least Squares Mean | Standard Error | litres | | baseline, week 24, pre-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 30 Minutes) | Change from baseline in peak forced expiratory volume in 1 second (at week 24, 30 minutes) | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Least Squares Mean | Standard Error | litres | | baseline, week 24, 30 minutes | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 60 Minutes) | Change from baseline in peak forced expiratory volume in 1 second (at week 24, 60 minutes) | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Least Squares Mean | Standard Error | litres | | baseline, week 24, 60 minutes | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 120 Minutes) | Change from baseline in peak forced expiratory volume in 1 second (at week 24, 120 minutes) | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Least Squares Mean | Standard Error | litres | | baseline, week 24, 120 minutes | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 180 Minutes) | Change from baseline in peak forced expiratory volume in 1 second (at week 24, 180 minutes) | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Least Squares Mean | Standard Error | litres | | baseline, week 24, 180 minutes | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | FVC AUC0-3 at Baseline | Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h) | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Mean | Standard Deviation | litres * hours | | baseline | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | FVC AUC0-3 at Week 8 Minus Baseline | Change from baseline in Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h) (week 8) | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Mean | Standard Deviation | litres * hours | | baseline, week 8 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | FVC AUC0-3 at Week 16 Minus Baseline | Change from baseline in Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h)(week 16) | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Mean | Standard Deviation | litres * hours | | baseline, week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | FVC AUC0-3 at Week 24 Minus Baseline | Change from baseline in Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h) (week 24) | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Least Squares Mean | Standard Error | litres * hours | | baseline, week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Trough Forced Vital Capacity (Baseline) | Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication. | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Mean | Standard Deviation | litres | | baseline | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Trough Forced Vital Capacity (at Week 8) | Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication. | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Mean | Standard Deviation | litres | | baseline, week 8 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Trough Forced Vital Capacity (at Week 16) | Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication. | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Mean | Standard Deviation | litres | | baseline, week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Trough Forced Vital Capacity (at Week 24) | Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication. | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Least Squares Mean | Standard Error | litres | | baseline, week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Peak Forced Vital Capacity (FVC) (Baseline) | Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Mean | Standard Deviation | litres | | baseline | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Peak Forced Vital Capacity (at Week 8) | Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit. | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Mean | Standard Deviation | litres | | baseline, week 8 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Peak Forced Vital Capacity (at Week 16) | Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit. | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Mean | Standard Deviation | litres | | baseline, week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Peak Forced Vital Capacity (at Week 24) | Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit. | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Least Squares Mean | Standard Error | litres | | baseline, week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Forced Vital Capacity (Baseline, Pre-dose) | Forced vital capacity (baseline, pre-dose) | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Mean | Standard Deviation | litres | | baseline | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Forced Vital Capacity (Baseline, 30 Minutes) | Forced vital capacity (baseline, 30 minutes) | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Mean | Standard Deviation | litres | | baseline, 30 minutes | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Forced Vital Capacity (Baseline, 60 Minutes) | Forced vital capacity (baseline, 60 minutes) | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Mean | Standard Deviation | litres | | baseline, 60 minutes | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Forced Vital Capacity (Baseline, 120 Minutes) | Forced vital capacity (baseline, 120 minutes) | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Mean | Standard Deviation | litres | | baseline, 120 minutes | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Forced Vital Capacity (Baseline, 180 Minutes) | Forced vital capacity (baseline, 180 minutes) | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Mean | Standard Deviation | litres | | baseline, 180 minutes | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Forced Vital Capacity (Week 8, Pre-dose) | Change from baseline in forced vital capacity (week 8, pre-dose) | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Mean | Standard Deviation | litres | | baseline, week 8, pre-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Forced Vital Capacity (Week 8, 30 Minutes) | Change from baseline in forced vital capacity (week 8, 30 minutes) | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Mean | Standard Deviation | litres | | baseline, week 8, 30 minutes | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Forced Vital Capacity (Week 8, 60 Minutes) | Change from baseline in forced vital capacity (week 8, 60 minutes) | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Mean | Standard Deviation | litres | | baseline, week 8, 60 minutes | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Forced Vital Capacity (Week 8, 120 Minutes) | Change from baseline in forced vital capacity (week 8, 120 minutes) | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Mean | Standard Deviation | litres | | baseline, week 8, 120 minutes | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Forced Vital Capacity (Week 8, 180 Minutes) | Change from baseline in forced vital capacity (week 8, 180 minutes) | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Mean | Standard Deviation | litres | | baseline, week 8, 180 minutes | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Forced Vital Capacity (Week 16, Pre-dose) | Change from baseline in forced vital capacity (week 16, pre-dose) | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Mean | Standard Deviation | litres | | baseline, week 16, pre-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Forced Vital Capacity (Week 16, 30 Minutes) | Change from baseline in forced vital capacity (week 16, 30 minutes) | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Mean | Standard Deviation | litres | | baseline, week 16, 30 minutes | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Forced Vital Capacity (Week 16, 60 Minutes) | Change from baseline in forced vital capacity (week 16, 60 minutes) | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Mean | Standard Deviation | litres | | baseline, week 16, 60 minutes | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Forced Vital Capacity (Week 16, 120 Minutes) | Change from baseline in forced vital capacity (week 16, 120 minutes) | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Mean | Standard Deviation | litres | | baseline, week 16, 120 minutes | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Forced Vital Capacity (Week 16, 180 Minutes) | Change from baseline in forced vital capacity (week 16, 180 minutes) | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Mean | Standard Deviation | litres | | baseline, week 16, 180 minutes | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Forced Vital Capacity (Week 24, Pre-dose) | Change from baseline in forced vital capacity (week 24, pre-dose) | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Least Squares Mean | Standard Error | litres | | baseline, week 24, pre-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Forced Vital Capacity (Week 24, 30 Minutes) | Change from baseline in forced vital capacity (week 24, 30 minutes) | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Least Squares Mean | Standard Error | litres | | baseline, week 24, 30 minutes | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Forced Vital Capacity (Week 24, 60 Minutes) | Change from baseline in forced vital capacity (week 24, 60 minutes) | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Least Squares Mean | Standard Error | litres | | baseline, week 24, 60 minutes | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Forced Vital Capacity (Week 24, 120 Minutes) | Change from baseline in forced vital capacity (week 24, 120 minutes) | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Least Squares Mean | Standard Error | litres | | baseline, week 24, 120 minutes | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Forced Vital Capacity (Week 24, 180 Minutes) | Change from baseline in forced vital capacity (week 24, 180 minutes) | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Least Squares Mean | Standard Error | litres | | baseline, week 24, 180 minutes | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Albuterol Use p.r.n. (Baseline) | Number of days that participants used albuterol prn per week | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Mean | Standard Deviation | days | | baseline | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Albuterol Use p.r.n. - (Week 4) | Difference in number of days that participants used albuterol prn per week between week 4 and baseline | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Mean | Standard Deviation | days | | baseline, week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Albuterol Use p.r.n. - (Week 8) | Difference in number of days that participants used albuterol prn per week between week 8 and baseline | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Mean | Standard Deviation | days | | baseline, week 8 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Albuterol Use p.r.n. -(Week 12) | Difference in number of days that participants used albuterol prn per week between week 12 and baseline | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Mean | Standard Deviation | days | | baseline, week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Albuterol Use p.r.n. - (Week 16) | Difference in number of days that participants used albuterol prn per week between week 16 and baseline | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Mean | Standard Deviation | days | | baseline, week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Albuterol Use p.r.n. -(Week 20) | Difference in number of days that participants used albuterol prn per week between week 20 and baseline | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Mean | Standard Deviation | days | | baseline, week 20 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Albuterol Use p.r.n. - (Week 24) | Difference in number of days that participants used albuterol prn per week between week 24 and baseline | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Least Squares Mean | Standard Error | days | | baseline, week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Number of Participants With Categorical Scores on Physician's Global Assessment (Baseline) | The physician's global assessment reflected the physician's opinion of the participant's overall clinical condition with respect to COPD. The evaluation was based on the participant's use of concomitant medications, as well as the number and severity of COPD exacerbations and related emergency room visits and/or hospitalizations since the last visit. The frequency and severity of symptoms ( cough, dyspnea, wheezing) and the impact of these on the participant's ability to exercise were considered. Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent. | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Number | | Participants | | baseline | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Number of Participants With Categorical Scores on Physician's Global Assessment (Week 12) | The physician's global assessment reflected the physician's opinion of the participant's overall clinical condition with respect to COPD. The evaluation was based on the participant's use of concomitant medications, as well as the number and severity of COPD exacerbations and related emergency room visits and/or hospitalizations since the last visit. The frequency and severity of symptoms ( cough, dyspnea, wheezing) and the impact of these on the participant's ability to exercise were considered. Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent. | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Number | | Participants | | week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Number of Participants With Categorical Scores on Physician's Global Assessment (Week 24) | The physician's global assessment reflected the physician's opinion of the participant's overall clinical condition with respect to COPD. The evaluation was based on the participant's use of concomitant medications, as well as the number and severity of COPD exacerbations and related emergency room visits and/or hospitalizations since the last visit. The frequency and severity of symptoms ( cough, dyspnea, wheezing) and the impact of these on the participant's ability to exercise were considered. Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent. | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Number | | Participants | | week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Number of Participants With Categorical Scores on Patient's Global Assessment (Baseline) | The patient's global assessment was based on the subject's need to take additional medications for breathing, their need for emergency room or hospital visits for COPD, and severity and amount of coughing, wheezing, and/or breathing discomfort experienced, and the impact of these symptoms on the subject's ability to exercise and perform daily activities. Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent. | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Number | | Participants | | baseline | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Number of Participants With Categorical Scores on Patient's Global Assessment (Week 12) | The patient's global assessment was based on the subject's need to take additional medications for breathing, their need for emergency room or hospital visits for COPD, and severity and amount of coughing, wheezing, and/or breathing discomfort experienced, and the impact of these symptoms on the subject's ability to exercise and perform daily activities. Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent. | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Number | | Participants | | week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Number of Participants With Categorical Scores on Patient's Global Assessment (Week 24) | The patient's global assessment was based on the subject's need to take additional medications for breathing, their need for emergency room or hospital visits for COPD, and severity and amount of coughing, wheezing, and/or breathing discomfort experienced, and the impact of these symptoms on the subject's ability to exercise and perform daily activities. Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent. | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Number | | Participants | | week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Baseline) | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Mean | Standard Deviation | units on a scale | | baseline | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 4) | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline. | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Least Squares Mean | Standard Error | units on a scale | | baseline, week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 8) | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline. | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Least Squares Mean | Standard Error | units on a scale | | baseline, week 8 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 12) | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline. | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Least Squares Mean | Standard Error | units on a scale | | baseline, week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 16) | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline. | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Least Squares Mean | Standard Error | units on a scale | | baseline, week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 20) | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline. | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Least Squares Mean | Standard Error | units on a scale | | baseline, week 20 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 24) | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline. | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Least Squares Mean | Standard Error | units on a scale | | baseline, week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Mean | Standard Deviation | units on a scale | | baseline | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 4) | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline. | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Least Squares Mean | Standard Error | units on a scale | | baseline, week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 8) | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline. | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Least Squares Mean | Standard Error | units on a scale | | baseline, week 8 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 12) | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline. | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Least Squares Mean | Standard Error | units on a scale | | baseline, week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 16) | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline. | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Least Squares Mean | Standard Error | units on a scale | | baseline, week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 20) | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline. | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Least Squares Mean | Standard Error | units on a scale | | baseline, week 20 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 24) | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline. | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Least Squares Mean | Standard Error | units on a scale | | baseline, week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Baseline) | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Mean | Standard Deviation | units on a scale | | baseline | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 4) | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline. | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Least Squares Mean | Standard Error | units on a scale | | baseline, week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 8) | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline. | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Least Squares Mean | Standard Error | units on a scale | | baseline, week 8 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 12) | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline. | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Least Squares Mean | Standard Error | units on a scale | | baseline, week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 16) | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline. | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Least Squares Mean | Standard Error | units on a scale | | baseline, week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 20) | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline. | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Least Squares Mean | Standard Error | units on a scale | | baseline, week 20 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 24) | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline. | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Least Squares Mean | Standard Error | units on a scale | | baseline, week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Baseline) | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Mean | Standard Deviation | units on a scale | | baseline | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 4) | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline. | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Least Squares Mean | Standard Error | units on a scale | | baseline, week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 8) | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline. | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Least Squares Mean | Standard Error | units on a scale | | baseline, week 8 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 12) | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline. | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Least Squares Mean | Standard Error | units on a scale | | baseline, week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 16) | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline. | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Least Squares Mean | Standard Error | units on a scale | | baseline, week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 20) | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline. | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Least Squares Mean | Standard Error | units on a scale | | baseline, week 20 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 24) | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline. | Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint | Posted | | Least Squares Mean | Standard Error | units on a scale | | baseline, week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Physical Activity (Light Intensity; Baseline) in Logarithm of Average Time Spent in Minutes Per Day | Light intensity is less than three metabolic equivalents. Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm. | Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days | Posted | | Mean | Standard Deviation | ln(minutes) | | baseline | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Physical Activity (Light Intensity; Week 4) in Logarithm of Average Time Spent in Minutes Per Day | Light intensity is less than three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm | Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days | Posted | | Least Squares Mean | Standard Error | ln(minutes) | | baseline, week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Physical Activity (Light Intensity; Week 8) in Logarithm of Average Time Spent in Minutes Per Day | Light intensity is less than three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm | Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days | Posted | | Least Squares Mean | Standard Error | ln(minutes) | | baseline, week 8 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Physical Activity (Light Intensity; Week 12) in Logarithm of Average Time Spent in Minutes Per Day | Light intensity defined as less than three metabolic equivalents. Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm | Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days | Posted | | Least Squares Mean | Standard Error | ln(minutes) | | baseline, week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Physical Activity (Light Intensity; Week 16) in Logarithm of Average Time Spent in Minutes Per Day | Light intensity is less than three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm | Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days | Posted | | Least Squares Mean | Standard Error | ln(minutes) | | baseline, week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Physical Activity (Light Intensity; Week 20) in Logarithm of Average Time Spent in Minutes Per Day | Light intensity is less than three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm | Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days | Posted | | Least Squares Mean | Standard Error | ln(minutes) | | baseline, week 20 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Physical Activity (Light Intensity; Week 24) in Logarithm of Average Time Spent in Minutes Per Day | Light intensity is less than three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm | Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days | Posted | | Least Squares Mean | Standard Error | ln(minutes) | | baseline, week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Physical Activity (Moderate or Higher Intensity; Baseline) in Logarithm of Average Time Spent in Minutes Per Day | Moderate or higher intensity is greater than or equal to three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm | Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days | Posted | | Mean | Standard Deviation | ln(minutes) | | baseline | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 4) in Logarithm of Average Time Spent in Minutes Per Day | Moderate or higher intensity is greater than or equal to three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm | Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days | Posted | | Least Squares Mean | Standard Error | ln(minutes) | | baseline, week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 8) in Logarithm of Average Time Spent in Minutes Per Day | Moderate or higher intensity is greater than or equal to three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm | Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days | Posted | | Least Squares Mean | Standard Error | ln(minutes) | | baseline, week 8 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 12) in Logarithm of Average Time Spent in Minutes Per Day | Moderate or higher intensity is greater than or equal to three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm | Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days | Posted | | Least Squares Mean | Standard Error | ln(minutes) | | baseline, week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 16) in Logarithm of Average Time Spent in Minutes Per Day | Moderate or higher intensity is greater than or equal to three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm | Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days | Posted | | Least Squares Mean | Standard Error | ln(minutes) | | baseline, week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 20) in Logarithm of Average Time Spent in Minutes Per Day | Moderate or higher intensity is greater than or equal to three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm | Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days | Posted | | Least Squares Mean | Standard Error | ln(minutes) | | baseline, week 20 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 24) in Logarithm of Average Time Spent in Minutes Per Day | Moderate or higher intensity is greater than or equal to three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm | Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days | Posted | | Least Squares Mean | Standard Error | ln(minutes) | | baseline, week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Number of Participants With Healthy Lifestyle (Baseline) | Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no | Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days | Posted | | Number | | Participants | | baseline | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Number of Participants With Healthy Lifestyle (Week 4) | Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no | Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days | Posted | | Number | | Participants | | week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Number of Participants With Healthy Lifestyle (Week 8) | Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no | Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days | Posted | | Number | | Participants | | week 8 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Number of Participants With Healthy Lifestyle (Week 12) | Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no | Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days | Posted | | Number | | Participants | | week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Number of Participants With Healthy Lifestyle (Week 16) | Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no | Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days | Posted | | Number | | Participants | | week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Number of Participants With Healthy Lifestyle (Week 20) | Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no | Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days | Posted | | Number | | Participants | | week 20 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Number of Participants With Healthy Lifestyle (Week 24) | Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no | Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days | Posted | | Number | | Participants | | week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Active Energy Expenditure (Baseline) | The amount of energy (kcal/day) that a person uses while physically active. | Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days | Posted | | Mean | Standard Deviation | kilo calories per day | | baseline | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Active Energy Expenditure (Week 4) | The amount of energy (kcal/day) that a person uses while physically active. | Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days | Posted | | Least Squares Mean | Standard Error | kilo calories per day | | baseline, week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Active Energy Expenditure (Week 8) | The amount of energy (kcal/day) that a person uses while physically active. | Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days | Posted | | Least Squares Mean | Standard Error | kilo calories per day | | baseline, week 8 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Active Energy Expenditure (Week 12) | The amount of energy (kcal/day) that a person uses while physically active. | Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days | Posted | | Least Squares Mean | Standard Error | kilo calories per day | | baseline, week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Active Energy Expenditure (Week 16) | The amount of energy (kcal/day) that a person uses while physically active. | Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days | Posted | | Least Squares Mean | Standard Error | kilo calories per day | | baseline, week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Active Energy Expenditure (Week 20) | The amount of energy (kcal/day) that a person uses while physically active. | Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days | Posted | | Least Squares Mean | Standard Error | kilo calories per day | | baseline, week 20 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Active Energy Expenditure (Week 24) | The amount of energy (kcal/day) that a person uses while physically active. | Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days | Posted | | Least Squares Mean | Standard Error | kilo calories per day | | baseline, week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Number of Steps Per Day (Baseline) | Number of steps per day (baseline) | Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days | Posted | | Mean | Standard Deviation | Steps | | baseline | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Number of Steps Per Day (Week 4) | Change from baseline in number of steps per day (week 4) | Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days | Posted | | Least Squares Mean | Standard Error | Steps | | baseline, week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Number of Steps Per Day(Week 8) | Change from baseline in number of steps per day (week 8) | Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days | Posted | | Least Squares Mean | Standard Error | Steps | | baseline, week 8 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Number of Steps Per Day (Week 12) | Change from baseline in Number of steps per day (week 12) | Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days | Posted | | Least Squares Mean | Standard Error | Steps | | baseline, week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Number of Steps Per Day (Week 16) | Change from baseline in number of steps per day (week 16) | Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days | Posted | | Least Squares Mean | Standard Error | Steps | | baseline, week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Number of Steps Per Day (Week 20) | Change from baseline in number of steps per day (week 20) | Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days | Posted | | Least Squares Mean | Standard Error | Steps | | baseline, week 20 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |
| Secondary | Change From Baseline in Number of Steps Per Day (Week 24) | Change from baseline in number of steps per day (week 24) | Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days | Posted | | Least Squares Mean | Standard Error | Steps | | baseline, week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matching tiotropium via HandiHaler® + PRN albuterol | | OG001 | Tiotropium | 18 mcg tiotropium via HandiHaler® + PRN albuterol |
| |