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Trial record 86 of 318 for:    FLUTICASONE AND SALMETEROL

Effect of Tiotropium Plus Salmeterol vs. Fluticasone/Salmeterol on Static Lung Volumes and Exercise Endurance in COPD

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ClinicalTrials.gov Identifier: NCT00530842
Recruitment Status : Completed
First Posted : September 18, 2007
Results First Posted : March 10, 2010
Last Update Posted : December 24, 2013
Sponsor:
Information provided by:
Boehringer Ingelheim

Study Type Interventional
Study Design Intervention Model: Crossover Assignment;   Primary Purpose: Treatment
Condition Pulmonary Disease, Chronic Obstructive
Interventions Drug: Tiotropium plus Salmeterol
Drug: Fluticasone/Salmeterol
Enrollment 344
Recruitment Details All participant flow data are presented by treatment sequence
Pre-assignment Details  
Arm/Group Title Tiotropium + Salmeterol / Fluticasone + Salmeterol Fluticasone + Salmeterol / Tiotropium + Salmeterol
Hide Arm/Group Description Tio 18mcg o.d. + Sal 50mcg b.i.d. / Flu+Sal 500+50mcg b.i.d. Flu+Sal 500+50mcg b.i.d. / Tio 18mcg o.d. + Sal 50mcg b.i.d.
Period Title: Overall Study
Started 172 172
Completed 149 151
Not Completed 23 21
Reason Not Completed
Adverse Event             10             6
Lack of Efficacy             2             1
Lost to Follow-up             0             4
Protocol Violation             3             2
Withdrawal by Subject             4             5
Individual different reasons             4             3
Period Title: Period 1
Started 172 172
Completed 158 161
Not Completed 14 11
Reason Not Completed
Adverse Event             7             3
Lack of Efficacy             1             1
Protocol Violation             2             1
Withdrawal by Subject             2             3
Individual different reasons             2             3
Period Title: Period 2
Started 157 160
Completed 149 151
Not Completed 8 9
Reason Not Completed
Adverse Event             3             3
Lack of Efficacy             1             0
Lost to Follow-up             0             4
Protocol Violation             1             0
Withdrawal by Subject             1             2
Individual different reasons             2             0
Arm/Group Title Tiotropium + Salmeterol / Fluticasone + Salmeterol Fluticasone + Salmeterol / Tiotropium + Salmeterol Total
Hide Arm/Group Description Tio 18mcg o.d. + Sal 50mcg b.i.d. / Flu+Sal 500+50mcg b.i.d. Flu+Sal 500+50mcg b.i.d. / Tio 18mcg o.d. + Sal 50mcg b.i.d. Total of all reporting groups
Overall Number of Baseline Participants 172 172 344
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 172 participants 172 participants 344 participants
61.5  (7.5) 60.6  (7.6) 61.0  (7.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 172 participants 172 participants 344 participants
Female
48
  27.9%
49
  28.5%
97
  28.2%
Male
124
  72.1%
123
  71.5%
247
  71.8%
1.Primary Outcome
Title Post-dose TGV(FRC) (After 8 Weeks)
Hide Description Post-dose TGV(FRC) (Thoracic Gas Volume; co-primary endpoint) after 8 weeks
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS using imputed values. The full analysis set (FAS) was defined to include all treated patients with any post-dosing efficacy data after at least 4 weeks for both investigational treatments in TGV(FRC) or endurance time.
Arm/Group Title Tiotropium + Salmeterol Fluticasone + Salmeterol
Hide Arm/Group Description:
Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
Overall Number of Participants Analyzed 309 309
Mean (Standard Error)
Unit of Measure: Litres
4.99  (0.07) 5.07  (0.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tiotropium + Salmeterol, Fluticasone + Salmeterol
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0482
Comments [Not Specified]
Method ANOVA
Comments ANOVA with fixed terms for sequence, treatment, and period and random term for subject within sequence.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.087
Confidence Interval (2-Sided) 95%
-0.174 to -0.001
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.044
Estimation Comments [Not Specified]
2.Primary Outcome
Title Endurance Time (After 8 Weeks)
Hide Description Endurance time to the point of symptom limitation after 8 weeks during a constant work rate exercise test at 75% Wcap (co-primary endpoint)
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS using imputed values
Arm/Group Title Tiotropium + Salmeterol Fluticasone + Salmeterol
Hide Arm/Group Description:
Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
Overall Number of Participants Analyzed 309 309
Median (Inter-Quartile Range)
Unit of Measure: Seconds
463
(316 to 691)
453
(307 to 720)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tiotropium + Salmeterol, Fluticasone + Salmeterol
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3407
Comments [Not Specified]
Method Wilcoxon signed−rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 3.0
Confidence Interval (2-Sided) 95%
-9.5 to 27.5
Estimation Comments The confidence interval was determined by Hodges−Lehmann method.
3.Secondary Outcome
Title Post-dose TGV(FRC) (After 4 Weeks)
Hide Description Post-dose TGV(FRC) (Thoracic Gas Volume) after 4 weeks
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS using imputed values
Arm/Group Title Tiotropium + Salmeterol Fluticasone + Salmeterol
Hide Arm/Group Description:
Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
Overall Number of Participants Analyzed 309 307
Mean (Standard Error)
Unit of Measure: Litres
5.00  (0.07) 5.19  (0.07)
4.Secondary Outcome
Title Endurance Time (After 4 Weeks)
Hide Description Endurance time to the point of symptom limitation after 4 weeks during a constant work rate exercise test at 75% Wcap (co-primary endpoint)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS using imputed values
Arm/Group Title Tiotropium + Salmeterol Fluticasone + Salmeterol
Hide Arm/Group Description:
Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
Overall Number of Participants Analyzed 309 309
Median (Inter-Quartile Range)
Unit of Measure: Seconds
458
(343 to 674)
450
(301 to 676)
5.Secondary Outcome
Title Static Lung Volumes
Hide Description Trough TGV(FRC) (Thoracic Gas Volume) after 8 weeks (measured by bodyphlethysmography)
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS using imputed values
Arm/Group Title Tiotropium + Salmeterol Fluticasone + Salmeterol
Hide Arm/Group Description:
Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
Overall Number of Participants Analyzed 309 309
Mean (Standard Error)
Unit of Measure: Litres
5.24  (0.08) 5.25  (0.08)
6.Secondary Outcome
Title Static Lung Volumes
Hide Description Trough TGV(FRC) (Thoracic Gas Volume) after 4 weeks (measured by bodyphlethysmography)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS using imputed values
Arm/Group Title Tiotropium + Salmeterol Fluticasone + Salmeterol
Hide Arm/Group Description:
Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
Overall Number of Participants Analyzed 309 309
Mean (Standard Error)
Unit of Measure: Litres
5.32  (0.08) 5.34  (0.08)
7.Secondary Outcome
Title Static Lung Volumes
Hide Description Trough RV (Residual Volume) after 8 weeks (measured by bodyphlethysmography)
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS using imputed values
Arm/Group Title Tiotropium + Salmeterol Fluticasone + Salmeterol
Hide Arm/Group Description:
Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
Overall Number of Participants Analyzed 309 309
Mean (Standard Error)
Unit of Measure: Litres
4.23  (0.08) 4.25  (0.08)
8.Secondary Outcome
Title Static Lung Volumes
Hide Description Trough RV (Residual Volume) after 4 weeks (measured by bodyphlethysmography)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS using imputed values
Arm/Group Title Tiotropium + Salmeterol Fluticasone + Salmeterol
Hide Arm/Group Description:
Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
Overall Number of Participants Analyzed 309 307
Mean (Standard Error)
Unit of Measure: Litres
4.28  (0.08) 4.35  (0.08)
9.Secondary Outcome
Title Static Lung Volumes
Hide Description Post-dose RV (Residual Volume) after 8 weeks (measured by bodyphlethysmography)
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS using imputed values
Arm/Group Title Tiotropium + Salmeterol Fluticasone + Salmeterol
Hide Arm/Group Description:
Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
Overall Number of Participants Analyzed 309 309
Mean (Standard Error)
Unit of Measure: Litres
3.92  (0.07) 4.07  (0.07)
10.Secondary Outcome
Title Static Lung Volumes
Hide Description Post-dose RV (Residual Volume) after 4 weeks (measured by bodyphlethysmography)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS using imputed values
Arm/Group Title Tiotropium + Salmeterol Fluticasone + Salmeterol
Hide Arm/Group Description:
Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
Overall Number of Participants Analyzed 309 307
Mean (Standard Error)
Unit of Measure: Litres
3.91  (0.07) 4.14  (0.07)
11.Secondary Outcome
Title Static Lung Volumes
Hide Description Trough IC (Inspiratory Capacity) after 8 weeks (measured by bodyphlethysmography)
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS using imputed values
Arm/Group Title Tiotropium + Salmeterol Fluticasone + Salmeterol
Hide Arm/Group Description:
Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
Overall Number of Participants Analyzed 309 309
Mean (Standard Error)
Unit of Measure: Litres
2.33  (0.04) 2.23  (0.04)
12.Secondary Outcome
Title Static Lung Volumes
Hide Description Trough IC (Inspiratory Capacity) after 4 weeks (measured by bodyphlethysmography)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS using imputed values
Arm/Group Title Tiotropium + Salmeterol Fluticasone + Salmeterol
Hide Arm/Group Description:
Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
Overall Number of Participants Analyzed 309 308
Mean (Standard Error)
Unit of Measure: Litres
2.28  (0.04) 2.23  (0.04)
13.Secondary Outcome
Title Static Lung Volumes
Hide Description Post-dose IC (Inspiratory Capacity) after 8 weeks (measured by bodyphlethysmography)
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS using imputed values
Arm/Group Title Tiotropium + Salmeterol Fluticasone + Salmeterol
Hide Arm/Group Description:
Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
Overall Number of Participants Analyzed 309 309
Mean (Standard Error)
Unit of Measure: Litres
2.47  (0.04) 2.35  (0.04)
14.Secondary Outcome
Title Static Lung Volumes
Hide Description Post-dose IC (Inspiratory Capacity) after 4 weeks (measured by bodyphlethysmography)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS using imputed values
Arm/Group Title Tiotropium + Salmeterol Fluticasone + Salmeterol
Hide Arm/Group Description:
Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
Overall Number of Participants Analyzed 309 308
Mean (Standard Error)
Unit of Measure: Litres
2.46  (0.05) 2.37  (0.05)
15.Secondary Outcome
Title Static Lung Volumes
Hide Description Trough IRV (Inspiratory Reserve Volume) after 8 weeks (measured by bodyphlethysmography)
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS using imputed values
Arm/Group Title Tiotropium + Salmeterol Fluticasone + Salmeterol
Hide Arm/Group Description:
Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
Overall Number of Participants Analyzed 280 281
Mean (Standard Error)
Unit of Measure: Litres
1.48  (0.04) 1.41  (0.04)
16.Secondary Outcome
Title Static Lung Volumes
Hide Description Trough IRV (Inspiratory Reserve Volume) after 4 weeks (measured by bodyphlethysmography)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS using imputed values
Arm/Group Title Tiotropium + Salmeterol Fluticasone + Salmeterol
Hide Arm/Group Description:
Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
Overall Number of Participants Analyzed 280 280
Mean (Standard Error)
Unit of Measure: Litres
1.47  (0.04) 1.42  (0.04)
17.Secondary Outcome
Title Static Lung Volumes
Hide Description Post-dose IRV (Inspiratory Reserve Volume) after 8 weeks (measured by bodyphlethysmography)
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS using imputed values
Arm/Group Title Tiotropium + Salmeterol Fluticasone + Salmeterol
Hide Arm/Group Description:
Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
Overall Number of Participants Analyzed 280 281
Mean (Standard Error)
Unit of Measure: Litres
1.62  (0.04) 1.55  (0.04)
18.Secondary Outcome
Title Static Lung Volumes
Hide Description Post-dose IRV (Inspiratory Reserve Volume) after 4 weeks (measured by bodyphlethysmography)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS using imputed values
Arm/Group Title Tiotropium + Salmeterol Fluticasone + Salmeterol
Hide Arm/Group Description:
Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
Overall Number of Participants Analyzed 280 280
Mean (Standard Error)
Unit of Measure: Litres
1.62  (0.04) 1.55  (0.04)
19.Secondary Outcome
Title Static Lung Volumes
Hide Description Trough TLC (Total Lung Capacity) after 8 weeks (measured by bodyphlethysmography)
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS using imputed values
Arm/Group Title Tiotropium + Salmeterol Fluticasone + Salmeterol
Hide Arm/Group Description:
Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
Overall Number of Participants Analyzed 309 309
Mean (Standard Error)
Unit of Measure: Litres
7.47  (0.09) 7.39  (0.09)
20.Secondary Outcome
Title Static Lung Volumes
Hide Description Trough TLC (Total Lung Capacity) after 4 weeks (measured by bodyphlethysmography)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS using imputed values
Arm/Group Title Tiotropium + Salmeterol Fluticasone + Salmeterol
Hide Arm/Group Description:
Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
Overall Number of Participants Analyzed 309 307
Mean (Standard Error)
Unit of Measure: Litres
7.52  (0.09) 7.51  (0.09)
21.Secondary Outcome
Title Static Lung Volumes
Hide Description Post-dose TLC (Total Lung Capacity) after 8 weeks (measured by bodyphlethysmography)
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS using imputed values
Arm/Group Title Tiotropium + Salmeterol Fluticasone + Salmeterol
Hide Arm/Group Description:
Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
Overall Number of Participants Analyzed 309 309
Mean (Standard Error)
Unit of Measure: Litres
7.36  (0.09) 7.36  (0.09)
22.Secondary Outcome
Title Static Lung Volumes
Hide Description Post-dose TLC (Total Lung Capacity) after 4 weeks (measured by bodyphlethysmography)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS using imputed values
Arm/Group Title Tiotropium + Salmeterol Fluticasone + Salmeterol
Hide Arm/Group Description:
Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
Overall Number of Participants Analyzed 309 307
Mean (Standard Error)
Unit of Measure: Litres
7.33  (0.09) 7.47  (0.09)
23.Secondary Outcome
Title Static Lung Volumes (Percent)
Hide Description Trough RV/TLC (Residual Volume over Total Lung Capacity) after 8 weeks (measured by bodyphlethysmography)
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS using imputed values
Arm/Group Title Tiotropium + Salmeterol Fluticasone + Salmeterol
Hide Arm/Group Description:
Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
Overall Number of Participants Analyzed 309 309
Mean (Standard Error)
Unit of Measure: Percent of RV over TLC
56.10  (0.54) 57.18  (0.54)
24.Secondary Outcome
Title Static Lung Volumes (Percent)
Hide Description Trough RV/TLC (Residual Volume over Total Lung Capacity) after 4 weeks (measured by bodyphlethysmography)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS using imputed values
Arm/Group Title Tiotropium + Salmeterol Fluticasone + Salmeterol
Hide Arm/Group Description:
Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
Overall Number of Participants Analyzed 309 307
Mean (Standard Error)
Unit of Measure: Percent of RV over TLC
56.57  (0.56) 57.47  (0.56)
25.Secondary Outcome
Title Static Lung Volumes (Percent)
Hide Description Post-dose RV/TLC (Residual Volume over Total Lung Capacity) after 8 weeks (measured by bodyphlethysmography)
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS using imputed values
Arm/Group Title Tiotropium + Salmeterol Fluticasone + Salmeterol
Hide Arm/Group Description:
Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
Overall Number of Participants Analyzed 309 309
Mean (Standard Error)
Unit of Measure: Percent of RV over TLC
52.79  (0.54) 55.02  (0.54)
26.Secondary Outcome
Title Static Lung Volumes (Percent)
Hide Description Post-dose RV/TLC (Residual Volume over Total Lung Capacity) after 4 weeks (measured by bodyphlethysmography)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS using imputed values
Arm/Group Title Tiotropium + Salmeterol Fluticasone + Salmeterol
Hide Arm/Group Description:
Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
Overall Number of Participants Analyzed 309 307
Mean (Standard Error)
Unit of Measure: Percent of RV over TLC
53.09  (0.57) 55.07  (0.57)
27.Secondary Outcome
Title Static Lung Volumes (Percent)
Hide Description Trough TGV/TLC (Thoracic Gas Volume over Total Lung Capacity) after 8 weeks (measured by bodyphlethysmography)
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS using imputed values
Arm/Group Title Tiotropium + Salmeterol Fluticasone + Salmeterol
Hide Arm/Group Description:
Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
Overall Number of Participants Analyzed 309 309
Mean (Standard Error)
Unit of Measure: Percent of TGV over TLC
69.87  (0.47) 70.94  (0.47)
28.Secondary Outcome
Title Static Lung Volumes (Percent)
Hide Description Trough TGV/TLC (Thoracic Gas Volume over Total Lung Capacity) after 4 weeks (measured by bodyphlethysmography)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS using imputed values
Arm/Group Title Tiotropium + Salmeterol Fluticasone + Salmeterol
Hide Arm/Group Description:
Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
Overall Number of Participants Analyzed 309 307
Mean (Standard Error)
Unit of Measure: Percent of TGV over TLC
70.59  (0.47) 70.99  (0.47)
29.Secondary Outcome
Title Static Lung Volumes (Percent)
Hide Description Post-dose TGV/TLC (Thoracic Gas Volume over Total Lung Capacity) after 8 weeks (measured by bodyphlethysmography)
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS using imputed values
Arm/Group Title Tiotropium + Salmeterol Fluticasone + Salmeterol
Hide Arm/Group Description:
Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
Overall Number of Participants Analyzed 309 309
Mean (Standard Error)
Unit of Measure: Percent of TGV over TLC
67.65  (0.49) 68.85  (0.49)
30.Secondary Outcome
Title Static Lung Volumes (Percent)
Hide Description Post-dose TGV/TLC (Thoracic Gas Volume over Total Lung Capacity) after 4 weeks (measured by bodyphlethysmography)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS using imputed values
Arm/Group Title Tiotropium + Salmeterol Fluticasone + Salmeterol
Hide Arm/Group Description:
Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
Overall Number of Participants Analyzed 309 307
Mean (Standard Error)
Unit of Measure: Percent of TGV over TLC
68.43  (0.49) 69.22  (0.49)
31.Secondary Outcome
Title Slow Vital Capacity (SVC)
Hide Description Trough SVC (Slow Vital Capacity) after 8 weeks (measured by spirometry)
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS using imputed values
Arm/Group Title Tiotropium + Salmeterol Fluticasone + Salmeterol
Hide Arm/Group Description:
Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
Overall Number of Participants Analyzed 306 304
Mean (Standard Error)
Unit of Measure: Litres
3.22  (0.05) 3.12  (0.05)
32.Secondary Outcome
Title Slow Vital Capacity (SVC)
Hide Description Trough SVC (Slow Vital Capacity) after 4 weeks (measured by spirometry)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS using imputed values
Arm/Group Title Tiotropium + Salmeterol Fluticasone + Salmeterol
Hide Arm/Group Description:
Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
Overall Number of Participants Analyzed 305 301
Mean (Standard Error)
Unit of Measure: Litres
3.19  (0.05) 3.12  (0.05)
33.Secondary Outcome
Title Slow Vital Capacity (SVC)
Hide Description Post-dose SVC (Slow Vital Capacity) after 8 weeks (measured by spirometry)
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS using imputed values
Arm/Group Title Tiotropium + Salmeterol Fluticasone + Salmeterol
Hide Arm/Group Description:
Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
Overall Number of Participants Analyzed 306 304
Mean (Standard Error)
Unit of Measure: Litres
3.42  (0.05) 3.28  (0.05)
34.Secondary Outcome
Title Slow Vital Capacity (SVC)
Hide Description Post-dose SVC (Slow Vital Capacity) after 4 weeks (measured by spirometry)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS using imputed values
Arm/Group Title Tiotropium + Salmeterol Fluticasone + Salmeterol
Hide Arm/Group Description:
Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
Overall Number of Participants Analyzed 305 301
Mean (Standard Error)
Unit of Measure: Litres
3.39  (0.05) 3.27  (0.05)
35.Secondary Outcome
Title Forced Expiratory Volume in 1 Second (FEV1)
Hide Description Trough FEV1 (Forced Expiratory Volume in 1 second) after 8 weeks (measured by spirometry)
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS using imputed values
Arm/Group Title Tiotropium + Salmeterol Fluticasone + Salmeterol
Hide Arm/Group Description:
Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
Overall Number of Participants Analyzed 309 309
Mean (Standard Error)
Unit of Measure: Litres
1.48  (0.03) 1.44  (0.03)
36.Secondary Outcome
Title Forced Expiratory Volume in 1 Second (FEV1)
Hide Description Trough FEV1 (Forced Expiratory Volume in 1 second) after 4 weeks (measured by spirometry)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS using imputed values
Arm/Group Title Tiotropium + Salmeterol Fluticasone + Salmeterol
Hide Arm/Group Description:
Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
Overall Number of Participants Analyzed 309 308
Mean (Standard Error)
Unit of Measure: Litres
1.48  (0.03) 1.45  (0.03)
37.Secondary Outcome
Title Forced Expiratory Volume in 1 Second (FEV1)
Hide Description Post-dose FEV1 (Forced Expiratory Volume in 1 second) after 8 weeks (measured by spirometry)
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS using imputed values
Arm/Group Title Tiotropium + Salmeterol Fluticasone + Salmeterol
Hide Arm/Group Description:
Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
Overall Number of Participants Analyzed 309 309
Mean (Standard Error)
Unit of Measure: Litres
1.62  (0.03) 1.55  (0.03)
38.Secondary Outcome
Title Forced Expiratory Volume in 1 Second (FEV1)
Hide Description Post-dose FEV1 (Forced Expiratory Volume in 1 second) after 4 weeks (measured by spirometry)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS using imputed values
Arm/Group Title Tiotropium + Salmeterol Fluticasone + Salmeterol
Hide Arm/Group Description:
Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
Overall Number of Participants Analyzed 309 308
Mean (Standard Error)
Unit of Measure: Litres
1.62  (0.03) 1.55  (0.03)
39.Secondary Outcome
Title Forced Expiratory Volume in 1 Second (FEV1)
Hide Description Trough percent predicted FEV1 (Forced Expiratory Volume in 1 second) according to ECCS after 8 weeks (measured by spirometry)
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS using imputed values
Arm/Group Title Tiotropium + Salmeterol Fluticasone + Salmeterol
Hide Arm/Group Description:
Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
Overall Number of Participants Analyzed 309 309
Mean (Standard Error)
Unit of Measure: Percent of predicted FEV1
50.27  (0.78) 49.12  (0.78)
40.Secondary Outcome
Title Forced Expiratory Volume in 1 Second (FEV1)
Hide Description Trough percent predicted FEV1 (Forced Expiratory Volume in 1 second) according to ECCS after 4 weeks (measured by spirometry)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS using imputed values
Arm/Group Title Tiotropium + Salmeterol Fluticasone + Salmeterol
Hide Arm/Group Description:
Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
Overall Number of Participants Analyzed 309 308
Mean (Standard Error)
Unit of Measure: Percent of predicted FEV1
50.40  (0.79) 49.26  (0.79)
41.Secondary Outcome
Title Forced Expiratory Volume in 1 Second (FEV1)
Hide Description Post-dose percent predicted FEV1 (Forced Expiratory Volume in 1 second) according to ECCS after 8 weeks (measured by spirometry)
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS using imputed values
Arm/Group Title Tiotropium + Salmeterol Fluticasone + Salmeterol
Hide Arm/Group Description:
Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
Overall Number of Participants Analyzed 309 309
Mean (Standard Error)
Unit of Measure: Percent of predicted FEV1
54.99  (0.82) 52.59  (0.82)
42.Secondary Outcome
Title Forced Expiratory Volume in 1 Second (FEV1)
Hide Description Post-dose percent predicted FEV1 (Forced Expiratory Volume in 1 second) according to ECCS after 4 weeks (measured by spirometry)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS using imputed values
Arm/Group Title Tiotropium + Salmeterol Fluticasone + Salmeterol
Hide Arm/Group Description:
Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
Overall Number of Participants Analyzed 309 308
Mean (Standard Error)
Unit of Measure: Percent of predicted FEV1
54.96  (0.82) 52.64  (0.82)
43.Secondary Outcome
Title Forced Vital Capacity (FVC)
Hide Description Trough FVC (Forced Vital Capacity) after 8 weeks (measured by spirometry)
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS using imputed values
Arm/Group Title Tiotropium + Salmeterol Fluticasone + Salmeterol
Hide Arm/Group Description:
Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
Overall Number of Participants Analyzed 309 309
Mean (Standard Error)
Unit of Measure: Litres
3.06  (0.05) 2.94  (0.05)
44.Secondary Outcome
Title Forced Vital Capacity (FVC)
Hide Description Trough FVC (Forced Vital Capacity) after 4 weeks (measured by spirometry)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS using imputed values
Arm/Group Title Tiotropium + Salmeterol Fluticasone + Salmeterol
Hide Arm/Group Description:
Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
Overall Number of Participants Analyzed 309 308
Mean (Standard Error)
Unit of Measure: Litres
3.04  (0.05) 2.93  (0.05)
45.Secondary Outcome
Title Forced Vital Capacity (FVC)
Hide Description Post-dose FVC (Forced Vital Capacity) after 8 weeks (measured by spirometry)
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS using imputed values
Arm/Group Title Tiotropium + Salmeterol Fluticasone + Salmeterol
Hide Arm/Group Description:
Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
Overall Number of Participants Analyzed 309 309
Mean (Standard Error)
Unit of Measure: Litres
3.26  (0.05) 3.11  (0.05)
46.Secondary Outcome
Title Forced Vital Capacity (FVC)
Hide Description Post-dose FVC (Forced Vital Capacity) after 4 weeks (measured by spirometry)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS using imputed values
Arm/Group Title Tiotropium + Salmeterol Fluticasone + Salmeterol
Hide Arm/Group Description:
Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
Overall Number of Participants Analyzed 309 308
Mean (Standard Error)
Unit of Measure: Litres
3.25  (0.05) 3.11  (0.05)
47.Secondary Outcome
Title FEV1 Over FVC (Percent)
Hide Description Trough FEV1 (Forced Expiratory Volume in 1 second) over FVC (Forced Vital Capacity) after 8 weeks (measured by spirometry)
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS using imputed values
Arm/Group Title Tiotropium + Salmeterol Fluticasone + Salmeterol
Hide Arm/Group Description:
Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
Overall Number of Participants Analyzed 309 309
Mean (Standard Error)
Unit of Measure: Percent of FEV1 over FVC
49.16  (0.68) 49.67  (0.68)
48.Secondary Outcome
Title FEV1 Over FVC (Percent)
Hide Description Trough FEV1 (Forced Expiratory Volume in 1 second) over FVC (Forced Vital Capacity) after 4 weeks (measured by spirometry)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS using imputed values
Arm/Group Title Tiotropium + Salmeterol Fluticasone + Salmeterol
Hide Arm/Group Description:
Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
Overall Number of Participants Analyzed 309 308
Mean (Standard Error)
Unit of Measure: Percent of FEV1 over FVC
49.74  (0.82) 50.62  (0.82)
49.Secondary Outcome
Title FEV1 Over FVC (Percent)
Hide Description Post-dose FEV1 (Forced Expiratory Volume in 1 second) over FVC (Forced Vital Capacity) after 8 weeks (measured by spirometry)
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS using imputed values
Arm/Group Title Tiotropium + Salmeterol Fluticasone + Salmeterol
Hide Arm/Group Description:
Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
Overall Number of Participants Analyzed 309 309
Mean (Standard Error)
Unit of Measure: Percent of FEV1 over FVC
50.77  (0.72) 50.66  (0.72)
50.Secondary Outcome
Title FEV1 Over FVC (Percent)
Hide Description Post-dose FEV1 (Forced Expiratory Volume in 1 second) over FVC (Forced Vital Capacity) after 4 weeks (measured by spirometry)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS using imputed values
Arm/Group Title Tiotropium + Salmeterol Fluticasone + Salmeterol
Hide Arm/Group Description:
Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
Overall Number of Participants Analyzed 309 308
Mean (Standard Error)
Unit of Measure: Percent of FEV1 over FVC
50.90  (0.73) 50.91  (0.73)
51.Secondary Outcome
Title Symptom Intensity During Exercise
Hide Description Isotime Borg dyspnea scale after 8 weeks, Unit on a Scale (min. 0, max 10), 0 = no dyspnea, 10 = worst imaginable dyspnea
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS using imputed values
Arm/Group Title Tiotropium + Salmeterol Fluticasone + Salmeterol
Hide Arm/Group Description:
Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
Overall Number of Participants Analyzed 309 309
Mean (Standard Error)
Unit of Measure: Unit on a Scale
4.77  (0.13) 4.98  (0.13)
52.Secondary Outcome
Title Symptom Intensity During Exercise
Hide Description Isotime Borg dyspnea scale after 4 weeks, Unit on a Scale (min. 0, max. 10), 0 = no dyspnea, 10 = worst imaginable dyspnea
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS using imputed values
Arm/Group Title Tiotropium + Salmeterol Fluticasone + Salmeterol
Hide Arm/Group Description:
Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
Overall Number of Participants Analyzed 309 309
Mean (Standard Error)
Unit of Measure: Unit on a Scale
4.80  (0.13) 5.02  (0.13)
53.Secondary Outcome
Title Symptom Intensity During Exercise
Hide Description Isotime Borg leg discomfort scale after 8 weeks, Unit on a Scale (min. 0, max. 10), 0 = no leg dyscomfort, 10 = worst imaginable leg dyscomfort
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS using imputed values
Arm/Group Title Tiotropium + Salmeterol Fluticasone + Salmeterol
Hide Arm/Group Description:
Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
Overall Number of Participants Analyzed 309 309
Mean (Standard Error)
Unit of Measure: Unit on a Scale
4.64  (0.15) 4.53  (0.15)
54.Secondary Outcome
Title Symptom Intensity During Exercise
Hide Description Isotime Borg leg discomfort scale after 4 weeks, Unit on a Scale (min. 0, max. 10), 0 = no leg dyscomfort, 10 = worst imaginable leg dyscomfort
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS using imputed values
Arm/Group Title Tiotropium + Salmeterol Fluticasone + Salmeterol
Hide Arm/Group Description:
Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
Overall Number of Participants Analyzed 309 309
Mean (Standard Error)
Unit of Measure: Unit on a Scale
4.63  (0.15) 4.63  (0.15)
55.Secondary Outcome
Title Dyspnea and Leg Discomfort
Hide Description Peak Borg dyspnea scale after 8 weeks, Unit on a Scale (min. 0, max 10)
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS using imputed values
Arm/Group Title Tiotropium + Salmeterol Fluticasone + Salmeterol
Hide Arm/Group Description:
Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
Overall Number of Participants Analyzed 309 309
Mean (Standard Deviation)
Unit of Measure: Unit on a Scale
6.52  (2.36) 6.61  (2.31)
56.Secondary Outcome
Title Dyspnea and Leg Discomfort
Hide Description Peak Borg leg discomfort scale after 8 weeks, Unit on a Scale (min. 0, max 10)
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS using imputed values
Arm/Group Title Tiotropium + Salmeterol Fluticasone + Salmeterol
Hide Arm/Group Description:
Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
Overall Number of Participants Analyzed 309 309
Mean (Standard Deviation)
Unit of Measure: Unit on a Scale
6.10  (3.03) 5.86  (3.01)
57.Secondary Outcome
Title Locus of Symptom Limitation at Peak Exercise During Exercise
Hide Description Reason for stopping exercise at baseline (leg discomfort, breathing discomfort, both or none)
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
FAS using imputed values
Arm/Group Title Tiotropium + Salmeterol Fluticasone + Salmeterol
Hide Arm/Group Description:
Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
Overall Number of Participants Analyzed 309 309
Measure Type: Number
Unit of Measure: Participants
Leg discomfort 53 53
Breathing discomfort 132 132
Both (leg and breathing discomfort) 92 92
None 32 32
58.Secondary Outcome
Title Locus of Symptom Limitation at Peak Exercise During Exercise
Hide Description Reason for stopping exercise after 4 weeks (leg discomfort, breathing discomfort, both or none)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS using imputed values
Arm/Group Title Tiotropium + Salmeterol Fluticasone + Salmeterol
Hide Arm/Group Description:
Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
Overall Number of Participants Analyzed 309 309
Measure Type: Number
Unit of Measure: Participants
Leg discomfort 89 72
Breathing discomfort 104 119
Both (leg and breathing discomfort) 78 78
None 38 40
59.Secondary Outcome
Title Locus of Symptom Limitation at Peak Exercise During Exercise
Hide Description Reason for stopping exercise after 8 weeks (leg discomfort, breathing discomfort, both or none)
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS using imputed values
Arm/Group Title Tiotropium + Salmeterol Fluticasone + Salmeterol
Hide Arm/Group Description:
Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
Overall Number of Participants Analyzed 309 309
Measure Type: Number
Unit of Measure: Participants
Leg discomfort 88 72
Breathing discomfort 112 131
Both (leg and breathing discomfort) 82 78
None 27 28
Time Frame From drug administration until end of second treatment period plus 30 days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tiotropium + Salmeterol (Period 1) Tiotropium + Salmeterol (Period 2) Fluticasone + Salmeterol (Period 1) Fluticasone + Salmeterol (Period 2)
Hide Arm/Group Description Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 2 Flu+Sal 500+50mcg b.i.d. in Period 1 Flu+Sal 500+50mcg b.i.d. in Period 2
All-Cause Mortality
Tiotropium + Salmeterol (Period 1) Tiotropium + Salmeterol (Period 2) Fluticasone + Salmeterol (Period 1) Fluticasone + Salmeterol (Period 2)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tiotropium + Salmeterol (Period 1) Tiotropium + Salmeterol (Period 2) Fluticasone + Salmeterol (Period 1) Fluticasone + Salmeterol (Period 2)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/172 (4.07%)   5/160 (3.13%)   4/172 (2.33%)   4/157 (2.55%) 
Cardiac disorders         
Arrhythmia  1  0/172 (0.00%)  0/160 (0.00%)  1/172 (0.58%)  0/157 (0.00%) 
Bundle branch block right  1  0/172 (0.00%)  0/160 (0.00%)  1/172 (0.58%)  0/157 (0.00%) 
Extrasystoles  1  1/172 (0.58%)  0/160 (0.00%)  0/172 (0.00%)  0/157 (0.00%) 
Tachycardia  1  0/172 (0.00%)  0/160 (0.00%)  1/172 (0.58%)  0/157 (0.00%) 
Injury, poisoning and procedural complications         
Fall  1  0/172 (0.00%)  0/160 (0.00%)  0/172 (0.00%)  1/157 (0.64%) 
Femur fracture  1  0/172 (0.00%)  0/160 (0.00%)  0/172 (0.00%)  1/157 (0.64%) 
Subdural haematoma  1  1/172 (0.58%)  0/160 (0.00%)  0/172 (0.00%)  0/157 (0.00%) 
Upper limb fracture  1  0/172 (0.00%)  0/160 (0.00%)  0/172 (0.00%)  1/157 (0.64%) 
Musculoskeletal and connective tissue disorders         
Foot deformity  1  0/172 (0.00%)  1/160 (0.63%)  0/172 (0.00%)  0/157 (0.00%) 
Musculeskeletal pain  1  1/172 (0.58%)  0/160 (0.00%)  0/172 (0.00%)  0/157 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Basal cell carcinoma  1  0/172 (0.00%)  0/160 (0.00%)  1/172 (0.58%)  0/157 (0.00%) 
Lung adenocarcinoma  1  0/172 (0.00%)  0/160 (0.00%)  1/172 (0.58%)  0/157 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Chronic obstructive pulmonary disease  1  3/172 (1.74%)  3/160 (1.88%)  0/172 (0.00%)  2/157 (1.27%) 
Sleep apnoea syndrome  1  0/172 (0.00%)  1/160 (0.63%)  0/172 (0.00%)  0/157 (0.00%) 
Vascular disorders         
Arterial occlusive disease  1  1/172 (0.58%)  0/160 (0.00%)  0/172 (0.00%)  0/157 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tiotropium + Salmeterol (Period 1) Tiotropium + Salmeterol (Period 2) Fluticasone + Salmeterol (Period 1) Fluticasone + Salmeterol (Period 2)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   18/172 (10.47%)   18/160 (11.25%)   21/172 (12.21%)   12/157 (7.64%) 
Infections and infestations         
Nasopharyngitis  1  3/172 (1.74%)  9/160 (5.63%)  9/172 (5.23%)  6/157 (3.82%) 
Respiratory, thoracic and mediastinal disorders         
Chronic obstructive pulmonary disease  1  16/172 (9.30%)  11/160 (6.88%)  12/172 (6.98%)  7/157 (4.46%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00530842     History of Changes
Other Study ID Numbers: 205.334
First Submitted: September 17, 2007
First Posted: September 18, 2007
Results First Submitted: December 30, 2009
Results First Posted: March 10, 2010
Last Update Posted: December 24, 2013