| Primary | Change From Baseline in Trough FEV1 After 48 Weeks | Change From Baseline in Trough Forced Expiratory Volume in 1 second (FEV1) after 48 weeks | Full Analysis Set - Clinic Spirometry (FAS-PFT) | Posted | | Mean | Standard Error | Litres | | 10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium Respimat 5mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg) | | OG001 | Tiotropium Respimat 10mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg) | | OG002 | Placebo | Placebo inhalation solution delivered from Respimat Inhaler (matching placebo) |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0000.077± 0.012
- OG0010.105± 0.012
- OG002-0.036± 0.012
|
|
| | 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 | ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value | <0.0001 | | Mean Difference (Final Values) | 0.113 | Standard Error of the Mean | 0.017 | | 95 | | | | | Tiotropium Respimat 5mcg - Placebo | No | Superiority or Other | | | | |
|
| Primary | Saint George's Respiratory Questionnaire (SGRQ) Total Score, Full Analysis Set - Saint George's Respiratory Questionnaire (FAS-QOL) | Rating scale of 3 domains - symptoms, activities and impact (weighted). Worst score = 100, best score = 0 | Full Analysis Set - Saint George's Respiratory Questionnaire (FAS-QOL) | Posted | | Mean | Standard Error | Points on a scale | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium Respimat 5mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg) | | OG001 | Tiotropium Respimat 10mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg) | | OG002 | Placebo | Placebo inhalation solution delivered from Respimat Inhaler (matching placebo) |
| |
| Primary | TDI Focal Score, Full Analysis Set - Transitional Dyspnoea Index (FAS-TDI) (Combined Studies) | Rating scale of 3 components - change in functional impairment, change in magnitude of tasks, change in magnitude of efforts. Worst score = -9, best score = +9 For this endpoint data of twin studies NCT00168844 and NCT00168831 was combined. | Full Analysis Set - Transitional Dyspnoea Index (FAS-TDI) | Posted | | Mean | Standard Error | Points on a scale | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium Respimat 5mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg) | | OG001 | Tiotropium Respimat 10mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg) | | OG002 | Placebo | Placebo inhalation solution delivered from Respimat Inhaler (matching placebo) |
| |
| Primary | COPD Exacerbation Rate, Safety Set (SS) (Combined Studies) | Number of Chronic Obstructive Pulmonary Disease (COPD) exacerbations per patient year For this endpoint data of the twin studies NCT00168844 and NCT00168831 was combined. | Safety Set. Combined analysis of studies NCT00168844 and NCT00168831. 670 patients analysed in total comprises 338 patients from NCT00168831 and 332 patients from study NCT00168844, 667 patients - 335 and 332, 653 patients - 334 and 319 respectively. | Posted | | Mean | Standard Deviation | Number of exacerbations per patient year | | 48 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium Respimat 5mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg) | | OG001 | Tiotropium Respimat 10mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg) | | OG002 | Placebo | Placebo inhalation solution delivered from Respimat Inhaler (matching placebo) |
| |
| Secondary | Change From Baseline in Heart Rate | Week 40 pre-dose - baseline | Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead electrocardiogram (ECG) and 24-hour Holter monitoring performed (see protocol and clinical trial report) | Posted | | Mean | Standard Deviation | beats per minute (bpm) | | Baseline to Week 40 pre-dose | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium Respimat 5mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg) | | OG001 | Tiotropium Respimat 10mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg) | | OG002 | Placebo | Placebo inhalation solution delivered from Respimat Inhaler (matching placebo) |
| |
| Secondary | Change From Baseline in PR Interval | | Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead electrocardiogram (ECG) and 24-hour Holter monitoring performed (see protocol and clinical trial report) | Posted | | Mean | Standard Deviation | milliseconds (msec) | | Baseline to Week 40 pre-dose | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium Respimat 5mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg) | | OG001 | Tiotropium Respimat 10mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg) | | OG002 | Placebo | Placebo inhalation solution delivered from Respimat Inhaler (matching placebo) |
| |
| Secondary | Change From Baseline in QRS Interval | Week 40 pre-dose - baseline | Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report) | Posted | | Mean | Standard Deviation | msec | | Baseline to Week 40 pre-dose | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium Respimat 5mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg) | | OG001 | Tiotropium Respimat 10mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg) | | OG002 | Placebo | Placebo inhalation solution delivered from Respimat Inhaler (matching placebo) |
| |
| Secondary | Change From Baseline in QT Interval | Week 40 pre-dose - baseline | Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report) | Posted | | Mean | Standard Deviation | msec | | Baseline to Week 40 pre-dose | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium Respimat 5mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg) | | OG001 | Tiotropium Respimat 10mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg) | | OG002 | Placebo | Placebo inhalation solution delivered from Respimat Inhaler (matching placebo) |
| |
| Secondary | Change From Baseline in QT Interval (Bazett) | Week 40 pre-dose - baseline | Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report) | Posted | | Mean | Standard Deviation | msec | | Baseline to Week 40 pre-dose | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium Respimat 5mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg) | | OG001 | Tiotropium Respimat 10mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg) | | OG002 | Placebo | Placebo inhalation solution delivered from Respimat Inhaler (matching placebo) |
| |
| Secondary | Change From Baseline in QT Interval (Fridericia) | Week 40 pre-dose - baseline | Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report) | Posted | | Mean | Standard Deviation | msec | | Baseline to Week 40 pre-dose | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium Respimat 5mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg) | | OG001 | Tiotropium Respimat 10mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg) | | OG002 | Placebo | Placebo inhalation solution delivered from Respimat Inhaler (matching placebo) |
| |
| Secondary | Change From Baseline in Heart Rate | | Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report) | Posted | | Mean | Standard Deviation | bpm | | Baseline to Week 40 | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium Respimat 5mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg) | | OG001 | Tiotropium Respimat 10mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg) | | OG002 | Placebo | Placebo inhalation solution delivered from Respimat Inhaler (matching placebo) |
| |
| Secondary | Change From Baseline in Supraventricular Premature Beat (SVPB) Total | | Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report) | Posted | | Mean | Standard Deviation | premature beats per 24 hours | | Baseline to Week 40 | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium Respimat 5mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg) | | OG001 | Tiotropium Respimat 10mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg) | | OG002 | Placebo | Placebo inhalation solution delivered from Respimat Inhaler (matching placebo) |
| |
| Secondary | Change From Baseline in SVPB Run Events | | Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report) | Posted | | Mean | Standard Deviation | events per 24 hours | | Baseline to Week 40 | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium Respimat 5mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg) | | OG001 | Tiotropium Respimat 10mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg) | | OG002 | Placebo | Placebo inhalation solution delivered from Respimat Inhaler (matching placebo) |
| |
| Secondary | Change From Baseline in SVPB Pairs | | Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report) | Posted | | Mean | Standard Deviation | pairs per 24 hours | | Baseline to Week 40 | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium Respimat 5mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg) | | OG001 | Tiotropium Respimat 10mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg) | | OG002 | Placebo | Placebo inhalation solution delivered from Respimat Inhaler (matching placebo) |
| |
| Secondary | Change From Baseline in Ventricular Premature Beat (VPB) Total | | Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report) | Posted | | Mean | Standard Deviation | premature beats per 24 hours | | Baseline to Week 40 | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium Respimat 5mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg) | | OG001 | Tiotropium Respimat 10mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg) | | OG002 | Placebo | Placebo inhalation solution delivered from Respimat Inhaler (matching placebo) |
| |
| Secondary | Change From Baseline in Ventricular Premature Beat (VPB) Run Events | | Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report) | Posted | | Mean | Standard Deviation | events per 24 hours | | Baseline to Week 40 | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium Respimat 5mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg) | | OG001 | Tiotropium Respimat 10mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg) | | OG002 | Placebo | Placebo inhalation solution delivered from Respimat Inhaler (matching placebo) |
| |
| Secondary | Change From Baseline in VPB Pairs | | Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report) | Posted | | Mean | Standard Deviation | pairs per 24 hours | | Baseline to Week 40 | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium Respimat 5mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg) | | OG001 | Tiotropium Respimat 10mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg) | | OG002 | Placebo | Placebo inhalation solution delivered from Respimat Inhaler (matching placebo) |
| |
| Secondary | Change From Baseline in Haematocrit, Packed Cell Volume (PCV) | | | Posted | | Mean | Standard Deviation | Percentage of erythrocytes | | Baseline to Week 48 or at premature discontinuation if before Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium Respimat 5mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg) | | OG001 | Tiotropium Respimat 10mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg) | | OG002 | Placebo | Placebo inhalation solution delivered from Respimat Inhaler (matching placebo) |
| |
| Secondary | Change From Baseline in Haemoglobin | | | Posted | | Mean | Standard Deviation | grams per litre (g/L) | | Baseline to Week 48 or at premature discontinuation if before Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium Respimat 5mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg) | | OG001 | Tiotropium Respimat 10mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg) | | OG002 | Placebo | Placebo inhalation solution delivered from Respimat Inhaler (matching placebo) |
| |
| Secondary | Change From Baseline in Red Blood Cell Count | | | Posted | | Mean | Standard Deviation | 10^12/Litre (L) | | Baseline to Week 48 or at premature discontinuation if before Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium Respimat 5mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg) | | OG001 | Tiotropium Respimat 10mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg) | | OG002 | Placebo | Placebo inhalation solution delivered from Respimat Inhaler (matching placebo) |
| |
| Secondary | Change From Baseline in White Blood Cell Count | | | Posted | | Mean | Standard Deviation | 10^9/Litre (L) | | Baseline to Week 48 or at premature discontinuation if before Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium Respimat 5mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg) | | OG001 | Tiotropium Respimat 10mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg) | | OG002 | Placebo | Placebo inhalation solution delivered from Respimat Inhaler (matching placebo) |
| |
| Secondary | Change From Baseline in Platelets | | | Posted | | Mean | Standard Deviation | 10^9/L | | Baseline to Week 48 or at premature discontinuation if before Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium Respimat 5mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg) | | OG001 | Tiotropium Respimat 10mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg) | | OG002 | Placebo | Placebo inhalation solution delivered from Respimat Inhaler (matching placebo) |
| |
| Secondary | Change From Baseline in Neutrophils | | | Posted | | Mean | Standard Deviation | percentage of white blood cell count | | Baseline to Week 48 or at premature discontinuation if before Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium Respimat 5mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg) | | OG001 | Tiotropium Respimat 10mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg) | | OG002 | Placebo | Placebo inhalation solution delivered from Respimat Inhaler (matching placebo) |
| |
| Secondary | Change From Baseline in Eosinophils | | | Posted | | Mean | Standard Deviation | percentage of white blood cell count | | Baseline to Week 48 or at premature discontinuation if before Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium Respimat 5mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg) | | OG001 | Tiotropium Respimat 10mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg) | | OG002 | Placebo | Placebo inhalation solution delivered from Respimat Inhaler (matching placebo) |
| |
| Secondary | Change From Baseline in Basophils | | | Posted | | Mean | Standard Deviation | percentage of white blood cell count | | Baseline to Week 48 or at premature discontinuation if before Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium Respimat 5mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg) | | OG001 | Tiotropium Respimat 10mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg) | | OG002 | Placebo | Placebo inhalation solution delivered from Respimat Inhaler (matching placebo) |
| |
| Secondary | Change From Baseline in Lymphocytes | | | Posted | | Mean | Standard Deviation | percentage of white blood cell count | | Baseline to Week 48 or at premature discontinuation if before Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium Respimat 5mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg) | | OG001 | Tiotropium Respimat 10mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg) | | OG002 | Placebo | Placebo inhalation solution delivered from Respimat Inhaler (matching placebo) |
| |
| Secondary | Change From Baseline in Monocytes | | | Posted | | Mean | Standard Deviation | percentage of white blood cell count | | Baseline to Week 48 or at premature discontinuation if before Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium Respimat 5mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg) | | OG001 | Tiotropium Respimat 10mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg) | | OG002 | Placebo | Placebo inhalation solution delivered from Respimat Inhaler (matching placebo) |
| |
| Secondary | Change From Baseline in Neutrophils (Absolute) | | | Posted | | Mean | Standard Deviation | 10^9/L | | Baseline to Week 48 or at premature discontinuation if before Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium Respimat 5mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg) | | OG001 | Tiotropium Respimat 10mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg) | | OG002 | Placebo | Placebo inhalation solution delivered from Respimat Inhaler (matching placebo) |
| |
| Secondary | Change From Baseline in Eosinophils (Absolute) | | | Posted | | Mean | Standard Deviation | 10^9/L | | Baseline to Week 48 or at premature discontinuation if before Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium Respimat 5mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg) | | OG001 | Tiotropium Respimat 10mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg) | | OG002 | Placebo | Placebo inhalation solution delivered from Respimat Inhaler (matching placebo) |
| |
| Secondary | Change From Baseline in Basophils (Absolute) | | | Posted | | Mean | Standard Deviation | 10^9/L | | Baseline to Week 48 or at premature discontinuation if before Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium Respimat 5mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg) | | OG001 | Tiotropium Respimat 10mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg) | | OG002 | Placebo | Placebo inhalation solution delivered from Respimat Inhaler (matching placebo) |
| |
| Secondary | Change From Baseline in Lymphocytes (Absolute) | | | Posted | | Mean | Standard Deviation | 10^9/L | | Baseline to Week 48 or at premature discontinuation if before Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium Respimat 5mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg) | | OG001 | Tiotropium Respimat 10mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg) | | OG002 | Placebo | Placebo inhalation solution delivered from Respimat Inhaler (matching placebo) |
| |
| Secondary | Change From Baseline in Monocytes (Absolute) | | | Posted | | Mean | Standard Deviation | 10^9/L | | Baseline to Week 48 or at premature discontinuation if before Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium Respimat 5mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg) | | OG001 | Tiotropium Respimat 10mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg) | | OG002 | Placebo | Placebo inhalation solution delivered from Respimat Inhaler (matching placebo) |
| |
| Secondary | Change From Baseline in Calcium | | | Posted | | Mean | Standard Deviation | millimoles per litre (mmol/L) | | Baseline to Week 48 or at premature discontinuation if before Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium Respimat 5mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg) | | OG001 | Tiotropium Respimat 10mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg) | | OG002 | Placebo | Placebo inhalation solution delivered from Respimat Inhaler (matching placebo) |
| |
| Secondary | Change From Baseline in Phosphate | | | Posted | | Mean | Standard Deviation | mmol/L | | Baseline to Week 48 or at premature discontinuation if before Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium Respimat 5mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg) | | OG001 | Tiotropium Respimat 10mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg) | | OG002 | Placebo | Placebo inhalation solution delivered from Respimat Inhaler (matching placebo) |
| |
| Secondary | Change From Baseline in Aspartate Transaminase/Glutamic-oxaloacetic Transaminase (AST/GOT), Serum Glutamic-oxaloacetic Transaminase (SGOT) | | | Posted | | Mean | Standard Deviation | Units per litre (U/L) | | Baseline to Week 48 or at premature discontinuation if before Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium Respimat 5mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg) | | OG001 | Tiotropium Respimat 10mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg) | | OG002 | Placebo | Placebo inhalation solution delivered from Respimat Inhaler (matching placebo) |
| |
| Secondary | Change From Baseline in Alanine Transaminase/Glutamic Pyruvate Transaminase (ALT/GPT), Serum Glutamate Pyruvate Transaminase (SGPT) | | | Posted | | Mean | Standard Deviation | U/L | | Baseline to Week 48 or at premature discontinuation if before Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium Respimat 5mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg) | | OG001 | Tiotropium Respimat 10mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg) | | OG002 | Placebo | Placebo inhalation solution delivered from Respimat Inhaler (matching placebo) |
| |
| Secondary | Change From Baseline in Alkaline Phosphatase | | | Posted | | Mean | Standard Deviation | U/L | | Baseline to Week 48 or at premature discontinuation if before Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium Respimat 5mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg) | | OG001 | Tiotropium Respimat 10mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg) | | OG002 | Placebo | Placebo inhalation solution delivered from Respimat Inhaler (matching placebo) |
| |
| Secondary | Change From Baseline in Lactic Dehyrogenase (LDH) | | | Posted | | Mean | Standard Deviation | U/L | | Baseline to Week 48 or at premature discontinuation if before Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium Respimat 5mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg) | | OG001 | Tiotropium Respimat 10mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg) | | OG002 | Placebo | Placebo inhalation solution delivered from Respimat Inhaler (matching placebo) |
| |
| Secondary | Change From Baseline in Glucose | | | Posted | | Mean | Standard Deviation | mmol/L | | Baseline to Week 48 or at premature discontinuation if before Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium Respimat 5mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg) | | OG001 | Tiotropium Respimat 10mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg) | | OG002 | Placebo | Placebo inhalation solution delivered from Respimat Inhaler (matching placebo) |
| |
| Secondary | Change From Baseline in Urea | | | Posted | | Mean | Standard Deviation | mmol/L | | Baseline to Week 48 or at premature discontinuation if before Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium Respimat 5mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg) | | OG001 | Tiotropium Respimat 10mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg) | | OG002 | Placebo | Placebo inhalation solution delivered from Respimat Inhaler (matching placebo) |
| |
| Secondary | Change From Baseline in Blood Urea Nitrogen | | | Posted | | Mean | Standard Deviation | milligrams per decilitre (mg/dL) | | Baseline to Week 48 or at premature discontinuation if before Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium Respimat 5mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg) | | OG001 | Tiotropium Respimat 10mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg) | | OG002 | Placebo | Placebo inhalation solution delivered from Respimat Inhaler (matching placebo) |
| |
| Secondary | Change From Baseline in Creatinine | | | Posted | | Mean | Standard Deviation | micromoles per litre (umol/L) | | Baseline to Week 48 or at premature discontinuation if before Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium Respimat 5mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg) | | OG001 | Tiotropium Respimat 10mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg) | | OG002 | Placebo | Placebo inhalation solution delivered from Respimat Inhaler (matching placebo) |
| |
| Secondary | Change From Baseline in Bilirubin, Total | | | Posted | | Mean | Standard Deviation | umol/L | | Baseline to Week 48 or at premature discontinuation if before Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium Respimat 5mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg) | | OG001 | Tiotropium Respimat 10mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg) | | OG002 | Placebo | Placebo inhalation solution delivered from Respimat Inhaler (matching placebo) |
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| Secondary | Change From Baseline in Uric Acid | | | Posted | | Mean | Standard Deviation | umol/L | | Baseline to Week 48 or at premature discontinuation if before Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium Respimat 5mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg) | | OG001 | Tiotropium Respimat 10mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg) | | OG002 | Placebo | Placebo inhalation solution delivered from Respimat Inhaler (matching placebo) |
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| Secondary | Change From Baseline in Protein, Total | | | Posted | | Mean | Standard Deviation | grams per litre (g/L) | | Baseline to Week 48 or at premature discontinuation if before Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium Respimat 5mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg) | | OG001 | Tiotropium Respimat 10mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg) | | OG002 | Placebo | Placebo inhalation solution delivered from Respimat Inhaler (matching placebo) |
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| Secondary | Change From Baseline in Albumin | | | Posted | | Mean | Standard Deviation | g/L | | Baseline to Week 48 or at premature discontinuation if before Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium Respimat 5mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg) | | OG001 | Tiotropium Respimat 10mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg) | | OG002 | Placebo | Placebo inhalation solution delivered from Respimat Inhaler (matching placebo) |
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| Secondary | Change From Baseline in Trough FEV1 After 2, 8, 16, 24, 32 and 40 Weeks | Change From Baseline in Trough Forced Expiratory Volume in 1 second (FEV1) after 2, 8, 16, 24, 32 and 40 weeks. The means are adjusted for centre, smoking status at entry and baseline value. | Full Analysis Set - Clinic Spirometry (FAS-PFT) | Posted | | Mean | Standard Error | Litres | | 10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium Respimat 5mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg) | | OG001 | Tiotropium Respimat 10mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg) | | OG002 | Placebo | Placebo inhalation solution delivered from Respimat Inhaler (matching placebo) |
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| Secondary | Change From Baseline in Trough FVC After 2, 8, 16, 24, 32, 40 and 48 Weeks | Change From Baseline in Trough Forced vital capacity (FVC) after 2, 8, 16, 24, 32, 40 and 48 weeks. The means are adjusted for centre, smoking status at entry and baseline value. | Full Analysis Set - Clinic Spirometry (FAS-PFT) | Posted | | Mean | Standard Error | Litres | | 10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium Respimat 5mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg) | | OG001 | Tiotropium Respimat 10mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg) | | OG002 | Placebo | Placebo inhalation solution delivered from Respimat Inhaler (matching placebo) |
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| Secondary | Change From Baseline in FEV1 AUC0-3 After 2, 8, 16, 24, 32, 40 and 48 Weeks | FEV1 AUC0-3 represents the Area under Curve over the time interval from 0 to 3 hours after 2, 8, 16, 24, 32, 40 and 48 weeks. The means are adjusted for centre, smoking status at entry and baseline value. | Full Analysis Set - Clinic Spirometry (FAS-PFT) | Posted | | Mean | Standard Error | Litres | | 10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium Respimat 5mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg) | | OG001 | Tiotropium Respimat 10mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg) | | OG002 | Placebo | Placebo inhalation solution delivered from Respimat Inhaler (matching placebo) |
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| Secondary | Change From Baseline in FVC AUC0-3 After 2, 8, 16, 24, 32, 40 and 48 Weeks | FVC AUC0-3 represents the Area under Curve over the time interval from 0 to 3 hours after 2, 8, 16, 24, 32, 40 and 48 weeks. The means are adjusted for centre, smoking status at entry and baseline value. | Full Analysis Set - Clinic Spirometry (FAS-PFT) | Posted | | Mean | Standard Error | Litres | | 10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium Respimat 5mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg) | | OG001 | Tiotropium Respimat 10mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg) | | OG002 | Placebo | Placebo inhalation solution delivered from Respimat Inhaler (matching placebo) |
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| Secondary | Weekly Mean Morning Pre-dose PEFRs | Weekly mean morning pre-dose peak expiratory flow rates (PEFRs). The means are adjusted for centre, smoking status at entry, and baseline value. | Full Analysis Set - Diary (FAS-DRY) | Posted | | Mean | Standard Error | Litres/minute | | Weeks 2, 8, 16, 24, 32, 40, 48 | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium Respimat 5mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg) | | OG001 | Tiotropium Respimat 10mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg) | | OG002 | Placebo | Placebo inhalation solution delivered from Respimat Inhaler (matching placebo) |
| |
| Secondary | Weekly Mean Morning Evening PEFRs | Weekly mean evening peak expiratory flow rates (PEFRs). The means are adjusted for centre, smoking status at entry, and baseline value. | Full Analysis Set - Diary (FAS-DRY) | Posted | | Mean | Standard Error | Litres/minute | | Weeks 2, 8, 16, 24, 32, 40, 48 | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium Respimat 5mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg) | | OG001 | Tiotropium Respimat 10mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg) | | OG002 | Placebo | Placebo inhalation solution delivered from Respimat Inhaler (matching placebo) |
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| Secondary | Weekly Mean Number of Puffs of Rescue Medication Per Day | Weekly mean number of puffs of rescue medication used per day as required (PRN salbutamol). The means are adjusted for centre, smoking status at entry, and baseline value. | Full Analysis Set - Diary (FAS-DRY) | Posted | | Mean | Standard Error | Puffs | | Weeks 2, 8, 16, 24, 32, 40, 48 | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium Respimat 5mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg) | | OG001 | Tiotropium Respimat 10mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg) | | OG002 | Placebo | Placebo inhalation solution delivered from Respimat Inhaler (matching placebo) |
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| Secondary | Mahler TDI Scores | Mahler Transitional Dyspnoea Index (TDI) scores measured as change in functional impairment, change in magnitude of tasks and change in magnitude of efforts over the treatment period. The means are adjusted for centre, smoking status at entry and baseline value. Worst score = -3, best score = +3 | Full Analysis Set - Transitional Dyspnoea Index (FAS-TDI) | Posted | | Mean | Standard Error | Points on a scale | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium Respimat 5mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg) | | OG001 | Tiotropium Respimat 10mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg) | | OG002 | Placebo | Placebo inhalation solution delivered from Respimat Inhaler (matching placebo) |
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| Secondary | Saint George's Respiratory Questionnaire (SGRQ) Scores | Saint George's Respiratory Questionnaire (SGRQ) Scores impacts, activities and symptoms. Worst score = 100, best score = 0. The means are adjusted for centre, smoking status at entry and baseline value. | Full Analysis Set - Saint George's Respiratory Questionnaire (FAS-QOL) | Posted | | Mean | Standard Error | Points on a scale | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium Respimat 5mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg) | | OG001 | Tiotropium Respimat 10mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg) | | OG002 | Placebo | Placebo inhalation solution delivered from Respimat Inhaler (matching placebo) |
| |
| Secondary | COPD Symptoms Scores | COPD symptoms Scores - wheezing, shortness of breath, coughing and tightness of chest over the treatment period. Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe The means are adjusted for centre, smoking status at entry and baseline value. | Full Analysis Set - COPD symptoms (FAS-SYM) | Posted | | Mean | Standard Error | Points on a scale | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium Respimat 5mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg) | | OG001 | Tiotropium Respimat 10mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg) | | OG002 | Placebo | Placebo inhalation solution delivered from Respimat Inhaler (matching placebo) |
| |
| Secondary | PGE Scores | Physician's Global evaluation (PGE) scores over the treatment period. Scale: 1-2 = Poor, 3-4 = Fair, 5-6 = Good, 7-8 = Excellent The means are adjusted for centre, smoking status at entry and baseline value. | Full Analysis Set - Physician's Global Evaluation (FAS-PGE) | Posted | | Mean | Standard Error | Points on a scale | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium Respimat 5mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg) | | OG001 | Tiotropium Respimat 10mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg) | | OG002 | Placebo | Placebo inhalation solution delivered from Respimat Inhaler (matching placebo) |
| |
| Secondary | PGR Scores | Patient's Global rating (PGR) scores over the treatment period. Scale: 1=much better to 7=much worse The means are adjusted for centre, smoking status at entry and baseline value. | Full Analysis Set - Patient's Global Rating (FAS-PGR) | Posted | | Mean | Standard Error | Points on a scale | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium Respimat 5mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg) | | OG001 | Tiotropium Respimat 10mcg | Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg) | | OG002 | Placebo | Placebo inhalation solution delivered from Respimat Inhaler (matching placebo) |
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