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Effect of Treatment BI 1744 CL (5 and 10 mcg) Versus Placebo on Exercise Endurance Time During Constant Work Rate Cycle Ergometry I

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ClinicalTrials.gov Identifier: NCT01040130
Recruitment Status : Completed
First Posted : December 29, 2009
Results First Posted : July 8, 2014
Last Update Posted : July 8, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition Pulmonary Disease, Chronic Obstructive
Interventions Drug: Olodaterol (BI 1744)
Drug: Placebo
Drug: Olodaterol (BI 1744) Placebo
Enrollment 151
Recruitment Details  
Pre-assignment Details This was a randomised, double-blind, placebo-controlled, 3-way crossover trial. The duration of each treatment period was 6 weeks with a 14 day washout period between treatments.
Arm/Group Title Placebo / Olo 5mcg / Olo 10mcg Placebo / Olo 10mcg / Olo 5mcg Olo 5mcg / Placebo / Olo 10mcg Olo 5mcg / Olo 10mcg / Placebo Olo 10mcg / Placebo / Olo 5mcg Olo 10mcg / Olo 5mcg / Placebo
Hide Arm/Group Description Patients were administered placebo in the first period, Olodaterol 5 mcg qd in the second period and Olodaterol 10 mcg qd in the third period. Olodaterol was administered via the Respimat inhaler. Patients were administered placebo in the first period, Olodaterol 10 mcg qd in the second period and Olodaterol 5 mcg qd in the third period. Olodaterol was administered via the Respimat inhaler. Patients were administered Olodaterol 5 mcg qd in the first period, placebo in the second period and Olodaterol 10 mcg qd in the third period. Olodaterol was administered via the Respimat inhaler. Patients were administered Olodaterol 5 mcg qd in the first period, Olodaterol 10 mcg qd in the second period and placebo in the third period. Olodaterol was administered via the Respimat inhaler. Patients were administered Olodaterol 10 mcg qd in the first period, placebo in the second period and Olodaterol 5 mcg qd in the third period. Olodaterol was administered via the Respimat inhaler. Patients were administered Olodaterol 10 mcg qd in the first period, Olodaterol 5 mcg qd in the second period and placebo in the third period. Olodaterol was administered via the Respimat inhaler.
Period Title: Overall Study
Started 25 [1] 25 25 25 25 26
Completed 22 [2] 22 23 20 25 22
Not Completed 3 3 2 5 0 4
Reason Not Completed
Adverse Event             1             1             0             5             0             3
Protocol Violation             0             0             2             0             0             0
Withdrawal by Subject             0             2             0             0             0             1
Other reasons not listed above             2             0             0             0             0             0
[1]
Number of patients entered and treated
[2]
Number of patients who did not discontinue from the trial.
Arm/Group Title Study Total
Hide Arm/Group Description Total number of patients treated in the study. This was a randomised, double-blind, placebo-controlled, 3-way crossover trial. 151 patients were assigned randomly to one of 3 treatment sequences in which they received each of 3 treatments. The duration of each treatment period was 6 weeks with a 14 day washout period between treatments.
Overall Number of Baseline Participants 151
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 151 participants
60.6  (7.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 151 participants
Female
35
  23.2%
Male
116
  76.8%
1.Primary Outcome
Title Adjusted Mean Endurance Time After 6 Weeks
Hide Description Primary endpoint was endurance time during constant work rate ergometry to symptom limitation at 75% of maximal work capacity after 6 weeks of treatment. Mixed effects model on log10 transformation data. Adjusted means are back transformed to report as geometric means. Standard errors (SEs) are calculated using the delta method.
Time Frame 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint.
Arm/Group Title Placebo Olo 5 mcg qd Olo 10 mcg qd
Hide Arm/Group Description:
Matching Placebo delivered by the Respimat Inhaler.
Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
Overall Number of Participants Analyzed 136 140 136
Geometric Mean (Standard Error)
Unit of Measure: seconds
369.81  (11.941) 421.58  (13.459) 420.72  (13.602)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Olo 5 mcg qd
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed effects repeated measures with treatment, baseline endurance time and period as fixed and patient as random effect. Means, CI back-transformed.
Method of Estimation Estimation Parameter Ratio to placebo
Estimated Value 1.140
Confidence Interval 95%
1.065 to 1.221
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.040
Estimation Comments Olo 5 mcg divided by Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Olo 10 mcg qd
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed effects repeated measures with treatment, baseline endurance time and period as fixed and patient as random effect. Means, CI back-transformed.
Method of Estimation Estimation Parameter Ratio to placebo
Estimated Value 1.138
Confidence Interval 95%
1.062 to 1.219
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.040
Estimation Comments Olo 10 mcg divided by Placebo
2.Secondary Outcome
Title Adjusted Mean Inspiratory Capacity at Isotime After 6 Weeks
Hide Description Isotime is defined as the endurance time of the constant work rate exercise test of shortest duration from Baseline visit, and Week 6 of each of the three treatment periods.
Time Frame 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.
Arm/Group Title Placebo Olo 5 mcg qd Olo 10 mcg qd
Hide Arm/Group Description:
Matching Placebo delivered by the Respimat Inhaler.
Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
Overall Number of Participants Analyzed 136 140 135
Least Squares Mean (Standard Error)
Unit of Measure: liters
1.917  (0.038) 2.099  (0.038) 2.091  (0.038)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Olo 5 mcg qd
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 Mixed Models Analysis
Comments Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.182
Confidence Interval 95%
0.112 to 0.252
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.036
Estimation Comments Olo 5 mcg minus Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Olo 10 mcg qd
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 Mixed Models Analysis
Comments Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.174
Confidence Interval 95%
0.104 to 0.245
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.036
Estimation Comments Olo 10 mcg minus Placebo
3.Secondary Outcome
Title Adjusted Mean Borg Scale of Breathing Discomfort at Isotime After 6 Weeks
Hide Description

Isotime is defined as the endurance time of the constant work rate exercise test of shortest duration from Baseline visit, and Week 6 of each of the three treatment periods.

Borg scale rates discomfort with breathing at rest, during exercise and at end-exercise on a scale from 0=Nothing at all to 10=Maximal discomfort.

Time Frame 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint.
Arm/Group Title Placebo Olo 5 mcg qd Olo 10 mcg qd
Hide Arm/Group Description:
Matching Placebo delivered by the Respimat Inhaler.
Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
Overall Number of Participants Analyzed 136 140 136
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
5.870  (0.185) 5.104  (0.182) 5.235  (0.185)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Olo 5 mcg qd
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0007
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.766
Confidence Interval 95%
-1.205 to -0.326
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.223
Estimation Comments Olo 5 mcg minus Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Olo 10 mcg qd
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0051
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.634
Confidence Interval 95%
-1.077 to -0.192
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.225
Estimation Comments Olo 10 mcg minus Placebo
4.Secondary Outcome
Title Adjusted Mean Inspiratory Capacity at Pre-exercise After 6 Weeks
Hide Description [Not Specified]
Time Frame 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.
Arm/Group Title Placebo Olo 5 mcg qd Olo 10 mcg qd
Hide Arm/Group Description:
Matching Placebo delivered by the Respimat Inhaler.
Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
Overall Number of Participants Analyzed 134 139 133
Least Squares Mean (Standard Error)
Unit of Measure: liters
2.220  (0.032) 2.478  (0.032) 2.513  (0.032)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Olo 5 mcg qd
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 Mixed Models Analysis
Comments Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.258
Confidence Interval 95%
0.191 to 0.325
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.034
Estimation Comments Olo 5 mcg minus Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Olo 10 mcg qd
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 Mixed Models Analysis
Comments Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.294
Confidence Interval 95%
0.226 to 0.362
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.035
Estimation Comments Olo 10 mcg minus Placebo
5.Secondary Outcome
Title Adjusted Mean Inspiratory Capacity at End of Exercise After 6 Weeks
Hide Description [Not Specified]
Time Frame 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.
Arm/Group Title Placebo Olo 5 mcg qd Olo 10 mcg qd
Hide Arm/Group Description:
Matching Placebo delivered by the Respimat Inhaler.
Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
Overall Number of Participants Analyzed 136 140 135
Least Squares Mean (Standard Error)
Unit of Measure: liters
1.887  (0.035) 2.067  (0.035) 2.024  (0.035)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Olo 5 mcg qd
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 Mixed Models Analysis
Comments Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.180
Confidence Interval 95%
0.107 to 0.252
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.037
Estimation Comments Olo 5 mcg minus Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Olo 10 mcg qd
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.137
Confidence Interval 95%
0.064 to 0.210
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.037
Estimation Comments Olo 10 mcg minus Placebo
6.Secondary Outcome
Title Adjusted Mean Borg Scale of Breathing Discomfort at Pre-exercise After 6 Weeks
Hide Description Borg scale rates discomfort with breathing at rest, during exercise and at end-exercise on a scale from 0=Nothing at all to 10=Maximal discomfort.
Time Frame 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.
Arm/Group Title Placebo Olo 5 mcg qd Olo 10 mcg qd
Hide Arm/Group Description:
Matching Placebo delivered by the Respimat Inhaler.
Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
Overall Number of Participants Analyzed 136 140 135
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
0.288  (0.041) 0.185  (0.040) 0.224  (0.041)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Olo 5 mcg qd
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0447
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.103
Confidence Interval 95%
-0.204 to -0.002
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.051
Estimation Comments Olo 5 mcg minus Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Olo 10 mcg qd
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2132
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.064
Confidence Interval 95%
-0.166 to 0.037
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.052
Estimation Comments Olo 10 mcg minus Placebo
7.Secondary Outcome
Title Adjusted Mean Borg Scale of Breathing Discomfort at End of Exercise After 6 Weeks
Hide Description Borg scale rates discomfort with breathing at rest, during exercise and at end-exercise on a scale from 0=Nothing at all to 10=Maximal discomfort.
Time Frame 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint.
Arm/Group Title Placebo Olo 5 mcg qd Olo 10 mcg qd
Hide Arm/Group Description:
Matching Placebo delivered by the Respimat Inhaler.
Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
Overall Number of Participants Analyzed 136 140 136
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
6.978  (0.143) 6.890  (0.141) 7.234  (0.143)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Olo 5 mcg qd
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5698
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.088
Confidence Interval 95%
-0.391 to 0.216
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.154
Estimation Comments Olo 5 mcg minus Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Olo 10 mcg qd
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1003
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.256
Confidence Interval 95%
-0.050 to 0.561
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.155
Estimation Comments Olo 10 mcg minus Placebo
8.Secondary Outcome
Title Adjusted Mean Functional Residual Capacity 30 Minutes Pre-dose After 6 Weeks
Hide Description [Not Specified]
Time Frame 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.
Arm/Group Title Placebo Olo 5 mcg qd Olo 10 mcg qd
Hide Arm/Group Description:
Matching Placebo delivered by the Respimat Inhaler.
Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
Overall Number of Participants Analyzed 134 139 134
Least Squares Mean (Standard Error)
Unit of Measure: liters
4.977  (0.062) 4.855  (0.061) 4.862  (0.062)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Olo 5 mcg qd
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0784
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.122
Confidence Interval 95%
-0.258 to 0.014
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.069
Estimation Comments Olo 5 mcg minus Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Olo 10 mcg qd
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1013
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.115
Confidence Interval 95%
-0.252 to 0.023
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.070
Estimation Comments Olo 10 mcg minus Placebo
9.Secondary Outcome
Title Adjusted Mean Functional Residual Capacity 1 Hour Post-dose After 6 Weeks
Hide Description [Not Specified]
Time Frame 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.
Arm/Group Title Placebo Olo 5 mcg qd Olo 10 mcg qd
Hide Arm/Group Description:
Matching Placebo delivered by the Respimat Inhaler.
Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
Overall Number of Participants Analyzed 134 139 134
Least Squares Mean (Standard Error)
Unit of Measure: liters
4.950  (0.064) 4.740  (0.063) 4.577  (0.064)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Olo 5 mcg qd
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0015
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.210
Confidence Interval 95%
-0.339 to -0.081
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.066
Estimation Comments Olo 5 mcg minus Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Olo 10 mcg qd
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 Mixed Models Analysis
Comments Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.373
Confidence Interval 95%
-0.503 to -0.243
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.066
Estimation Comments Olo 10 mcg minus Placebo
10.Secondary Outcome
Title Adjusted Mean Inspiratory Capacity 30 Minutes Pre-dose After 6 Weeks
Hide Description Measured using body plethysmography
Time Frame 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.
Arm/Group Title Placebo Olo 5 mcg qd Olo 10 mcg qd
Hide Arm/Group Description:
Matching Placebo delivered by the Respimat Inhaler.
Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
Overall Number of Participants Analyzed 135 140 134
Least Squares Mean (Standard Error)
Unit of Measure: liters
2.170  (0.040) 2.289  (0.040) 2.262  (0.040)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Olo 5 mcg qd
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.119
Confidence Interval 95%
0.052 to 0.185
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.034
Estimation Comments Olo 5 mcg minus Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Olo 10 mcg qd
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0073
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.092
Confidence Interval 95%
0.025 to 0.159
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.034
Estimation Comments Olo 10 mcg minus Placebo
11.Secondary Outcome
Title Adjusted Mean Inspiratory Capacity 1 Hour Post-dose After 6 Weeks
Hide Description Measured using body plethysmography
Time Frame 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.
Arm/Group Title Placebo Olo 5 mcg qd Olo 10 mcg qd
Hide Arm/Group Description:
Matching Placebo delivered by the Respimat Inhaler.
Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
Overall Number of Participants Analyzed 135 140 134
Least Squares Mean (Standard Error)
Unit of Measure: liters
2.221  (0.040) 2.427  (0.040) 2.437  (0.040)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Olo 5 mcg qd
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 Mixed Models Analysis
Comments Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.206
Confidence Interval 95%
0.136 to 0.275
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.035
Estimation Comments Olo 5 mcg minus Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Olo 10 mcg qd
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 Mixed Models Analysis
Comments Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.216
Confidence Interval 95%
0.146 to 0.285
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.036
Estimation Comments Olo 10 mcg minus Placebo
12.Secondary Outcome
Title Adjusted Mean Total Lung Capacity 30 Minutes Pre-dose After 6 Weeks
Hide Description Measured using body plethysmography
Time Frame 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.
Arm/Group Title Placebo Olo 5 mcg qd Olo 10 mcg qd
Hide Arm/Group Description:
Matching Placebo delivered by the Respimat Inhaler.
Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
Overall Number of Participants Analyzed 135 140 134
Least Squares Mean (Standard Error)
Unit of Measure: liters
7.142  (0.064) 7.148  (0.063) 7.121  (0.064)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Olo 5 mcg qd
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9239
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.006
Confidence Interval 95%
-0.115 to 0.127
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.062
Estimation Comments Olo 5 mcg minus Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Olo 10 mcg qd
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7368
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.021
Confidence Interval 95%
-0.144 to 0.102
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.062
Estimation Comments Olo 10 mcg minus Placebo
13.Secondary Outcome
Title Adjusted Mean Total Lung Capacity 1 Hour Post-dose After 6 Weeks
Hide Description [Not Specified]
Time Frame 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.
Arm/Group Title Placebo Olo 5 mcg qd Olo 10 mcg qd
Hide Arm/Group Description:
Matching Placebo delivered by the Respimat Inhaler.
Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
Overall Number of Participants Analyzed 135 140 134
Least Squares Mean (Standard Error)
Unit of Measure: liters
7.156  (0.066) 7.142  (0.066) 6.997  (0.067)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Olo 5 mcg qd
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8302
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.014
Confidence Interval 95%
-0.146 to 0.118
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.067
Estimation Comments Olo 5 mcg minus Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Olo 10 mcg qd
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0202
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.159
Confidence Interval 95%
-0.292 to -0.025
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.068
Estimation Comments Olo 10 mcg minus Placebo
14.Secondary Outcome
Title Adjusted Mean Forced Expiratory Volume in 1 Second, 30 Minutes Pre-dose After 6 Weeks
Hide Description [Not Specified]
Time Frame 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.
Arm/Group Title Placebo Olo 5 mcg qd Olo 10 mcg qd
Hide Arm/Group Description:
Matching Placebo delivered by the Respimat Inhaler.
Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
Overall Number of Participants Analyzed 136 137 137
Least Squares Mean (Standard Error)
Unit of Measure: liters
1.475  (0.017) 1.564  (0.017) 1.576  (0.017)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Olo 5 mcg qd
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 Mixed Models Analysis
Comments Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.089
Confidence Interval 95%
0.056 to 0.123
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.017
Estimation Comments Olo 5 mcg minus Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Olo 10 mcg qd
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 Mixed Models Analysis
Comments Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.101
Confidence Interval 95%
0.068 to 0.134
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.017
Estimation Comments Olo 10 mcg minus Placebo
15.Secondary Outcome
Title Adjusted Mean Forced Expiratory Volume in 1 Second, 1 Hour Post-dose After 6 Weeks
Hide Description [Not Specified]
Time Frame 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.
Arm/Group Title Placebo Olo 5 mcg qd Olo 10 mcg qd
Hide Arm/Group Description:
Matching Placebo delivered by the Respimat Inhaler.
Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
Overall Number of Participants Analyzed 136 137 137
Least Squares Mean (Standard Error)
Unit of Measure: liters
1.473  (0.019) 1.698  (0.019) 1.699  (0.019)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Olo 5 mcg qd
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 Mixed Models Analysis
Comments Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.224
Confidence Interval 95%
0.191 to 0.258
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.017
Estimation Comments Olo 5 mcg minus Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Olo 10 mcg qd
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 Mixed Models Analysis
Comments Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.226
Confidence Interval 95%
0.193 to 0.259
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.017
Estimation Comments Olo 10 mcg minus Placebo
16.Secondary Outcome
Title Adjusted Mean Forced Vital Capacity, 30 Minutes Pre-dose After 6 Weeks
Hide Description [Not Specified]
Time Frame 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.
Arm/Group Title Placebo Olo 5 mcg qd Olo 10 mcg qd
Hide Arm/Group Description:
Matching Placebo delivered by the Respimat Inhaler.
Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
Overall Number of Participants Analyzed 135 136 136
Least Squares Mean (Standard Error)
Unit of Measure: liters
3.212  (0.037) 3.319  (0.037) 3.310  (0.037)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Olo 5 mcg qd
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.107
Confidence Interval 95%
0.046 to 0.167
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.031
Estimation Comments Olo 5 mcg minus Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Olo 10 mcg qd
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0017
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.098
Confidence Interval 95%
0.037 to 0.158
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.031
Estimation Comments Olo 10 mcg minus Placebo
17.Secondary Outcome
Title Adjusted Mean Forced Vital Capacity, 1 Hour Post-dose After 6 Weeks
Hide Description [Not Specified]
Time Frame 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.
Arm/Group Title Placebo Olo 5 mcg qd Olo 10 mcg qd
Hide Arm/Group Description:
Matching Placebo delivered by the Respimat Inhaler.
Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
Overall Number of Participants Analyzed 135 136 136
Least Squares Mean (Standard Error)
Unit of Measure: liters
3.187  (0.034) 3.471  (0.034) 3.477  (0.034)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Olo 5 mcg qd
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 Mixed Models Analysis
Comments Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.285
Confidence Interval 95%
0.227 to 0.342
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.029
Estimation Comments Olo 5 mcg minus Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Olo 10 mcg qd
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 Mixed Models Analysis
Comments Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.290
Confidence Interval 95%
0.233 to 0.348
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.029
Estimation Comments Olo 10 mcg minus Placebo
18.Secondary Outcome
Title Adjusted Mean Peak Expiratory Flow Rate, 30 Minutes Pre-dose After 6 Weeks
Hide Description [Not Specified]
Time Frame 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.
Arm/Group Title Placebo Olo 5 mcg qd Olo 10 mcg qd
Hide Arm/Group Description:
Matching Placebo delivered by the Respimat Inhaler.
Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
Overall Number of Participants Analyzed 136 137 137
Least Squares Mean (Standard Error)
Unit of Measure: liters/second
4.374  (0.059) 4.692  (0.059) 4.677  (0.059)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Olo 5 mcg qd
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 Mixed Models Analysis
Comments Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.318
Confidence Interval 95%
0.207 to 0.429
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.056
Estimation Comments Olo 5 mcg minus Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Olo 10 mcg qd
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 Mixed Models Analysis
Comments Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.303
Confidence Interval 95%
0.192 to 0.414
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.056
Estimation Comments Olo 10 mcg minus Placebo
19.Secondary Outcome
Title Adjusted Mean Peak Expiratory Flow Rate, 1 Hour Post-dose After 6 Weeks
Hide Description [Not Specified]
Time Frame 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.
Arm/Group Title Placebo Olo 5 mcg qd Olo 10 mcg qd
Hide Arm/Group Description:
Matching Placebo delivered by the Respimat Inhaler.
Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
Overall Number of Participants Analyzed 136 137 137
Least Squares Mean (Standard Error)
Unit of Measure: liters/second
4.363  (0.063) 4.949  (0.063) 4.981  (0.063)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Olo 5 mcg qd
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 Mixed Models Analysis
Comments Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.585
Confidence Interval 95%
0.470 to 0.701
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.063
Estimation Comments Olo 5 mcg minus Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Olo 10 mcg qd
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 Mixed Models Analysis
Comments Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.618
Confidence Interval 95%
0.502 to 0.734
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.059
Estimation Comments Olo 10 mcg minus Placebo
20.Secondary Outcome
Title Change From Baseline to Day 43 in Blood Pressure
Hide Description Change from Baseline to Day 43 in Blood Pressure with spirometry. Baseline is defined as mean of pre-treatment values at a given time point.
Time Frame Baseline and Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated set. Statistics only include patients with both a baseline and a post dose value.
Arm/Group Title Placebo Olo 5 mcg Olo 10 mcg
Hide Arm/Group Description:
Matching Placebo delivered by the Respimat Inhaler.
Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
Overall Number of Participants Analyzed 131 133 136
Mean (Standard Deviation)
Unit of Measure: mmHg
Systolic blood pressure -3.5  (15.64) -2.7  (16.82) -3.3  (16.47)
Diastolic blood pressure -1.7  (7.9) -1.8  (8.36) -1.1  (9.16)
21.Secondary Outcome
Title Change From Baseline to Day 43 in Pulse Rate
Hide Description Change from Baseline to Day 43 in Pulse rate with spirometry. Baseline is defined as mean of pre-treatment values at a given time point.
Time Frame Baseline and Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated set. Statistics only include patients with both a baseline and a post dose value.
Arm/Group Title Placebo Olo 5 mcg Olo 10 mcg
Hide Arm/Group Description:
Matching Placebo delivered by the Respimat Inhaler.
Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
Overall Number of Participants Analyzed 138 142 141
Mean (Standard Deviation)
Unit of Measure: beats/min
-5.1  (13.63) -5.1  (13.88) -3  (12.61)
22.Secondary Outcome
Title Number of Patients With Notable Changes in Heart Rate
Hide Description Number of Patients with notable changes in heart rate (HR). Notable HR increase defined as >=25% increase and on-treatment HR > 100 bpm; Notable HR decrease defined as >=25% decrease and on-treatment HR < 50 bpm.
Time Frame Baseline and Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated set.
Arm/Group Title Placebo Olo 5 mcg Olo 10 mcg
Hide Arm/Group Description:
Matching Placebo delivered by the Respimat Inhaler.
Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
Overall Number of Participants Analyzed 138 141 140
Measure Type: Number
Unit of Measure: percentage of participants
30 min pre-dose: increase (N=138, 139, 140) 0.7 0.7 0.7
30 min pre-dose: decrease (N=138, 139, 140) 1.4 2.9 2.1
30 min pre-dose: no change (N=138, 139, 140) 97.8 96.4 97.1
40 min post-dose: increase (N=138, 141, 138) 2.2 1.4 2.9
40 min post-dose: decrease (N=138, 141, 138) 4.3 5.0 6.5
40 min post-dose: no change (N=138, 141, 138) 93.5 93.6 90.6
23.Secondary Outcome
Title Number of Patients With Notable Increase in PR Intervals
Hide Description Number of Patients with notable increase in PR intervals. Notable PR interval increase defined as >=25% increase and on-treatment PR interval > 200 ms.
Time Frame Baseline and Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated set.
Arm/Group Title Placebo Olo 5 mcg Olo 10 mcg
Hide Arm/Group Description:
Matching Placebo delivered by the Respimat Inhaler.
Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
Overall Number of Participants Analyzed 137 140 139
Measure Type: Number
Unit of Measure: percentage of participants
30 min pre-dose: increase (N=137, 137, 139) 0.0 0.7 0.0
30 min pre-dose: no increase (N=137, 137, 139) 100.0 99.3 100.0
40 min post-dose: increase (N=137, 140, 137) 0.0 0.0 0.7
40 min post-dose: no increase (N=137, 140, 137) 100.0 100.0 99.3
24.Secondary Outcome
Title Number of Patients With Notable Increase in QRS Intervals
Hide Description Number of Patients with notable increase in QRS intervals. Notable QRS interval increase defined as >=10% increase and on-treatment QRS interval > 110 ms.
Time Frame Baseline and Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated set.
Arm/Group Title Placebo Olo 5 mcg Olo 10 mcg
Hide Arm/Group Description:
Matching Placebo delivered by the Respimat Inhaler.
Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
Overall Number of Participants Analyzed 138 141 140
Measure Type: Number
Unit of Measure: percentage of participants
30 min pre-dose: increase (N=138, 139, 140) 0.7 0.7 0.0
30 min pre-dose: no increase (N=138, 139, 140) 99.3 99.3 100.0
40 min post-dose: increase (N=138, 141, 138) 0.7 0.7 0.7
40 min post-dose: no increase (N=138, 141, 138) 99.3 99.3 99.3
Time Frame 6 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Olo 5 mcg Olo 10 mcg
Hide Arm/Group Description Matching Placebo delivered by the Respimat Inhaler. Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
All-Cause Mortality
Placebo Olo 5 mcg Olo 10 mcg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Olo 5 mcg Olo 10 mcg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/143 (2.10%)   3/147 (2.04%)   3/143 (2.10%) 
Cardiac disorders       
Atrial fibrillation  1  0/143 (0.00%)  0/147 (0.00%)  1/143 (0.70%) 
Coronary artery occlusion  1  1/143 (0.70%)  0/147 (0.00%)  0/143 (0.00%) 
Infections and infestations       
Pneumonia  1  1/143 (0.70%)  0/147 (0.00%)  0/143 (0.00%) 
Injury, poisoning and procedural complications       
Fibula fracture  1  0/143 (0.00%)  1/147 (0.68%)  0/143 (0.00%) 
Renal and urinary disorders       
Diabetic nephropathy  1  0/143 (0.00%)  1/147 (0.68%)  0/143 (0.00%) 
Glomerulonephritis membranoproliferative  1  0/143 (0.00%)  1/147 (0.68%)  0/143 (0.00%) 
Renal failure  1  0/143 (0.00%)  1/147 (0.68%)  0/143 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Chronic obstructive pulmonary disease  1  2/143 (1.40%)  1/147 (0.68%)  2/143 (1.40%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Olo 5 mcg Olo 10 mcg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/143 (5.59%)   10/147 (6.80%)   5/143 (3.50%) 
Respiratory, thoracic and mediastinal disorders       
Chronic obstructive pulmonary disease  1  8/143 (5.59%)  10/147 (6.80%)  5/143 (3.50%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
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
Results Point of Contact
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01040130     History of Changes
Other Study ID Numbers: 1222.37
2009-014395-21 ( EudraCT Number: EudraCT )
First Submitted: December 28, 2009
First Posted: December 29, 2009
Results First Submitted: March 28, 2014
Results First Posted: July 8, 2014
Last Update Posted: July 8, 2014