| Primary | 90% Constant Work Rate (CWR) Treadmill Endurance Time at 96 Weeks - Double-Blind Phase | Efficacy was assessed by measuring the exercise duration during a treadmill exercise test. | Full Analysis Set (FAS) includes all treated participants with a baseline and any post-dosing exercise duration data | Posted | | Least Squares Mean | 95% Confidence Interval | seconds | | baseline, 96 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | Tiotropium | Patients randomized to treatment with Tiotropium 18 micrograms |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000297.1(265.0 to 333.0)
- OG001336.6(302.5 to 374.7)
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Mixed Models Analysis | | 0.1062 | Based on a MMRM analysis with terms for treatment, centre and baseline. | Adjusted mean ratio | 1.13 | | | | 95 | 0.97 | 1.32 | | | | No | Superiority or Other | | |
|
| Secondary | 90% Constant Work Rate (CWR) Treadmill Endurance Time at 8 Weeks - Double-Blind Phase | Efficacy was assessed by measuring the exercise duration during a treadmill exercise test. | | Posted | | Least Squares Mean | 95% Confidence Interval | seconds | | baseline, 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | Tiotropium | Patients randomized to treatment with Tiotropium 18 micrograms |
| |
| Secondary | 90% Constant Work Rate (CWR) Treadmill Endurance Time at 16 Weeks - Double-Blind Phase | Efficacy was assessed by measuring the exercise duration during a treadmill exercise test. | | Posted | | Least Squares Mean | 95% Confidence Interval | seconds | | baseline, 16 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | Tiotropium | Patients randomized to treatment with Tiotropium 18 micrograms |
| |
| Secondary | 90% Constant Work Rate (CWR) Treadmill Endurance Time at 32 Weeks - Double-Blind Phase | Efficacy was assessed by measuring the exercise duration during a treadmill exercise test. | | Posted | | Least Squares Mean | 95% Confidence Interval | seconds | | baseline, 32 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | Tiotropium | Patients randomized to treatment with Tiotropium 18 micrograms |
| |
| Secondary | 90% Constant Work Rate (CWR) Treadmill Endurance Time at 48 Weeks - Double-Blind Phase | Efficacy was assessed by measuring the exercise duration during a treadmill exercise test. | | Posted | | Least Squares Mean | 95% Confidence Interval | seconds | | baseline, 48 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | Tiotropium | Patients randomized to treatment with Tiotropium 18 micrograms |
| |
| Secondary | 90% Constant Work Rate (CWR) Treadmill Endurance Time at 64 Weeks - Double-Blind Phase | Efficacy was assessed by measuring the exercise duration during a treadmill exercise test. | | Posted | | Least Squares Mean | 95% Confidence Interval | seconds | | baseline, 64 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | Tiotropium | Patients randomized to treatment with Tiotropium 18 micrograms |
| |
| Secondary | 90% Constant Work Rate (CWR) Treadmill Endurance Time at 80 Weeks - Double-Blind Phase | Efficacy was assessed by measuring the exercise duration during a treadmill exercise test. | | Posted | | Least Squares Mean | 95% Confidence Interval | seconds | | baseline, 80 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | Tiotropium | Patients randomized to treatment with Tiotropium 18 micrograms |
| |
| Secondary | Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 8 Weeks - Double-Blind Phase | FEV1 is the maximal amount of air you can forcefully exhale in one second. | | Posted | | Least Squares Mean | Standard Error | liters | | baseline, 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | Tiotropium | Patients randomized to treatment with Tiotropium 18 micrograms |
| |
| Secondary | Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 16 Weeks - Double-Blind Phase | FEV1 is the maximal amount of air you can forcefully exhale in one second. | | Posted | | Least Squares Mean | Standard Error | liters | | baseline, 16 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | Tiotropium | Patients randomized to treatment with Tiotropium 18 micrograms |
| |
| Secondary | Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 32 Weeks - Double-Blind Phase | FEV1 is the maximal amount of air you can forcefully exhale in one second. | | Posted | | Least Squares Mean | Standard Error | liters | | baseline, 32 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | Tiotropium | Patients randomized to treatment with Tiotropium 18 micrograms |
| |
| Secondary | Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 48 Weeks - Double-Blind Phase | FEV1 is the maximal amount of air you can forcefully exhale in one second. | | Posted | | Least Squares Mean | Standard Error | liters | | baseline, 48 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | Tiotropium | Patients randomized to treatment with Tiotropium 18 micrograms |
| |
| Secondary | Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 64 Weeks - Double-Blind Phase | FEV1 is the maximal amount of air you can forcefully exhale in one second. | | Posted | | Least Squares Mean | Standard Error | liters | | baseline, 64 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | Tiotropium | Patients randomized to treatment with Tiotropium 18 micrograms |
| |
| Secondary | Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 80 Weeks - Double-Blind Phase | FEV1 is the maximal amount of air you can forcefully exhale in one second. | | Posted | | Least Squares Mean | Standard Error | liters | | baseline, 80 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | Tiotropium | Patients randomized to treatment with Tiotropium 18 micrograms |
| |
| Secondary | Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 96 Weeks - Double-Blind Phase | FEV1 is the maximal amount of air you can forcefully exhale in one second. | | Posted | | Least Squares Mean | Standard Error | liters | | baseline, 96 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | Tiotropium | Patients randomized to treatment with Tiotropium 18 micrograms |
| |
| Secondary | Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 8 Weeks - Double-Blind Phase | FEV1 is the maximal amount of air you can forcefully exhale in one second. | | Posted | | Least Squares Mean | Standard Error | liters | | baseline, 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | Tiotropium | Patients randomized to treatment with Tiotropium 18 micrograms |
| |
| Secondary | Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 16 Weeks - Double-Blind Phase | FEV1 is the maximal amount of air you can forcefully exhale in one second. | | Posted | | Least Squares Mean | Standard Error | liters | | baseline, 16 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | Tiotropium | Patients randomized to treatment with Tiotropium 18 micrograms |
| |
| Secondary | Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 32 Weeks - Double-Blind Phase | FEV1 is the maximal amount of air you can forcefully exhale in one second. | | Posted | | Least Squares Mean | Standard Error | liters | | baseline, 32 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | Tiotropium | Patients randomized to treatment with Tiotropium 18 micrograms |
| |
| Secondary | Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 48 Weeks - Double-Blind Phase | FEV1 is the maximal amount of air you can forcefully exhale in one second. | | Posted | | Least Squares Mean | Standard Error | liters | | baseline, 48 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | Tiotropium | Patients randomized to treatment with Tiotropium 18 micrograms |
| |
| Secondary | Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 64 Weeks - Double-Blind Phase | FEV1 is the maximal amount of air you can forcefully exhale in one second. | | Posted | | Least Squares Mean | Standard Error | liters | | baseline, 64 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | Tiotropium | Patients randomized to treatment with Tiotropium 18 micrograms |
| |
| Secondary | Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 80 Weeks - Double-Blind Phase | FEV1 is the maximal amount of air you can forcefully exhale in one second. | | Posted | | Least Squares Mean | Standard Error | liters | | baseline, 80 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | Tiotropium | Patients randomized to treatment with Tiotropium 18 micrograms |
| |
| Secondary | Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 96 Weeks - Double-Blind Phase | FEV1 is the maximal amount of air you can forcefully exhale in one second. | | Posted | | Least Squares Mean | Standard Error | liters | | baseline, 96 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | Tiotropium | Patients randomized to treatment with Tiotropium 18 micrograms |
| |
| Secondary | Pre-treatment Forced Vital Capacity (FVC) at 8 Weeks - Double-Blind Phase | FVC is the volume of air that can be forcibly blown out after full inspiration. | | Posted | | Least Squares Mean | Standard Error | liters | | baseline, 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | Tiotropium | Patients randomized to treatment with Tiotropium 18 micrograms |
| |
| Secondary | Pre-treatment Forced Vital Capacity (FVC) at 16 Weeks - Double-Blind Phase | FVC is the volume of air that can be forcibly blown out after full inspiration. | | Posted | | Least Squares Mean | Standard Error | liters | | baseline, 16 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | Tiotropium | Patients randomized to treatment with Tiotropium 18 micrograms |
| |
| Secondary | Pre-treatment Forced Vital Capacity (FVC) at 32 Weeks - Double-Blind Phase | FVC is the volume of air that can be forcibly blown out after full inspiration. | | Posted | | Least Squares Mean | Standard Error | liters | | baseline, 32 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | Tiotropium | Patients randomized to treatment with Tiotropium 18 micrograms |
| |
| Secondary | Pre-treatment Forced Vital Capacity (FVC) at 48 Weeks - Double-Blind Phase | FVC is the volume of air that can be forcibly blown out after full inspiration. | | Posted | | Least Squares Mean | Standard Error | liters | | baseline, 48 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | Tiotropium | Patients randomized to treatment with Tiotropium 18 micrograms |
| |
| Secondary | Pre-treatment Forced Vital Capacity (FVC) at 64 Weeks - Double-Blind Phase | FVC is the volume of air that can be forcibly blown out after full inspiration. | | Posted | | Least Squares Mean | Standard Error | liters | | baseline, 64 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | Tiotropium | Patients randomized to treatment with Tiotropium 18 micrograms |
| |
| Secondary | Pre-treatment Forced Vital Capacity (FVC) at 80 Weeks - Double-Blind Phase | FVC is the volume of air that can be forcibly blown out after full inspiration. | | Posted | | Least Squares Mean | Standard Error | liters | | baseline, 80 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | Tiotropium | Patients randomized to treatment with Tiotropium 18 micrograms |
| |
| Secondary | Pre-treatment Forced Vital Capacity (FVC) at 96 Weeks - Double-Blind Phase | FVC is the volume of air that can be forcibly blown out after full inspiration. | | Posted | | Least Squares Mean | Standard Error | liters | | baseline, 96 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | Tiotropium | Patients randomized to treatment with Tiotropium 18 micrograms |
| |
| Secondary | Post-treatment Forced Vital Capacity (FVC) at 8 Weeks - Double-Blind Phase | FVC is the volume of air that can be forcibly blown out after full inspiration. | | Posted | | Least Squares Mean | Standard Error | liters | | baseline, 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | Tiotropium | Patients randomized to treatment with Tiotropium 18 micrograms |
| |
| Secondary | Post-treatment Forced Vital Capacity (FVC) at 16 Weeks - Double-Blind Phase | FVC is the volume of air that can be forcibly blown out after full inspiration. | | Posted | | Least Squares Mean | Standard Error | liters | | baseline, 16 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | Tiotropium | Patients randomized to treatment with Tiotropium 18 micrograms |
| |
| Secondary | Post-treatment Forced Vital Capacity (FVC) at 32 Weeks - Double-Blind Phase | FVC is the volume of air that can be forcibly blown out after full inspiration. | | Posted | | Least Squares Mean | Standard Error | liters | | baseline, 32 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | Tiotropium | Patients randomized to treatment with Tiotropium 18 micrograms |
| |
| Secondary | Post-treatment Forced Vital Capacity (FVC) at 48 Weeks - Double-Blind Phase | FVC is the volume of air that can be forcibly blown out after full inspiration. | | Posted | | Least Squares Mean | Standard Error | liters | | baseline, 48 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | Tiotropium | Patients randomized to treatment with Tiotropium 18 micrograms |
| |
| Secondary | Post-treatment Forced Vital Capacity (FVC) at 64 Weeks - Double-Blind Phase | FVC is the volume of air that can be forcibly blown out after full inspiration. | | Posted | | Least Squares Mean | Standard Error | liters | | baseline, 64 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | Tiotropium | Patients randomized to treatment with Tiotropium 18 micrograms |
| |
| Secondary | Post-treatment Forced Vital Capacity (FVC) at 80 Weeks - Double-Blind Phase | FVC is the volume of air that can be forcibly blown out after full inspiration. | | Posted | | Least Squares Mean | Standard Error | liters | | baseline, 80 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | Tiotropium | Patients randomized to treatment with Tiotropium 18 micrograms |
| |
| Secondary | Post-treatment Forced Vital Capacity (FVC) at 96 Weeks - Double-Blind Phase | FVC is the volume of air that can be forcibly blown out after full inspiration. | | Posted | | Least Squares Mean | Standard Error | liters | | baseline, 96 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | Tiotropium | Patients randomized to treatment with Tiotropium 18 micrograms |
| |
| Secondary | Borg Scale of Dyspnea at Isotime After 96 Weeks - Double-Blind Phase | Borg scale assessed degreee of discomfort on a scale from 0 (Nothing at all) to 10 (Maximal) | | Posted | | Least Squares Mean | Standard Error | units on scale | | baseline, 96 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | Tiotropium | Patients randomized to treatment with Tiotropium 18 micrograms |
| |
| Secondary | Borg Scale of Peak Dyspnea After 96 Weeks - Double-Blind Phase | Borg scale assessed degreee of discomfort on a scale from 0 (Nothing at all) to 10 (Maximal) | | Posted | | Least Squares Mean | Standard Error | unit on scale | | baseline, 96 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | Tiotropium | Patients randomized to treatment with Tiotropium 18 micrograms |
| |
| Secondary | Borg Scale of Peak Leg Discomfort After 96 Weeks - Double-Blind Phase | Borg scale assessed degreee of discomfort on a scale from 0 (Nothing at all) to 10 (Maximal) | | Posted | | Least Squares Mean | Standard Error | unit on scale | | baseline, 96 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | Tiotropium | Patients randomized to treatment with Tiotropium 18 micrograms |
| |
| Secondary | Change From Baseline in Physician Global Evaluation at 8 Weeks - Double-Blind Phase | The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent) | | Posted | | Mean | Standard Error | unit on scale | | baseline, 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | Tiotropium | Patients randomized to treatment with Tiotropium 18 micrograms |
| |
| Secondary | Change From Baseline in Physician Global Evaluation at 16 Weeks - Double-Blind Phase | The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent) | | Posted | | Mean | Standard Error | units on scale | | baseline, 16 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | Tiotropium | Patients randomized to treatment with Tiotropium 18 micrograms |
| |
| Secondary | Change From Baseline in Physician Global Evaluation at 32 Weeks - Double-Blind Phase | The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent) | | Posted | | Mean | Standard Error | units on scale | | baseline, 32 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | Tiotropium | Patients randomized to treatment with Tiotropium 18 micrograms |
| |
| Secondary | Change From Baseline in Physician Global Evaluation at 48 Weeks - Double-Blind Phase | The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent) | | Posted | | Mean | Standard Error | units on scale | | baseline, 48 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | Tiotropium | Patients randomized to treatment with Tiotropium 18 micrograms |
| |
| Secondary | Change From Baseline in Physician Global Evaluation at 64 Weeks - Double-Blind Phase | The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent) | | Posted | | Mean | Standard Error | units on scale | | baseline, 64 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | Tiotropium | Patients randomized to treatment with Tiotropium 18 micrograms |
| |
| Secondary | Change From Baseline in Physician Global Evaluation at 80 Weeks - Double-Blind Phase | The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent) | | Posted | | Mean | Standard Error | units on scale | | baseline, 80 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | Tiotropium | Patients randomized to treatment with Tiotropium 18 micrograms |
| |
| Secondary | Change From Baseline in Physician Global Evaluation at 96 Weeks - Double-Blind Phase | The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent) | | Posted | | Mean | Standard Error | units on scale | | baseline, 96 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | Tiotropium | Patients randomized to treatment with Tiotropium 18 micrograms |
| |
| Secondary | Change From Baseline in Patient Global Evaluation at 8 Weeks - Double-Blind Phase | The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent) | | Posted | | Mean | Standard Error | units on scale | | baseline, 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | Tiotropium | Patients randomized to treatment with Tiotropium 18 micrograms |
| |
| Secondary | Change From Baseline in Patient Global Evaluation at 16 Weeks - Double-Blind Phase | The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent) | | Posted | | Mean | Standard Error | units on scale | | baseline, 16 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | Tiotropium | Patients randomized to treatment with Tiotropium 18 micrograms |
| |
| Secondary | Change From Baseline in Patient Global Evaluation at 32 Weeks - Double-Blind Phase | The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent) | | Posted | | Mean | Standard Error | units on scale | | baseline, 32 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | Tiotropium | Patients randomized to treatment with Tiotropium 18 micrograms |
| |
| Secondary | Change From Baseline in Patient Global Evaluation at 48 Weeks - Double-Blind Phase | The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent) | | Posted | | Mean | Standard Error | units on scale | | baseline, 48 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | Tiotropium | Patients randomized to treatment with Tiotropium 18 micrograms |
| |
| Secondary | Change From Baseline in Patient Global Evaluation at 64 Weeks - Double-Blind Phase | The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent) | | Posted | | Mean | Standard Error | units on scale | | baseline, 64 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | Tiotropium | Patients randomized to treatment with Tiotropium 18 micrograms |
| |
| Secondary | Change From Baseline in Patient Global Evaluation at 80 Weeks - Double-Blind Phase | The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent) | | Posted | | Mean | Standard Error | units on scale | | baseline, 80 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | Tiotropium | Patients randomized to treatment with Tiotropium 18 micrograms |
| |
| Secondary | Change From Baseline in Patient Global Evaluation at 96 Weeks - Double-Blind Phase | The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent) | | Posted | | Mean | Standard Error | units on scale | | baseline, 96 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | Tiotropium | Patients randomized to treatment with Tiotropium 18 micrograms |
| |
| Secondary | Saint George's Respiratory Questionnaire Total Score at 96 Weeks - Double-Blind Phase | Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status. | | Posted | | Least Squares Mean | Standard Error | units on scale | | baseline, 96 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | Tiotropium | Patients randomized to treatment with Tiotropium 18 micrograms |
| |
| Secondary | Saint George's Respiratory Questionnaire Activity Component Score at 96 Weeks - Double-Blind Phase | Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status. | | Posted | | Least Squares Mean | Standard Error | units on scale | | baseline, 96 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | Tiotropium | Patients randomized to treatment with Tiotropium 18 micrograms |
| |
| Secondary | Saint George's Respiratory Questionnaire Impact Component Score at 96 Weeks - Double-Blind Phase | Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status. | | Posted | | Least Squares Mean | Standard Error | units on scale | | baseline, 96 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | Tiotropium | Patients randomized to treatment with Tiotropium 18 micrograms |
| |
| Secondary | Saint George's Respiratory Questionnaire Symptoms Component Score at 96 Weeks - Double-Blind Phase | Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status. | | Posted | | Least Squares Mean | Standard Error | units on scale | | baseline, 96 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | Tiotropium | Patients randomized to treatment with Tiotropium 18 micrograms |
| |
| Secondary | Patients With COPD Exacerbation (Survival Analysis) - Double-Blind Phase | COPD exacerbation is a complex of symptoms related to COPD with a duration of three days or more requiring a change of treatment. | | Posted | | Number | | participants | | baseline, 96 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | Tiotropium | Patients randomized to treatment with Tiotropium 18 micrograms |
| |
| Secondary | 90% Constant Work Rate (CWR) Treadmill Endurance Time at 100 Weeks - Open-Label Phase | Efficacy was assessed by measuring the exercise duration during a treadmill exercise test. | | Posted | | Least Squares Mean | 95% Confidence Interval | seconds | | baseline, 100 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo / Open Tiotropium | Patients receive open label tiotropium following placebo | | OG001 | Tiotropium / Open Tiotropium | Patients receive open label tiotropium following tiotropium |
| |
| Secondary | Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 100 Weeks - Open-Label Phase | FEV1 is the maximal amount of air you can forcefully exhale in one second. | | Posted | | Least Squares Mean | Standard Error | liters | | baseline, 100 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo / Open Tiotropium | Patients receive open label tiotropium following placebo | | OG001 | Tiotropium / Open Tiotropium | Patients receive open label tiotropium following tiotropium |
| |
| Secondary | Post-treatment Forced Vital Capacity (FVC) at 100 Weeks - Open-Label Phase | FVC is the volume of air that can be forcibly blown out after full inspiration. | | Posted | | Least Squares Mean | Standard Error | liters | | baseline, 100 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo / Open Tiotropium | Patients receive open label tiotropium following placebo | | OG001 | Tiotropium / Open Tiotropium | Patients receive open label tiotropium following tiotropium |
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| Secondary | Saint George's Respiratory Questionnaire Total Score at 100 Weeks - Open-Label Phase | Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status. | | Posted | | Least Squares Mean | Standard Error | units on scale | | baseline, 100 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo / Open Tiotropium | Patients receive open label tiotropium following placebo | | OG001 | Tiotropium / Open Tiotropium | Patients receive open label tiotropium following tiotropium |
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| Secondary | Saint George's Respiratory Questionnaire Activity Component Score at 100 Weeks - Open-Label Phase | Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status. | | Posted | | Least Squares Mean | Standard Error | units on scale | | baseline, 100 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo / Open Tiotropium | Patients receive open label tiotropium following placebo | | OG001 | Tiotropium / Open Tiotropium | Patients receive open label tiotropium following tiotropium |
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| Secondary | Saint George's Respiratory Questionnaire Impact Component Score at 100 Weeks - Open-Label Phase | Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status. | | Posted | | Least Squares Mean | Standard Error | units on scale | | baseline, 100 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo / Open Tiotropium | Patients receive open label tiotropium following placebo | | OG001 | Tiotropium / Open Tiotropium | Patients receive open label tiotropium following tiotropium |
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| Secondary | Saint George's Respiratory Questionnaire Symptoms Component Score at 100 Weeks - Open-Label Phase | Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status. | | Posted | | Least Squares Mean | Standard Error | units on scale | | baseline, 100 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo / Open Tiotropium | Patients receive open label tiotropium following placebo | | OG001 | Tiotropium / Open Tiotropium | Patients receive open label tiotropium following tiotropium |
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| Secondary | Clinical Relevant Abnormalities for Vital Signs and Physical Examination, Including Vital Status | Clinical Relevant Abnormalities for Vital Signs and Physical examination, including vital status. Any new or clinically relevant worsening of baseline conditions was reported as Adverse Events. | | Posted | | Number | | participants | | From first drug administration until 30 days after last drug administration | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | Tiotropium | Patients randomized to treatment with Tiotropium 18 micrograms | | OG002 | Placebo / Open Tiotropium | Patients receive open label tiotropium following placebo | | OG003 | Tiotropium / Open Tiotropium | Patients receive open label tiotropium following tiotropium |
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