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Tiotropium / Respimat One-Year Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00168844
Recruitment Status : Completed
First Posted : September 15, 2005
Results First Posted : October 7, 2009
Last Update Posted : May 20, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition Pulmonary Disease, Chronic Obstructive
Interventions Drug: Tiotropium Inhalation Solution
Other: Placebo
Enrollment 983
Recruitment Details Feb 2003 - Jun 2004, hospital and primary care clinics
Pre-assignment Details  
Arm/Group Title Tiotropium Respimat 5mcg (Tio R5) Tiotropium Respimat 10mcg (Tio R10) Placebo
Hide Arm/Group Description Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg) Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg) Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
Period Title: Overall Study
Started 332 332 319
Completed 277 277 228
Not Completed 55 55 91
Reason Not Completed
Adverse Event             31             32             48
Lost to Follow-up             4             5             11
Withdrawal by Subject             12             9             19
Protocol Violation             2             2             4
Other             6             7             9
Arm/Group Title Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo Total
Hide Arm/Group Description Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg) Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg) Placebo inhalation solution delivered from Respimat Inhaler (matching placebo) Total of all reporting groups
Overall Number of Baseline Participants 332 332 319 983
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 332 participants 332 participants 319 participants 983 participants
65  (8.2) 64.6  (8.4) 64.7  (8.9) 64.8  (8.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 332 participants 332 participants 319 participants 983 participants
Female
89
  26.8%
80
  24.1%
67
  21.0%
236
  24.0%
Male
243
  73.2%
252
  75.9%
252
  79.0%
747
  76.0%
1.Primary Outcome
Title Change From Baseline in Trough FEV1 at Week 48, Full Analysis Set - Clinic Spirometry (FAS-PFT)
Hide Description Trough Forced Expiratory Volume in 1 second (FEV1)
Time Frame 10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set - Clinic Spirometry (FAS-PFT)
Arm/Group Title Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo
Hide Arm/Group Description:
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
Overall Number of Participants Analyzed 326 320 296
Mean (Standard Error)
Unit of Measure: Litres
0.097  (0.013) 0.116  (0.014) -0.046  (0.014)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tiotropium Respimat 5mcg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA analysis with terms for treatment, smoking status at entry,centre and baseline value.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.142
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.019
Estimation Comments Tiotropium Respimat 5mcg - Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tiotropium Respimat 10mcg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA analysis with terms for treatment, smoking status at entry,centre and baseline value.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.161
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.020
Estimation Comments Tiotropium Respimat 10mcg - Placebo
2.Primary Outcome
Title Saint George's Respiratory Questionnaire (SGRQ) Total Score, Full Analysis Set - Saint George's Respiratory Questionnaire (FAS-QOL)
Hide Description Rating scale of 3 domains - symptoms, activities and impact (weighted). Worst score = 100, best score = 0
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set - Saint George's Respiratory Questionnaire (FAS-QOL)
Arm/Group Title Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo
Hide Arm/Group Description:
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
Overall Number of Participants Analyzed 318 315 275
Mean (Standard Error)
Unit of Measure: Points on a scale
39.648  (0.676) 38.675  (0.679) 42.917  (0.728)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tiotropium Respimat 5mcg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0011
Comments [Not Specified]
Method ANCOVA
Comments The means are adjusted for centre, smoking status at entry and baseline value.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.269
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.996
Estimation Comments Tiotropium Respimat 5mcg - Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tiotropium Respimat 10mcg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments The means are adjusted for centre, smoking status at entry and baseline value.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.242
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.999
Estimation Comments Tiotropium Respimat 10mcg - Placebo
3.Primary Outcome
Title TDI Focal Score, Full Analysis Set - Transitional Dyspnoea Index (FAS-TDI) (Combined Studies)
Hide Description

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.

Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set - Transitional Dyspnoea Index (FAS-TDI)
Arm/Group Title Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo
Hide Arm/Group Description:
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
Overall Number of Participants Analyzed 628 618 552
Mean (Standard Error)
Unit of Measure: Points on a scale
1.890  (0.112) 1.913  (0.113) 0.837  (0.120)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tiotropium Respimat 5mcg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments The means are adjusted for centre, smoking status at entry and baseline value.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.053
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.165
Estimation Comments Tiotropium Respimat 5mcg - Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tiotropium Respimat 10mcg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments The means are adjusted for centre, smoking status at entry and baseline value.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.075
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.166
Estimation Comments [Not Specified]
4.Primary Outcome
Title COPD Exacerbation Rate, Safety Set (SS) (Combined Studies)
Hide Description

Number of Chronic Obstructive Pulmonary Disease (COPD) exacerbations per patient year.

For this endpoint data of the twin studies NCT00168844 and NCT00168831 was combined.

Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo
Hide Arm/Group Description:
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
Overall Number of Participants Analyzed 670 667 653
Mean (Standard Deviation)
Unit of Measure: Number of exacerbations per patient year
0.93  (2.02) 1.02  (3.05) 1.91  (8.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tiotropium Respimat 5mcg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.782
Confidence Interval (2-Sided) 95%
0.687 to 0.890
Estimation Comments Tiotropium Respimat 5mcg - Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tiotropium Respimat 10mcg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.725
Confidence Interval (2-Sided) 95%
0.635 to 0.828
Estimation Comments Tiotropium Respimat 10mcg - Placebo
5.Secondary Outcome
Title Change From Baseline in Heart Rate
Hide Description Week 40 pre-dose - baseline
Time Frame Baseline to Week 40 pre-dose
Hide Outcome Measure Data
Hide Analysis Population Description
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)
Arm/Group Title Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo
Hide Arm/Group Description:
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
Overall Number of Participants Analyzed 155 135 109
Mean (Standard Deviation)
Unit of Measure: beats per minute (bpm)
2.1  (12.4) 3.6  (10.5) 1.8  (9.7)
6.Secondary Outcome
Title Change From Baseline in PR Interval
Hide Description [Not Specified]
Time Frame Baseline to Week 40 pre-dose
Hide Outcome Measure Data
Hide Analysis Population Description
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)
Arm/Group Title Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo
Hide Arm/Group Description:
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
Overall Number of Participants Analyzed 150 131 105
Mean (Standard Deviation)
Unit of Measure: milliseconds (msec)
-0.8  (20.2) -2.5  (15.1) -0.5  (15.3)
7.Secondary Outcome
Title Change From Baseline in QRS Interval
Hide Description Week 40 pre-dose - baseline
Time Frame Baseline to Week 40 pre-dose
Hide Outcome Measure Data
Hide Analysis Population Description
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)
Arm/Group Title Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo
Hide Arm/Group Description:
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
Overall Number of Participants Analyzed 155 135 109
Mean (Standard Deviation)
Unit of Measure: msec
0.9  (9.4) 1.7  (12.1) -1.1  (10.3)
8.Secondary Outcome
Title Change From Baseline in QT Interval
Hide Description Week 40 pre-dose - baseline
Time Frame Baseline to Week 40 pre-dose
Hide Outcome Measure Data
Hide Analysis Population Description
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)
Arm/Group Title Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo
Hide Arm/Group Description:
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
Overall Number of Participants Analyzed 155 135 109
Mean (Standard Deviation)
Unit of Measure: msec
-4.6  (26.5) -3.5  (25.2) -3.2  (22.3)
9.Secondary Outcome
Title Change From Baseline in QT Interval (Bazett)
Hide Description Week 40 pre-dose - baseline
Time Frame Baseline to Week 40 pre-dose
Hide Outcome Measure Data
Hide Analysis Population Description
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)
Arm/Group Title Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo
Hide Arm/Group Description:
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
Overall Number of Participants Analyzed 155 135 109
Mean (Standard Deviation)
Unit of Measure: msec
-0.5  (29.9) 5.4  (24.0) 2.5  (23.4)
10.Secondary Outcome
Title Change From Baseline in QT Interval (Fridericia)
Hide Description Week 40 pre-dose - baseline
Time Frame Baseline to Week 40 pre-dose
Hide Outcome Measure Data
Hide Analysis Population Description
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)
Arm/Group Title Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo
Hide Arm/Group Description:
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
Overall Number of Participants Analyzed 155 135 109
Mean (Standard Deviation)
Unit of Measure: msec
-2.0  (24.3) 2.2  (21.3) 0.5  (19.5)
11.Secondary Outcome
Title Change From Baseline in Heart Rate
Hide Description Week 40 - baseline
Time Frame Baseline to Week 40
Hide Outcome Measure Data
Hide Analysis Population Description
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)
Arm/Group Title Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo
Hide Arm/Group Description:
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
Overall Number of Participants Analyzed 77 66 56
Mean (Standard Deviation)
Unit of Measure: bpm
0.3  (5.4) 1.2  (6.4) 0.3  (6.6)
12.Secondary Outcome
Title Change From Baseline in Supraventricular Premature Beat (SVPB) Total
Hide Description Week 40 - baseline
Time Frame Baseline to Week 40
Hide Outcome Measure Data
Hide Analysis Population Description
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)
Arm/Group Title Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo
Hide Arm/Group Description:
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
Overall Number of Participants Analyzed 77 66 56
Mean (Standard Deviation)
Unit of Measure: premature beats per 24 hours
-3.4  (94.2) 6.8  (87.4) 20.9  (125.8)
13.Secondary Outcome
Title Holter (24-hour Period) - SVPB (Supraventricular Premature Beat) Run Events Change From Baseline in Supraventricular Premature Beat (SVPB) Run Events
Hide Description Week 40 - baseline
Time Frame Baseline to Week 40
Hide Outcome Measure Data
Hide Analysis Population Description
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)
Arm/Group Title Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo
Hide Arm/Group Description:
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
Overall Number of Participants Analyzed 77 66 56
Mean (Standard Deviation)
Unit of Measure: events per 24 hours
0.0  (0.6) -0.1  (0.5) -0.1  (1.6)
14.Secondary Outcome
Title Change From Baseline in SVPB Pairs
Hide Description Week 40 - baseline
Time Frame Baseline to Week 40
Hide Outcome Measure Data
Hide Analysis Population Description
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)
Arm/Group Title Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo
Hide Arm/Group Description:
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
Overall Number of Participants Analyzed 77 66 56
Mean (Standard Deviation)
Unit of Measure: pairs per 24 hours
-0.4  (4.0) -0.2  (2.3) 2.0  (16.4)
15.Secondary Outcome
Title Change From Baseline in Ventricular Premature Beat (VPB) Total
Hide Description Week 40 - baseline
Time Frame Baseline to Week 40
Hide Outcome Measure Data
Hide Analysis Population Description
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)
Arm/Group Title Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo
Hide Arm/Group Description:
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
Overall Number of Participants Analyzed 77 66 56
Mean (Standard Deviation)
Unit of Measure: premature beats per 24 hours
-14.3  (105.9) 4.6  (68.8) -24.1  (182.3)
16.Secondary Outcome
Title Change From Baseline in VPB Run Events
Hide Description Week 40 - baseline
Time Frame Baseline to Week 40
Hide Outcome Measure Data
Hide Analysis Population Description
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)
Arm/Group Title Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo
Hide Arm/Group Description:
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
Overall Number of Participants Analyzed 77 66 56
Mean (Standard Deviation)
Unit of Measure: events per 24 hours
0.0  (0.1) 0.0  (0.1) 0.0  (0.0)
17.Secondary Outcome
Title Change From Baseline in VPB Pairs
Hide Description Week 40 - baseline
Time Frame Baseline to Week 40
Hide Outcome Measure Data
Hide Analysis Population Description
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)
Arm/Group Title Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo
Hide Arm/Group Description:
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
Overall Number of Participants Analyzed 77 66 56
Mean (Standard Deviation)
Unit of Measure: pairs per 24 hours
-0.2  (1.6) -0.1  (3.8) -0.9  (5.7)
18.Secondary Outcome
Title Change From Baseline in Haematocrit, Packed Cell Volume (PCV)
Hide Description Volume of red cells (erythrocytes) in blood, expressed as a fraction (percentage) of the total volume of blood
Time Frame Baseline to Week 48 or at premature discontinuation if before Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set
Arm/Group Title Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo
Hide Arm/Group Description:
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
Overall Number of Participants Analyzed 280 282 244
Mean (Standard Deviation)
Unit of Measure: Percentage of erythrocytes
0  (4) -1  (4) 0  (4)
19.Secondary Outcome
Title Change From Baseline in Haemoglobin
Hide Description Week 48 - baseline
Time Frame Baseline to Week 48 or at premature discontinuation if before Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set
Arm/Group Title Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo
Hide Arm/Group Description:
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
Overall Number of Participants Analyzed 291 289 255
Mean (Standard Deviation)
Unit of Measure: grams per litre (g/L)
-1  (10) -2  (11) 1  (12)
20.Secondary Outcome
Title Change From Baseline in Red Blood Cell Count
Hide Description Week 48 - baseline
Time Frame Baseline to Week 48 or at premature discontinuation if before Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set
Arm/Group Title Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo
Hide Arm/Group Description:
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
Overall Number of Participants Analyzed 291 289 254
Mean (Standard Deviation)
Unit of Measure: 10^12/Litre (L)
0.0  (0.3) -0.1  (0.3) 0.0  (0.3)
21.Secondary Outcome
Title Change From Baseline in White Blood Cell Count
Hide Description Week 48 - baseline
Time Frame Baseline to Week 48 or at premature discontinuation if before Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set
Arm/Group Title Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo
Hide Arm/Group Description:
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
Overall Number of Participants Analyzed 291 289 255
Mean (Standard Deviation)
Unit of Measure: 10^9/Litre (L)
0.1  (1.4) 0.0  (1.5) 0.2  (1.5)
22.Secondary Outcome
Title Change From Baseline in Platelets
Hide Description Week 48 - baseline
Time Frame Baseline to Week 48 or at premature discontinuation if before Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set
Arm/Group Title Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo
Hide Arm/Group Description:
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
Overall Number of Participants Analyzed 288 280 250
Mean (Standard Deviation)
Unit of Measure: 10^9/L
4  (30) 1  (31) 7  (30)
23.Secondary Outcome
Title Change From Baseline in Neutrophils
Hide Description Week 48 - baseline
Time Frame Baseline to Week 48 or at premature discontinuation if before Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set
Arm/Group Title Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo
Hide Arm/Group Description:
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
Overall Number of Participants Analyzed 288 289 254
Mean (Standard Deviation)
Unit of Measure: percentage of white blood cell count
1  (8) 1  (8) 1  (8)
24.Secondary Outcome
Title Change From Baseline in Eosinophils
Hide Description Week 48 - baseline
Time Frame Baseline to Week 48 or at premature discontinuation if before Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set
Arm/Group Title Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo
Hide Arm/Group Description:
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
Overall Number of Participants Analyzed 288 289 254
Mean (Standard Deviation)
Unit of Measure: percentage of white blood cell count
0  (2) 0  (2) 0  (2)
25.Secondary Outcome
Title Change From Baseline in Basophils
Hide Description Week 48 - baseline
Time Frame Baseline to Week 48 or at premature discontinuation if before Week 48
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Safety Set
Arm/Group Title Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo
Hide Arm/Group Description:
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
Overall Number of Participants Analyzed 288 289 254
Mean (Standard Deviation)
Unit of Measure: percentage of white blood cell count
0  (0) 0  (0) 0  (0)
26.Secondary Outcome
Title Change From Baseline in Lymphocytes
Hide Description Week 48 - baseline
Time Frame Baseline to Week 48 or at premature discontinuation if before Week 48
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Safety Set
Arm/Group Title Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo
Hide Arm/Group Description:
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
Overall Number of Participants Analyzed 288 289 254
Mean (Standard Deviation)
Unit of Measure: percentage of white blood cell count
-1  (4) -1  (4) 0  (4)
27.Secondary Outcome
Title Change From Baseline in Monocytes
Hide Description Week 48 - baseline
Time Frame Baseline to Week 48 or at premature discontinuation if before Week 48
Hide Outcome Measure Data
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Safety Set
Arm/Group Title Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo
Hide Arm/Group Description:
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
Overall Number of Participants Analyzed 288 289 254
Mean (Standard Deviation)
Unit of Measure: percentage of white blood cell count
0  (4) 0  (3) 0  (4)
28.Secondary Outcome
Title Change From Baseline in Neutrophils (Absolute)
Hide Description Week 48 - baseline
Time Frame Baseline to Week 48 or at premature discontinuation if before Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set
Arm/Group Title Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo
Hide Arm/Group Description:
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
Overall Number of Participants Analyzed 288 289 254
Mean (Standard Deviation)
Unit of Measure: 10^9/L
0.2  (1.5) 0.1  (1.6) 0.2  (1.6)
29.Secondary Outcome
Title Change From Baseline in Lymphocytes (Absolute)
Hide Description Week 48 - baseline
Time Frame Baseline to Week 48 or at premature discontinuation if before Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set
Arm/Group Title Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo
Hide Arm/Group Description:
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
Overall Number of Participants Analyzed 288 289 254
Mean (Standard Deviation)
Unit of Measure: 10^9/L
0.0  (0.6) -0.1  (0.7) 0.1  (0.6)
30.Secondary Outcome
Title Change From Baseline in Eosinophils (Absolute)
Hide Description Week 48 - baseline
Time Frame Baseline to Week 48 or at premature discontinuation if before Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set
Arm/Group Title Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo
Hide Arm/Group Description:
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
Overall Number of Participants Analyzed 288 289 254
Mean (Standard Deviation)
Unit of Measure: 10^9/L
0.0  (0.1) 0.0  (0.1) 0.0  (0.1)
31.Secondary Outcome
Title Change From Baseline in Basophils (Absolute)
Hide Description Week 48 - baseline
Time Frame Baseline to Week 48 or at premature discontinuation if before Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set
Arm/Group Title Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo
Hide Arm/Group Description:
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
Overall Number of Participants Analyzed 288 289 254
Mean (Standard Deviation)
Unit of Measure: 10^9/L
0.0  (0.1) 0.0  (0.1) 0.0  (0.0)
32.Secondary Outcome
Title Change From Baseline in Monocytes (Absolute)
Hide Description Week 48 - baseline
Time Frame Baseline to Week 48 or at premature discontinuation if before Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set
Arm/Group Title Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo
Hide Arm/Group Description:
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
Overall Number of Participants Analyzed 288 289 254
Mean (Standard Deviation)
Unit of Measure: 10^9/L
0.0  (0.2) 0.0  (0.2) 0.0  (0.2)
33.Secondary Outcome
Title Change From Baseline in Calcium
Hide Description Week 48 - baseline
Time Frame Baseline to Week 48 or at premature discontinuation if before Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set
Arm/Group Title Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo
Hide Arm/Group Description:
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
Overall Number of Participants Analyzed 289 295 259
Mean (Standard Deviation)
Unit of Measure: millimoles per litre (mmol/L)
0.0  (0.1) 0.0  (0.1) 0.0  (0.2)
34.Secondary Outcome
Title Change From Baseline in Phosphate
Hide Description Week 48 - baseline
Time Frame Baseline to Week 48 or at premature discontinuation if before Week 48
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Safety Set
Arm/Group Title Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo
Hide Arm/Group Description:
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
Overall Number of Participants Analyzed 291 296 261
Mean (Standard Deviation)
Unit of Measure: mmol/L
0.02  (0.25) 0.00  (0.23) 0.01  (0.23)
35.Secondary Outcome
Title Change From Baseline in Aspartate Transaminase (AST)/Glutamic-Oxaloacetic Transaminase (GOT), Serum GOT (SGOT)
Hide Description Week 48 - baseline
Time Frame Baseline to Week 48 or at premature discontinuation if before Week 48
Hide Outcome Measure Data
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Safety Set
Arm/Group Title Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo
Hide Arm/Group Description:
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
Overall Number of Participants Analyzed 292 296 261
Mean (Standard Deviation)
Unit of Measure: Units per litre (U/L)
-3  (17) -1  (13) 0  (17)
36.Secondary Outcome
Title Change From Baseline in Alanine Transaminase (ALT)/Glutamic Pyruvic Transaminase (GPT), Serum GPT (SGPT)
Hide Description Week 48 - baseline
Time Frame Baseline to Week 48 or at premature discontinuation if before Week 48
Hide Outcome Measure Data
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Safety Set
Arm/Group Title Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo
Hide Arm/Group Description:
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
Overall Number of Participants Analyzed 292 296 261
Mean (Standard Deviation)
Unit of Measure: U/L
-2  (13) -1  (15) -1  (15)
37.Secondary Outcome
Title Change From Baseline in Alkaline Phosphatase
Hide Description Week 48 - baseline
Time Frame Baseline to Week 48 or at premature discontinuation if before Week 48
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Safety Set
Arm/Group Title Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo
Hide Arm/Group Description:
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
Overall Number of Participants Analyzed 290 295 259
Mean (Standard Deviation)
Unit of Measure: U/L
-3  (21) -6  (20) -5  (27)
38.Secondary Outcome
Title Change From Baseline in Lactic Dehydrogenase (LDH)
Hide Description Week 48 - baseline
Time Frame Baseline to Week 48 or at premature discontinuation if before Week 48
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Safety Set
Arm/Group Title Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo
Hide Arm/Group Description:
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
Overall Number of Participants Analyzed 290 296 261
Mean (Standard Deviation)
Unit of Measure: U/L
4  (60) 2  (87) 0  (63)
39.Secondary Outcome
Title Change From Baseline in Glucose
Hide Description Week 48 - baseline
Time Frame Baseline to Week 48 or at premature discontinuation if before Week 48
Hide Outcome Measure Data
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Safety Set
Arm/Group Title Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo
Hide Arm/Group Description:
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
Overall Number of Participants Analyzed 285 292 256
Mean (Standard Deviation)
Unit of Measure: mmol/L
-0.09  (1.82) 0.07  (1.95) 0.17  (2.21)
40.Secondary Outcome
Title Change From Baseline in Urea
Hide Description Week 48 - baseline
Time Frame Baseline to Week 48 or at premature discontinuation if before Week 48
Hide Outcome Measure Data
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Safety Set
Arm/Group Title Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo
Hide Arm/Group Description:
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
Overall Number of Participants Analyzed 291 296 261
Mean (Standard Deviation)
Unit of Measure: mmol/L
0.1  (2.0) 0.0  (2.3) 0.0  (2.1)
41.Secondary Outcome
Title Change From Baseline in Blood Urea Nitrogen
Hide Description Week 48 - baseline
Time Frame Baseline to Week 48 or at premature discontinuation if before Week 48
Hide Outcome Measure Data
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Safety Set
Arm/Group Title Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo
Hide Arm/Group Description:
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
Overall Number of Participants Analyzed 291 296 261
Mean (Standard Deviation)
Unit of Measure: milligrams per decilitre (mg/dL)
0.1  (3.2) 0.0  (3.7) -0.1  (3.4)
42.Secondary Outcome
Title Change From Baseline in Creatinine
Hide Description Week 48 - baseline
Time Frame Baseline to Week 48 or at premature discontinuation if before Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set
Arm/Group Title Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo
Hide Arm/Group Description:
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
Overall Number of Participants Analyzed 292 296 261
Mean (Standard Deviation)
Unit of Measure: micromoles per litre (umol/L)
2.7  (9.6) 1.0  (11.1) 1.7  (10.4)
43.Secondary Outcome
Title Change From Baseline in Bilirubin, Total
Hide Description Week 48 - baseline
Time Frame Baseline to Week 48 or at premature discontinuation if before Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set
Arm/Group Title Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo
Hide Arm/Group Description:
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
Overall Number of Participants Analyzed 291 296 261
Mean (Standard Deviation)
Unit of Measure: umol/L
0.0  (4.5) -0.1  (4.4) 0.0  (4.0)
44.Secondary Outcome
Title Change From Baseline in Uric Acid
Hide Description Week 48 - baseline
Time Frame Baseline to Week 48 or at premature discontinuation if before Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set
Arm/Group Title Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo
Hide Arm/Group Description:
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
Overall Number of Participants Analyzed 291 296 261
Mean (Standard Deviation)
Unit of Measure: umol/L
13.55  (78.13) 1.03  (82.35) 7.83  (88.05)
45.Secondary Outcome
Title Change From Baseline in Protein, Total
Hide Description Week 48 - baseline
Time Frame Baseline to Week 48 or at premature discontinuation if before Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set
Arm/Group Title Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo
Hide Arm/Group Description:
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
Overall Number of Participants Analyzed 291 296 261
Mean (Standard Deviation)
Unit of Measure: grams per litre (g/L)
-1  (5) -1  (5) -1  (5)
46.Secondary Outcome
Title Change From Baseline in Albumin
Hide Description Week 48 - baseline
Time Frame Baseline to Week 48 or at premature discontinuation if before Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set
Arm/Group Title Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo
Hide Arm/Group Description:
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
Overall Number of Participants Analyzed 291 296 261
Mean (Standard Deviation)
Unit of Measure: g/L
1  (4) 1  (4) 1  (4)
47.Secondary Outcome
Title Change From Baseline in Trough FEV1 After 2, 8, 16, 24, 32 and 40 Weeks
Hide Description 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.
Time Frame 10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication
Hide Outcome Measure Data
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Full Analysis Set - Clinic Spirometry (FAS-PFT)
Arm/Group Title Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo
Hide Arm/Group Description:
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
Overall Number of Participants Analyzed 326 320 296
Mean (Standard Error)
Unit of Measure: Litres
Week 2 0.118  (0.011) 0.133  (0.011) 0.013  (0.012)
Week 8 0.124  (0.012) 0.150  (0.012) -0.004  (0.013)
Week 16 0.121  (0.013) 0.125  (0.014) -0.022  (0.014)
Week 24 0.125  (0.013) 0.121  (0.013) -0.009  (0.013)
Week 32 0.124  (0.013) 0.132  (0.013) -0.025  (0.014)
Week 40 0.107  (0.013) 0.133  (0.013) -0.031  (0.014)
48.Secondary Outcome
Title Change From Baseline in Trough FVC After 2, 8, 16, 24, 32, 40 and 48 Weeks
Hide Description 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.
Time Frame 10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set - Clinic Spirometry (FAS-PFT)
Arm/Group Title Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo
Hide Arm/Group Description:
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
Overall Number of Participants Analyzed 326 320 296
Mean (Standard Error)
Unit of Measure: Litres
Week 2 0.163  (0.023) 0.278  (0.024) 0.025  (0.025)
Week 8 0.168  (0.024) 0.300  (0.024) 0.009  (0.025)
Week 16 0.145  (0.026) 0.267  (0.027) -0.019  (0.028)
Week 24 0.155  (0.026) 0.274  (0.026) -0.012  (0.027)
Week 32 0.156  (0.026) 0.276  (0.026) -0.038  (0.028)
Week 40 0.130  (0.026) 0.294  (0.027) -0.043  (0.028)
Week 48 0.108  (0.027) 0.253  (0.027) -0.070  (0.028)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tiotropium Respimat 5mcg, Placebo
Comments Analysis for week 48
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA analysis with terms for treatment, smoking status at entry,centre and baseline value.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.178
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.039
Estimation Comments Tiotropium Respimat 5mcg - Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tiotropium Respimat 10mcg, Placebo
Comments Analysis for week 48
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA analysis with terms for treatment, smoking status at entry,centre and baseline value.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.323
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.039
Estimation Comments Tiotropium Respimat 10mcg - Placebo
49.Secondary Outcome
Title Change From Baseline in FEV1 AUC0-3 After 2, 8, 16, 24, 32, 40 and 48 Weeks
Hide Description 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.
Time Frame 10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set - Clinic Spirometry (FAS-PFT)
Arm/Group Title Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo
Hide Arm/Group Description:
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
Overall Number of Participants Analyzed 326 320 296
Mean (Standard Error)
Unit of Measure: Litres
Week 2 0.256  (0.012) 0.258  (0.012) 0.045  (0.013)
Week 8 0.246  (0.013) 0.274  (0.013) 0.041  (0.014)
Week 16 0.241  (0.014) 0.248  (0.014) 0.024  (0.015)
Week 24 0.242  (0.014) 0.241  (0.014) 0.026  (0.014)
Week 32 0.239  (0.014) 0.240  (0.014) 0.019  (0.015)
Week 40 0.225  (0.014) 0.233  (0.014) 0.003  (0.015)
Week 48 0.212  (0.014) 0.226  (0.014) -0.008  (0.015)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tiotropium Respimat 5mcg, Placebo
Comments Analysis for week 48
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.220
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.021
Estimation Comments Tiotropium Respimat 5mcg - Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tiotropium Respimat 10mcg, Placebo
Comments Analysis for week 48
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.234
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.021
Estimation Comments Tiotropium Respimat 10mcg - Placebo
50.Secondary Outcome
Title Change From Baseline in FVC AUC0-3 After 2, 8, 16, 24, 32, 40 and 48 Weeks
Hide Description 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.
Time Frame 10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set - Clinic Spirometry (FAS-PFT)
Arm/Group Title Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo
Hide Arm/Group Description:
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
Overall Number of Participants Analyzed 326 320 296
Mean (Standard Error)
Unit of Measure: Litres
Week 2 0.421  (0.024) 0.492  (0.024) 0.130  (0.025)
Week 8 0.397  (0.026) 0.538  (0.026) 0.126  (0.027)
Week 16 0.376  (0.028) 0.487  (0.028) 0.076  (0.029)
Week 24 0.364  (0.027) 0.465  (0.027) 0.067  (0.029)
Week 32 0.357  (0.028) 0.465  (0.028) 0.049  (0.029)
Week 40 0.328  (0.028) 0.453  (0.028) 0.034  (0.029)
Week 48 0.312  (0.028) 0.422  (0.028) 0.003  (0.029)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tiotropium Respimat 5mcg, Placebo
Comments Analysis for week 48
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.310
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.041
Estimation Comments Tiotropium Respimat 5mcg - Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tiotropium Respimat 10mcg, Placebo
Comments Analysis for week 48
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.419
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.041
Estimation Comments Tiotropium Respimat 10mcg - Placebo
51.Secondary Outcome
Title Weekly Mean Morning Pre-dose PEFRs
Hide Description Weekly mean morning pre-dose peak expiratory flow rates (PEFRs). The means are adjusted for centre, smoking status at entry, and baseline value.
Time Frame Weeks 2, 8, 16, 24, 32, 40, 48
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Hide Analysis Population Description
Full Analysis Set - Diary (FAS-DRY)
Arm/Group Title Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo
Hide Arm/Group Description:
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
Overall Number of Participants Analyzed 323 323 293
Mean (Standard Error)
Unit of Measure: Litres/minute
Week 2 255.4  (1.8) 261.5  (1.8) 235.4  (1.9)
Week 8 259.0  (2.5) 265.6  (2.5) 241.8  (2.7)
Week 16 262.7  (3.0) 269.0  (3.0) 241.1  (3.1)
Week 24 265.7  (3.2) 270.1  (3.2) 244.3  (3.3)
Week 32 267.2  (3.4) 275.1  (3.4) 244.7  (3.6)
Week 40 267.0  (3.4) 276.7  (3.4) 247.4  (3.6)
Week 48 268.5  (3.6) 279.0  (3.6) 245.9  (3.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tiotropium Respimat 5mcg, Placebo
Comments Analysis for week 48
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 22.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.3
Estimation Comments Tiotropium Respimat 5mcg - Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tiotropium Respimat 10mcg, Placebo
Comments Analysis for week 48
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 33.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.3
Estimation Comments Tiotropium Respimat 10mcg - Placebo
52.Secondary Outcome
Title Weekly Mean Evening PEFRs
Hide Description Weekly mean evening peak expiratory flow rates (PEFRs). The means are adjusted for centre, smoking status at entry, and baseline value.
Time Frame Weeks 2, 8, 16, 24, 32, 40, 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set - Diary (FAS-DRY)
Arm/Group Title Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo
Hide Arm/Group Description:
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
Overall Number of Participants Analyzed 323 322 293
Mean (Standard Error)
Unit of Measure: Litres/minute
Week 2 270.6  (2.0) 279.2  (2.0) 249.3  (2.1)
Week 8 274.5  (2.7) 282.1  (2.7) 253.4  (2.9)
Week 16 278.0  (3.1) 284.1  (3.1) 252.7  (3.2)
Week 24 280.0  (3.3) 287.0  (3.3) 254.7  (3.4)
Week 32 281.8  (3.4) 290.6  (3.4) 255.0  (3.6)
Week 40 283.1  (3.6) 292.2  (3.6) 257.1  (3.7)
Week 48 282.5  (3.9) 292.5  (3.9) 257.0  (4.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tiotropium Respimat 5mcg, Placebo
Comments Analysis for week 48
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 25.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.6
Estimation Comments Tiotropium Respimat 5mcg - Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tiotropium Respimat 10mcg, Placebo
Comments Analysis for week 48
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 35.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.6
Estimation Comments Tiotropium Respimat 10mcg - Placebo
53.Secondary Outcome
Title Weekly Mean Number of Puffs of Rescue Medication Per Day
Hide Description 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.
Time Frame Weeks 2, 8, 16, 24, 32, 40, 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set - Diary (FAS-DRY)
Arm/Group Title Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo
Hide Arm/Group Description:
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
Overall Number of Participants Analyzed 324 323 293
Mean (Standard Error)
Unit of Measure: Puffs
Week 2 1.9  (0.1) 1.9  (0.1) 2.7  (0.1)
Week 8 2.0  (0.1) 2.0  (0.1) 2.7  (0.1)
Week 16 2.1  (0.1) 2.0  (0.1) 2.8  (0.1)
Week 24 2.1  (0.1) 2.2  (0.1) 3.0  (0.1)
Week 32 2.2  (0.1) 2.2  (0.1) 3.0  (0.1)
Week 40 2.2  (0.1) 2.2  (0.1) 3.0  (0.1)
Week 48 2.3  (0.1) 2.2  (0.1) 3.1  (0.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tiotropium Respimat 5mcg, Placebo
Comments Analysis for week 48
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.8
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.2
Estimation Comments Tiotropium Respimat 5mcg - Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tiotropium Respimat 10mcg, Placebo
Comments Analysis for week 48
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.9
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.2
Estimation Comments Tiotropium Respimat 10mcg - Placebo
54.Secondary Outcome
Title Mahler TDI Scores
Hide Description

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

Time Frame Week 48
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Hide Analysis Population Description
Full Analysis Set - Transitional Dyspnoea Index (FAS-TDI)
Arm/Group Title Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo
Hide Arm/Group Description:
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
Overall Number of Participants Analyzed 318 313 273
Mean (Standard Error)
Unit of Measure: Points on a scale
Functional Impairment 0.606  (0.049) 0.679  (0.050) 0.255  (0.053)
Magnitude of Task 0.650  (0.052) 0.673  (0.052) 0.291  (0.056)
Magnitude of Effort 0.633  (0.056) 0.706  (0.056) 0.240  (0.060)
55.Secondary Outcome
Title Saint George's Respiratory Questionnaire (SGRQ) Scores
Hide Description

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.

Time Frame Week 48
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Full Analysis Set - Saint George's Respiratory Questionnaire (FAS-QOL)
Arm/Group Title Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo
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Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
Overall Number of Participants Analyzed 318 315 275
Mean (Standard Error)
Unit of Measure: Points on a scale
Symptoms 42.323  (1.064) 41.798  (1.070) 47.835  (1.146)
Activities 56.317  (0.823) 55.180  (0.828) 58.629  (0.887)
Impacts 29.413  (0.743) 28.054  (0.747) 32.466  (0.801)
56.Secondary Outcome
Title COPD Symptoms Scores
Hide Description

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.

Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set - COPD symptoms (FAS-SYM)
Arm/Group Title Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo
Hide Arm/Group Description:
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
Overall Number of Participants Analyzed 326 321 295
Mean (Standard Error)
Unit of Measure: Points on a scale
Wheezing 0.67  (0.04) 0.65  (0.04) 0.91  (0.04)
Shortness of Breath 1.35  (0.04) 1.31  (0.04) 1.51  (0.04)
Coughing 1.05  (0.04) 1.04  (0.04) 1.21  (0.04)
Tightness of Chest 0.61  (0.04) 0.50  (0.04) 0.78  (0.04)
57.Secondary Outcome
Title PGE Scores
Hide Description

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.

Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set - Physician's Global Evaluation (FAS-PGE)
Arm/Group Title Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo
Hide Arm/Group Description:
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
Overall Number of Participants Analyzed 327 322 295
Mean (Standard Error)
Unit of Measure: Points on a scale
5.18  (0.06) 5.18  (0.06) 4.62  (0.06)
58.Secondary Outcome
Title PGR Score
Hide Description

Patient's Global rating (PGR) score 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.

Time Frame Week 48
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Hide Analysis Population Description
Full Analysis Set - Patient's Global Rating (FAS-PGR)
Arm/Group Title Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo
Hide Arm/Group Description:
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
Overall Number of Participants Analyzed 319 316 276
Mean (Standard Error)
Unit of Measure: Points on a scale
3.05  (0.07) 2.86  (0.07) 3.52  (0.08)
Time Frame From first drug administration until 30 days after last drug administration.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo
Hide Arm/Group Description Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg) Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg) Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
All-Cause Mortality
Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   45   53   54 
Blood and lymphatic system disorders       
Anaemia  1  0/332 (0.00%)  1/332 (0.30%)  0/319 (0.00%) 
Coagulopathy  1  0/332 (0.00%)  1/332 (0.30%)  0/319 (0.00%) 
Cardiac disorders       
Angina pectoris  1  2/332 (0.60%)  1/332 (0.30%)  1/319 (0.31%) 
Angina unstable  1  0/332 (0.00%)  1/332 (0.30%)  0/319 (0.00%) 
Atrial fibrillation  1  1/332 (0.30%)  1/332 (0.30%)  1/319 (0.31%) 
Atrial flutter  1  0/332 (0.00%)  1/332 (0.30%)  0/319 (0.00%) 
Cardiac failure  1  3/332 (0.90%)  0/332 (0.00%)  0/319 (0.00%) 
Cardiac failure congestive  1  1/332 (0.30%)  1/332 (0.30%)  1/319 (0.31%) 
Coronary artery disease  1  1/332 (0.30%)  0/332 (0.00%)  1/319 (0.31%) 
Coronary artery insufficiency  1  0/332 (0.00%)  1/332 (0.30%)  0/319 (0.00%) 
Myocardial infarction  1  1/332 (0.30%)  0/332 (0.00%)  3/319 (0.94%) 
Pericardial effusion  1  1/332 (0.30%)  0/332 (0.00%)  0/319 (0.00%) 
Ventricular tachycardia  1  0/332 (0.00%)  1/332 (0.30%)  0/319 (0.00%) 
Eye disorders       
Cataract  1  1/332 (0.30%)  1/332 (0.30%)  0/319 (0.00%) 
Retinal tear  1  0/332 (0.00%)  1/332 (0.30%)  0/319 (0.00%) 
Gastrointestinal disorders       
Abdominal pain  1  1/332 (0.30%)  0/332 (0.00%)  0/319 (0.00%) 
Colonic polyp  1  0/332 (0.00%)  0/332 (0.00%)  1/319 (0.31%) 
Gastritis  1  0/332 (0.00%)  1/332 (0.30%)  0/319 (0.00%) 
Gastrointestinal haemorrhage  1  1/332 (0.30%)  0/332 (0.00%)  2/319 (0.63%) 
Haemorrhoids  1  0/332 (0.00%)  1/332 (0.30%)  0/319 (0.00%) 
Ileus  1  0/332 (0.00%)  1/332 (0.30%)  0/319 (0.00%) 
Inguinal hernia  1  0/332 (0.00%)  3/332 (0.90%)  0/319 (0.00%) 
Intestinal obstruction  1  0/332 (0.00%)  0/332 (0.00%)  1/319 (0.31%) 
Oesophageal haemorrhage  1  1/332 (0.30%)  0/332 (0.00%)  0/319 (0.00%) 
Rectocele  1  0/332 (0.00%)  1/332 (0.30%)  0/319 (0.00%) 
General disorders       
Adverse drug reaction  1  0/332 (0.00%)  1/332 (0.30%)  0/319 (0.00%) 
Asthenia  1  1/332 (0.30%)  1/332 (0.30%)  0/319 (0.00%) 
Chest pain  1  1/332 (0.30%)  0/332 (0.00%)  1/319 (0.31%) 
Death  1  0/332 (0.00%)  5/332 (1.51%)  2/319 (0.63%) 
Non-cardiac chest pain  1  0/332 (0.00%)  1/332 (0.30%)  0/319 (0.00%) 
Pain  1  0/332 (0.00%)  0/332 (0.00%)  1/319 (0.31%) 
Hepatobiliary disorders       
Bile duct stone  1  0/332 (0.00%)  0/332 (0.00%)  1/319 (0.31%) 
Cholecystitis acute  1  0/332 (0.00%)  1/332 (0.30%)  0/319 (0.00%) 
Cholelithiasis  1  0/332 (0.00%)  1/332 (0.30%)  2/319 (0.63%) 
Immune system disorders       
Drug hypersensitivity  1  0/332 (0.00%)  0/332 (0.00%)  1/319 (0.31%) 
Infections and infestations       
Aspergillosis  1  0/332 (0.00%)  0/332 (0.00%)  1/319 (0.31%) 
Bronchial infection  1  0/332 (0.00%)  0/332 (0.00%)  1/319 (0.31%) 
Bronchitis  1  0/332 (0.00%)  1/332 (0.30%)  0/319 (0.00%) 
Bronchitis acute  1  0/332 (0.00%)  0/332 (0.00%)  1/319 (0.31%) 
Bronchopneumonia  1  1/332 (0.30%)  0/332 (0.00%)  0/319 (0.00%) 
Cellulitis  1  0/332 (0.00%)  1/332 (0.30%)  2/319 (0.63%) 
Diverticulitis  1  0/332 (0.00%)  1/332 (0.30%)  0/319 (0.00%) 
Gastroenteritis  1  1/332 (0.30%)  0/332 (0.00%)  1/319 (0.31%) 
Lobar pneumonia  1  0/332 (0.00%)  0/332 (0.00%)  2/319 (0.63%) 
Lower respiratory tract infection  1  1/332 (0.30%)  0/332 (0.00%)  0/319 (0.00%) 
Pneumonia  1  6/332 (1.81%)  4/332 (1.20%)  0/319 (0.00%) 
Respiratory tract infection  1  0/332 (0.00%)  0/332 (0.00%)  1/319 (0.31%) 
Sepsis  1  0/332 (0.00%)  0/332 (0.00%)  1/319 (0.31%) 
Superinfection lung  1  0/332 (0.00%)  0/332 (0.00%)  1/319 (0.31%) 
Urosepsis  1  0/332 (0.00%)  0/332 (0.00%)  1/319 (0.31%) 
Injury, poisoning and procedural complications       
Cardiac pacemaker malfunction  1  1/332 (0.30%)  0/332 (0.00%)  0/319 (0.00%) 
Clavicle fracture  1  0/332 (0.00%)  0/332 (0.00%)  1/319 (0.31%) 
Concussion  1  1/332 (0.30%)  0/332 (0.00%)  0/319 (0.00%) 
Femur fracture  1  1/332 (0.30%)  0/332 (0.00%)  1/319 (0.31%) 
Hip fracture  1  0/332 (0.00%)  0/332 (0.00%)  1/319 (0.31%) 
Humerus fracture  1  1/332 (0.30%)  0/332 (0.00%)  1/319 (0.31%) 
Joint dislocation  1  0/332 (0.00%)  0/332 (0.00%)  1/319 (0.31%) 
Ligament injury  1  0/332 (0.00%)  1/332 (0.30%)  0/319 (0.00%) 
Neck injury  1  0/332 (0.00%)  0/332 (0.00%)  1/319 (0.31%) 
Tendon rupture  1  0/332 (0.00%)  1/332 (0.30%)  0/319 (0.00%) 
Metabolism and nutrition disorders       
Dehydration  1  0/332 (0.00%)  1/332 (0.30%)  0/319 (0.00%) 
Hypoglycaemia  1  0/332 (0.00%)  0/332 (0.00%)  1/319 (0.31%) 
Musculoskeletal and connective tissue disorders       
Back pain  1  0/332 (0.00%)  1/332 (0.30%)  0/319 (0.00%) 
Intervertebral disc protrusion  1  0/332 (0.00%)  0/332 (0.00%)  1/319 (0.31%) 
Osteoarthritis  1  0/332 (0.00%)  1/332 (0.30%)  0/319 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Basal cell carcinoma  1  2/332 (0.60%)  0/332 (0.00%)  0/319 (0.00%) 
Bladder cancer  1  0/332 (0.00%)  1/332 (0.30%)  0/319 (0.00%) 
Bladder cancer stage II  1  0/332 (0.00%)  1/332 (0.30%)  0/319 (0.00%) 
Bronchial carcinoma  1  1/332 (0.30%)  0/332 (0.00%)  0/319 (0.00%) 
Bronchioloalveolar carcinoma  1  1/332 (0.30%)  0/332 (0.00%)  0/319 (0.00%) 
Colon cancer  1  0/332 (0.00%)  1/332 (0.30%)  0/319 (0.00%) 
Gastrointestinal carcinoma  1  0/332 (0.00%)  0/332 (0.00%)  1/319 (0.31%) 
Laryngeal cancer  1  0/332 (0.00%)  0/332 (0.00%)  1/319 (0.31%) 
Lung neoplasm malignant  1  1/332 (0.30%)  0/332 (0.00%)  1/319 (0.31%) 
Malignant melanoma  1  1/332 (0.30%)  0/332 (0.00%)  0/319 (0.00%) 
Neoplasm malignant  1  1/332 (0.30%)  0/332 (0.00%)  0/319 (0.00%) 
Oesophageal cancer metastatic  1  0/332 (0.00%)  1/332 (0.30%)  0/319 (0.00%) 
Prostate cancer  1  1/332 (0.30%)  1/332 (0.30%)  2/319 (0.63%) 
Renal neoplasm  1  1/332 (0.30%)  0/332 (0.00%)  0/319 (0.00%) 
Salivary gland adenoma  1  0/332 (0.00%)  0/332 (0.00%)  1/319 (0.31%) 
Small cell lung cancer stage unspecified  1  1/332 (0.30%)  0/332 (0.00%)  0/319 (0.00%) 
Squamous cell carcinoma  1  0/332 (0.00%)  1/332 (0.30%)  0/319 (0.00%) 
Nervous system disorders       
Cerebral infarction  1  0/332 (0.00%)  1/332 (0.30%)  0/319 (0.00%) 
Cerebrovascular accident  1  0/332 (0.00%)  1/332 (0.30%)  2/319 (0.63%) 
Dysarthria  1  1/332 (0.30%)  0/332 (0.00%)  0/319 (0.00%) 
Facial paresis  1  0/332 (0.00%)  0/332 (0.00%)  1/319 (0.31%) 
Guillain-Barre syndrome  1  0/332 (0.00%)  1/332 (0.30%)  0/319 (0.00%) 
Ischaemic stroke  1  0/332 (0.00%)  1/332 (0.30%)  0/319 (0.00%) 
Normal pressure hydrocephalus  1  1/332 (0.30%)  0/332 (0.00%)  0/319 (0.00%) 
Sciatica  1  1/332 (0.30%)  0/332 (0.00%)  0/319 (0.00%) 
Syncope  1  0/332 (0.00%)  0/332 (0.00%)  1/319 (0.31%) 
Psychiatric disorders       
Aggression  1  0/332 (0.00%)  0/332 (0.00%)  1/319 (0.31%) 
Confusional state  1  2/332 (0.60%)  0/332 (0.00%)  0/319 (0.00%) 
Renal and urinary disorders       
Cystocele  1  0/332 (0.00%)  1/332 (0.30%)  0/319 (0.00%) 
Haematuria  1  0/332 (0.00%)  1/332 (0.30%)  0/319 (0.00%) 
Renal cyst  1  0/332 (0.00%)  1/332 (0.30%)  0/319 (0.00%) 
Renal failure acute  1  0/332 (0.00%)  1/332 (0.30%)  0/319 (0.00%) 
Urinary retention  1  0/332 (0.00%)  2/332 (0.60%)  0/319 (0.00%) 
Urinary tract obstruction  1  0/332 (0.00%)  1/332 (0.30%)  0/319 (0.00%) 
Reproductive system and breast disorders       
Benign prostatic hyperplasia  1  0/332 (0.00%)  1/332 (0.30%)  0/319 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Acute pulmonary oedema  1  1/332 (0.30%)  0/332 (0.00%)  0/319 (0.00%) 
Acute respiratory failure  1  0/332 (0.00%)  1/332 (0.30%)  0/319 (0.00%) 
Chronic obstructive airways disease exacerbated  1  13/332 (3.92%)  11/332 (3.31%)  17/319 (5.33%) 
Cough  1  0/332 (0.00%)  1/332 (0.30%)  0/319 (0.00%) 
Diaphragmatic hernia  1  0/332 (0.00%)  1/332 (0.30%)  0/319 (0.00%) 
Dyspnoea  1  2/332 (0.60%)  0/332 (0.00%)  0/319 (0.00%) 
Haemoptysis  1  1/332 (0.30%)  1/332 (0.30%)  1/319 (0.31%) 
Hypercapnia  1  0/332 (0.00%)  0/332 (0.00%)  1/319 (0.31%) 
Lung disorder  1  0/332 (0.00%)  0/332 (0.00%)  1/319 (0.31%) 
Pulmonary hypertension  1  1/332 (0.30%)  0/332 (0.00%)  0/319 (0.00%) 
Respiratory failure  1  1/332 (0.30%)  0/332 (0.00%)  1/319 (0.31%) 
Skin and subcutaneous tissue disorders       
Eczema  1  1/332 (0.30%)  0/332 (0.00%)  0/319 (0.00%) 
Hyperkeratosis  1  0/332 (0.00%)  0/332 (0.00%)  1/319 (0.31%) 
Psoriasis  1  1/332 (0.30%)  0/332 (0.00%)  0/319 (0.00%) 
Skin ulcer  1  1/332 (0.30%)  0/332 (0.00%)  0/319 (0.00%) 
Vascular disorders       
Deep vein thrombosis  1  0/332 (0.00%)  1/332 (0.30%)  0/319 (0.00%) 
Hypertension  1  0/332 (0.00%)  1/332 (0.30%)  0/319 (0.00%) 
Hypotension  1  0/332 (0.00%)  0/332 (0.00%)  1/319 (0.31%) 
Peripheral vascular disorder  1  0/332 (0.00%)  1/332 (0.30%)  0/319 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (8.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tiotropium Respimat 5mcg Tiotropium Respimat 10mcg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   147   160   145 
Gastrointestinal disorders       
Dry mouth  1  15/332 (4.52%)  44/332 (13.25%)  4/319 (1.25%) 
Infections and infestations       
Nasopharyngitis  1  41/332 (12.35%)  31/332 (9.34%)  30/319 (9.40%) 
Musculoskeletal and connective tissue disorders       
Back pain  1  18/332 (5.42%)  13/332 (3.92%)  15/319 (4.70%) 
Respiratory, thoracic and mediastinal disorders       
Chronic obstructive airways disease exacerbated  1  95/332 (28.61%)  94/332 (28.31%)  114/319 (35.74%) 
Cough  1  14/332 (4.22%)  16/332 (4.82%)  16/319 (5.02%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (8.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim
Organization: Boehringer Ingelheim
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
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ClinicalTrials.gov Identifier: NCT00168844     History of Changes
Other Study ID Numbers: 205.254
First Submitted: September 12, 2005
First Posted: September 15, 2005
Results First Submitted: January 30, 2009
Results First Posted: October 7, 2009
Last Update Posted: May 20, 2014