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Tiotropium / Respimat One Year Study in COPD.

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ClinicalTrials.gov Identifier: NCT00387088
Recruitment Status : Completed
First Posted : October 12, 2006
Results First Posted : January 22, 2010
Last Update Posted : May 16, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

Study Type Interventional
Study Design Intervention Model: Parallel Assignment;   Primary Purpose: Treatment
Condition Pulmonary Disease, Chronic Obstructive
Interventions Device: Respimat
Drug: Tiotropium
Enrollment 3991
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tiotropium Placebo
Hide Arm/Group Description Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded) Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Period Title: Overall Study
Started 1989 2002
Completed 1671 1629
Not Completed 318 373
Reason Not Completed
Adverse Event             143             156
Protocol Violation             47             35
Withdrawal by Subject             20             35
Lack of Efficacy             28             67
Lost to Follow-up             22             28
Other             58             52
Arm/Group Title Tiotropium Placebo Total
Hide Arm/Group Description Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded) Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded) Total of all reporting groups
Overall Number of Baseline Participants 1952 1965 3917
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1952 participants 1965 participants 3917 participants
64.8  (9.1) 64.8  (9) 64.80  (9.00)
[1]
Measure Description: The TS was made up of all randomised and treated participants excluding 74 patients with potential fraudulent data from one investigator site
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1952 participants 1965 participants 3917 participants
Female
428
  21.9%
452
  23.0%
880
  22.5%
Male
1524
  78.1%
1513
  77.0%
3037
  77.5%
[1]
Measure Description: The TS was made up of all randomised and treated participants excluding 74 patients with potential fraudulent data from one investigator site
1.Primary Outcome
Title Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 337
Hide Description Trough FEV1 is defined as the FEV1 measured at the -10 min time point at the end of the dosing interval (24 h post drug administration).
Time Frame Baseline and Day 337
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 133 participants from the FAS were excluded due to insufficient FEV1 data.
Arm/Group Title Tiotropium Placebo
Hide Arm/Group Description:
Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Overall Number of Participants Analyzed 1889 1870
Least Squares Mean (Standard Error)
Unit of Measure: Litres
0.119  (0.007) 0.018  (0.007)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tiotropium, 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 with pooled centre, LABA use, and treatment fitted as main effects and the baseline trough FEV1 as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.102
Confidence Interval (2-Sided) 95%
0.085 to 0.118
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.009
Estimation Comments [Not Specified]
2.Primary Outcome
Title Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
Hide Description Time to first COPD exacerbation (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment). Time is days from start of study treatment to onset of exacerbation.
Time Frame During actual study treatment period (planned Day 1 to Day 337)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data.
Arm/Group Title Tiotropium Placebo
Hide Arm/Group Description:
Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Overall Number of Participants Analyzed 1939 1953
Median (95% Confidence Interval)
Unit of Measure: Days
NA [1] 
(NA to NA)
NA [1] 
(354.0 to NA)
[1]
As <50% of the patients experienced an exacerbation in both treatment groups the median and 95% confidence interval were not estimable. Refer to the secondary endpoint 'Number of patients with at least one COPD exacerbation' for further information.
3.Secondary Outcome
Title Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 29
Hide Description Trough FEV1 is the mean volume of air that can be forced out in one second after taking a deep breath approximately 24 hours after the last administration of study drug.
Time Frame Baseline and Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 147 participants from the FAS were excluded due to insufficient FEV1 data.
Arm/Group Title Tiotropium Placebo
Hide Arm/Group Description:
Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Overall Number of Participants Analyzed 1879 1866
Least Squares Mean (Standard Error)
Unit of Measure: Litres
0.11  (0.005) 0.017  (0.005)
4.Secondary Outcome
Title Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 169
Hide Description Trough FEV1 is the mean volume of air that can be forced out in one second after taking a deep breath approximately 24 hours after the last administration of study drug.
Time Frame Baseline and Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 133 participants from the FAS were excluded due to insufficient FEV1 data.
Arm/Group Title Tiotropium Placebo
Hide Arm/Group Description:
Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Overall Number of Participants Analyzed 1889 1870
Least Squares Mean (Standard Error)
Unit of Measure: Litres
0.121  (0.006) 0.018  (0.006)
5.Secondary Outcome
Title Number of COPD Exacerbations Per Patient - Exposure Adjusted
Hide Description Number of COPD exacerbations (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient adjusted by length of treatment exposure (i.e. number of exacerbations multiplied by 365.25 and then divided by days of treatment exposure)
Time Frame During actual study treatment period (planned Day 1 to Day 337)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data.
Arm/Group Title Tiotropium Placebo
Hide Arm/Group Description:
Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Overall Number of Participants Analyzed 1939 1953
Median (Full Range)
Unit of Measure: COPD exacerbations per year
0
(0 to 21.5)
0
(0 to 182.6)
6.Secondary Outcome
Title Number of COPD Exacerbations Per Patient - naïve Estimate
Hide Description Number of COPD exacerbations (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient not adjusted for treatment exposure (i.e. naïve estimate)
Time Frame During actual study treatment period (planned Day 1 to Day 337)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data.
Arm/Group Title Tiotropium Placebo
Hide Arm/Group Description:
Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Overall Number of Participants Analyzed 1939 1953
Median (Full Range)
Unit of Measure: COPD exacerbations
0
(0 to 9)
0
(0 to 10)
7.Secondary Outcome
Title Number of Patients With at Least One COPD Exacerbation
Hide Description Number of patients with at least one COPD exacerbation (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment)
Time Frame During actual study treatment period (planned Day 1 to Day 337)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data.
Arm/Group Title Tiotropium Placebo
Hide Arm/Group Description:
Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Overall Number of Participants Analyzed 1939 1953
Measure Type: Number
Unit of Measure: participants
685 842
8.Secondary Outcome
Title Time to First Hospitalisation for COPD Exacerbation
Hide Description Time to first hospitalisation for COPD exacerbation (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment). Time is days from start of study treatment to onset of exacerbation
Time Frame During actual study treatment period (planned Day 1 to Day 337)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data.
Arm/Group Title Tiotropium Placebo
Hide Arm/Group Description:
Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Overall Number of Participants Analyzed 1939 1953
Median (95% Confidence Interval)
Unit of Measure: Days
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
As <50% of the patients experienced an exacerbation in both treatment groups the median and 95% confidence interval were not estimable. Refer to the secondary endpoint 'Number of patients with at least one COPD exacerbation' for further information.
9.Secondary Outcome
Title Number of Hospitalisations for COPD Exacerbations Per Patient - Exposure Adjusted
Hide Description Number of hospitalisations for COPD exacerbations (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient adjusted by length of treatment exposure (i.e. no. of exacerbations multiplied by 365.25 and then divided by days of treatment exposure)
Time Frame During actual study treatment period (planned Day 1 to Day 337)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data.
Arm/Group Title Tiotropium Placebo
Hide Arm/Group Description:
Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Overall Number of Participants Analyzed 1939 1953
Median (Full Range)
Unit of Measure: hospitalisations for COPD exacerbations
0
(0 to 21.5)
0
(0 to 91.3)
10.Secondary Outcome
Title Number of Hospitalisations for COPD Exacerbations Per Patient - naïve Estimate
Hide Description Number of hospitalisations for COPD exacerbations (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient not adjusted for treatment exposure (i.e. naïve estimate)
Time Frame During actual study treatment period (planned Day 1 to Day 337)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data.
Arm/Group Title Tiotropium Placebo
Hide Arm/Group Description:
Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Overall Number of Participants Analyzed 1939 1953
Median (Full Range)
Unit of Measure: hospitalisations for COPD exacerbations
0
(0 to 5)
0
(0 to 4)
11.Secondary Outcome
Title Number of Patients With at Least One Hospitalisation for a COPD Exacerbation
Hide Description Number of patients with at least one hospitalisation for a COPD exacerbation (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment)
Time Frame During actual study treatment period (planned Day 1 to Day 337)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data.
Arm/Group Title Tiotropium Placebo
Hide Arm/Group Description:
Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Overall Number of Participants Analyzed 1939 1953
Measure Type: Number
Unit of Measure: participants
161 198
12.Secondary Outcome
Title Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Day 337
Hide Description The SGRQ total score measures quality of life on a continuous scale ranging from 0=best state to 100=worst state
Time Frame Baseline and Day 337
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 534 participants from the FAS were excluded due to insufficient SGRQ data.
Arm/Group Title Tiotropium Placebo
Hide Arm/Group Description:
Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Overall Number of Participants Analyzed 1690 1668
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-4.726  (0.372) -1.787  (0.374)
13.Secondary Outcome
Title Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Day 169
Hide Description The SGRQ total score measures quality of life on a continuous scale ranging from 0=best state to 100=worst state
Time Frame Baseline and Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 534 participants from the FAS were excluded due to insufficient SGRQ data.
Arm/Group Title Tiotropium Placebo
Hide Arm/Group Description:
Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Overall Number of Participants Analyzed 1690 1668
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-4.764  (0.348) -2.568  (0.35)
14.Secondary Outcome
Title Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Domain Score at Day 337
Hide Description The SGRQ domain score (symptom, activity and impact) measures quality of life on a continuous scale ranging from 0=best state to 100=worst state
Time Frame Baseline and Day 337
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. Up to 534 participants from the FAS were excluded due to insufficient SGRQ data.
Arm/Group Title Tiotropium Placebo
Hide Arm/Group Description:
Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Overall Number of Participants Analyzed 1939 1953
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Symptoms (N=1704,1688) -7.260  (0.546) -3.307  (0.548)
Activities (N=1690,1668) -3.196  (0.456) -0.226  (0.460)
Impacts (N=1690,1668) -4.873  (0.409) -2.038  (0.412)
15.Secondary Outcome
Title Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Domain Score at Day 169
Hide Description The SGRQ domain score (symptom, activity and impact) measures quality of life on a continuous scale ranging from 0=best state to 100=worst state
Time Frame Baseline and Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. Up to 534 participants from the FAS were excluded due to insufficient SGRQ data.
Arm/Group Title Tiotropium Placebo
Hide Arm/Group Description:
Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Overall Number of Participants Analyzed 1939 1953
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Symptoms (N=1704,1688) -6.555  (0.530) -3.268  (0.532)
Activities (N=1690,1668) -3.573  (0.432) -1.218  (0.435)
Impacts (N=1690,1668) -4.917  (0.390) -2.935  (0.392)
16.Secondary Outcome
Title Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 29
Hide Description Trough FVC is the mean maximum volume of air that can be forcibly expired from the lungs; measured approximately 24 hours after the last administration of study drug.
Time Frame Baseline and Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 147 participants from the FAS were excluded due to insufficient FVC data.
Arm/Group Title Tiotropium Placebo
Hide Arm/Group Description:
Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Overall Number of Participants Analyzed 1879 1866
Least Squares Mean (Standard Error)
Unit of Measure: Litres
0.176  (0.009) 0.025  (0.009)
17.Secondary Outcome
Title Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 169
Hide Description Trough FVC is the mean maximum volume of air that can be forcibly expired from the lungs; measured approximately 24 hours after the last administration of study drug.
Time Frame Baseline and Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 133 participants from the FAS were excluded due to insufficient FVC data.
Arm/Group Title Tiotropium Placebo
Hide Arm/Group Description:
Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Overall Number of Participants Analyzed 1889 1870
Least Squares Mean (Standard Error)
Unit of Measure: Litres
0.179  (0.010) 0.019  (0.010)
18.Secondary Outcome
Title Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 337
Hide Description Trough FVC is the mean maximum volume of air that can be forcibly expired from the lungs; measured approximately 24 hours after the last administration of study drug.
Time Frame Baseline and Day 337
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 133 participants from the FAS were excluded due to insufficient FVC data.
Arm/Group Title Tiotropium Placebo
Hide Arm/Group Description:
Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Overall Number of Participants Analyzed 1889 1870
Least Squares Mean (Standard Error)
Unit of Measure: Litres
0.168  (0.011) -0.001  (0.011)
19.Secondary Outcome
Title Marked Changes From Baseline in Vital Signs at End of Treatment
Hide Description

Marked changes from baseline in vital signs (diastolic and systolic blood pressure (DBP and SBP) and pulse rate (PR)) at end of treatment.

SBP - Increase means SBP >150 mmHg and an increase above baseline of >25 mmHg. SBP - Decrease means SBP <100 mmHg and a decrease below baseline of >10 mmHg.

DBP - Increase means DBP >90 mmHg and an increase above baseline of >10 mmHg. DBP - Decrease means DBP <60 mmHg and a decrease below baseline of >10 mmHg.

PR - Increase means PR >100 bpm and an increase above baseline of >10 bpm. PR - Decrease means PR <60 bpm and a decrease below baseline of >10 bpm.

Time Frame Baseline and end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Treated set
Arm/Group Title Tiotropium Placebo
Hide Arm/Group Description:
Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Overall Number of Participants Analyzed 1747 1749
Measure Type: Number
Unit of Measure: participants
SBP - Increase 29 31
SBP - Decrease 6 12
DBP - Increase 40 39
DBP - Decrease 9 14
PR - Increase 35 43
PR - Decrease 26 26
20.Secondary Outcome
Title Clinically Relevant Findings in Physical Examination and ECG
Hide Description Clinically relevant findings in Physical Examination and ECG at end of treatment
Time Frame End of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Treated set
Arm/Group Title Tiotropium Placebo
Hide Arm/Group Description:
Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Overall Number of Participants Analyzed 1952 1965
Measure Type: Number
Unit of Measure: participants
Phys. Exam - No new/worsened finding 1723 1733
Phys. Exam - new or worsened finding 22 17
Phys. Exam - Missing 207 215
ECG - No new/worsened finding 1674 1677
ECG - new or worsened finding 37 39
ECG - Missing 241 249
Time Frame From first drug administration until 30 days after last drug administration.
Adverse Event Reporting Description 74 patients were excluded from the treated set due to potential fraudulent data from one investigator site
 
Arm/Group Title Tiotropium Placebo
Hide Arm/Group Description Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded) Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
All-Cause Mortality
Tiotropium Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tiotropium Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   342/1952 (17.52%)   336/1965 (17.10%) 
Blood and lymphatic system disorders     
Anaemia  1  1/1952 (0.05%)  0/1965 (0.00%) 
Leukocytosis  1  0/1952 (0.00%)  1/1965 (0.05%) 
Lymphadenopathy mediastinal  1  0/1952 (0.00%)  1/1965 (0.05%) 
Normochromic normocytic anaemia  1  1/1952 (0.05%)  0/1965 (0.00%) 
Thrombocytopenia  1  0/1952 (0.00%)  1/1965 (0.05%) 
Cardiac disorders     
Acute coronary syndrome  1  3/1952 (0.15%)  2/1965 (0.10%) 
Acute myocardial infarction  1  2/1952 (0.10%)  5/1965 (0.25%) 
Angina pectoris  1  4/1952 (0.20%)  3/1965 (0.15%) 
Angina unstable  1  1/1952 (0.05%)  5/1965 (0.25%) 
Aortic valve incompetence  1  1/1952 (0.05%)  0/1965 (0.00%) 
Arrhythmia  1  2/1952 (0.10%)  1/1965 (0.05%) 
Arteriosclerosis coronary artery  1  0/1952 (0.00%)  1/1965 (0.05%) 
Atrial fibrillation  1  3/1952 (0.15%)  2/1965 (0.10%) 
Atrial flutter  1  1/1952 (0.05%)  0/1965 (0.00%) 
Atrioventricular block  1  0/1952 (0.00%)  2/1965 (0.10%) 
Atrioventricular block complete  1  0/1952 (0.00%)  1/1965 (0.05%) 
Bradyarrhythmia  1  1/1952 (0.05%)  0/1965 (0.00%) 
Bradycardia  1  1/1952 (0.05%)  0/1965 (0.00%) 
Cardiac arrest  1  2/1952 (0.10%)  1/1965 (0.05%) 
Cardiac failure  1  8/1952 (0.41%)  10/1965 (0.51%) 
Cardiac failure congestive  1  5/1952 (0.26%)  4/1965 (0.20%) 
Cardiac valve disease  1  0/1952 (0.00%)  1/1965 (0.05%) 
Cardio-respiratory arrest  1  4/1952 (0.20%)  1/1965 (0.05%) 
Cardiogenic shock  1  1/1952 (0.05%)  0/1965 (0.00%) 
Cardiomyopathy  1  1/1952 (0.05%)  0/1965 (0.00%) 
Cardiopulmonary failure  1  1/1952 (0.05%)  1/1965 (0.05%) 
Congestive cardiomyopathy  1  0/1952 (0.00%)  1/1965 (0.05%) 
Cor pulmonale  1  2/1952 (0.10%)  3/1965 (0.15%) 
Cor pulmonale acute  1  0/1952 (0.00%)  1/1965 (0.05%) 
Coronary artery disease  1  5/1952 (0.26%)  2/1965 (0.10%) 
Coronary artery occlusion  1  1/1952 (0.05%)  0/1965 (0.00%) 
Coronary artery stenosis  1  0/1952 (0.00%)  1/1965 (0.05%) 
Left ventricular failure  1  2/1952 (0.10%)  1/1965 (0.05%) 
Mitral valve incompetence  1  0/1952 (0.00%)  2/1965 (0.10%) 
Myocardial infarction  1  5/1952 (0.26%)  5/1965 (0.25%) 
Myocardial ischaemia  1  5/1952 (0.26%)  0/1965 (0.00%) 
Palpitations  1  1/1952 (0.05%)  0/1965 (0.00%) 
Pericardial effusion  1  1/1952 (0.05%)  1/1965 (0.05%) 
Pericarditis  1  1/1952 (0.05%)  0/1965 (0.00%) 
Right ventricular failure  1  1/1952 (0.05%)  1/1965 (0.05%) 
Sinus arrhythmia  1  1/1952 (0.05%)  0/1965 (0.00%) 
Sinus tachycardia  1  1/1952 (0.05%)  0/1965 (0.00%) 
Supraventricular tachycardia  1  1/1952 (0.05%)  1/1965 (0.05%) 
Tachycardia  1  1/1952 (0.05%)  1/1965 (0.05%) 
Tricuspid valve disease  1  0/1952 (0.00%)  1/1965 (0.05%) 
Tricuspid valve incompetence  1  0/1952 (0.00%)  1/1965 (0.05%) 
Ventricular extrasystoles  1  0/1952 (0.00%)  1/1965 (0.05%) 
Ventricular tachycardia  1  1/1952 (0.05%)  0/1965 (0.00%) 
Ear and labyrinth disorders     
Tinnitus  1  0/1952 (0.00%)  1/1965 (0.05%) 
Vertigo  1  1/1952 (0.05%)  1/1965 (0.05%) 
Vertigo positional  1  1/1952 (0.05%)  0/1965 (0.00%) 
Endocrine disorders     
Hyperthyroidism  1  1/1952 (0.05%)  0/1965 (0.00%) 
Eye disorders     
Cataract  1  0/1952 (0.00%)  1/1965 (0.05%) 
Retinal artery occlusion  1  1/1952 (0.05%)  0/1965 (0.00%) 
Gastrointestinal disorders     
Abdominal distension  1  1/1952 (0.05%)  0/1965 (0.00%) 
Abdominal pain  1  2/1952 (0.10%)  1/1965 (0.05%) 
Abdominal strangulated hernia  1  1/1952 (0.05%)  0/1965 (0.00%) 
Ascites  1  1/1952 (0.05%)  0/1965 (0.00%) 
Chilaiditi's syndrome  1  1/1952 (0.05%)  0/1965 (0.00%) 
Colitis ischaemic  1  1/1952 (0.05%)  1/1965 (0.05%) 
Colonic polyp  1  1/1952 (0.05%)  0/1965 (0.00%) 
Constipation  1  2/1952 (0.10%)  0/1965 (0.00%) 
Crohn's disease  1  0/1952 (0.00%)  1/1965 (0.05%) 
Diarrhoea  1  0/1952 (0.00%)  5/1965 (0.25%) 
Duodenal ulcer  1  0/1952 (0.00%)  2/1965 (0.10%) 
Duodenal ulcer haemorrhage  1  1/1952 (0.05%)  0/1965 (0.00%) 
Dyspepsia  1  0/1952 (0.00%)  1/1965 (0.05%) 
Dysphagia  1  1/1952 (0.05%)  0/1965 (0.00%) 
Enterocutaneous fistula  1  1/1952 (0.05%)  0/1965 (0.00%) 
Erosive oesophagitis  1  1/1952 (0.05%)  0/1965 (0.00%) 
Food poisoning  1  0/1952 (0.00%)  1/1965 (0.05%) 
Gastric polyps  1  1/1952 (0.05%)  0/1965 (0.00%) 
Gastric ulcer haemorrhage  1  1/1952 (0.05%)  0/1965 (0.00%) 
Gastritis  1  1/1952 (0.05%)  2/1965 (0.10%) 
Gastritis erosive  1  1/1952 (0.05%)  0/1965 (0.00%) 
Gastritis haemorrhagic  1  0/1952 (0.00%)  1/1965 (0.05%) 
Gastrooesophageal reflux disease  1  2/1952 (0.10%)  1/1965 (0.05%) 
Haematemesis  1  1/1952 (0.05%)  0/1965 (0.00%) 
Inguinal hernia  1  6/1952 (0.31%)  6/1965 (0.31%) 
Intestinal ischaemia  1  1/1952 (0.05%)  0/1965 (0.00%) 
Intestinal obstruction  1  2/1952 (0.10%)  1/1965 (0.05%) 
Intra-abdominal haematoma  1  0/1952 (0.00%)  1/1965 (0.05%) 
Large intestine perforation  1  2/1952 (0.10%)  0/1965 (0.00%) 
Melaena  1  1/1952 (0.05%)  0/1965 (0.00%) 
Nausea  1  1/1952 (0.05%)  1/1965 (0.05%) 
Pancreatitis  1  1/1952 (0.05%)  0/1965 (0.00%) 
Pancreatitis acute  1  0/1952 (0.00%)  1/1965 (0.05%) 
Peptic ulcer  1  1/1952 (0.05%)  0/1965 (0.00%) 
Peptic ulcer haemorrhage  1  0/1952 (0.00%)  1/1965 (0.05%) 
Proctocolitis  1  1/1952 (0.05%)  0/1965 (0.00%) 
Rectal haemorrhage  1  2/1952 (0.10%)  0/1965 (0.00%) 
Reflux oesophagitis  1  1/1952 (0.05%)  2/1965 (0.10%) 
Umbilical hernia  1  1/1952 (0.05%)  1/1965 (0.05%) 
Upper gastrointestinal haemorrhage  1  0/1952 (0.00%)  2/1965 (0.10%) 
Volvulus  1  1/1952 (0.05%)  0/1965 (0.00%) 
General disorders     
Asthenia  1  2/1952 (0.10%)  1/1965 (0.05%) 
Chest discomfort  1  2/1952 (0.10%)  0/1965 (0.00%) 
Chest pain  1  4/1952 (0.20%)  0/1965 (0.00%) 
Death  1  5/1952 (0.26%)  1/1965 (0.05%) 
Drowning  1  2/1952 (0.10%)  0/1965 (0.00%) 
Drug interaction  1  1/1952 (0.05%)  0/1965 (0.00%) 
Malaise  1  0/1952 (0.00%)  1/1965 (0.05%) 
Mass  1  2/1952 (0.10%)  0/1965 (0.00%) 
Oedema peripheral  1  2/1952 (0.10%)  1/1965 (0.05%) 
Pitting oedema  1  0/1952 (0.00%)  1/1965 (0.05%) 
Polyp  1  1/1952 (0.05%)  0/1965 (0.00%) 
Pyrexia  1  1/1952 (0.05%)  1/1965 (0.05%) 
Sudden death  1  2/1952 (0.10%)  1/1965 (0.05%) 
Hepatobiliary disorders     
Bile duct stone  1  0/1952 (0.00%)  1/1965 (0.05%) 
Cholecysititis  1  1/1952 (0.05%)  1/1965 (0.05%) 
Cholecysititis acute  1  0/1952 (0.00%)  3/1965 (0.15%) 
Cholelithiasis  1  0/1952 (0.00%)  2/1965 (0.10%) 
Hepatitis acute  1  0/1952 (0.00%)  1/1965 (0.05%) 
Hyperbilirubinaemia  1  1/1952 (0.05%)  0/1965 (0.00%) 
Immune system disorders     
Anaphylactic reaction  1  0/1952 (0.00%)  1/1965 (0.05%) 
Infections and infestations     
Abscess intestinal  1  1/1952 (0.05%)  0/1965 (0.00%) 
Acute sinusitis  1  0/1952 (0.00%)  1/1965 (0.05%) 
Appendicitis  1  1/1952 (0.05%)  0/1965 (0.00%) 
Bronchitis  1  7/1952 (0.36%)  6/1965 (0.31%) 
Bronchopneumonia  1  2/1952 (0.10%)  4/1965 (0.20%) 
Bronchopulmonary aspergillosis  1  1/1952 (0.05%)  0/1965 (0.00%) 
Bursitis infective  1  0/1952 (0.00%)  1/1965 (0.05%) 
Cellulitis  1  2/1952 (0.10%)  1/1965 (0.05%) 
Clostridium difficile colitis  1  1/1952 (0.05%)  0/1965 (0.00%) 
Cystitis  1  1/1952 (0.05%)  0/1965 (0.00%) 
Diverticulitis  1  2/1952 (0.10%)  1/1965 (0.05%) 
Empyema  1  1/1952 (0.05%)  0/1965 (0.00%) 
Endocarditis  1  1/1952 (0.05%)  0/1965 (0.00%) 
Epiglottitis haemophilus  1  1/1952 (0.05%)  0/1965 (0.00%) 
Febrile infection  1  1/1952 (0.05%)  0/1965 (0.00%) 
Gastroenteritis  1  1/1952 (0.05%)  6/1965 (0.31%) 
Gastroenteritis viral  1  1/1952 (0.05%)  1/1965 (0.05%) 
Herpes zoster  1  0/1952 (0.00%)  3/1965 (0.15%) 
Infection  1  0/1952 (0.00%)  2/1965 (0.10%) 
Infective exacerbation of chronic obstructive airways disease  1  9/1952 (0.46%)  18/1965 (0.92%) 
Influenza  1  0/1952 (0.00%)  2/1965 (0.10%) 
Lobar pneumonia  1  3/1952 (0.15%)  7/1965 (0.36%) 
Localised infection  1  0/1952 (0.00%)  1/1965 (0.05%) 
Lower respiratory tract infection  1  0/1952 (0.00%)  6/1965 (0.31%) 
Lung infection  1  0/1952 (0.00%)  2/1965 (0.10%) 
Lung infection pseudomonal  1  1/1952 (0.05%)  0/1965 (0.00%) 
Osteomyelitis  1  1/1952 (0.05%)  0/1965 (0.00%) 
Osteomyelitis chronic  1  0/1952 (0.00%)  1/1965 (0.05%) 
Pharyngeal abscess  1  1/1952 (0.05%)  0/1965 (0.00%) 
Pneumococcal sepsis  1  1/1952 (0.05%)  0/1965 (0.00%) 
Pneumonia  1  26/1952 (1.33%)  37/1965 (1.88%) 
Postoperative wound infection  1  1/1952 (0.05%)  0/1965 (0.00%) 
Pyelonephritis  1  2/1952 (0.10%)  0/1965 (0.00%) 
Pyelonephritis acute  1  0/1952 (0.00%)  1/1965 (0.05%) 
Rectal abscess  1  0/1952 (0.00%)  1/1965 (0.05%) 
Respiratory tract infection  1  2/1952 (0.10%)  2/1965 (0.10%) 
Sepsis  1  4/1952 (0.20%)  2/1965 (0.10%) 
Septic shock  1  2/1952 (0.10%)  2/1965 (0.10%) 
Staphylococcal infection  1  0/1952 (0.00%)  1/1965 (0.05%) 
Subcutaneous abscess  1  0/1952 (0.00%)  1/1965 (0.05%) 
Tuberculosis  1  1/1952 (0.05%)  1/1965 (0.05%) 
Upper respiratory tract infection  1  3/1952 (0.15%)  2/1965 (0.10%) 
Urinary tract infection  1  0/1952 (0.00%)  1/1965 (0.05%) 
Urinary tract infection fungal  1  1/1952 (0.05%)  0/1965 (0.00%) 
Injury, poisoning and procedural complications     
Accident  1  1/1952 (0.05%)  0/1965 (0.00%) 
Arthropod sting  1  0/1952 (0.00%)  1/1965 (0.05%) 
Chest injury  1  1/1952 (0.05%)  0/1965 (0.00%) 
Fall  1  5/1952 (0.26%)  4/1965 (0.20%) 
Femoral neck fracture  1  1/1952 (0.05%)  2/1965 (0.10%) 
Femur fracture  1  0/1952 (0.00%)  1/1965 (0.05%) 
Head injury  1  1/1952 (0.05%)  1/1965 (0.05%) 
Hip fracture  1  1/1952 (0.05%)  0/1965 (0.00%) 
Joint dislocation  1  0/1952 (0.00%)  1/1965 (0.05%) 
Lower limb fracture  1  0/1952 (0.00%)  1/1965 (0.05%) 
Patella fracture  1  0/1952 (0.00%)  1/1965 (0.05%) 
Radius fracture  1  0/1952 (0.00%)  1/1965 (0.05%) 
Rib fracture  1  3/1952 (0.15%)  1/1965 (0.05%) 
Road traffic accident  1  4/1952 (0.20%)  1/1965 (0.05%) 
Spinal compression fracture  1  0/1952 (0.00%)  1/1965 (0.05%) 
Splenic rupture  1  1/1952 (0.05%)  0/1965 (0.00%) 
Sternal fracture  1  1/1952 (0.05%)  0/1965 (0.00%) 
Subdural haematoma  1  2/1952 (0.10%)  0/1965 (0.00%) 
Tendon injury  1  0/1952 (0.00%)  1/1965 (0.05%) 
Thermal burn  1  0/1952 (0.00%)  1/1965 (0.05%) 
Thoracic vertebral fracture  1  1/1952 (0.05%)  1/1965 (0.05%) 
Upper limb fracture  1  2/1952 (0.10%)  0/1965 (0.00%) 
Investigations     
Alanine aminotransferase increased  1  0/1952 (0.00%)  1/1965 (0.05%) 
Aspartate aminotransferase increased  1  0/1952 (0.00%)  1/1965 (0.05%) 
Blood alcohol increased  1  1/1952 (0.05%)  0/1965 (0.00%) 
Blood glucose increased  1  1/1952 (0.05%)  1/1965 (0.05%) 
Blood pressure increased  1  1/1952 (0.05%)  0/1965 (0.00%) 
Chest x-ray abnormal  1  1/1952 (0.05%)  0/1965 (0.00%) 
Prostatic specific antigen increased  1  1/1952 (0.05%)  0/1965 (0.00%) 
Weight decreased  1  1/1952 (0.05%)  0/1965 (0.00%) 
Metabolism and nutrition disorders     
Diabetes mellitus  1  0/1952 (0.00%)  1/1965 (0.05%) 
Diabetes mellitus inadequate control  1  2/1952 (0.10%)  0/1965 (0.00%) 
Diabetic foot  1  2/1952 (0.10%)  0/1965 (0.00%) 
Electrolyte imbalance  1  0/1952 (0.00%)  1/1965 (0.05%) 
Gout  1  1/1952 (0.05%)  0/1965 (0.00%) 
Hypercalcaemia  1  0/1952 (0.00%)  1/1965 (0.05%) 
Hypoglycaemia  1  1/1952 (0.05%)  1/1965 (0.05%) 
Hypokalaemia  1  2/1952 (0.10%)  2/1965 (0.10%) 
Hypomagnesaemia  1  0/1952 (0.00%)  1/1965 (0.05%) 
Hyponatraemia  1  0/1952 (0.00%)  2/1965 (0.10%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  2/1952 (0.10%)  2/1965 (0.10%) 
Bursitis  1  0/1952 (0.00%)  1/1965 (0.05%) 
Cervical spinal stenosis  1  0/1952 (0.00%)  1/1965 (0.05%) 
Facet joint syndrome  1  0/1952 (0.00%)  1/1965 (0.05%) 
Intervertebral disc protrusion  1  1/1952 (0.05%)  0/1965 (0.00%) 
Joint swelling  1  1/1952 (0.05%)  0/1965 (0.00%) 
Lumbar spinal stenosis  1  1/1952 (0.05%)  0/1965 (0.00%) 
Muscular weakness  1  1/1952 (0.05%)  0/1965 (0.00%) 
Musculoskeletal chest pain  1  0/1952 (0.00%)  2/1965 (0.10%) 
Myalgia  1  0/1952 (0.00%)  1/1965 (0.05%) 
Osteoarthritis  1  1/1952 (0.05%)  0/1965 (0.00%) 
Osteoporotic fracture  1  1/1952 (0.05%)  0/1965 (0.00%) 
Pain in extremity  1  0/1952 (0.00%)  1/1965 (0.05%) 
Rotator cuff syndrome  1  1/1952 (0.05%)  1/1965 (0.05%) 
Spinal osteoarthritis  1  1/1952 (0.05%)  0/1965 (0.00%) 
Tenosynovitis  1  0/1952 (0.00%)  1/1965 (0.05%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acute myelomonocytic leukaemia  1  1/1952 (0.05%)  0/1965 (0.00%) 
Basal cell carcinoma  1  1/1952 (0.05%)  1/1965 (0.05%) 
Benigh neoplasm of bladder  1  1/1952 (0.05%)  0/1965 (0.00%) 
Benign neoplasm of thyroid gland  1  0/1952 (0.00%)  1/1965 (0.05%) 
Bladder cancer  1  1/1952 (0.05%)  2/1965 (0.10%) 
Bladder neoplasm  1  2/1952 (0.10%)  1/1965 (0.05%) 
Bladder transitional cell carcinoma  1  1/1952 (0.05%)  0/1965 (0.00%) 
Bone cancer metastatic  1  0/1952 (0.00%)  1/1965 (0.05%) 
Brain cancer metastatic  1  0/1952 (0.00%)  1/1965 (0.05%) 
Brain neoplasm  1  3/1952 (0.15%)  0/1965 (0.00%) 
Breast cancer  1  1/1952 (0.05%)  1/1965 (0.05%) 
Bronchial carcinoma  1  3/1952 (0.15%)  2/1965 (0.10%) 
Colon adenoma  1  1/1952 (0.05%)  0/1965 (0.00%) 
Colon cancer  1  2/1952 (0.10%)  1/1965 (0.05%) 
Gastric cancer  1  3/1952 (0.15%)  1/1965 (0.05%) 
Gastrointestinal carcinoma  1  0/1952 (0.00%)  1/1965 (0.05%) 
Hepatic cancer metastatic  1  0/1952 (0.00%)  1/1965 (0.05%) 
Hepatic neoplasm malignant  1  1/1952 (0.05%)  3/1965 (0.15%) 
Hypopharyngeal neoplasm  1  0/1952 (0.00%)  1/1965 (0.05%) 
Keratoacanthoma  1  1/1952 (0.05%)  0/1965 (0.00%) 
Lung adenocarcinoma  1  0/1952 (0.00%)  1/1965 (0.05%) 
Lung neoplasm  1  1/1952 (0.05%)  1/1965 (0.05%) 
Lung neoplasm malignant  1  10/1952 (0.51%)  2/1965 (0.10%) 
Lung squamous cell carcinoma stage unspecified  1  1/1952 (0.05%)  0/1965 (0.00%) 
Meningioma  1  1/1952 (0.05%)  0/1965 (0.00%) 
Metastases to bone  1  0/1952 (0.00%)  1/1965 (0.05%) 
Metastases to liver  1  1/1952 (0.05%)  0/1965 (0.00%) 
Metastases to lung  1  1/1952 (0.05%)  0/1965 (0.00%) 
Metastases to skin  1  1/1952 (0.05%)  0/1965 (0.00%) 
Metastases to spine  1  1/1952 (0.05%)  0/1965 (0.00%) 
Multiple myeloma  1  1/1952 (0.05%)  0/1965 (0.00%) 
Neoplasm  1  0/1952 (0.00%)  1/1965 (0.05%) 
Neoplasm prostate  1  1/1952 (0.05%)  0/1965 (0.00%) 
Non-small cell lung cancer  1  1/1952 (0.05%)  0/1965 (0.00%) 
Non-small cell lung cancer metastatic  1  0/1952 (0.00%)  1/1965 (0.05%) 
Prostate cancer  1  2/1952 (0.10%)  1/1965 (0.05%) 
Renal cancer  1  0/1952 (0.00%)  1/1965 (0.05%) 
Renal neoplasm  1  1/1952 (0.05%)  0/1965 (0.00%) 
Squamous cell carcinoma  1  2/1952 (0.10%)  0/1965 (0.00%) 
Nervous system disorders     
Ataxia  1  0/1952 (0.00%)  1/1965 (0.05%) 
Carotid artery stenosis  1  0/1952 (0.00%)  2/1965 (0.10%) 
Carpal tunnel syndrome  1  1/1952 (0.05%)  0/1965 (0.00%) 
Cerebral circulatory failure  1  0/1952 (0.00%)  1/1965 (0.05%) 
Cerebral haemorrhage  1  1/1952 (0.05%)  0/1965 (0.00%) 
Cerebral infarction  1  3/1952 (0.15%)  2/1965 (0.10%) 
Cerebral thrombosis  1  1/1952 (0.05%)  0/1965 (0.00%) 
Cerebrovascular accident  1  0/1952 (0.00%)  2/1965 (0.10%) 
Cerebrovascular disorder  1  0/1952 (0.00%)  1/1965 (0.05%) 
Cervical myelopathy  1  0/1952 (0.00%)  1/1965 (0.05%) 
Convulsion  1  1/1952 (0.05%)  0/1965 (0.00%) 
Dementia  1  0/1952 (0.00%)  1/1965 (0.05%) 
Dizziness  1  1/1952 (0.05%)  2/1965 (0.10%) 
Dysarthria  1  1/1952 (0.05%)  0/1965 (0.00%) 
Hemiplegia  1  1/1952 (0.05%)  0/1965 (0.00%) 
Ischaemic stroke  1  2/1952 (0.10%)  1/1965 (0.05%) 
Lethargy  1  0/1952 (0.00%)  1/1965 (0.05%) 
Loss of consciousness  1  1/1952 (0.05%)  1/1965 (0.05%) 
Monoparesis  1  0/1952 (0.00%)  1/1965 (0.05%) 
Presyncope  1  1/1952 (0.05%)  0/1965 (0.00%) 
Sciatica  1  0/1952 (0.00%)  1/1965 (0.05%) 
Somnolence  1  0/1952 (0.00%)  1/1965 (0.05%) 
Syncope  1  2/1952 (0.10%)  0/1965 (0.00%) 
Syncope vasovagal  1  1/1952 (0.05%)  0/1965 (0.00%) 
Transient ischaemic attack  1  2/1952 (0.10%)  3/1965 (0.15%) 
Unresponsive to stimuli  1  1/1952 (0.05%)  0/1965 (0.00%) 
Vascular dementia  1  0/1952 (0.00%)  1/1965 (0.05%) 
Haemorrhagic cerebral infarction  2  0/1952 (0.00%)  1/1965 (0.05%) 
Psychiatric disorders     
Completed suicide  1  0/1952 (0.00%)  1/1965 (0.05%) 
Confusional state  1  1/1952 (0.05%)  2/1965 (0.10%) 
Delirium  1  0/1952 (0.00%)  1/1965 (0.05%) 
Depression  1  0/1952 (0.00%)  1/1965 (0.05%) 
Mental status changes  1  0/1952 (0.00%)  1/1965 (0.05%) 
Psychotic disorder  1  0/1952 (0.00%)  1/1965 (0.05%) 
Stress  1  1/1952 (0.05%)  0/1965 (0.00%) 
Suicide attempt  1  1/1952 (0.05%)  0/1965 (0.00%) 
Renal and urinary disorders     
Calculus ureteric  1  2/1952 (0.10%)  1/1965 (0.05%) 
Dysuria  1  1/1952 (0.05%)  0/1965 (0.00%) 
Haematuria  1  2/1952 (0.10%)  0/1965 (0.00%) 
Hydronephrosis  1  0/1952 (0.00%)  1/1965 (0.05%) 
Incontinence  1  0/1952 (0.00%)  1/1965 (0.05%) 
Nephrolithiasis  1  1/1952 (0.05%)  0/1965 (0.00%) 
Nephrotic syndrome  1  1/1952 (0.05%)  0/1965 (0.00%) 
Renal failure  1  3/1952 (0.15%)  1/1965 (0.05%) 
Renal failure acute  1  3/1952 (0.15%)  2/1965 (0.10%) 
Urethral meatus stenosis  1  0/1952 (0.00%)  1/1965 (0.05%) 
Urinary retention  1  5/1952 (0.26%)  1/1965 (0.05%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1  6/1952 (0.31%)  3/1965 (0.15%) 
Prostatic haemorrhage  1  1/1952 (0.05%)  0/1965 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory distress syndrome  1  0/1952 (0.00%)  1/1965 (0.05%) 
Acute respiratory failure  1  4/1952 (0.20%)  3/1965 (0.15%) 
Asphyxia  1  1/1952 (0.05%)  0/1965 (0.00%) 
Atelectasis  1  1/1952 (0.05%)  0/1965 (0.00%) 
Chronic obstructive pulmonary disease  1  130/1952 (6.66%)  155/1965 (7.89%) 
Cough  1  2/1952 (0.10%)  1/1965 (0.05%) 
Dyspnoea  1  10/1952 (0.51%)  4/1965 (0.20%) 
Dyspnoea exertional  1  1/1952 (0.05%)  0/1965 (0.00%) 
Emphysema  1  2/1952 (0.10%)  1/1965 (0.05%) 
Epistaxis  1  1/1952 (0.05%)  1/1965 (0.05%) 
Haemoptysis  1  3/1952 (0.15%)  3/1965 (0.15%) 
Haemothorax  1  1/1952 (0.05%)  0/1965 (0.00%) 
Hypoxia  1  2/1952 (0.10%)  1/1965 (0.05%) 
Lung disorder  1  1/1952 (0.05%)  1/1965 (0.05%) 
Lung infiltration  1  0/1952 (0.00%)  1/1965 (0.05%) 
Pleural effusion  1  2/1952 (0.10%)  2/1965 (0.10%) 
Pneumonia aspiration  1  2/1952 (0.10%)  0/1965 (0.00%) 
Pneumothorax  1  6/1952 (0.31%)  7/1965 (0.36%) 
Pulmonary embolism  1  3/1952 (0.15%)  2/1965 (0.10%) 
Pulmonary fistula  1  0/1952 (0.00%)  1/1965 (0.05%) 
Pulmonary hypertension  1  1/1952 (0.05%)  0/1965 (0.00%) 
Pulmonary mass  1  0/1952 (0.00%)  1/1965 (0.05%) 
Pulmonary oedema  1  3/1952 (0.15%)  1/1965 (0.05%) 
Respiratory acidosis  1  0/1952 (0.00%)  1/1965 (0.05%) 
Respiratory arrest  1  2/1952 (0.10%)  0/1965 (0.00%) 
Respiratory disorder  1  0/1952 (0.00%)  1/1965 (0.05%) 
Respiratory failure  1  9/1952 (0.46%)  11/1965 (0.56%) 
Tachypnoea  1  0/1952 (0.00%)  1/1965 (0.05%) 
Skin and subcutaneous tissue disorders     
Lichen nitidus  1  1/1952 (0.05%)  0/1965 (0.00%) 
Pruritus  1  1/1952 (0.05%)  0/1965 (0.00%) 
Rash  1  0/1952 (0.00%)  1/1965 (0.05%) 
Social circumstances     
Living in residential institution  1  1/1952 (0.05%)  0/1965 (0.00%) 
Surgical and medical procedures     
Gallbladder operation  1  1/1952 (0.05%)  0/1965 (0.00%) 
Hysterectomy  1  0/1952 (0.00%)  1/1965 (0.05%) 
Ileostomy closure  1  1/1952 (0.05%)  0/1965 (0.00%) 
Shoulder arthroplasty  1  0/1952 (0.00%)  1/1965 (0.05%) 
Urethrotomy  1  1/1952 (0.05%)  0/1965 (0.00%) 
Vascular disorders     
Aortic aneurysm  1  2/1952 (0.10%)  2/1965 (0.10%) 
Aortic rupture  1  0/1952 (0.00%)  1/1965 (0.05%) 
Aortic stenosis  1  0/1952 (0.00%)  1/1965 (0.05%) 
Arterial stenosis  1  1/1952 (0.05%)  0/1965 (0.00%) 
Arteriosclerosis  1  0/1952 (0.00%)  1/1965 (0.05%) 
Deep vein thrombosis  1  0/1952 (0.00%)  1/1965 (0.05%) 
Haemorrhage  1  0/1952 (0.00%)  1/1965 (0.05%) 
Hypertension  1  1/1952 (0.05%)  0/1965 (0.00%) 
Hypertensive crisis  1  1/1952 (0.05%)  0/1965 (0.00%) 
Hypotension  1  2/1952 (0.10%)  2/1965 (0.10%) 
Hypovolaemic shock  1  0/1952 (0.00%)  1/1965 (0.05%) 
Intermittent claudication  1  1/1952 (0.05%)  0/1965 (0.00%) 
Phlebitis  1  0/1952 (0.00%)  1/1965 (0.05%) 
Venous insufficiency  1  0/1952 (0.00%)  1/1965 (0.05%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
2
Term from vocabulary, MedDRA (11.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tiotropium Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   866/1952 (44.36%)   926/1965 (47.12%) 
Infections and infestations     
Nasopharyngitis  1  157/1952 (8.04%)  151/1965 (7.68%) 
Upper respiratory tract infection  1  97/1952 (4.97%)  123/1965 (6.26%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  561/1952 (28.74%)  659/1965 (33.54%) 
Dyspnoea  1  122/1952 (6.25%)  144/1965 (7.33%) 
Cough  1  123/1952 (6.30%)  106/1965 (5.39%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
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
Name/Title: Boehringer Ingelheim Pharmaceuticals
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00387088     History of Changes
Other Study ID Numbers: 205.372
2006-001009-27
First Submitted: October 11, 2006
First Posted: October 12, 2006
Results First Submitted: November 13, 2009
Results First Posted: January 22, 2010
Last Update Posted: May 16, 2014