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Tiotropium Once Daily 18 Mcg Versus Salmeterol Twice Daily 50 Mcg on Time to First Exacerbation in COPD Patients.

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ClinicalTrials.gov Identifier: NCT00563381
Recruitment Status : Completed
First Posted : November 26, 2007
Results First Posted : May 17, 2011
Last Update Posted : December 24, 2013
Sponsor:
Collaborator:
Pfizer
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 bromide
Drug: Salmeterol
Drug: Placebo Salmeterol
Drug: Placebo Tiotropium
Enrollment 7376
Recruitment Details  
Pre-assignment Details There were 8 patients (4:4 on Tiotropium and Salmeterol respectively) randomized but not treated
Arm/Group Title Tiotropium Salmeterol
Hide Arm/Group Description Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID) Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
Period Title: Overall Study
Started 3707 [1] 3669 [1]
Completed 3122 [2] 3021 [2]
Not Completed 585 648
Reason Not Completed
Adverse Event             264             292
Protocol Violation             66             74
Lost to Follow-up             7             15
Withdrawal by Subject             192             209
Lack of Efficacy             32             24
Individual different reasons             24             34
[1]
Started treatment
[2]
Completed treatment
Arm/Group Title Tiotropium Salmeterol Total
Hide Arm/Group Description Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID) Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily Total of all reporting groups
Overall Number of Baseline Participants 3707 3669 7376
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3707 participants 3669 participants 7376 participants
62.9  (9.0) 62.8  (9.0) 62.9  (9.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3707 participants 3669 participants 7376 participants
Female
948
  25.6%
922
  25.1%
1870
  25.4%
Male
2759
  74.4%
2747
  74.9%
5506
  74.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3707 participants 3669 participants 7376 participants
Asian 5 3 8
Black 9 9 18
White 3693 3657 7350
1.Primary Outcome
Title First Occurrence of (Moderate or Severe) COPD Exacerbation
Hide Description First occurrence analysed by Cox regression as time to first exacerbation and reported as hazard ratio. An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment
Arm/Group Title Tiotropium Salmeterol
Hide Arm/Group Description:
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
Overall Number of Participants Analyzed 3707 3669
Measure Type: Number
Unit of Measure: number of first occurrences
1277 1414
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tiotropium, Salmeterol
Comments Tiotropium versus Salmeterol
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Cox
Comments Treatment effect adjusted for pooled centre
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.83
Confidence Interval 95%
0.77 to 0.90
Estimation Comments [Not Specified]
2.Secondary Outcome
Title COPD Exacerbations Per Patient-year Leading to Hospitalisation
Hide Description An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment
Arm/Group Title Tiotropium Salmeterol
Hide Arm/Group Description:
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
Overall Number of Participants Analyzed 3707 3669
Mean (95% Confidence Interval)
Unit of Measure: Hospitalizations per patient-year
0.09
(0.09 to 0.10)
0.13
(0.12 to 0.14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tiotropium, Salmeterol
Comments Tiotropium vs. Salmeterol
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 Poisson regression correcting for overdisperion and adjusted for treatment exposure
Method of Estimation Estimation Parameter Rate ratio (ratio of incidence rates)
Estimated Value 0.73
Confidence Interval 95%
0.66 to 0.82
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.04
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants With at Least One COPD Exacerbation
Hide Description An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment
Arm/Group Title Tiotropium Salmeterol
Hide Arm/Group Description:
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
Overall Number of Participants Analyzed 3707 3669
Measure Type: Number
Unit of Measure: Participants
Participants with (at least one) event 1277 1414
Participants with no event 2430 2255
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tiotropium, Salmeterol
Comments Tiotropium versus Salmeterol
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.90
Confidence Interval 95%
0.85 to 0.95
Estimation Comments [Not Specified]
4.Secondary Outcome
Title COPD Exacerbations Per Patient-year
Hide Description [Not Specified]
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment
Arm/Group Title Tiotropium Salmeterol
Hide Arm/Group Description:
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
Overall Number of Participants Analyzed 3707 3669
Mean (95% Confidence Interval)
Unit of Measure: exacerbations per patient-year
0.64
(0.61 to 0.67)
0.72
(0.68 to 0.75)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tiotropium, Salmeterol
Comments Tiotropium versus Salmeterol
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0017
Comments [Not Specified]
Method Poisson regression
Comments Poisson regression correcting for overdisperion and adjusted for treatment exposure
Method of Estimation Estimation Parameter Rate ratio (ratio of incidence rates)
Estimated Value 0.89
Confidence Interval 95%
0.83 to 0.96
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.03
Estimation Comments [Not Specified]
5.Secondary Outcome
Title First Occurrence of COPD Exacerbation Leading to Hospitalization
Hide Description First occurrence analysed by Cox regression as time to first exacerbation leading to hospitalisation and reported as hazard ratio. An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment
Arm/Group Title Tiotropium Salmeterol
Hide Arm/Group Description:
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
Overall Number of Participants Analyzed 3707 3669
Measure Type: Number
Unit of Measure: number of first occurrences
262 336
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tiotropium, Salmeterol
Comments Tiotropium versus Salmeterol
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Cox
Comments Treatment effect adjusted for pooled centre
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.72
Confidence Interval 95%
0.61 to 0.85
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Number of Participants With at Least One COPD Exacerbation Leading to Hospitalisation
Hide Description An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment
Arm/Group Title Tiotropium Salmeterol
Hide Arm/Group Description:
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
Overall Number of Participants Analyzed 3707 3669
Measure Type: Number
Unit of Measure: Participants
Participants with (at least one) event 262 336
Participants with no event 3445 3333
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tiotropium, Salmeterol
Comments Tiotropium versus Salmeterol
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.77
Confidence Interval 95%
0.66 to 0.89
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Occurrence of Premature Discontinuation of Trial Medication
Hide Description Occurrence analysed by Cox regression as time to premature discontinuation of trial medication and reported as hazard ratio
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment
Arm/Group Title Tiotropium Salmeterol
Hide Arm/Group Description:
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
Overall Number of Participants Analyzed 3707 3669
Measure Type: Number
Unit of Measure: number of first occurrences
585 648
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tiotropium, Salmeterol
Comments Tiotropium versus Salmeterol
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0242
Comments [Not Specified]
Method Regression, Cox
Comments Treatment effect adjusted for pooled centre
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.88
Confidence Interval 95%
0.78 to 0.98
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Number of Participants With Premature Discontinuation of Trial Medication
Hide Description [Not Specified]
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment
Arm/Group Title Tiotropium Salmeterol
Hide Arm/Group Description:
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
Overall Number of Participants Analyzed 3707 3669
Measure Type: Number
Unit of Measure: Participants
Participants with (at least one) event 585 648
Participants with no event 3122 3021
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tiotropium, Salmeterol
Comments Tiotropium versus Salmeterol
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0406
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.90
Confidence Interval 95%
0.82 to 1.00
Estimation Comments [Not Specified]
9.Secondary Outcome
Title First Occurrence of COPD Exacerbation or Discontinuation of Trial Medication Because of Worsening of Underlying Disease, Whichever Comes First
Hide Description First occurrence analysed by Cox regression as time to first exacerbation or discontinuation of trial medication because of worsening of underlying disease, whichever comes first and reported as hazard ratio. An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment
Arm/Group Title Tiotropium Salmeterol
Hide Arm/Group Description:
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
Overall Number of Participants Analyzed 3707 3669
Measure Type: Number
Unit of Measure: number of first occurrences
1316 1448
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tiotropium, Salmeterol
Comments Tiotropium versus Salmeterol
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Cox
Comments Treatment effect adjusted for pooled centre
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.84
Confidence Interval 95%
0.78 to 0.91
Estimation Comments [Not Specified]
10.Secondary Outcome
Title First Occurrence of COPD Exacerbations Treated With Systemic Steroids
Hide Description First occurrence analysed by Cox regression as time to first exacerbation treated with systemic steroids and reported as hazard ratio. An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment
Arm/Group Title Tiotropium Salmeterol
Hide Arm/Group Description:
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
Overall Number of Participants Analyzed 3707 3669
Measure Type: Number
Unit of Measure: number of first occurrences
715 852
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tiotropium, Salmeterol
Comments Tiotropium versus Salmeterol
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Cox
Comments Treatment effect adjusted for pooled centre
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.77
Confidence Interval 95%
0.69 to 0.85
Estimation Comments [Not Specified]
11.Secondary Outcome
Title First Occurrence of COPD Exacerbations Treated With Antibiotics
Hide Description First occurrence analysed by Cox regression as time to first exacerbation treated with antibiotics and reported as hazard ratio. An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment
Arm/Group Title Tiotropium Salmeterol
Hide Arm/Group Description:
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
Overall Number of Participants Analyzed 3707 3669
Measure Type: Number
Unit of Measure: number of first occurrences
1154 1259
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tiotropium, Salmeterol
Comments Tiotropium versus Salmeterol
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Cox
Comments Treatment effect adjusted for pooled centre
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.85
Confidence Interval 95%
0.78 to 0.92
Estimation Comments [Not Specified]
12.Secondary Outcome
Title First Occurrence of COPD Exacerbations Treated With Systemic Steroids and Antibiotics
Hide Description First occurrence analysed by Cox regression as time to first exacerbation treated with systemic steroids and antibiotics and reported as hazard ratio. An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment
Arm/Group Title Tiotropium Salmeterol
Hide Arm/Group Description:
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
Overall Number of Participants Analyzed 3707 3669
Measure Type: Number
Unit of Measure: number of first occurrences
562 671
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tiotropium, Salmeterol
Comments Tiotropium versus Salmeterol
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Cox
Comments Treatment effect adjusted for pooled centre
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.76
Confidence Interval 95%
0.68 to 0.86
Estimation Comments [Not Specified]
13.Secondary Outcome
Title COPD Exacerbations Treated With Systemic Steroids Per Patient-year
Hide Description An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment
Arm/Group Title Tiotropium Salmeterol
Hide Arm/Group Description:
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
Overall Number of Participants Analyzed 3707 3669
Mean (95% Confidence Interval)
Unit of Measure: exacerbations per patient-year
0.33
(0.31 to 0.36)
0.41
(0.38 to 0.43)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tiotropium, Salmeterol
Comments Tiotropium versus Salmeterol
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 Poisson regression correcting for overdispersion and adjusted for treatment exposure
Method of Estimation Estimation Parameter Rate ratio (ratio of incidence rates)
Estimated Value 0.82
Confidence Interval 95%
0.76 to 0.90
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.04
Estimation Comments [Not Specified]
14.Secondary Outcome
Title COPD Exacerbations Treated With Antibiotics Per Patient-year
Hide Description An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment
Arm/Group Title Tiotropium Salmeterol
Hide Arm/Group Description:
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
Overall Number of Participants Analyzed 3707 3669
Mean (95% Confidence Interval)
Unit of Measure: exacerbations per patient-year
0.53
(0.50 to 0.56)
0.59
(0.56 to 0.62)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tiotropium, Salmeterol
Comments Tiotropium versus Salmeterol
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0036
Comments [Not Specified]
Method Poisson regression
Comments Poisson regression correcting for overdisperion and adjusted for treatment exposure
Method of Estimation Estimation Parameter Rate ratio (ratio of incidence rates)
Estimated Value 0.90
Confidence Interval 95%
0.84 to 0.97
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.03
Estimation Comments [Not Specified]
15.Secondary Outcome
Title COPD Exacerbations Treated With Systemic Steroids and Antibiotics Per Patient-year
Hide Description An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment
Arm/Group Title Tiotropium Salmeterol
Hide Arm/Group Description:
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
Overall Number of Participants Analyzed 3707 3669
Mean (95% Confidence Interval)
Unit of Measure: exacerbations per patient-year
0.23
(0.21 to 0.24)
0.28
(0.27 to 0.30)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tiotropium, Salmeterol
Comments Tiotropium versus Salmeterol
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 Poisson regression correcting for overdisperion and adjusted for treatment exposure
Method of Estimation Estimation Parameter Rate ratio (ratio of incidence rates)
Estimated Value 0.80
Confidence Interval 95%
0.73 to 0.88
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.04
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 1
Hide Description PEFR means peak expiratory flow rate and is measured in liter per minute
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples
Arm/Group Title Tiotropium Salmeterol
Hide Arm/Group Description:
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
Overall Number of Participants Analyzed 2446 2434
Mean (Standard Error)
Unit of Measure: liter per minute (L/min)
222.85  (0.81) 224.45  (0.81)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tiotropium, Salmeterol
Comments Tiotropium versus Salmeterol
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1035
Comments [Not Specified]
Method Mixed Effects Repeated Measures Model
Comments Mixed effects repeated measures model (MMRM) (fixed terms: treatment, centre, week, treatment*week; covariates: baseline PEFR, baseline PEFR*week)
Method of Estimation Estimation Parameter difference in peak expiratory flow rates
Estimated Value -1.60
Confidence Interval 95%
-3.53 to 0.33
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 2
Hide Description PEFR means peak expiratory flow rate and is measured in liter per minute
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples
Arm/Group Title Tiotropium Salmeterol
Hide Arm/Group Description:
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
Overall Number of Participants Analyzed 2413 2377
Mean (Standard Error)
Unit of Measure: liter per minute (L/min)
225.15  (0.81) 227.21  (0.81)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tiotropium, Salmeterol
Comments Tiotropium versus Salmeterol
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0369
Comments [Not Specified]
Method Mixed Effects Repeated Measures Model
Comments Mixed effects repeated measures model (MRMM)(fixed terms: treatment, centre, week, treatment*week; covariates: baseline PEFR, baseline PEFR*week).
Method of Estimation Estimation Parameter difference in peak expiratory flow rates
Estimated Value -2.06
Confidence Interval 95%
-3.99 to -0.12
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 3
Hide Description PEFR means peak expiratory flow rate and is measured in liter per minute
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples
Arm/Group Title Tiotropium Salmeterol
Hide Arm/Group Description:
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
Overall Number of Participants Analyzed 2394 2357
Mean (Standard Error)
Unit of Measure: liter per minute (L/min)
226.31  (0.81) 228.38  (0.81)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tiotropium, Salmeterol
Comments Tiotropium versus Salmeterol
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0362
Comments [Not Specified]
Method Mixed Effects Repeated Measures Model
Comments MMRM (fixed terms: treatment, centre, week, treatment*week; covariates: baseline PEFR, baseline PEFR*week)
Method of Estimation Estimation Parameter difference in peak expiratory flow rates
Estimated Value -2.07
Confidence Interval 95%
-4.00 to -0.13
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 4
Hide Description PEFR means peak expiratory flow rate and is measured in liter per minute
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples
Arm/Group Title Tiotropium Salmeterol
Hide Arm/Group Description:
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
Overall Number of Participants Analyzed 2380 2349
Mean (Standard Error)
Unit of Measure: liter per minute (L/min)
227.37  (0.81) 229.25  (0.81)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tiotropium, Salmeterol
Comments Tiotropium versus Salmeterol
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0573
Comments [Not Specified]
Method Mixed Effects Repeated Measures Model
Comments MMRM (fixed terms: treatment, centre, week, treatment*week; covariates: baseline PEFR, baseline PEFR*week)
Method of Estimation Estimation Parameter difference in peak expiratory flow rates
Estimated Value -1.88
Confidence Interval 95%
-3.82 to 0.06
Estimation Comments [Not Specified]
20.Secondary Outcome
Title Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 5
Hide Description PEFR means peak expiratory flow rate and is measured in liter per minute
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples
Arm/Group Title Tiotropium Salmeterol
Hide Arm/Group Description:
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
Overall Number of Participants Analyzed 2360 2335
Mean (Standard Error)
Unit of Measure: liter per minute (L/min)
228.27  (0.81) 229.37  (0.81)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tiotropium, Salmeterol
Comments Tiotropium versus Salmeterol
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2641
Comments [Not Specified]
Method Mixed Effects Repeated Measures Model
Comments MMRM (fixed terms: treatment, centre, week, treatment*week; covariates: baseline PEFR, baseline PEFR*week)
Method of Estimation Estimation Parameter difference in peak expiratory flow rates
Estimated Value -1.10
Confidence Interval 95%
-3.04 to 0.83
Estimation Comments [Not Specified]
21.Secondary Outcome
Title Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 6
Hide Description PEFR means peak expiratory flow rate and is measured in liter per minute
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples
Arm/Group Title Tiotropium Salmeterol
Hide Arm/Group Description:
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
Overall Number of Participants Analyzed 2351 2319
Mean (Standard Error)
Unit of Measure: liter per minute (L/min)
228.80  (0.82) 229.81  (0.81)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tiotropium, Salmeterol
Comments Tiotropium versus Salmeterol
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3068
Comments [Not Specified]
Method Mixed Effects Repeated Measures Model
Comments MMRM (fixed terms: treatment, centre, week, treatment*week; covariates: baseline PEFR, baseline PEFR*week)
Method of Estimation Estimation Parameter difference in peak expiratory flow rates
Estimated Value -1.01
Confidence Interval 95%
-2.95 to 0.93
Estimation Comments [Not Specified]
22.Secondary Outcome
Title Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 7
Hide Description PEFR means peak expiratory flow rate and is measured in liter per minute
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples
Arm/Group Title Tiotropium Salmeterol
Hide Arm/Group Description:
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
Overall Number of Participants Analyzed 2339 2306
Mean (Standard Error)
Unit of Measure: liter per minute (L/min)
229.35  (0.82) 230.13  (0.82)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tiotropium, Salmeterol
Comments Tiotropium versus Salmeterol
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4299
Comments [Not Specified]
Method Mixed Effects Repeated Measures Model
Comments MMRM (fixed terms: treatment, centre, week, treatment*week; covariates: baseline PEFR, baseline PEFR*week)
Method of Estimation Estimation Parameter difference in peak expiratory flow rates
Estimated Value -0.78
Confidence Interval 95%
-2.72 to 1.16
Estimation Comments [Not Specified]
23.Secondary Outcome
Title Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 8
Hide Description PEFR means peak expiratory flow rate and is measured in liter per minute
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples
Arm/Group Title Tiotropium Salmeterol
Hide Arm/Group Description:
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
Overall Number of Participants Analyzed 2319 2278
Mean (Standard Error)
Unit of Measure: liter per minute (L/min)
229.95  (0.82) 230.43  (0.82)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tiotropium, Salmeterol
Comments Tiotropium versus Salmeterol
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6277
Comments [Not Specified]
Method Mixed Effects Repeated Measures Model
Comments MMRM (fixed terms: treatment, centre, week, treatment*week; covariates: baseline PEFR, baseline PEFR*week)
Method of Estimation Estimation Parameter difference in peak expiratory flow rates
Estimated Value -0.48
Confidence Interval 95%
-2.42 to 1.46
Estimation Comments [Not Specified]
24.Secondary Outcome
Title Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 9
Hide Description PEFR means peak expiratory flow rate and is measured in liter per minute
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples
Arm/Group Title Tiotropium Salmeterol
Hide Arm/Group Description:
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
Overall Number of Participants Analyzed 2279 2234
Mean (Standard Error)
Unit of Measure: liter per minute (L/min)
229.72  (0.82) 230.57  (0.82)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tiotropium, Salmeterol
Comments Tiotropium versus Salmeterol
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3931
Comments [Not Specified]
Method Mixed Effects Repeated Measures Model
Comments MMRM (fixed terms: treatment, centre, week, treatment*week; covariates: baseline PEFR, baseline PEFR*week)
Method of Estimation Estimation Parameter difference in peak expiratory flow rates
Estimated Value -0.85
Confidence Interval 95%
-2.80 to 1.10
Estimation Comments [Not Specified]
25.Secondary Outcome
Title Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 10
Hide Description PEFR means peak expiratory flow rate and is measured in liter per minute
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples
Arm/Group Title Tiotropium Salmeterol
Hide Arm/Group Description:
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
Overall Number of Participants Analyzed 2285 2235
Mean (Standard Error)
Unit of Measure: liter per minute (L/min)
230.30  (0.82) 231.27  (0.82)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tiotropium, Salmeterol
Comments Tiotropium versus Salmeterol
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3297
Comments [Not Specified]
Method Mixed Effects Repeated Measures Model
Comments MMRM (fixed terms: treatment, centre, week, treatment*week; covariates: baseline PEFR, baseline PEFR*week)
Method of Estimation Estimation Parameter difference in peak expiratory flow rates
Estimated Value -0.97
Confidence Interval 95%
-2.92 to 0.98
Estimation Comments [Not Specified]
26.Secondary Outcome
Title Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 11
Hide Description PEFR means peak expiratory flow rate and is measured in liter per minute
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples
Arm/Group Title Tiotropium Salmeterol
Hide Arm/Group Description:
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
Overall Number of Participants Analyzed 2289 2228
Mean (Standard Error)
Unit of Measure: liter per minute (L/min)
230.61  (0.82) 231.91  (0.82)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tiotropium, Salmeterol
Comments Tiotropium versus Salmeterol
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1904
Comments [Not Specified]
Method Mixed Effects Repeated Measures Model
Comments MMRM (fixed terms: treatment, centre, week, treatment*week; covariates: baseline PEFR, baseline PEFR*week)
Method of Estimation Estimation Parameter difference in peak expiratory flow rates
Estimated Value -1.30
Confidence Interval 95%
-3.25 to 0.65
Estimation Comments [Not Specified]
27.Secondary Outcome
Title Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 12
Hide Description PEFR means peak expiratory flow rate and is measured in liter per minute
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples
Arm/Group Title Tiotropium Salmeterol
Hide Arm/Group Description:
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
Overall Number of Participants Analyzed 2286 2214
Mean (Standard Error)
Unit of Measure: liter per minute (L/min)
231.04  (0.82) 232.04  (0.82)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tiotropium, Salmeterol
Comments Tiotropium versus Salmeterol
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3172
Comments [Not Specified]
Method Mixed Effects Repeated Measures Model
Comments MMRM (fixed terms: treatment, centre, week, treatment*week; covariates: baseline PEFR, baseline PEFR*week)
Method of Estimation Estimation Parameter difference in peak expiratory flow rates
Estimated Value -0.99
Confidence Interval 95%
-2.94 to 0.95
Estimation Comments [Not Specified]
28.Secondary Outcome
Title Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 13
Hide Description PEFR means peak expiratory flow rate and is measured in liter per minute
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples
Arm/Group Title Tiotropium Salmeterol
Hide Arm/Group Description:
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
Overall Number of Participants Analyzed 2278 2212
Mean (Standard Error)
Unit of Measure: liter per minute (L/min)
231.23  (0.82) 231.89  (0.82)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tiotropium, Salmeterol
Comments Tiotropium versus Salmeterol
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5017
Comments [Not Specified]
Method Mixed Effects Repeated Measures Model
Comments MMRM (fixed terms: treatment, centre, week, treatment*week; covariates: baseline PEFR, baseline PEFR*week)
Method of Estimation Estimation Parameter difference in peak expiratory flow rates
Estimated Value -0.67
Confidence Interval 95%
-2.62 to 1.28
Estimation Comments [Not Specified]
29.Secondary Outcome
Title Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 14
Hide Description PEFR means peak expiratory flow rate and is measured in liter per minute
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples
Arm/Group Title Tiotropium Salmeterol
Hide Arm/Group Description:
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
Overall Number of Participants Analyzed 2264 2211
Mean (Standard Error)
Unit of Measure: liter per minute (L/min)
231.19  (0.82) 232.42  (0.82)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tiotropium, Salmeterol
Comments Tiotropium versus Salmeterol
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2174
Comments [Not Specified]
Method Mixed Effects Repeated Measures Model
Comments MMRM (fixed terms: treatment, centre, week, treatment*week; covariates: baseline PEFR, baseline PEFR*week)
Method of Estimation Estimation Parameter difference in peak expiratory flow rates
Estimated Value -1.23
Confidence Interval 95%
-3.18 to 0.72
Estimation Comments [Not Specified]
30.Secondary Outcome
Title Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 15
Hide Description PEFR means peak expiratory flow rate and is measured in liter per minute
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples
Arm/Group Title Tiotropium Salmeterol
Hide Arm/Group Description:
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
Overall Number of Participants Analyzed 2256 2193
Mean (Standard Error)
Unit of Measure: liter per minute (L/min)
231.64  (0.82) 232.75  (0.82)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tiotropium, Salmeterol
Comments Tiotropium versus Salmeterol
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2682
Comments [Not Specified]
Method Mixed Effects Repeated Measures Model
Comments MMRM (fixed terms: treatment, centre, week, treatment*week; covariates: baseline PEFR, baseline PEFR*week)
Method of Estimation Estimation Parameter difference in peak expiratory flow rates
Estimated Value -1.10
Confidence Interval 95%
-3.05 to 0.85
Estimation Comments [Not Specified]
31.Secondary Outcome
Title Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 16
Hide Description PEFR means peak expiratory flow rate and is measured in liter per minute
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples
Arm/Group Title Tiotropium Salmeterol
Hide Arm/Group Description:
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
Overall Number of Participants Analyzed 2240 2174
Mean (Standard Error)
Unit of Measure: liter per minute (L/min)
232.06  (0.82) 232.65  (0.82)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tiotropium, Salmeterol
Comments Tiotropium versus Salmeterol
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5520
Comments [Not Specified]
Method Mixed Effects Repeated Measures Model
Comments MMRM (fixed terms: treatment, centre, week, treatment*week; covariates: baseline PEFR, baseline PEFR*week)
Method of Estimation Estimation Parameter difference in peak expiratory flow rates
Estimated Value -0.59
Confidence Interval 95%
-2.55 to 1.36
Estimation Comments [Not Specified]
Time Frame 52 weeks (while on treatment with study drugs + 30 days)
Adverse Event Reporting Description The term “Chronic obstructive pulmonary disease” under “Other Adverse Events” contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
 
Arm/Group Title Tiotropium Salmeterol
Hide Arm/Group Description Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID) Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
All-Cause Mortality
Tiotropium Salmeterol
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tiotropium Salmeterol
Affected / at Risk (%) Affected / at Risk (%)
Total   545/3707 (14.70%)   606/3669 (16.52%) 
Blood and lymphatic system disorders     
Anaemia  1  1/3707 (0.03%)  3/3669 (0.08%) 
Haemorrhagic anaemia  1  1/3707 (0.03%)  0/3669 (0.00%) 
Iron deficiency anaemia  1  1/3707 (0.03%)  0/3669 (0.00%) 
Lymphadenopathy  1  0/3707 (0.00%)  1/3669 (0.03%) 
Splenitis  1  1/3707 (0.03%)  0/3669 (0.00%) 
Cardiac disorders     
Acute coronary syndrome  1  2/3707 (0.05%)  2/3669 (0.05%) 
Acute myocardial infarction  1  3/3707 (0.08%)  1/3669 (0.03%) 
Angina pectoris  1  9/3707 (0.24%)  5/3669 (0.14%) 
Angina unstable  1  2/3707 (0.05%)  2/3669 (0.05%) 
Arrhythmia  1  1/3707 (0.03%)  1/3669 (0.03%) 
Arrhythmia supraventricular  1  1/3707 (0.03%)  0/3669 (0.00%) 
Arteriosclerosis coronary artery  1  1/3707 (0.03%)  1/3669 (0.03%) 
Atrial fibrillation  1  12/3707 (0.32%)  14/3669 (0.38%) 
Atrial flutter  1  1/3707 (0.03%)  1/3669 (0.03%) 
Atrioventricular block  1  0/3707 (0.00%)  1/3669 (0.03%) 
Atrioventricular block second degree  1  0/3707 (0.00%)  1/3669 (0.03%) 
Bradycardia  1  0/3707 (0.00%)  1/3669 (0.03%) 
Cardiac arrest  1  2/3707 (0.05%)  2/3669 (0.05%) 
Cardiac failure  1  17/3707 (0.46%)  21/3669 (0.57%) 
Cardiac failure acute  1  2/3707 (0.05%)  1/3669 (0.03%) 
Cardiac failure chronic  1  0/3707 (0.00%)  1/3669 (0.03%) 
Cardiac failure congestive  1  1/3707 (0.03%)  0/3669 (0.00%) 
Cardiac fibrillation  1  1/3707 (0.03%)  0/3669 (0.00%) 
Cardiogenic shock  1  1/3707 (0.03%)  0/3669 (0.00%) 
Cardiomyopathy  1  3/3707 (0.08%)  0/3669 (0.00%) 
Cardiopulmonary failure  1  4/3707 (0.11%)  3/3669 (0.08%) 
Cardiovascular disorder  1  0/3707 (0.00%)  1/3669 (0.03%) 
Cardiovascular insufficiency  1  4/3707 (0.11%)  0/3669 (0.00%) 
Congestive cardiomyopathy  1  0/3707 (0.00%)  1/3669 (0.03%) 
Cor pulmonale  1  4/3707 (0.11%)  5/3669 (0.14%) 
Cor pulmonale chronic  1  1/3707 (0.03%)  2/3669 (0.05%) 
Coronary artery disease  1  4/3707 (0.11%)  5/3669 (0.14%) 
Coronary artery insufficiency  1  1/3707 (0.03%)  2/3669 (0.05%) 
Coronary artery stenosis  1  2/3707 (0.05%)  1/3669 (0.03%) 
Dressler's syndrome  1  1/3707 (0.03%)  0/3669 (0.00%) 
Extrasystoles  1  0/3707 (0.00%)  2/3669 (0.05%) 
Ischaemic cardiomyopathy  1  1/3707 (0.03%)  1/3669 (0.03%) 
Left ventricular failure  1  2/3707 (0.05%)  0/3669 (0.00%) 
Mitral valve stenosis  1  1/3707 (0.03%)  0/3669 (0.00%) 
Myocardial infarction  1  20/3707 (0.54%)  13/3669 (0.35%) 
Myocardial ischaemia  1  11/3707 (0.30%)  6/3669 (0.16%) 
Nodal rhythm  1  1/3707 (0.03%)  0/3669 (0.00%) 
Pericarditis  1  0/3707 (0.00%)  1/3669 (0.03%) 
Postinfarction angina  1  1/3707 (0.03%)  0/3669 (0.00%) 
Right ventricular failure  1  1/3707 (0.03%)  4/3669 (0.11%) 
Sinoatrial block  1  0/3707 (0.00%)  1/3669 (0.03%) 
Sinus bradycardia  1  1/3707 (0.03%)  0/3669 (0.00%) 
Supraventricular tachycardia  1  1/3707 (0.03%)  0/3669 (0.00%) 
Tachyarrhythmia  1  1/3707 (0.03%)  0/3669 (0.00%) 
Tachycardia  1  1/3707 (0.03%)  1/3669 (0.03%) 
Ventricular fibrillation  1  0/3707 (0.00%)  1/3669 (0.03%) 
Ear and labyrinth disorders     
Tinnitus  1  0/3707 (0.00%)  1/3669 (0.03%) 
Tympanosclerosis  1  0/3707 (0.00%)  1/3669 (0.03%) 
Vertigo  1  0/3707 (0.00%)  1/3669 (0.03%) 
Vestibular ataxia  1  1/3707 (0.03%)  0/3669 (0.00%) 
Vestibular disorder  1  1/3707 (0.03%)  0/3669 (0.00%) 
Endocrine disorders     
Hypercalcaemia of malignancy  1  0/3707 (0.00%)  1/3669 (0.03%) 
Hyperthyroidism  1  0/3707 (0.00%)  1/3669 (0.03%) 
Hypoparathyroidism  1  1/3707 (0.03%)  0/3669 (0.00%) 
Hypothyroidism  1  1/3707 (0.03%)  0/3669 (0.00%) 
Eye disorders     
Cataract  1  6/3707 (0.16%)  3/3669 (0.08%) 
Eye disorder  1  1/3707 (0.03%)  0/3669 (0.00%) 
Eyelid ptosis  1  1/3707 (0.03%)  0/3669 (0.00%) 
Glaucoma  1  0/3707 (0.00%)  1/3669 (0.03%) 
Iridocyclitis  1  0/3707 (0.00%)  1/3669 (0.03%) 
Retinal detachment  1  0/3707 (0.00%)  1/3669 (0.03%) 
Scleritis  1  1/3707 (0.03%)  0/3669 (0.00%) 
Visual impairment  1  1/3707 (0.03%)  0/3669 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1  2/3707 (0.05%)  4/3669 (0.11%) 
Abdominal pain upper  1  3/3707 (0.08%)  0/3669 (0.00%) 
Anal polyp  1  0/3707 (0.00%)  1/3669 (0.03%) 
Colitis  1  0/3707 (0.00%)  1/3669 (0.03%) 
Colonic polyp  1  1/3707 (0.03%)  0/3669 (0.00%) 
Diarrhoea  1  2/3707 (0.05%)  2/3669 (0.05%) 
Diverticulitis oesophageal  1  0/3707 (0.00%)  1/3669 (0.03%) 
Diverticulum  1  0/3707 (0.00%)  1/3669 (0.03%) 
Duodenal perforation  1  0/3707 (0.00%)  1/3669 (0.03%) 
Duodenal ulcer  1  3/3707 (0.08%)  2/3669 (0.05%) 
Duodenal ulcer haemorrhage  1  1/3707 (0.03%)  1/3669 (0.03%) 
Dyspepsia  1  0/3707 (0.00%)  1/3669 (0.03%) 
Enamel anomaly  1  0/3707 (0.00%)  1/3669 (0.03%) 
Enteritis  1  1/3707 (0.03%)  0/3669 (0.00%) 
Epiploic appendagitis  1  1/3707 (0.03%)  0/3669 (0.00%) 
Gastric ulcer  1  1/3707 (0.03%)  1/3669 (0.03%) 
Gastric ulcer haemorrhage  1  2/3707 (0.05%)  1/3669 (0.03%) 
Gastric ulcer perforation  1  1/3707 (0.03%)  0/3669 (0.00%) 
Gastritis  1  3/3707 (0.08%)  2/3669 (0.05%) 
Gastritis erosive  1  1/3707 (0.03%)  0/3669 (0.00%) 
Gastroduodenitis  1  0/3707 (0.00%)  1/3669 (0.03%) 
Gastrointestinal haemorrhage  1  0/3707 (0.00%)  1/3669 (0.03%) 
Haemorrhoidal haemorrhage  1  0/3707 (0.00%)  1/3669 (0.03%) 
Haemorrhoids  1  2/3707 (0.05%)  1/3669 (0.03%) 
Ileus  1  1/3707 (0.03%)  0/3669 (0.00%) 
Inflammatory bowel disease  1  0/3707 (0.00%)  1/3669 (0.03%) 
Inguinal hernia  1  2/3707 (0.05%)  1/3669 (0.03%) 
Intestinal infarction  1  0/3707 (0.00%)  1/3669 (0.03%) 
Intestinal ischaemia  1  1/3707 (0.03%)  0/3669 (0.00%) 
Intestinal obstruction  1  1/3707 (0.03%)  0/3669 (0.00%) 
Mesenteric artery thrombosis  1  1/3707 (0.03%)  0/3669 (0.00%) 
Pancreatic necrosis  1  1/3707 (0.03%)  0/3669 (0.00%) 
Pancreatitis acute  1  2/3707 (0.05%)  2/3669 (0.05%) 
Pancreatitis haemorrhagic  1  1/3707 (0.03%)  0/3669 (0.00%) 
Pancreatitis relapsing  1  0/3707 (0.00%)  1/3669 (0.03%) 
Parotid gland enlargement  1  0/3707 (0.00%)  1/3669 (0.03%) 
Peptic ulcer  1  0/3707 (0.00%)  1/3669 (0.03%) 
Peptic ulcer perforation  1  1/3707 (0.03%)  0/3669 (0.00%) 
Peritonitis  1  1/3707 (0.03%)  1/3669 (0.03%) 
Rectal polyp  1  1/3707 (0.03%)  0/3669 (0.00%) 
Subileus  1  0/3707 (0.00%)  1/3669 (0.03%) 
Varices oesophageal  1  0/3707 (0.00%)  1/3669 (0.03%) 
General disorders     
Chest pain  1  4/3707 (0.11%)  6/3669 (0.16%) 
Chills  1  0/3707 (0.00%)  1/3669 (0.03%) 
Death  1  3/3707 (0.08%)  7/3669 (0.19%) 
Device dislocation  1  1/3707 (0.03%)  1/3669 (0.03%) 
Drowning  1  2/3707 (0.05%)  0/3669 (0.00%) 
Drug intolerance  1  0/3707 (0.00%)  1/3669 (0.03%) 
Gait disturbance  1  0/3707 (0.00%)  1/3669 (0.03%) 
General physical health deterioration  1  0/3707 (0.00%)  1/3669 (0.03%) 
Hernia  1  0/3707 (0.00%)  1/3669 (0.03%) 
Hypothermia  1  0/3707 (0.00%)  1/3669 (0.03%) 
Inflammation  1  0/3707 (0.00%)  1/3669 (0.03%) 
Malaise  1  0/3707 (0.00%)  1/3669 (0.03%) 
Multi-organ failure  1  5/3707 (0.13%)  0/3669 (0.00%) 
Oedema peripheral  1  0/3707 (0.00%)  2/3669 (0.05%) 
Pyrexia  1  1/3707 (0.03%)  1/3669 (0.03%) 
Sudden cardiac death  1  0/3707 (0.00%)  1/3669 (0.03%) 
Sudden death  1  0/3707 (0.00%)  2/3669 (0.05%) 
Hepatobiliary disorders     
Bile duct obstruction  1  1/3707 (0.03%)  0/3669 (0.00%) 
Cholangitis  1  0/3707 (0.00%)  1/3669 (0.03%) 
Cholecystitis  1  2/3707 (0.05%)  3/3669 (0.08%) 
Cholecystitis acute  1  3/3707 (0.08%)  0/3669 (0.00%) 
Cholecystitis chronic  1  1/3707 (0.03%)  0/3669 (0.00%) 
Cholelithiasis  1  3/3707 (0.08%)  0/3669 (0.00%) 
Gallbladder polyp  1  0/3707 (0.00%)  1/3669 (0.03%) 
Jaundice  1  0/3707 (0.00%)  1/3669 (0.03%) 
Liver disorder  1  2/3707 (0.05%)  1/3669 (0.03%) 
Immune system disorders     
Anaphylactic reaction  1  0/3707 (0.00%)  1/3669 (0.03%) 
Infections and infestations     
Actinomycosis  1  0/3707 (0.00%)  1/3669 (0.03%) 
Appendicitis  1  2/3707 (0.05%)  1/3669 (0.03%) 
Borrelia infection  1  0/3707 (0.00%)  1/3669 (0.03%) 
Bronchiectasis  1  1/3707 (0.03%)  0/3669 (0.00%) 
Bronchitis  1  3/3707 (0.08%)  1/3669 (0.03%) 
Bronchitis bacterial  1  1/3707 (0.03%)  1/3669 (0.03%) 
Bronchopneumonia  1  4/3707 (0.11%)  3/3669 (0.08%) 
Candidiasis  1  1/3707 (0.03%)  0/3669 (0.00%) 
Cellulitis  1  0/3707 (0.00%)  3/3669 (0.08%) 
Cholangitis suppurative  1  1/3707 (0.03%)  0/3669 (0.00%) 
Clostridium difficile colitis  1  0/3707 (0.00%)  1/3669 (0.03%) 
Dermatitis infected  1  1/3707 (0.03%)  0/3669 (0.00%) 
Diabetic gangrene  1  0/3707 (0.00%)  1/3669 (0.03%) 
Diverticulitis  1  0/3707 (0.00%)  1/3669 (0.03%) 
Empyema  1  1/3707 (0.03%)  0/3669 (0.00%) 
Erysipelas  1  0/3707 (0.00%)  1/3669 (0.03%) 
Gangrene  1  0/3707 (0.00%)  1/3669 (0.03%) 
Gastroenteritis  1  3/3707 (0.08%)  0/3669 (0.00%) 
Groin abscess  1  0/3707 (0.00%)  1/3669 (0.03%) 
H1N1 influenza  1  1/3707 (0.03%)  0/3669 (0.00%) 
Hepatitis B  1  0/3707 (0.00%)  1/3669 (0.03%) 
Hepatitis C  1  1/3707 (0.03%)  0/3669 (0.00%) 
Herpes zoster  1  1/3707 (0.03%)  0/3669 (0.00%) 
Infection  1  0/3707 (0.00%)  1/3669 (0.03%) 
Infective exacerbation of chronic obstructive airways disease  1  2/3707 (0.05%)  4/3669 (0.11%) 
Influenza  1  0/3707 (0.00%)  2/3669 (0.05%) 
Kidney infection  1  1/3707 (0.03%)  0/3669 (0.00%) 
Laryngitis  1  1/3707 (0.03%)  0/3669 (0.00%) 
Lobar pneumonia  1  3/3707 (0.08%)  1/3669 (0.03%) 
Lower respiratory tract infection  1  3/3707 (0.08%)  1/3669 (0.03%) 
Lung abscess  1  1/3707 (0.03%)  2/3669 (0.05%) 
Lyme disease  1  1/3707 (0.03%)  0/3669 (0.00%) 
Nosocomial infection  1  0/3707 (0.00%)  1/3669 (0.03%) 
Oesophageal candidiasis  1  0/3707 (0.00%)  1/3669 (0.03%) 
Oral candidiasis  1  1/3707 (0.03%)  0/3669 (0.00%) 
Orchitis  1  0/3707 (0.00%)  2/3669 (0.05%) 
Otitis media chronic  1  0/3707 (0.00%)  1/3669 (0.03%) 
Peritonsillar abscess  1  0/3707 (0.00%)  2/3669 (0.05%) 
Pilonidal cyst  1  0/3707 (0.00%)  1/3669 (0.03%) 
Pneumonia  1  54/3707 (1.46%)  64/3669 (1.74%) 
Pneumonia necrotising  1  0/3707 (0.00%)  1/3669 (0.03%) 
Pneumonia staphylococcal  1  1/3707 (0.03%)  0/3669 (0.00%) 
Pneumonia streptococcal  1  1/3707 (0.03%)  0/3669 (0.00%) 
Pneumonia viral  1  0/3707 (0.00%)  1/3669 (0.03%) 
Post procedural infection  1  0/3707 (0.00%)  1/3669 (0.03%) 
Pseudomembranous colitis  1  0/3707 (0.00%)  1/3669 (0.03%) 
Pulmonary tuberculosis  1  1/3707 (0.03%)  1/3669 (0.03%) 
Pyelonephritis  1  2/3707 (0.05%)  1/3669 (0.03%) 
Pyothorax  1  0/3707 (0.00%)  1/3669 (0.03%) 
Respiratory tract infection  1  1/3707 (0.03%)  4/3669 (0.11%) 
Rickettsiosis  1  1/3707 (0.03%)  0/3669 (0.00%) 
Sepsis  1  3/3707 (0.08%)  2/3669 (0.05%) 
Septic shock  1  2/3707 (0.05%)  2/3669 (0.05%) 
Sinusitis  1  0/3707 (0.00%)  1/3669 (0.03%) 
Staphylococcal infection  1  0/3707 (0.00%)  1/3669 (0.03%) 
Staphylococcal sepsis  1  2/3707 (0.05%)  0/3669 (0.00%) 
Subcutaneous abscess  1  1/3707 (0.03%)  0/3669 (0.00%) 
Superinfection bacterial  1  1/3707 (0.03%)  0/3669 (0.00%) 
Tracheobronchitis  1  1/3707 (0.03%)  0/3669 (0.00%) 
Tuberculosis  1  1/3707 (0.03%)  2/3669 (0.05%) 
Upper respiratory tract infection  1  0/3707 (0.00%)  4/3669 (0.11%) 
Urinary tract infection  1  5/3707 (0.13%)  1/3669 (0.03%) 
Wound sepsis  1  1/3707 (0.03%)  0/3669 (0.00%) 
Injury, poisoning and procedural complications     
Accident at work  1  0/3707 (0.00%)  1/3669 (0.03%) 
Alcohol poisoning  1  0/3707 (0.00%)  1/3669 (0.03%) 
Arthropod sting  1  0/3707 (0.00%)  1/3669 (0.03%) 
Cerebral haemorrhage traumatic  1  0/3707 (0.00%)  1/3669 (0.03%) 
Chest injury  1  1/3707 (0.03%)  1/3669 (0.03%) 
Concussion  1  1/3707 (0.03%)  0/3669 (0.00%) 
Contusion  1  2/3707 (0.05%)  2/3669 (0.05%) 
Fall  1  9/3707 (0.24%)  7/3669 (0.19%) 
Femoral neck fracture  1  1/3707 (0.03%)  1/3669 (0.03%) 
Femur fracture  1  2/3707 (0.05%)  1/3669 (0.03%) 
Fibula fracture  1  1/3707 (0.03%)  0/3669 (0.00%) 
Foot fracture  1  0/3707 (0.00%)  1/3669 (0.03%) 
Frostbite  1  0/3707 (0.00%)  1/3669 (0.03%) 
Hand fracture  1  1/3707 (0.03%)  0/3669 (0.00%) 
Head injury  1  3/3707 (0.08%)  1/3669 (0.03%) 
Humerus fracture  1  1/3707 (0.03%)  2/3669 (0.05%) 
Joint injury  1  1/3707 (0.03%)  0/3669 (0.00%) 
Ligament rupture  1  1/3707 (0.03%)  0/3669 (0.00%) 
Lumbar vertebral fracture  1  0/3707 (0.00%)  1/3669 (0.03%) 
Multiple drug overdose  1  0/3707 (0.00%)  1/3669 (0.03%) 
Multiple injuries  1  0/3707 (0.00%)  1/3669 (0.03%) 
Muscle rupture  1  1/3707 (0.03%)  0/3669 (0.00%) 
Postoperative wound complication  1  1/3707 (0.03%)  0/3669 (0.00%) 
Radius fracture  1  0/3707 (0.00%)  1/3669 (0.03%) 
Rib fracture  1  4/3707 (0.11%)  0/3669 (0.00%) 
Road traffic accident  1  4/3707 (0.11%)  1/3669 (0.03%) 
Spinal column injury  1  1/3707 (0.03%)  0/3669 (0.00%) 
Spinal compression fracture  1  0/3707 (0.00%)  1/3669 (0.03%) 
Spinal fracture  1  0/3707 (0.00%)  1/3669 (0.03%) 
Subdural haematoma  1  3/3707 (0.08%)  0/3669 (0.00%) 
Tendon rupture  1  2/3707 (0.05%)  0/3669 (0.00%) 
Thermal burn  1  0/3707 (0.00%)  1/3669 (0.03%) 
Thoracic vertebral fracture  1  0/3707 (0.00%)  1/3669 (0.03%) 
Tibia fracture  1  1/3707 (0.03%)  0/3669 (0.00%) 
Wound  1  1/3707 (0.03%)  0/3669 (0.00%) 
Investigations     
Arteriogram coronary  1  1/3707 (0.03%)  0/3669 (0.00%) 
Investigation  1  0/3707 (0.00%)  1/3669 (0.03%) 
Weight decreased  1  2/3707 (0.05%)  1/3669 (0.03%) 
Metabolism and nutrition disorders     
Cachexia  1  0/3707 (0.00%)  2/3669 (0.05%) 
Diabetes mellitus  1  1/3707 (0.03%)  4/3669 (0.11%) 
Diabetes mellitus inadequate control  1  0/3707 (0.00%)  1/3669 (0.03%) 
Hyperglycaemia  1  1/3707 (0.03%)  0/3669 (0.00%) 
Hyperkalaemia  1  1/3707 (0.03%)  0/3669 (0.00%) 
Hypertriglyceridaemia  1  1/3707 (0.03%)  0/3669 (0.00%) 
Hypokalaemia  1  1/3707 (0.03%)  1/3669 (0.03%) 
Hypomagnesaemia  1  1/3707 (0.03%)  0/3669 (0.00%) 
Hyponatraemia  1  0/3707 (0.00%)  1/3669 (0.03%) 
Tetany  1  1/3707 (0.03%)  0/3669 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthritis  1  0/3707 (0.00%)  1/3669 (0.03%) 
Arthropathy  1  1/3707 (0.03%)  0/3669 (0.00%) 
Back pain  1  2/3707 (0.05%)  4/3669 (0.11%) 
Bone pain  1  0/3707 (0.00%)  2/3669 (0.05%) 
Bursitis  1  1/3707 (0.03%)  0/3669 (0.00%) 
Dental alveolar anomaly  1  0/3707 (0.00%)  1/3669 (0.03%) 
Dupuytren's contracture  1  1/3707 (0.03%)  0/3669 (0.00%) 
Intervertebral disc protrusion  1  1/3707 (0.03%)  1/3669 (0.03%) 
Lumbar spinal stenosis  1  0/3707 (0.00%)  1/3669 (0.03%) 
Muscle atrophy  1  0/3707 (0.00%)  1/3669 (0.03%) 
Musculoskeletal chest pain  1  0/3707 (0.00%)  1/3669 (0.03%) 
Neck pain  1  0/3707 (0.00%)  1/3669 (0.03%) 
Osteoarthritis  1  1/3707 (0.03%)  5/3669 (0.14%) 
Osteochondrosis  1  1/3707 (0.03%)  1/3669 (0.03%) 
Osteoporosis  1  0/3707 (0.00%)  2/3669 (0.05%) 
Pain in extremity  1  0/3707 (0.00%)  1/3669 (0.03%) 
Polymyalgia rheumatica  1  0/3707 (0.00%)  1/3669 (0.03%) 
Rotator cuff syndrome  1  1/3707 (0.03%)  0/3669 (0.00%) 
Soft tissue necrosis  1  0/3707 (0.00%)  1/3669 (0.03%) 
Spinal disorder  1  1/3707 (0.03%)  0/3669 (0.00%) 
Spinal osteoarthritis  1  1/3707 (0.03%)  0/3669 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma  1  3/3707 (0.08%)  1/3669 (0.03%) 
Benign breast neoplasm  1  1/3707 (0.03%)  0/3669 (0.00%) 
Bladder cancer  1  4/3707 (0.11%)  1/3669 (0.03%) 
Bladder neoplasm  1  1/3707 (0.03%)  0/3669 (0.00%) 
Bladder papilloma  1  1/3707 (0.03%)  0/3669 (0.00%) 
Bladder transitional cell carcinoma  1  0/3707 (0.00%)  2/3669 (0.05%) 
Breast cancer  1  0/3707 (0.00%)  2/3669 (0.05%) 
Bronchial carcinoma  1  4/3707 (0.11%)  2/3669 (0.05%) 
Carcinoid tumour pulmonary  1  0/3707 (0.00%)  1/3669 (0.03%) 
Cholesteatoma  1  0/3707 (0.00%)  1/3669 (0.03%) 
Chronic lymphocytic leukaemia  1  1/3707 (0.03%)  0/3669 (0.00%) 
Colon cancer  1  0/3707 (0.00%)  2/3669 (0.05%) 
Gallbladder cancer  1  0/3707 (0.00%)  1/3669 (0.03%) 
Gastric cancer  1  1/3707 (0.03%)  0/3669 (0.00%) 
Haemangioma of liver  1  1/3707 (0.03%)  0/3669 (0.00%) 
Hepatic neoplasm  1  1/3707 (0.03%)  0/3669 (0.00%) 
Hepatic neoplasm malignant  1  0/3707 (0.00%)  2/3669 (0.05%) 
Histiocytosis  1  1/3707 (0.03%)  0/3669 (0.00%) 
Hypopharyngeal cancer  1  0/3707 (0.00%)  2/3669 (0.05%) 
Lip neoplasm malignant stage unspecified  1  1/3707 (0.03%)  0/3669 (0.00%) 
Lipoma  1  1/3707 (0.03%)  0/3669 (0.00%) 
Lung adenocarcinoma  1  0/3707 (0.00%)  1/3669 (0.03%) 
Lung carcinoma cell type unspecified stage III  1  1/3707 (0.03%)  0/3669 (0.00%) 
Lung neoplasm  1  1/3707 (0.03%)  1/3669 (0.03%) 
Lung neoplasm malignant  1  9/3707 (0.24%)  7/3669 (0.19%) 
Lung squamous cell carcinoma stage unspecified  1  1/3707 (0.03%)  2/3669 (0.05%) 
Lymphocytic leukaemia  1  0/3707 (0.00%)  1/3669 (0.03%) 
Lymphoma  1  1/3707 (0.03%)  0/3669 (0.00%) 
Malignant melanoma  1  0/3707 (0.00%)  1/3669 (0.03%) 
Metastases to bone  1  0/3707 (0.00%)  1/3669 (0.03%) 
Metastases to central nervous system  1  1/3707 (0.03%)  1/3669 (0.03%) 
Metastases to liver  1  0/3707 (0.00%)  3/3669 (0.08%) 
Metastases to lung  1  0/3707 (0.00%)  1/3669 (0.03%) 
Metastases to lymph nodes  1  0/3707 (0.00%)  1/3669 (0.03%) 
Metastases to peritoneum  1  1/3707 (0.03%)  0/3669 (0.00%) 
Metastases to retroperitoneum  1  0/3707 (0.00%)  1/3669 (0.03%) 
Metastasis  1  1/3707 (0.03%)  0/3669 (0.00%) 
Metastatic carcinoid tumour  1  0/3707 (0.00%)  1/3669 (0.03%) 
Metastatic gastric cancer  1  1/3707 (0.03%)  0/3669 (0.00%) 
Neoplasm malignant  1  2/3707 (0.05%)  0/3669 (0.00%) 
Non-small cell lung cancer  1  2/3707 (0.05%)  3/3669 (0.08%) 
Oral papilloma  1  1/3707 (0.03%)  0/3669 (0.00%) 
Pancreatic carcinoma  1  2/3707 (0.05%)  2/3669 (0.05%) 
Pancreatic carcinoma metastatic  1  1/3707 (0.03%)  1/3669 (0.03%) 
Pancreatic neoplasm  1  0/3707 (0.00%)  1/3669 (0.03%) 
Paraneoplastic syndrome  1  0/3707 (0.00%)  1/3669 (0.03%) 
Pharyngeal cancer stage unspecified  1  1/3707 (0.03%)  0/3669 (0.00%) 
Pleural mesothelioma  1  1/3707 (0.03%)  0/3669 (0.00%) 
Prostate cancer  1  2/3707 (0.05%)  2/3669 (0.05%) 
Prostatic adenoma  1  1/3707 (0.03%)  0/3669 (0.00%) 
Rectal cancer  1  0/3707 (0.00%)  1/3669 (0.03%) 
Renal neoplasm  1  1/3707 (0.03%)  1/3669 (0.03%) 
Salivary gland cancer  1  1/3707 (0.03%)  0/3669 (0.00%) 
Small cell lung cancer stage unspecified  1  2/3707 (0.05%)  0/3669 (0.00%) 
Tongue neoplasm malignant stage unspecified  1  1/3707 (0.03%)  0/3669 (0.00%) 
Tonsil cancer  1  0/3707 (0.00%)  1/3669 (0.03%) 
Nervous system disorders     
Axonal neuropathy  1  0/3707 (0.00%)  1/3669 (0.03%) 
Brain oedema  1  2/3707 (0.05%)  3/3669 (0.08%) 
Carotid artery stenosis  1  1/3707 (0.03%)  1/3669 (0.03%) 
Cerebral circulatory failure  1  1/3707 (0.03%)  0/3669 (0.00%) 
Cerebral haematoma  1  0/3707 (0.00%)  1/3669 (0.03%) 
Cerebral haemorrhage  1  1/3707 (0.03%)  1/3669 (0.03%) 
Cerebral ischaemia  1  2/3707 (0.05%)  0/3669 (0.00%) 
Cerebrovascular accident  1  3/3707 (0.08%)  9/3669 (0.25%) 
Cervical root pain  1  0/3707 (0.00%)  1/3669 (0.03%) 
Coma  1  0/3707 (0.00%)  2/3669 (0.05%) 
Convulsion  1  0/3707 (0.00%)  2/3669 (0.05%) 
Diabetic ketoacidotic hyperglycaemic coma  1  1/3707 (0.03%)  0/3669 (0.00%) 
Dizziness  1  1/3707 (0.03%)  0/3669 (0.00%) 
Encephalopathy  1  1/3707 (0.03%)  0/3669 (0.00%) 
Epilepsy  1  1/3707 (0.03%)  0/3669 (0.00%) 
Headache  1  0/3707 (0.00%)  1/3669 (0.03%) 
Hypercapnic encephalopathy  1  0/3707 (0.00%)  1/3669 (0.03%) 
Ischaemic stroke  1  3/3707 (0.08%)  2/3669 (0.05%) 
Neuralgia  1  0/3707 (0.00%)  1/3669 (0.03%) 
Paresis  1  1/3707 (0.03%)  0/3669 (0.00%) 
Polyneuropathy  1  1/3707 (0.03%)  1/3669 (0.03%) 
Postictal state  1  0/3707 (0.00%)  1/3669 (0.03%) 
Sciatica  1  1/3707 (0.03%)  1/3669 (0.03%) 
Subarachnoid haemorrhage  1  1/3707 (0.03%)  1/3669 (0.03%) 
Syncope  1  5/3707 (0.13%)  2/3669 (0.05%) 
Transient ischaemic attack  1  3/3707 (0.08%)  2/3669 (0.05%) 
Psychiatric disorders     
Alcohol abuse  1  0/3707 (0.00%)  1/3669 (0.03%) 
Alcoholism  1  0/3707 (0.00%)  2/3669 (0.05%) 
Completed suicide  1  1/3707 (0.03%)  1/3669 (0.03%) 
Confusional state  1  0/3707 (0.00%)  2/3669 (0.05%) 
Delirium tremens  1  0/3707 (0.00%)  1/3669 (0.03%) 
Depression  1  3/3707 (0.08%)  3/3669 (0.08%) 
Drug abuse  1  1/3707 (0.03%)  0/3669 (0.00%) 
Renal and urinary disorders     
Glomerulonephritis chronic  1  1/3707 (0.03%)  0/3669 (0.00%) 
Haematuria  1  0/3707 (0.00%)  1/3669 (0.03%) 
Nephropathy  1  0/3707 (0.00%)  1/3669 (0.03%) 
Renal failure  1  4/3707 (0.11%)  1/3669 (0.03%) 
Renal failure acute  1  3/3707 (0.08%)  1/3669 (0.03%) 
Urinary retention  1  4/3707 (0.11%)  0/3669 (0.00%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1  1/3707 (0.03%)  1/3669 (0.03%) 
Epididymitis  1  0/3707 (0.00%)  1/3669 (0.03%) 
Prostatitis  1  1/3707 (0.03%)  1/3669 (0.03%) 
Respiratory, thoracic and mediastinal disorders     
Acute pulmonary oedema  1  0/3707 (0.00%)  1/3669 (0.03%) 
Acute respiratory failure  1  1/3707 (0.03%)  4/3669 (0.11%) 
Allergic granulomatous angiitis  1  1/3707 (0.03%)  0/3669 (0.00%) 
Aspiration  1  0/3707 (0.00%)  1/3669 (0.03%) 
Atelectasis  1  1/3707 (0.03%)  0/3669 (0.00%) 
Bronchopneumopathy  1  1/3707 (0.03%)  0/3669 (0.00%) 
Bronchostenosis  1  0/3707 (0.00%)  1/3669 (0.03%) 
Bullous lung disease  1  1/3707 (0.03%)  3/3669 (0.08%) 
Chronic obstructive pulmonary disease  1  270/3707 (7.28%)  335/3669 (9.13%) 
Chronic respiratory failure  1  2/3707 (0.05%)  1/3669 (0.03%) 
Dyspnoea  1  1/3707 (0.03%)  5/3669 (0.14%) 
Eosinophilic pneumonia  1  0/3707 (0.00%)  1/3669 (0.03%) 
Epistaxis  1  1/3707 (0.03%)  2/3669 (0.05%) 
Haemoptysis  1  4/3707 (0.11%)  1/3669 (0.03%) 
Haemothorax  1  3/3707 (0.08%)  0/3669 (0.00%) 
Hydrothorax  1  1/3707 (0.03%)  2/3669 (0.05%) 
Hypoxia  1  0/3707 (0.00%)  1/3669 (0.03%) 
Lung infiltration  1  1/3707 (0.03%)  0/3669 (0.00%) 
Nasal polyps  1  0/3707 (0.00%)  1/3669 (0.03%) 
Oropharyngeal swelling  1  0/3707 (0.00%)  1/3669 (0.03%) 
Pleural effusion  1  3/3707 (0.08%)  1/3669 (0.03%) 
Pleurisy  1  1/3707 (0.03%)  1/3669 (0.03%) 
Pneumothorax  1  3/3707 (0.08%)  5/3669 (0.14%) 
Pulmonary artery thrombosis  1  2/3707 (0.05%)  0/3669 (0.00%) 
Pulmonary embolism  1  7/3707 (0.19%)  6/3669 (0.16%) 
Pulmonary fibrosis  1  1/3707 (0.03%)  0/3669 (0.00%) 
Pulmonary granuloma  1  1/3707 (0.03%)  0/3669 (0.00%) 
Pulmonary hypertension  1  1/3707 (0.03%)  3/3669 (0.08%) 
Pulmonary oedema  1  1/3707 (0.03%)  0/3669 (0.00%) 
Respiratory arrest  1  0/3707 (0.00%)  1/3669 (0.03%) 
Respiratory disorder  1  0/3707 (0.00%)  1/3669 (0.03%) 
Respiratory failure  1  16/3707 (0.43%)  20/3669 (0.55%) 
Throat lesion  1  1/3707 (0.03%)  0/3669 (0.00%) 
Vasomotor rhinitis  1  1/3707 (0.03%)  0/3669 (0.00%) 
Skin and subcutaneous tissue disorders     
Actinic keratosis  1  1/3707 (0.03%)  0/3669 (0.00%) 
Drug eruption  1  1/3707 (0.03%)  0/3669 (0.00%) 
Psoriasis  1  1/3707 (0.03%)  0/3669 (0.00%) 
Seborrhoeic dermatitis  1  1/3707 (0.03%)  0/3669 (0.00%) 
Skin ulcer  1  0/3707 (0.00%)  2/3669 (0.05%) 
Social circumstances     
Social problem  1  1/3707 (0.03%)  0/3669 (0.00%) 
Surgical and medical procedures     
Alcohol detoxification  1  0/3707 (0.00%)  1/3669 (0.03%) 
Intraocular lens implant  1  1/3707 (0.03%)  0/3669 (0.00%) 
Surgery  1  1/3707 (0.03%)  0/3669 (0.00%) 
Vocal cord polypectomy  1  0/3707 (0.00%)  1/3669 (0.03%) 
Vascular disorders     
Aortic aneurysm  1  2/3707 (0.05%)  4/3669 (0.11%) 
Aortic dissection  1  1/3707 (0.03%)  1/3669 (0.03%) 
Aortic stenosis  1  1/3707 (0.03%)  0/3669 (0.00%) 
Arteriosclerosis  1  3/3707 (0.08%)  3/3669 (0.08%) 
Arteriosclerosis obliterans  1  1/3707 (0.03%)  2/3669 (0.05%) 
Arteriovenous fistula  1  1/3707 (0.03%)  0/3669 (0.00%) 
Circulatory collapse  1  5/3707 (0.13%)  1/3669 (0.03%) 
Deep vein thrombosis  1  5/3707 (0.13%)  1/3669 (0.03%) 
Embolism  1  0/3707 (0.00%)  1/3669 (0.03%) 
Femoral artery occlusion  1  0/3707 (0.00%)  1/3669 (0.03%) 
Haematoma  1  1/3707 (0.03%)  0/3669 (0.00%) 
Hypertension  1  9/3707 (0.24%)  5/3669 (0.14%) 
Hypertensive crisis  1  3/3707 (0.08%)  4/3669 (0.11%) 
Hypotension  1  1/3707 (0.03%)  0/3669 (0.00%) 
Iliac artery occlusion  1  1/3707 (0.03%)  1/3669 (0.03%) 
Peripheral arterial occlusive disease  1  4/3707 (0.11%)  2/3669 (0.05%) 
Peripheral embolism  1  0/3707 (0.00%)  1/3669 (0.03%) 
Peripheral ischaemia  1  1/3707 (0.03%)  0/3669 (0.00%) 
Superior vena caval occlusion  1  1/3707 (0.03%)  0/3669 (0.00%) 
Vascular occlusion  1  1/3707 (0.03%)  0/3669 (0.00%) 
Venous thrombosis  1  0/3707 (0.00%)  1/3669 (0.03%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 13.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tiotropium Salmeterol
Affected / at Risk (%) Affected / at Risk (%)
Total   495/3707 (13.35%)   581/3669 (15.84%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  495/3707 (13.35%)  581/3669 (15.84%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 13.0
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
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00563381     History of Changes
Other Study ID Numbers: 205.389
EUDRACT2007-001840-33
First Submitted: November 22, 2007
First Posted: November 26, 2007
Results First Submitted: March 29, 2011
Results First Posted: May 17, 2011
Last Update Posted: December 24, 2013