Effect of Tiotropium Plus Salmeterol vs. Fluticasone/Salm... | NCT00530842

Measure	Description	Time Frame
Post-dose TGV(FRC) (After 8 Weeks)	Post-dose TGV(FRC) (Thoracic Gas Volume; co-primary endpoint) after 8 weeks	8 weeks
Endurance Time (After 8 Weeks)	Endurance time to the point of symptom limitation after 8 weeks during a constant work rate exercise test at 75% Wcap (co-primary endpoint)	8 weeks

Measure	Description	Time Frame
Post-dose TGV(FRC) (After 4 Weeks)	Post-dose TGV(FRC) (Thoracic Gas Volume) after 4 weeks	4 weeks
Endurance Time (After 4 Weeks)	Endurance time to the point of symptom limitation after 4 weeks during a constant work rate exercise test at 75% Wcap (co-primary endpoint)

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
205.334.4309 Boehringer Ingelheim Investigational Site		Gänserndorf			Austria
205.334.4308 Boehringer Ingelheim Investigational Site

PubMed Identifier	Type	Citation	Retractions
22749044	Derived	Magnussen H, Paggiaro P, Schmidt H, Kesten S, Metzdorf N, Maltais F. Effect of combination treatment on lung volumes and exercise endurance time in COPD. Respir Med. 2012 Oct;106(10):1413-20. doi: 10.1016/j.rmed.2012.05.011. Epub 2012 Jun 28.

Label	URL
Related Info	View source

ID	Title	Description
FG000	Tiotropium + Salmeterol / Fluticasone + Salmeterol	Tio 18mcg o.d. + Sal 50mcg b.i.d. / Flu+Sal 500+50mcg b.i.d.
FG001	Fluticasone + Salmeterol / Tiotropium + Salmeterol	Flu+Sal 500+50mcg b.i.d. / Tio 18mcg o.d. + Sal 50mcg b.i.d.

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Post-dose TGV(FRC) (After 8 Weeks)

Post-dose TGV(FRC) (Thoracic Gas Volume; co-primary endpoint) after 8 weeks

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.

Posted

Mean

Standard Error

Litres

8 weeks

ID	Title	Description
OG000	Tiotropium + Salmeterol	Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
OG001	Fluticasone + Salmeterol	Flu+Sal 500+50mcg b.i.d. in Period 1 or 2

Units	Counts
Participants	OG000309 OG001309

Title

Denominators

Categories

Title	Measurements
	OG0004.99± 0.07 OG0015.07± 0.07

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANOVA	ANOVA with fixed terms for sequence, treatment, and period and random term for subject within sequence.	0.0482		Mean Difference (Final Values)	-0.087	Standard Error of the Mean	0.044	2-Sided	95	-0.174	-0.001				No	Superiority or Other

Primary

Endurance Time (After 8 Weeks)

Endurance time to the point of symptom limitation after 8 weeks during a constant work rate exercise test at 75% Wcap (co-primary endpoint)

FAS using imputed values

Posted

Median

Inter-Quartile Range

Seconds

8 weeks

ID	Title	Description
OG000	Tiotropium + Salmeterol	Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
OG001	Fluticasone + Salmeterol	Flu+Sal 500+50mcg b.i.d. in Period 1 or 2

Units	Counts
Participants	OG000

Secondary

Post-dose TGV(FRC) (After 4 Weeks)

Post-dose TGV(FRC) (Thoracic Gas Volume) after 4 weeks

FAS using imputed values

Posted

Mean

Standard Error

Litres

4 weeks

ID	Title	Description
OG000	Tiotropium + Salmeterol	Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
OG001	Fluticasone + Salmeterol	Flu+Sal 500+50mcg b.i.d. in Period 1 or 2

Units	Counts
Participants	OG000

Secondary

Endurance Time (After 4 Weeks)

Endurance time to the point of symptom limitation after 4 weeks during a constant work rate exercise test at 75% Wcap (co-primary endpoint)

FAS using imputed values

Posted

Median

Inter-Quartile Range

Seconds

4 weeks

ID	Title	Description
OG000	Tiotropium + Salmeterol	Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
OG001	Fluticasone + Salmeterol	Flu+Sal 500+50mcg b.i.d. in Period 1 or 2

Units	Counts
Participants	OG000

Secondary

Static Lung Volumes

Trough TGV(FRC) (Thoracic Gas Volume) after 8 weeks (measured by bodyphlethysmography)

FAS using imputed values

Posted

Mean

Standard Error

Litres

8 weeks

ID	Title	Description
OG000	Tiotropium + Salmeterol	Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
OG001	Fluticasone + Salmeterol	Flu+Sal 500+50mcg b.i.d. in Period 1 or 2

Units	Counts
Participants	OG000

Secondary

Static Lung Volumes

Trough TGV(FRC) (Thoracic Gas Volume) after 4 weeks (measured by bodyphlethysmography)

FAS using imputed values

Posted

Mean

Standard Error

Litres

4 weeks

ID	Title	Description
OG000	Tiotropium + Salmeterol	Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
OG001	Fluticasone + Salmeterol	Flu+Sal 500+50mcg b.i.d. in Period 1 or 2

Units	Counts
Participants	OG000

Secondary

Static Lung Volumes

Trough RV (Residual Volume) after 8 weeks (measured by bodyphlethysmography)

FAS using imputed values

Posted

Mean

Standard Error

Litres

8 weeks

ID	Title	Description
OG000	Tiotropium + Salmeterol	Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
OG001	Fluticasone + Salmeterol	Flu+Sal 500+50mcg b.i.d. in Period 1 or 2

Units	Counts
Participants	OG000

Secondary

Static Lung Volumes

Trough RV (Residual Volume) after 4 weeks (measured by bodyphlethysmography)

FAS using imputed values

Posted

Mean

Standard Error

Litres

4 weeks

ID	Title	Description
OG000	Tiotropium + Salmeterol	Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
OG001	Fluticasone + Salmeterol	Flu+Sal 500+50mcg b.i.d. in Period 1 or 2

Units	Counts
Participants	OG000

Secondary

Static Lung Volumes

Post-dose RV (Residual Volume) after 8 weeks (measured by bodyphlethysmography)

FAS using imputed values

Posted

Mean

Standard Error

Litres

8 weeks

ID	Title	Description
OG000	Tiotropium + Salmeterol	Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
OG001	Fluticasone + Salmeterol	Flu+Sal 500+50mcg b.i.d. in Period 1 or 2

Units	Counts
Participants	OG000

Secondary

Static Lung Volumes

Post-dose RV (Residual Volume) after 4 weeks (measured by bodyphlethysmography)

FAS using imputed values

Posted

Mean

Standard Error

Litres

4 weeks

ID	Title	Description
OG000	Tiotropium + Salmeterol	Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
OG001	Fluticasone + Salmeterol	Flu+Sal 500+50mcg b.i.d. in Period 1 or 2

Units	Counts
Participants	OG000

Secondary

Static Lung Volumes

Trough IC (Inspiratory Capacity) after 8 weeks (measured by bodyphlethysmography)

FAS using imputed values

Posted

Mean

Standard Error

Litres

8 weeks

ID	Title	Description
OG000	Tiotropium + Salmeterol	Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
OG001	Fluticasone + Salmeterol	Flu+Sal 500+50mcg b.i.d. in Period 1 or 2

Units	Counts
Participants	OG000

Secondary

Static Lung Volumes

Trough IC (Inspiratory Capacity) after 4 weeks (measured by bodyphlethysmography)

FAS using imputed values

Posted

Mean

Standard Error

Litres

4 weeks

ID	Title	Description
OG000	Tiotropium + Salmeterol	Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
OG001	Fluticasone + Salmeterol	Flu+Sal 500+50mcg b.i.d. in Period 1 or 2

Units	Counts
Participants	OG000

Secondary

Static Lung Volumes

Post-dose IC (Inspiratory Capacity) after 8 weeks (measured by bodyphlethysmography)

FAS using imputed values

Posted

Mean

Standard Error

Litres

8 weeks

ID	Title	Description
OG000	Tiotropium + Salmeterol	Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
OG001	Fluticasone + Salmeterol	Flu+Sal 500+50mcg b.i.d. in Period 1 or 2

Units	Counts
Participants	OG000

Secondary

Static Lung Volumes

Post-dose IC (Inspiratory Capacity) after 4 weeks (measured by bodyphlethysmography)

FAS using imputed values

Posted

Mean

Standard Error

Litres

4 weeks

ID	Title	Description
OG000	Tiotropium + Salmeterol	Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
OG001	Fluticasone + Salmeterol	Flu+Sal 500+50mcg b.i.d. in Period 1 or 2

Units	Counts
Participants	OG000

Secondary

Static Lung Volumes

Trough IRV (Inspiratory Reserve Volume) after 8 weeks (measured by bodyphlethysmography)

FAS using imputed values

Posted

Mean

Standard Error

Litres

8 weeks

ID	Title	Description
OG000	Tiotropium + Salmeterol	Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
OG001	Fluticasone + Salmeterol	Flu+Sal 500+50mcg b.i.d. in Period 1 or 2

Units	Counts
Participants	OG000

Secondary

Static Lung Volumes

Trough IRV (Inspiratory Reserve Volume) after 4 weeks (measured by bodyphlethysmography)

FAS using imputed values

Posted

Mean

Standard Error

Litres

4 weeks

ID	Title	Description
OG000	Tiotropium + Salmeterol	Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
OG001	Fluticasone + Salmeterol	Flu+Sal 500+50mcg b.i.d. in Period 1 or 2

Units	Counts
Participants	OG000

Secondary

Static Lung Volumes

Post-dose IRV (Inspiratory Reserve Volume) after 8 weeks (measured by bodyphlethysmography)

FAS using imputed values

Posted

Mean

Standard Error

Litres

8 weeks

ID	Title	Description
OG000	Tiotropium + Salmeterol	Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
OG001	Fluticasone + Salmeterol	Flu+Sal 500+50mcg b.i.d. in Period 1 or 2

Units	Counts
Participants	OG000

Secondary

Static Lung Volumes

Post-dose IRV (Inspiratory Reserve Volume) after 4 weeks (measured by bodyphlethysmography)

FAS using imputed values

Posted

Mean

Standard Error

Litres

4 weeks

ID	Title	Description
OG000	Tiotropium + Salmeterol	Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
OG001	Fluticasone + Salmeterol	Flu+Sal 500+50mcg b.i.d. in Period 1 or 2

Units	Counts
Participants	OG000

Secondary

Static Lung Volumes

Trough TLC (Total Lung Capacity) after 8 weeks (measured by bodyphlethysmography)

FAS using imputed values

Posted

Mean

Standard Error

Litres

8 weeks

ID	Title	Description
OG000	Tiotropium + Salmeterol	Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
OG001	Fluticasone + Salmeterol	Flu+Sal 500+50mcg b.i.d. in Period 1 or 2

Units	Counts
Participants	OG000

Secondary

Static Lung Volumes

Trough TLC (Total Lung Capacity) after 4 weeks (measured by bodyphlethysmography)

FAS using imputed values

Posted

Mean

Standard Error

Litres

4 weeks

ID	Title	Description
OG000	Tiotropium + Salmeterol	Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
OG001	Fluticasone + Salmeterol	Flu+Sal 500+50mcg b.i.d. in Period 1 or 2

Units	Counts
Participants	OG000

Secondary

Static Lung Volumes

Post-dose TLC (Total Lung Capacity) after 8 weeks (measured by bodyphlethysmography)

FAS using imputed values

Posted

Mean

Standard Error

Litres

8 weeks

ID	Title	Description
OG000	Tiotropium + Salmeterol	Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
OG001	Fluticasone + Salmeterol	Flu+Sal 500+50mcg b.i.d. in Period 1 or 2

Units	Counts
Participants	OG000

Secondary

Static Lung Volumes

Post-dose TLC (Total Lung Capacity) after 4 weeks (measured by bodyphlethysmography)

FAS using imputed values

Posted

Mean

Standard Error

Litres

4 weeks

ID	Title	Description
OG000	Tiotropium + Salmeterol	Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
OG001	Fluticasone + Salmeterol	Flu+Sal 500+50mcg b.i.d. in Period 1 or 2

Units	Counts
Participants	OG000

Secondary

Static Lung Volumes (Percent)

Trough RV/TLC (Residual Volume over Total Lung Capacity) after 8 weeks (measured by bodyphlethysmography)

FAS using imputed values

Posted

Mean

Standard Error

Percent of RV over TLC

8 weeks

ID	Title	Description
OG000	Tiotropium + Salmeterol	Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
OG001	Fluticasone + Salmeterol	Flu+Sal 500+50mcg b.i.d. in Period 1 or 2

Units	Counts
Participants	OG000

Secondary

Static Lung Volumes (Percent)

Trough RV/TLC (Residual Volume over Total Lung Capacity) after 4 weeks (measured by bodyphlethysmography)

FAS using imputed values

Posted

Mean

Standard Error

Percent of RV over TLC

4 weeks

ID	Title	Description
OG000	Tiotropium + Salmeterol	Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
OG001	Fluticasone + Salmeterol	Flu+Sal 500+50mcg b.i.d. in Period 1 or 2

Units	Counts
Participants	OG000

Secondary

Static Lung Volumes (Percent)

Post-dose RV/TLC (Residual Volume over Total Lung Capacity) after 8 weeks (measured by bodyphlethysmography)

FAS using imputed values

Posted

Mean

Standard Error

Percent of RV over TLC

8 weeks

ID	Title	Description
OG000	Tiotropium + Salmeterol	Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
OG001	Fluticasone + Salmeterol	Flu+Sal 500+50mcg b.i.d. in Period 1 or 2

Units	Counts
Participants	OG000

Secondary

Static Lung Volumes (Percent)

Post-dose RV/TLC (Residual Volume over Total Lung Capacity) after 4 weeks (measured by bodyphlethysmography)

FAS using imputed values

Posted

Mean

Standard Error

Percent of RV over TLC

4 weeks

ID	Title	Description
OG000	Tiotropium + Salmeterol	Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
OG001	Fluticasone + Salmeterol	Flu+Sal 500+50mcg b.i.d. in Period 1 or 2

Units	Counts
Participants	OG000

Secondary

Static Lung Volumes (Percent)

Trough TGV/TLC (Thoracic Gas Volume over Total Lung Capacity) after 8 weeks (measured by bodyphlethysmography)

FAS using imputed values

Posted

Mean

Standard Error

Percent of TGV over TLC

8 weeks

ID	Title	Description
OG000	Tiotropium + Salmeterol	Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
OG001	Fluticasone + Salmeterol	Flu+Sal 500+50mcg b.i.d. in Period 1 or 2

Units	Counts
Participants	OG000

Secondary

Static Lung Volumes (Percent)

Trough TGV/TLC (Thoracic Gas Volume over Total Lung Capacity) after 4 weeks (measured by bodyphlethysmography)

FAS using imputed values

Posted

Mean

Standard Error

Percent of TGV over TLC

4 weeks

ID	Title	Description
OG000	Tiotropium + Salmeterol	Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
OG001	Fluticasone + Salmeterol	Flu+Sal 500+50mcg b.i.d. in Period 1 or 2

Units	Counts
Participants	OG000

Secondary

Static Lung Volumes (Percent)

Post-dose TGV/TLC (Thoracic Gas Volume over Total Lung Capacity) after 8 weeks (measured by bodyphlethysmography)

FAS using imputed values

Posted

Mean

Standard Error

Percent of TGV over TLC

8 weeks

ID	Title	Description
OG000	Tiotropium + Salmeterol	Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
OG001	Fluticasone + Salmeterol	Flu+Sal 500+50mcg b.i.d. in Period 1 or 2

Units	Counts
Participants	OG000

Secondary

Static Lung Volumes (Percent)

Post-dose TGV/TLC (Thoracic Gas Volume over Total Lung Capacity) after 4 weeks (measured by bodyphlethysmography)

FAS using imputed values

Posted

Mean

Standard Error

Percent of TGV over TLC

4 weeks

ID	Title	Description
OG000	Tiotropium + Salmeterol	Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
OG001	Fluticasone + Salmeterol	Flu+Sal 500+50mcg b.i.d. in Period 1 or 2

Units	Counts
Participants	OG000

Secondary

Slow Vital Capacity (SVC)

Trough SVC (Slow Vital Capacity) after 8 weeks (measured by spirometry)

FAS using imputed values

Posted

Mean

Standard Error

Litres

8 weeks

ID	Title	Description
OG000	Tiotropium + Salmeterol	Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
OG001	Fluticasone + Salmeterol	Flu+Sal 500+50mcg b.i.d. in Period 1 or 2

Units	Counts
Participants	OG000

Secondary

Slow Vital Capacity (SVC)

Trough SVC (Slow Vital Capacity) after 4 weeks (measured by spirometry)

FAS using imputed values

Posted

Mean

Standard Error

Litres

4 weeks

ID	Title	Description
OG000	Tiotropium + Salmeterol	Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
OG001	Fluticasone + Salmeterol	Flu+Sal 500+50mcg b.i.d. in Period 1 or 2

Units	Counts
Participants	OG000

Secondary

Slow Vital Capacity (SVC)

Post-dose SVC (Slow Vital Capacity) after 8 weeks (measured by spirometry)

FAS using imputed values

Posted

Mean

Standard Error

Litres

8 weeks

ID	Title	Description
OG000	Tiotropium + Salmeterol	Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
OG001	Fluticasone + Salmeterol	Flu+Sal 500+50mcg b.i.d. in Period 1 or 2

Units	Counts
Participants	OG000

Secondary

Slow Vital Capacity (SVC)

Post-dose SVC (Slow Vital Capacity) after 4 weeks (measured by spirometry)

FAS using imputed values

Posted

Mean

Standard Error

Litres

4 weeks

ID	Title	Description
OG000	Tiotropium + Salmeterol	Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
OG001	Fluticasone + Salmeterol	Flu+Sal 500+50mcg b.i.d. in Period 1 or 2

Units	Counts
Participants	OG000

Secondary

Forced Expiratory Volume in 1 Second (FEV1)

Trough FEV1 (Forced Expiratory Volume in 1 second) after 8 weeks (measured by spirometry)

FAS using imputed values

Posted

Mean

Standard Error

Litres

8 weeks

ID	Title	Description
OG000	Tiotropium + Salmeterol	Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
OG001	Fluticasone + Salmeterol	Flu+Sal 500+50mcg b.i.d. in Period 1 or 2

Units	Counts
Participants	OG000

Secondary

Forced Expiratory Volume in 1 Second (FEV1)

Trough FEV1 (Forced Expiratory Volume in 1 second) after 4 weeks (measured by spirometry)

FAS using imputed values

Posted

Mean

Standard Error

Litres

4 weeks

ID	Title	Description
OG000	Tiotropium + Salmeterol	Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
OG001	Fluticasone + Salmeterol	Flu+Sal 500+50mcg b.i.d. in Period 1 or 2

Units	Counts
Participants	OG000

Secondary

Forced Expiratory Volume in 1 Second (FEV1)

Post-dose FEV1 (Forced Expiratory Volume in 1 second) after 8 weeks (measured by spirometry)

FAS using imputed values

Posted

Mean

Standard Error

Litres

8 weeks

ID	Title	Description
OG000	Tiotropium + Salmeterol	Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
OG001	Fluticasone + Salmeterol	Flu+Sal 500+50mcg b.i.d. in Period 1 or 2

Units	Counts
Participants	OG000

Secondary

Forced Expiratory Volume in 1 Second (FEV1)

Post-dose FEV1 (Forced Expiratory Volume in 1 second) after 4 weeks (measured by spirometry)

FAS using imputed values

Posted

Mean

Standard Error

Litres

4 weeks

ID	Title	Description
OG000	Tiotropium + Salmeterol	Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
OG001	Fluticasone + Salmeterol	Flu+Sal 500+50mcg b.i.d. in Period 1 or 2

Units	Counts
Participants	OG000

Secondary

Forced Expiratory Volume in 1 Second (FEV1)

Trough percent predicted FEV1 (Forced Expiratory Volume in 1 second) according to ECCS after 8 weeks (measured by spirometry)

FAS using imputed values

Posted

Mean

Standard Error

Percent of predicted FEV1

8 weeks

ID	Title	Description
OG000	Tiotropium + Salmeterol	Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
OG001	Fluticasone + Salmeterol	Flu+Sal 500+50mcg b.i.d. in Period 1 or 2

Units	Counts
Participants	OG000

Secondary

Forced Expiratory Volume in 1 Second (FEV1)

Trough percent predicted FEV1 (Forced Expiratory Volume in 1 second) according to ECCS after 4 weeks (measured by spirometry)

FAS using imputed values

Posted

Mean

Standard Error

Percent of predicted FEV1

4 weeks

ID	Title	Description
OG000	Tiotropium + Salmeterol	Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
OG001	Fluticasone + Salmeterol	Flu+Sal 500+50mcg b.i.d. in Period 1 or 2

Units	Counts
Participants	OG000

Secondary

Forced Expiratory Volume in 1 Second (FEV1)

Post-dose percent predicted FEV1 (Forced Expiratory Volume in 1 second) according to ECCS after 8 weeks (measured by spirometry)

FAS using imputed values

Posted

Mean

Standard Error

Percent of predicted FEV1

8 weeks

ID	Title	Description
OG000	Tiotropium + Salmeterol	Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
OG001	Fluticasone + Salmeterol	Flu+Sal 500+50mcg b.i.d. in Period 1 or 2

Units	Counts
Participants	OG000

Secondary

Forced Expiratory Volume in 1 Second (FEV1)

Post-dose percent predicted FEV1 (Forced Expiratory Volume in 1 second) according to ECCS after 4 weeks (measured by spirometry)

FAS using imputed values

Posted

Mean

Standard Error

Percent of predicted FEV1

4 weeks

ID	Title	Description
OG000	Tiotropium + Salmeterol	Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
OG001	Fluticasone + Salmeterol	Flu+Sal 500+50mcg b.i.d. in Period 1 or 2

Units	Counts
Participants	OG000

Secondary

Forced Vital Capacity (FVC)

Trough FVC (Forced Vital Capacity) after 8 weeks (measured by spirometry)

FAS using imputed values

Posted

Mean

Standard Error

Litres

8 weeks

ID	Title	Description
OG000	Tiotropium + Salmeterol	Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
OG001	Fluticasone + Salmeterol	Flu+Sal 500+50mcg b.i.d. in Period 1 or 2

Units	Counts
Participants	OG000

Secondary

Forced Vital Capacity (FVC)

Trough FVC (Forced Vital Capacity) after 4 weeks (measured by spirometry)

FAS using imputed values

Posted

Mean

Standard Error

Litres

4 weeks

ID	Title	Description
OG000	Tiotropium + Salmeterol	Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
OG001	Fluticasone + Salmeterol	Flu+Sal 500+50mcg b.i.d. in Period 1 or 2

Units	Counts
Participants	OG000

Secondary

Forced Vital Capacity (FVC)

Post-dose FVC (Forced Vital Capacity) after 8 weeks (measured by spirometry)

FAS using imputed values

Posted

Mean

Standard Error

Litres

8 weeks

ID	Title	Description
OG000	Tiotropium + Salmeterol	Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
OG001	Fluticasone + Salmeterol	Flu+Sal 500+50mcg b.i.d. in Period 1 or 2

Units	Counts
Participants	OG000

Secondary

Forced Vital Capacity (FVC)

Post-dose FVC (Forced Vital Capacity) after 4 weeks (measured by spirometry)

FAS using imputed values

Posted

Mean

Standard Error

Litres

4 weeks

ID	Title	Description
OG000	Tiotropium + Salmeterol	Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
OG001	Fluticasone + Salmeterol	Flu+Sal 500+50mcg b.i.d. in Period 1 or 2

Units	Counts
Participants	OG000

Secondary

FEV1 Over FVC (Percent)

Trough FEV1 (Forced Expiratory Volume in 1 second) over FVC (Forced Vital Capacity) after 8 weeks (measured by spirometry)

FAS using imputed values

Posted

Mean

Standard Error

Percent of FEV1 over FVC

8 weeks

ID	Title	Description
OG000	Tiotropium + Salmeterol	Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
OG001	Fluticasone + Salmeterol	Flu+Sal 500+50mcg b.i.d. in Period 1 or 2

Units	Counts
Participants	OG000

Secondary

FEV1 Over FVC (Percent)

Trough FEV1 (Forced Expiratory Volume in 1 second) over FVC (Forced Vital Capacity) after 4 weeks (measured by spirometry)

FAS using imputed values

Posted

Mean

Standard Error

Percent of FEV1 over FVC

4 weeks

ID	Title	Description
OG000	Tiotropium + Salmeterol	Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
OG001	Fluticasone + Salmeterol	Flu+Sal 500+50mcg b.i.d. in Period 1 or 2

Units	Counts
Participants	OG000

Secondary

FEV1 Over FVC (Percent)

Post-dose FEV1 (Forced Expiratory Volume in 1 second) over FVC (Forced Vital Capacity) after 8 weeks (measured by spirometry)

FAS using imputed values

Posted

Mean

Standard Error

Percent of FEV1 over FVC

8 weeks

ID	Title	Description
OG000	Tiotropium + Salmeterol	Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
OG001	Fluticasone + Salmeterol	Flu+Sal 500+50mcg b.i.d. in Period 1 or 2

Units	Counts
Participants	OG000

Secondary

FEV1 Over FVC (Percent)

Post-dose FEV1 (Forced Expiratory Volume in 1 second) over FVC (Forced Vital Capacity) after 4 weeks (measured by spirometry)

FAS using imputed values

Posted

Mean

Standard Error

Percent of FEV1 over FVC

4 weeks

ID	Title	Description
OG000	Tiotropium + Salmeterol	Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
OG001	Fluticasone + Salmeterol	Flu+Sal 500+50mcg b.i.d. in Period 1 or 2

Units	Counts
Participants	OG000

Secondary

Symptom Intensity During Exercise

Isotime Borg dyspnea scale after 8 weeks, Unit on a Scale (min. 0, max 10), 0 = no dyspnea, 10 = worst imaginable dyspnea

FAS using imputed values

Posted

Mean

Standard Error

Unit on a Scale

8 weeks

ID	Title	Description
OG000	Tiotropium + Salmeterol	Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
OG001	Fluticasone + Salmeterol	Flu+Sal 500+50mcg b.i.d. in Period 1 or 2

Units	Counts
Participants	OG000

Secondary

Symptom Intensity During Exercise

Isotime Borg dyspnea scale after 4 weeks, Unit on a Scale (min. 0, max. 10), 0 = no dyspnea, 10 = worst imaginable dyspnea

FAS using imputed values

Posted

Mean

Standard Error

Unit on a Scale

4 weeks

ID	Title	Description
OG000	Tiotropium + Salmeterol	Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
OG001	Fluticasone + Salmeterol	Flu+Sal 500+50mcg b.i.d. in Period 1 or 2

Units	Counts
Participants	OG000

Secondary

Symptom Intensity During Exercise

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

FAS using imputed values

Posted

Mean

Standard Error

Unit on a Scale

8 weeks

ID	Title	Description
OG000	Tiotropium + Salmeterol	Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
OG001	Fluticasone + Salmeterol	Flu+Sal 500+50mcg b.i.d. in Period 1 or 2

Units	Counts
Participants	OG000

Secondary

Symptom Intensity During Exercise

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

FAS using imputed values

Posted

Mean

Standard Error

Unit on a Scale

4 weeks

ID	Title	Description
OG000	Tiotropium + Salmeterol	Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
OG001	Fluticasone + Salmeterol	Flu+Sal 500+50mcg b.i.d. in Period 1 or 2

Units	Counts
Participants	OG000

Secondary

Dyspnea and Leg Discomfort

Peak Borg dyspnea scale after 8 weeks, Unit on a Scale (min. 0, max 10)

FAS using imputed values

Posted

Mean

Standard Deviation

Unit on a Scale

8 weeks

ID	Title	Description
OG000	Tiotropium + Salmeterol	Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
OG001	Fluticasone + Salmeterol	Flu+Sal 500+50mcg b.i.d. in Period 1 or 2

Units	Counts
Participants	OG000

Secondary

Dyspnea and Leg Discomfort

Peak Borg leg discomfort scale after 8 weeks, Unit on a Scale (min. 0, max 10)

FAS using imputed values

Posted

Mean

Standard Deviation

Unit on a Scale

8 weeks

ID	Title	Description
OG000	Tiotropium + Salmeterol	Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
OG001	Fluticasone + Salmeterol	Flu+Sal 500+50mcg b.i.d. in Period 1 or 2

Units	Counts
Participants	OG000

Secondary

Locus of Symptom Limitation at Peak Exercise During Exercise

Reason for stopping exercise at baseline (leg discomfort, breathing discomfort, both or none)

FAS using imputed values

Posted

Number

Participants

baseline

ID	Title	Description
OG000	Tiotropium + Salmeterol	Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
OG001	Fluticasone + Salmeterol	Flu+Sal 500+50mcg b.i.d. in Period 1 or 2

Units	Counts
Participants	OG000

Secondary

Locus of Symptom Limitation at Peak Exercise During Exercise

Reason for stopping exercise after 4 weeks (leg discomfort, breathing discomfort, both or none)

FAS using imputed values

Posted

Number

Participants

4 weeks

ID	Title	Description
OG000	Tiotropium + Salmeterol	Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
OG001	Fluticasone + Salmeterol	Flu+Sal 500+50mcg b.i.d. in Period 1 or 2

Units	Counts
Participants	OG000

Secondary

Locus of Symptom Limitation at Peak Exercise During Exercise

Reason for stopping exercise after 8 weeks (leg discomfort, breathing discomfort, both or none)

FAS using imputed values

Posted

Number

Participants

8 weeks

ID	Title	Description
OG000	Tiotropium + Salmeterol	Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
OG001	Fluticasone + Salmeterol	Flu+Sal 500+50mcg b.i.d. in Period 1 or 2

Units	Counts
Participants	OG000

Name	Type	Description	Arm Group Labels	Other Names
Tiotropium plus Salmeterol	Drug
Fluticasone/Salmeterol	Drug

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Tiotropium + Salmeterol (Period 1)	Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1	7	172	18	172
EG001	Tiotropium + Salmeterol (Period 2)	Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 2	5	160	18	160
EG002	Fluticasone + Salmeterol (Period 1)	Flu+Sal 500+50mcg b.i.d. in Period 1	4	172	21	172
EG003	Fluticasone + Salmeterol (Period 2)	Flu+Sal 500+50mcg b.i.d. in Period 2	4	157	12	157

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Arrhythmia	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected172 at risk EG0010 affected160 at risk EG0021 affected172 at risk EG0030 affected157 at risk
Arterial occlusive disease	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected172 at risk EG0010 affected160 at risk EG0020 affected172 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected172 at risk EG0010 affected160 at risk EG0021 affected172 at risk EG003
Bundle branch block right	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected172 at risk EG0010 affected160 at risk EG0021 affected172 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected172 at risk EG0013 affected160 at risk EG0020 affected172 at risk EG003
Extrasystoles	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected172 at risk EG0010 affected160 at risk EG0020 affected172 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected172 at risk EG0010 affected160 at risk EG0020 affected172 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected172 at risk EG0010 affected160 at risk EG0020 affected172 at risk EG003
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected172 at risk EG0011 affected160 at risk EG0020 affected172 at risk EG003
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected172 at risk EG0010 affected160 at risk EG0021 affected172 at risk EG003
Musculeskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected172 at risk EG0010 affected160 at risk EG0020 affected172 at risk EG003
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected172 at risk EG0011 affected160 at risk EG0020 affected172 at risk EG003
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected172 at risk EG0010 affected160 at risk EG0020 affected172 at risk EG003
Tachycardia	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected172 at risk EG0010 affected160 at risk EG0021 affected172 at risk EG003
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected172 at risk EG0010 affected160 at risk EG0020 affected172 at risk EG003

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment		EG00016 affected172 at risk EG00111 affected160 at risk EG00212 affected172 at risk EG0037 affected157 at risk
Nasopharyngitis	Infections and infestations	MedDRA 11.1	Systematic Assessment		EG0003 affected172 at risk EG0019 affected160 at risk EG0029 affected172 at risk EG003

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Title	Description
BG000	Tiotropium + Salmeterol / Fluticasone + Salmeterol	Tio 18mcg o.d. + Sal 50mcg b.i.d. / Flu+Sal 500+50mcg b.i.d.
BG001	Fluticasone + Salmeterol / Tiotropium + Salmeterol	Flu+Sal 500+50mcg b.i.d. / Tio 18mcg o.d. + Sal 50mcg b.i.d.
BG002	Total	Total of all reporting groups

ID	Term
D000069447	Tiotropium Bromide
D000068299	Salmeterol Xinafoate
D000068297	Fluticasone-Salmeterol Drug Combination

ID	Term
D012602	Scopolamine Derivatives
D014326	Tropanes
D053961	Azabicyclo Compounds
D001372	Aza Compounds
D009930	Organic Chemicals
D000470	Alkaloids
D006571	Heterocyclic Compounds
D019086	Bridged Bicyclo Compounds, Heterocyclic
D006572	Heterocyclic Compounds, Bridged-Ring
D000420	Albuterol
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D000588	Amines
D010627	Phenethylamines
D005021	Ethylamines
D000068298	Fluticasone
D000730	Androstadienes
D000736	Androstenes
D000731	Androstanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D004338	Drug Combinations
D004364	Pharmaceutical Preparations