Respimat® Combivent Trial in Chronic Obstructive Pulmonary Disease (COPD) - Study Results

Study Type:	Interventional
Condition:	Pulmonary Disease, Chronic Obstructive
Interventions:	Drug: Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI Drug: COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat Drug: Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
STARTED	486	491	483
COMPLETED	438	436	422
NOT COMPLETED	48	55	61

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg	Total
Number of Participants [units: participants]	486	491	483	1460
Age [units: years] Mean ± Standard Deviation	63.8 ± 8.7	64.2 ± 9.2	64.3 ± 8.6	64.1 ± 8.8
Gender [units: participants]
Female	170	169	166	505
Male	316	322	317	955

Outcome Measures

1. Primary:

FEV1 AUC0-6 at Day 85 [ Before drug administration to 6 hours after drug administration on Day 85 ]

Measure Type	Primary
Measure Title	FEV1 AUC0-6 at Day 85
Measure Description	Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 85
Time Frame	Before drug administration to 6 hours after drug administration on Day 85
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set for Pulmonary Function Test Data

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	474	482	468
FEV1 AUC0-6 at Day 85 [units: liters] Least Squares Mean ± Standard Error	0.145 ± 0.007	0.149 ± 0.007	0.119 ± 0.007

Statistical Analysis 1 for FEV1 AUC0-6 at Day 85

Groups ^[1]	COMBIVENT Respimat 20/100 Mcg vs. COMBIVENT CFC-MDI 36/206 Mcg
Non-Inferiority/Equivalence Test ^[2]	Yes
Method ^[3]	ANCOVA
P Value ^[4]	0.7135
Mean Difference (Final Values) ^[5]	-0.0035
Standard Error of the mean	± 0.0095
95% Confidence Interval	( -0.0222 to 0.0152 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	Non-inferiority margin is 0.05 liter
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

2. Primary:

FEV1 AUC0-4 at Day 85 [ Before drug administration to 4 hours after drug administration on Day 85 ]

Measure Type	Primary
Measure Title	FEV1 AUC0-4 at Day 85
Measure Description	Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 85
Time Frame	Before drug administration to 4 hours after drug administration on Day 85
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set for Pulmonary Function Test Data

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	474	482	468
FEV1 AUC0-4 at Day 85 [units: liters] Least Squares Mean ± Standard Error	0.189 ± 0.007	0.190 ± 0.007	0.142 ± 0.007

Statistical Analysis 1 for FEV1 AUC0-4 at Day 85

Groups ^[1]	COMBIVENT Respimat 20/100 Mcg vs. Ipratropium Respimat 20 Mcg
Method ^[2]	ANCOVA
P Value ^[3]	< 0.0001
Mean Difference (Final Values) ^[4]	0.047
Standard Error of the mean	± 0.01
95% Confidence Interval	( 0.028 to 0.066 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

3. Primary:

FEV1 AUC4-6 at Day 85 [ Between 4 hours and 6 hours after drug administration on Day 85 ]

Measure Type	Primary
Measure Title	FEV1 AUC4-6 at Day 85
Measure Description	Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 85
Time Frame	Between 4 hours and 6 hours after drug administration on Day 85
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set for Pulmonary Function Test Data 4-6 hours

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	447	449	427
FEV1 AUC4-6 at Day 85 [units: liters] Least Squares Mean ± Standard Error	0.056 ± 0.008	0.066 ± 0.008	0.073 ± 0.008

Statistical Analysis 1 for FEV1 AUC4-6 at Day 85

Groups ^[1]	COMBIVENT Respimat 20/100 Mcg vs. Ipratropium Respimat 20 Mcg
Non-Inferiority/Equivalence Test ^[2]	Yes
Method ^[3]	ANCOVA
P Value ^[4]	0.1389
Mean Difference (Final Values) ^[5]	-0.017
Standard Error of the mean	± 0.011
95% Confidence Interval	( -0.039 to 0.005 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	Non-inferiority margin is 0.05 liters
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

4. Secondary:

FEV1 AUC0-6 at Day 1 [ Before drug administration to 6 hours after drug administration on Day 1 ]

Measure Type	Secondary
Measure Title	FEV1 AUC0-6 at Day 1
Measure Description	Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 1
Time Frame	Before drug administration to 6 hours after drug administration on Day 1
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set for Pulmonary Function Test Data

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	474	482	468
FEV1 AUC0-6 at Day 1 [units: liters] Least Squares Mean ± Standard Error	0.173 ± 0.008	0.189 ± 0.008	0.124 ± 0.008

Statistical Analysis 1 for FEV1 AUC0-6 at Day 1

Groups ^[1]	COMBIVENT Respimat 20/100 Mcg vs. COMBIVENT CFC-MDI 36/206 Mcg
Non-Inferiority/Equivalence Test ^[2]	Yes
Method ^[3]	ANCOVA
P Value ^[4]	0.124
Mean Difference (Final Values) ^[5]	-0.016
Standard Error of the mean	± 0.010
95% Confidence Interval	( -0.036 to 0.004 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	This analysis is purely exploratory. Non-inferiority margin is not established for this comparison.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

5. Secondary:

FEV1 AUC0-6 at Day 29 [ Before drug administration to 6 hours after drug administration on Day 29 ]

Measure Type	Secondary
Measure Title	FEV1 AUC0-6 at Day 29
Measure Description	Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 29
Time Frame	Before drug administration to 6 hours after drug administration on Day 29
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set for Pulmonary Function Test Data

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	474	482	468
FEV1 AUC0-6 at Day 29 [units: liters] Least Squares Mean ± Standard Error	0.154 ± 0.007	0.161 ± 0.007	0.127 ± 0.007

Statistical Analysis 1 for FEV1 AUC0-6 at Day 29

Groups ^[1]	COMBIVENT Respimat 20/100 Mcg vs. COMBIVENT CFC-MDI 36/206 Mcg
Non-Inferiority/Equivalence Test ^[2]	Yes
Method ^[3]	ANCOVA
P Value ^[4]	0.4888
Mean Difference (Final Values) ^[5]	-0.007
Standard Error of the mean	± 0.01
95% Confidence Interval	( -0.026 to 0.013 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	This analysis is purely exploratory. Non-inferiority margin is not established for this comparison.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

6. Secondary:

FEV1 AUC0-6 at Day 57 [ Before drug administration to 6 hours after drug administration on Day 57 ]

Measure Type	Secondary
Measure Title	FEV1 AUC0-6 at Day 57
Measure Description	Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 57
Time Frame	Before drug administration to 6 hours after drug administration on Day 57
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set for Pulmonary Function Test Data

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	474	482	468
FEV1 AUC0-6 at Day 57 [units: liters] Least Squares Mean ± Standard Error	0.146 ± 0.007	0.16 ± 0.007	0.118 ± 0.007

Statistical Analysis 1 for FEV1 AUC0-6 at Day 57

Groups ^[1]	COMBIVENT Respimat 20/100 Mcg vs. COMBIVENT CFC-MDI 36/206 Mcg
Non-Inferiority/Equivalence Test ^[2]	Yes
Method ^[3]	ANCOVA
P Value ^[4]	0.1433
Mean Difference (Final Values) ^[5]	-0.014
95% Confidence Interval	( -0.033 to 0.005 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	This analysis is purely exploratory. Non-inferiority margin is not established for this comparison.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

7. Secondary:

FEV1 AUC0-4 at Day 1 [ Before drug administration to 4 hours after drug administration on Day 1 ]

Measure Type	Secondary
Measure Title	FEV1 AUC0-4 at Day 1
Measure Description	Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 1
Time Frame	Before drug administration to 4 hours after drug administration on Day 1
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set for Pulmonary Function Test Data

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	474	482	468
FEV1 AUC0-4 at Day 1 [units: liters] Least Squares Mean ± Standard Error	0.211 ± 0.008	0.227 ± 0.008	0.149 ± 0.008

Statistical Analysis 1 for FEV1 AUC0-4 at Day 1

Groups ^[1]	COMBIVENT Respimat 20/100 Mcg vs. Ipratropium Respimat 20 Mcg
Method ^[2]	ANCOVA
P Value ^[3]	< 0.0001
Mean Difference (Final Values) ^[4]	0.061
Standard Error of the mean	± 0.011
95% Confidence Interval	( 0.04 to 0.083 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis is purely exploratory.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

8. Secondary:

FEV1 AUC0-4 at Day 29 [ Before drug administration to 4 hours after drug administration on Day 29 ]

Measure Type	Secondary
Measure Title	FEV1 AUC0-4 at Day 29
Measure Description	Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 29
Time Frame	Before drug administration to 4 hours after drug administration on Day 29
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set for Pulmonary Function Test Data

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	474	482	468
FEV1 AUC0-4 at Day 29 [units: liters] Least Squares Mean ± Standard Error	0.197 ± 0.008	0.198 ± 0.008	0.153 ± 0.008

Statistical Analysis 1 for FEV1 AUC0-4 at Day 29

Groups ^[1]	COMBIVENT Respimat 20/100 Mcg vs. Ipratropium Respimat 20 Mcg
Method ^[2]	ANCOVA
P Value ^[3]	< 0.0001
Mean Difference (Final Values) ^[4]	0.044
Standard Error of the mean	± 0.01
95% Confidence Interval	( 0.024 to 0.065 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis is purely exploratory.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

9. Secondary:

FEV1 AUC0-4 at Day 57 [ Before drug administration to 4 hours after drug administration on Day 57 ]

Measure Type	Secondary
Measure Title	FEV1 AUC0-4 at Day 57
Measure Description	Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 57
Time Frame	Before drug administration to 4 hours after drug administration on Day 57
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set for Pulmonary Function Test Data

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	474	482	468
FEV1 AUC0-4 at Day 57 [units: liters] Least Squares Mean ± Standard Error	0.188 ± 0.007	0.200 ± 0.007	0.141 ± 0.007

Statistical Analysis 1 for FEV1 AUC0-4 at Day 57

Groups ^[1]	COMBIVENT Respimat 20/100 Mcg vs. Ipratropium Respimat 20 Mcg
Method ^[2]	ANCOVA
P Value ^[3]	< 0.0001
Mean Difference (Final Values) ^[4]	0.047
Standard Error of the mean	± 0.01
95% Confidence Interval	( 0.027 to 0.067 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis is purely exploratory.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

10. Secondary:

FEV1 AUC4-6 at Day 1 [ Between 4 hours and 6 hours after drug administration on Day 1 ]

Measure Type	Secondary
Measure Title	FEV1 AUC4-6 at Day 1
Measure Description	Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 1
Time Frame	Between 4 hours and 6 hours after drug administration on Day 1
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set for Pulmonary Function Test Data 4-6 hours

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	447	449	427
FEV1 AUC4-6 at Day 1 [units: liters] Least Squares Mean ± Standard Error	0.1 ± 0.008	0.115 ± 0.009	0.074 ± 0.009

Statistical Analysis 1 for FEV1 AUC4-6 at Day 1

Groups ^[1]	COMBIVENT Respimat 20/100 Mcg vs. Ipratropium Respimat 20 Mcg
Non-Inferiority/Equivalence Test ^[2]	Yes
Method ^[3]	ANCOVA
P Value ^[4]	0.0258
Mean Difference (Final Values) ^[5]	0.026
Standard Error of the mean	± 0.012
95% Confidence Interval	( 0.003 to 0.049 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	This analysis is purely exploratory. Non-inferiority margin is not established.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

11. Secondary:

FEV1 AUC4-6 at Day 29 [ Between 4 hours and 6 hours after drug administration on Day 29 ]

Measure Type	Secondary
Measure Title	FEV1 AUC4-6 at Day 29
Measure Description	Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 29
Time Frame	Between 4 hours and 6 hours after drug administration on Day 29
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set for Pulmonary Function Test Data 4-6 hours

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	447	449	427
FEV1 AUC4-6 at Day 29 [units: liters] Least Squares Mean ± Standard Error	0.068 ± 0.008	0.087 ± 0.008	0.078 ± 0.008

Statistical Analysis 1 for FEV1 AUC4-6 at Day 29

Groups ^[1]	COMBIVENT Respimat 20/100 Mcg vs. Ipratropium Respimat 20 Mcg
Non-Inferiority/Equivalence Test ^[2]	Yes
Method ^[3]	ANCOVA
P Value ^[4]	0.3749
Mean Difference (Final Values) ^[5]	-0.01
Standard Error of the mean	± 0.011
95% Confidence Interval	( -0.032 to 0.012 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	This analysis is purely exploratory. Non-inferiority margin is not established.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

12. Secondary:

FEV1 AUC4-6 at Day 57 [ Between 4 hours and 6 hours after drug administration on Day 57 ]

Measure Type	Secondary
Measure Title	FEV1 AUC4-6 at Day 57
Measure Description	Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 57
Time Frame	Between 4 hours and 6 hours after drug administration on Day 57
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set for Pulmonary Function Test Data 4-6 hours

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	447	449	427
FEV1 AUC4-6 at Day 57 [units: liters] Least Squares Mean ± Standard Error	0.063 ± 0.008	0.084 ± 0.008	0.073 ± 0.008

Statistical Analysis 1 for FEV1 AUC4-6 at Day 57

Groups ^[1]	COMBIVENT Respimat 20/100 Mcg vs. Ipratropium Respimat 20 Mcg
Non-Inferiority/Equivalence Test ^[2]	Yes
Method ^[3]	ANCOVA
P Value ^[4]	0.3355
Mean Difference (Final Values) ^[5]	-0.011
Standard Error of the mean	± 0.011
95% Confidence Interval	( -0.033 to 0.011 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	This analysis is purely exploratory. Non-inferiority margin is not established.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

13. Secondary:

Peak FEV1 Response at Day 1 [ Within the first 2-hour post-treatment interval on Day 1 ]

Measure Type	Secondary
Measure Title	Peak FEV1 Response at Day 1
Measure Description	Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 1
Time Frame	Within the first 2-hour post-treatment interval on Day 1
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set for Pulmonary Function Test Data

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	474	482	468
Peak FEV1 Response at Day 1 [units: liters] Least Squares Mean ± Standard Error	0.302 ± 0.008	0.323 ± 0.008	0.237 ± 0.008

Statistical Analysis 1 for Peak FEV1 Response at Day 1

Groups ^[1]	COMBIVENT Respimat 20/100 Mcg vs. COMBIVENT CFC-MDI 36/206 Mcg
Non-Inferiority/Equivalence Test ^[2]	Yes
Method ^[3]	ANCOVA
P Value ^[4]	0.0743
Mean Difference (Final Values) ^[5]	-0.02
Standard Error of the mean	± 0.011
95% Confidence Interval	( -0.042 to 0.002 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	This analysis is purely exploratory. Non-inferiority margin is not established.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

14. Secondary:

Peak FEV1 Response at Day 29 [ Within the first 2-hour post-treatment interval on Day 29 ]

Measure Type	Secondary
Measure Title	Peak FEV1 Response at Day 29
Measure Description	Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 29
Time Frame	Within the first 2-hour post-treatment interval on Day 29
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set for Pulmonary Function Test Data

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	474	482	468
Peak FEV1 Response at Day 29 [units: liters] Least Squares Mean ± Standard Error	0.302 ± 0.008	0.296 ± 0.008	0.237 ± 0.008

Statistical Analysis 1 for Peak FEV1 Response at Day 29

Groups ^[1]	COMBIVENT Respimat 20/100 Mcg vs. COMBIVENT CFC-MDI 36/206 Mcg
Non-Inferiority/Equivalence Test ^[2]	Yes
Method ^[3]	ANCOVA
P Value ^[4]	0.5711
Mean Difference (Final Values) ^[5]	0.006
Standard Error of the mean	± 0.011
95% Confidence Interval	( -0.015 to 0.028 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	This analysis is purely exploratory. Non-inferiority margin is not established.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

15. Secondary:

Peak FEV1 Response at Day 57 [ Within the first 2-hour post-treatment interval on Day 57 ]

Measure Type	Secondary
Measure Title	Peak FEV1 Response at Day 57
Measure Description	Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 57
Time Frame	Within the first 2-hour post-treatment interval on Day 57
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set for Pulmonary Function Test Data

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	474	482	468
Peak FEV1 Response at Day 57 [units: liters] Least Squares Mean ± Standard Error	0.284 ± 0.008	0.296 ± 0.008	0.223 ± 0.008

Statistical Analysis 1 for Peak FEV1 Response at Day 57

Groups ^[1]	COMBIVENT Respimat 20/100 Mcg vs. COMBIVENT CFC-MDI 36/206 Mcg
Non-Inferiority/Equivalence Test ^[2]	Yes
Method ^[3]	ANCOVA
P Value ^[4]	0.2274
Mean Difference (Final Values) ^[5]	-0.013
Standard Error of the mean	± 0.011
95% Confidence Interval	( -0.033 to 0.008 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	This analysis is purely exploratory. Non-inferiority margin is not established.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

16. Secondary:

Peak FEV1 Response at Day 85 [ Within the first 2-hour post-treatment interval on Day 85 ]

Measure Type	Secondary
Measure Title	Peak FEV1 Response at Day 85
Measure Description	Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 85
Time Frame	Within the first 2-hour post-treatment interval on Day 85
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set for Pulmonary Function Test Data

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	474	482	468
Peak FEV1 Response at Day 85 [units: liters] Least Squares Mean ± Standard Error	0.293 ± 0.008	0.290 ± 0.008	0.225 ± 0.008

Statistical Analysis 1 for Peak FEV1 Response at Day 85

Groups ^[1]	COMBIVENT Respimat 20/100 Mcg vs. COMBIVENT CFC-MDI 36/206 Mcg
Non-Inferiority/Equivalence Test ^[2]	Yes
Method ^[3]	ANCOVA
P Value ^[4]	0.8065
Mean Difference (Final Values) ^[5]	0.003
Standard Error of the mean	± 0.011
95% Confidence Interval	( -0.018 to 0.024 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	This analysis is purely exploratory. Non-inferiority margin is not established.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

17. Secondary:

Peak FEV1 Response at Day 1 [ Within the first 2-hour post-treatment interval on Day 1 ]

Measure Type	Secondary
Measure Title	Peak FEV1 Response at Day 1
Measure Description	Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 1
Time Frame	Within the first 2-hour post-treatment interval on Day 1
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set for Pulmonary Function Test Data

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	474	482	468
Peak FEV1 Response at Day 1 [units: liters] Least Squares Mean ± Standard Error	0.302 ± 0.008	0.323 ± 0.008	0.237 ± 0.008

Statistical Analysis 1 for Peak FEV1 Response at Day 1

Groups ^[1]	COMBIVENT Respimat 20/100 Mcg vs. Ipratropium Respimat 20 Mcg
Method ^[2]	ANCOVA
P Value ^[3]	< 0.0001
Mean Difference (Final Values) ^[4]	0.065
Standard Error of the mean	± 0.011
95% Confidence Interval	( 0.043 to 0.087 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis is purely exploratory.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

18. Secondary:

Peak FEV1 Response at Day 29 [ Within the first 2-hour post-treatment interval on Day 29 ]

Measure Type	Secondary
Measure Title	Peak FEV1 Response at Day 29
Measure Description	Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 29
Time Frame	Within the first 2-hour post-treatment interval on Day 29
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set for Pulmonary Function Test Data

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	474	482	468
Peak FEV1 Response at Day 29 [units: liters] Least Squares Mean ± Standard Error	0.302 ± 0.008	0.296 ± 0.008	0.237 ± 0.008

Statistical Analysis 1 for Peak FEV1 Response at Day 29

Groups ^[1]	COMBIVENT Respimat 20/100 Mcg vs. Ipratropium Respimat 20 Mcg
Method ^[2]	ANCOVA
P Value ^[3]	< 0.0001
Mean Difference (Final Values) ^[4]	0.065
Standard Error of the mean	± 0.011
95% Confidence Interval	( 0.044 to 0.087 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis is purely exploratory.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

19. Secondary:

Peak FEV1 Response at Day 57 [ Within the first 2-hour post-treatment interval on Day 57 ]

Measure Type	Secondary
Measure Title	Peak FEV1 Response at Day 57
Measure Description	Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 57
Time Frame	Within the first 2-hour post-treatment interval on Day 57
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set for Pulmonary Function Test Data

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	474	482	468
Peak FEV1 Response at Day 57 [units: liters] Least Squares Mean ± Standard Error	0.284 ± 0.008	0.296 ± 0.008	0.223 ± 0.008

Statistical Analysis 1 for Peak FEV1 Response at Day 57

Groups ^[1]	COMBIVENT Respimat 20/100 Mcg vs. Ipratropium Respimat 20 Mcg
Method ^[2]	ANCOVA
P Value ^[3]	< 0.0001
Mean Difference (Final Values) ^[4]	0.06
Standard Error of the mean	± 0.011
95% Confidence Interval	( 0.04 to 0.081 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis is purely exploratory.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

20. Secondary:

Peak FEV1 Response at Day 85 [ Within the first 2-hour post-treatment interval on Day 85 ]

Measure Type	Secondary
Measure Title	Peak FEV1 Response at Day 85
Measure Description	Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 85
Time Frame	Within the first 2-hour post-treatment interval on Day 85
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set for Pulmonary Function Test Data

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	474	482	468
Peak FEV1 Response at Day 85 [units: liters] Least Squares Mean ± Standard Error	0.293 ± 0.008	0.290 ± 0.008	0.225 ± 0.008

Statistical Analysis 1 for Peak FEV1 Response at Day 85

Groups ^[1]	COMBIVENT Respimat 20/100 Mcg vs. Ipratropium Respimat 20 Mcg
Method ^[2]	ANCOVA
P Value ^[3]	< 0.0001
Mean Difference (Final Values) ^[4]	0.068
Standard Error of the mean	± 0.011
95% Confidence Interval	( 0.047 to 0.089 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis is purely exploratory.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

21. Secondary:

Time to Onset of Therapeutic FEV1 Response at Day 1 [ Within the first 2-hour post-treatment interval at Day 1 ]

Measure Type	Secondary
Measure Title	Time to Onset of Therapeutic FEV1 Response at Day 1
Measure Description	Achievement of recorded FEV1 measurement of at least 1.15 times of the corresponding test-day baseline value at any time during the first 2 hours of observation after drug administration at Day 1
Time Frame	Within the first 2-hour post-treatment interval at Day 1
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set for Pulmonary Function Test Data

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	474	482	468
Time to Onset of Therapeutic FEV1 Response at Day 1 [units: Minutes]	13	12	28

No statistical analysis provided for Time to Onset of Therapeutic FEV1 Response at Day 1

22. Secondary:

Time to Onset of Therapeutic FEV1 Response at Day 29 [ Within the first 2-hour post-treatment interval at Day 29 ]

Measure Type	Secondary
Measure Title	Time to Onset of Therapeutic FEV1 Response at Day 29
Measure Description	Achievement of recorded FEV1 measurement of at least 1.15 times of the corresponding test-day baseline value at any time during the first 2 hours of observation after drug administration at Day 29
Time Frame	Within the first 2-hour post-treatment interval at Day 29
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set for Pulmonary Function Test Data

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	474	482	468
Time to Onset of Therapeutic FEV1 Response at Day 29 [units: Minutes]	12	13	27

No statistical analysis provided for Time to Onset of Therapeutic FEV1 Response at Day 29

23. Secondary:

Time to Onset of Therapeutic FEV1 Response at Day 57 [ Within the first 2-hour post-treatment interval at Day 57 ]

Measure Type	Secondary
Measure Title	Time to Onset of Therapeutic FEV1 Response at Day 57
Measure Description	Achievement of recorded FEV1 measurement of at least 1.15 times of the corresponding test-day baseline value at any time during the first 2 hours of observation after drug administration at Day 57
Time Frame	Within the first 2-hour post-treatment interval at Day 57
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set for Pulmonary Function Test Data

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	474	482	468
Time to Onset of Therapeutic FEV1 Response at Day 57 [units: Minutes]	13	12	29

No statistical analysis provided for Time to Onset of Therapeutic FEV1 Response at Day 57

24. Secondary:

Time to Onset of Therapeutic FEV1 Response at Day 85 [ Within the first 2-hour post-treatment interval at Day 85 ]

Measure Type	Secondary
Measure Title	Time to Onset of Therapeutic FEV1 Response at Day 85
Measure Description	Achievement of recorded FEV1 measurement of at least 1.15 times of the corresponding test-day baseline value at any time during the first 2 hours of observation after drug administration at Day 85
Time Frame	Within the first 2-hour post-treatment interval at Day 85
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set for Pulmonary Function Test Data

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	474	482	468
Time to Onset of Therapeutic FEV1 Response at Day 85 [units: Minutes]	12	13	27

No statistical analysis provided for Time to Onset of Therapeutic FEV1 Response at Day 85

25. Secondary:

Duration of Therapeutic FEV1 Response at Day 1 [ During the 6-hour observation period after drug administration at Day 1 ]

Measure Type	Secondary
Measure Title	Duration of Therapeutic FEV1 Response at Day 1
Measure Description	The time interval between the onset and the the termination of a therapeutic FEV1 response (at least 1.15 times the corresponding test-day baseline value) during the 6-hour observation period at Day 1
Time Frame	During the 6-hour observation period after drug administration at Day 1
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set for Pulmonary Function Test Data

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	474	482	468
Duration of Therapeutic FEV1 Response at Day 1 [units: Minutes]	189	219	104

No statistical analysis provided for Duration of Therapeutic FEV1 Response at Day 1

26. Secondary:

Duration of Therapeutic FEV1 Response at Day 29 [ During the 6-hour observation period after drug administration at Day 29 ]

Measure Type	Secondary
Measure Title	Duration of Therapeutic FEV1 Response at Day 29
Measure Description	The time interval between the onset and the the termination of a therapeutic FEV1 response (at least 1.15 times the corresponding test-day baseline value) during the 6-hour observation period at Day 29
Time Frame	During the 6-hour observation period after drug administration at Day 29
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set for Pulmonary Function Test Data

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	474	482	468
Duration of Therapeutic FEV1 Response at Day 29 [units: Minutes]	170	178	122

No statistical analysis provided for Duration of Therapeutic FEV1 Response at Day 29

27. Secondary:

Duration of Therapeutic FEV1 Response at Day 57 [ During the 6-hour observation period after drug administration at Day 57 ]

Measure Type	Secondary
Measure Title	Duration of Therapeutic FEV1 Response at Day 57
Measure Description	The time interval between the onset and the the termination of a therapeutic FEV1 response (at least 1.15 times the corresponding test-day baseline value) during the 6-hour observation period at Day 57
Time Frame	During the 6-hour observation period after drug administration at Day 57
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set for Pulmonary Function Test Data

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	474	482	468
Duration of Therapeutic FEV1 Response at Day 57 [units: Minutes]	165	194	84

No statistical analysis provided for Duration of Therapeutic FEV1 Response at Day 57

28. Secondary:

Duration of Therapeutic FEV1 Response at Day 85 [ During the 6-hour observation period after drug administration at Day 85 ]

Measure Type	Secondary
Measure Title	Duration of Therapeutic FEV1 Response at Day 85
Measure Description	The time interval between the onset and the the termination of a therapeutic FEV1 response (at least 1.15 times the corresponding test-day baseline value) during the 6-hour observation period at Day 85
Time Frame	During the 6-hour observation period after drug administration at Day 85
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set for Pulmonary Function Test Data

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	474	482	468
Duration of Therapeutic FEV1 Response at Day 85 [units: Minutes]	168	172	70

No statistical analysis provided for Duration of Therapeutic FEV1 Response at Day 85

29. Secondary:

Time to Peak FEV1 Response at Day 1 [ Within the 6-hour post-treatment observation period at Day 1 ]

Measure Type	Secondary
Measure Title	Time to Peak FEV1 Response at Day 1
Measure Description	The first time point at which the maximum change in recorded FEV1 data from the corresponding test-day baseline occurred during the 6-hours observation period after drug administration at Day 1
Time Frame	Within the 6-hour post-treatment observation period at Day 1
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set for Pulmonary Function Test Data

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	474	482	468
Time to Peak FEV1 Response at Day 1 [units: Minutes]	60	60	120

No statistical analysis provided for Time to Peak FEV1 Response at Day 1

30. Secondary:

Time to Peak FEV1 Response at Day 29 [ Within the 6-hour post-treatment observation period at Day 29 ]

Measure Type	Secondary
Measure Title	Time to Peak FEV1 Response at Day 29
Measure Description	The first time point at which the maximum change in recorded FEV1 data from the corresponding test-day baseline occurred during the 6-hours observation period after drug administration at Day 29
Time Frame	Within the 6-hour post-treatment observation period at Day 29
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set for Pulmonary Function Test Data

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	474	482	468
Time to Peak FEV1 Response at Day 29 [units: Minutes]	60	60	120

No statistical analysis provided for Time to Peak FEV1 Response at Day 29

31. Secondary:

Time to Peak FEV1 Response at Day 57 [ Within the 6-hour post-treatment observation period at Day 57 ]

Measure Type	Secondary
Measure Title	Time to Peak FEV1 Response at Day 57
Measure Description	The first time point at which the maximum change in recorded FEV1 data from the corresponding test-day baseline occurred during the 6-hours observation period after drug administration at Day 57
Time Frame	Within the 6-hour post-treatment observation period at Day 57
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set for Pulmonary Function Test Data

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	474	482	468
Time to Peak FEV1 Response at Day 57 [units: Minutes]	60	60	60

No statistical analysis provided for Time to Peak FEV1 Response at Day 57

32. Secondary:

Time to Peak FEV1 Response at Day 85 [ Within the 6-hour post-treatment observation period at Day 85 ]

Measure Type	Secondary
Measure Title	Time to Peak FEV1 Response at Day 85
Measure Description	The first time point at which the maximum change in recorded FEV1 data from the corresponding test-day baseline occurred during the 6-hours observation period after drug administration at Day 85
Time Frame	Within the 6-hour post-treatment observation period at Day 85
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set for Pulmonary Function Test Data

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	474	482	468
Time to Peak FEV1 Response at Day 85 [units: Minutes]	60	60	60

No statistical analysis provided for Time to Peak FEV1 Response at Day 85

33. Secondary:

FVC AUC0-6 at Day 1 [ Before drug administration to 6 hours after drug administration at Day 1 ]

Measure Type	Secondary
Measure Title	FVC AUC0-6 at Day 1
Measure Description	Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 1
Time Frame	Before drug administration to 6 hours after drug administration at Day 1
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set for Pulmonary Function Test Data

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	474	482	468
FVC AUC0-6 at Day 1 [units: liters] Least Squares Mean ± Standard Error	0.337 ± 0.015	0.354 ± 0.015	0.25 ± 0.016

Statistical Analysis 1 for FVC AUC0-6 at Day 1

Groups ^[1]	COMBIVENT Respimat 20/100 Mcg vs. COMBIVENT CFC-MDI 36/206 Mcg
Non-Inferiority/Equivalence Test ^[2]	Yes
Method ^[3]	ANCOVA
P Value ^[4]	0.417
Mean Difference (Final Values) ^[5]	-0.017
Standard Error of the mean	± 0.021
95% Confidence Interval	( -0.058 to 0.024 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	This analysis is purely exploratory. Non-inferiority margin is not established.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

34. Secondary:

FVC AUC0-6 at Day 29 [ Before drug administration to 6 hours after drug administration at Day 29 ]

Measure Type	Secondary
Measure Title	FVC AUC0-6 at Day 29
Measure Description	Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 29
Time Frame	Before drug administration to 6 hours after drug administration at Day 29
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set for Pulmonary Function Test Data

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	474	482	468
FVC AUC0-6 at Day 29 [units: liters] Least Squares Mean ± Standard Error	0.3 ± 0.015	0.319 ± 0.015	0.246 ± 0.015

Statistical Analysis 1 for FVC AUC0-6 at Day 29

Groups ^[1]	COMBIVENT Respimat 20/100 Mcg vs. COMBIVENT CFC-MDI 36/206 Mcg
Non-Inferiority/Equivalence Test ^[2]	Yes
Method ^[3]	ANCOVA
P Value ^[4]	0.3505
Mean Difference (Final Values) ^[5]	-0.019
Standard Error of the mean	± 0.02
95% Confidence Interval	( -0.059 to 0.021 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	This analysis is purely exploratory. Non-inferiority margin is not established.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

35. Secondary:

FVC AUC0-6 at Day 57 [ Before drug administration to 6 hours after drug administration on Day 57 ]

Measure Type	Secondary
Measure Title	FVC AUC0-6 at Day 57
Measure Description	Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 57
Time Frame	Before drug administration to 6 hours after drug administration on Day 57
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set for Pulmonary Function Test Data

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	474	482	468
FVC AUC0-6 at Day 57 [units: liters] Least Squares Mean ± Standard Error	0.284 ± 0.015	0.303 ± 0.015	0.22 ± 0.015

Statistical Analysis 1 for FVC AUC0-6 at Day 57

Groups ^[1]	COMBIVENT Respimat 20/100 Mcg vs. COMBIVENT CFC-MDI 36/206 Mcg
Non-Inferiority/Equivalence Test ^[2]	Yes
Method ^[3]	ANCOVA
P Value ^[4]	0.3499
Mean Difference (Final Values) ^[5]	-0.019
Standard Error of the mean	± 0.02
95% Confidence Interval	( -0.058 to 0.021 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	This analysis is purely exploratory. Non-inferiority margin is not established.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

36. Secondary:

FVC AUC0-6 at Day 85 [ Before drug administration to 6 hours after drug administration on Day 85 ]

Measure Type	Secondary
Measure Title	FVC AUC0-6 at Day 85
Measure Description	Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 85
Time Frame	Before drug administration to 6 hours after drug administration on Day 85
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set for Pulmonary Function Test Data

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	474	482	468
FVC AUC0-6 at Day 85 [units: liters] Least Squares Mean ± Standard Error	0.279 ± 0.015	0.283 ± 0.015	0.219 ± 0.015

Statistical Analysis 1 for FVC AUC0-6 at Day 85

Groups ^[1]	COMBIVENT Respimat 20/100 Mcg vs. COMBIVENT CFC-MDI 36/206 Mcg
Non-Inferiority/Equivalence Test ^[2]	Yes
Method ^[3]	ANCOVA
P Value ^[4]	0.8288
Mean Difference (Final Values) ^[5]	-0.004
Standard Error of the mean	± 0.02
95% Confidence Interval	( -0.044 to 0.035 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	This analysis is purely exploratory. Non-inferiority margin is not established.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

37. Secondary:

FVC AUC0-4 at Day 1 [ Before drug administration to 4 hours after drug administration on Day 1 ]

Measure Type	Secondary
Measure Title	FVC AUC0-4 at Day 1
Measure Description	Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 1
Time Frame	Before drug administration to 4 hours after drug administration on Day 1
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set for Pulmonary Function Test Data

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	474	482	468
FVC AUC0-4 at Day 1 [units: liters] Least Squares Mean ± Standard Error	0.408 ± 0.016	0.422 ± 0.016	0.297 ± 0.016

Statistical Analysis 1 for FVC AUC0-4 at Day 1

Groups ^[1]	COMBIVENT Respimat 20/100 Mcg vs. Ipratropium Respimat 20 Mcg
Method ^[2]	ANCOVA
P Value ^[3]	< 0.0001
Mean Difference (Final Values) ^[4]	0.112
Standard Error of the mean	± 0.022
95% Confidence Interval	( 0.069 to 0.154 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis is purely exploratory.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

38. Secondary:

FVC AUC0-4 at Day 29 [ Before drug administration to 4 hours after drug administration on Day 29 ]

Measure Type	Secondary
Measure Title	FVC AUC0-4 at Day 29
Measure Description	Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 29
Time Frame	Before drug administration to 4 hours after drug administration on Day 29
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set for Pulmonary Function Test Data

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	474	482	468
FVC AUC0-4 at Day 29 [units: liters] Least Squares Mean ± Standard Error	0.381 ± 0.015	0.388 ± 0.015	0.291 ± 0.016

Statistical Analysis 1 for FVC AUC0-4 at Day 29

Groups ^[1]	COMBIVENT Respimat 20/100 Mcg vs. Ipratropium Respimat 20 Mcg
Method ^[2]	ANCOVA
P Value ^[3]	< 0.0001
Mean Difference (Final Values) ^[4]	0.09
Standard Error of the mean	± 0.021
95% Confidence Interval	( 0.049 to 0.132 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis is purely exploratory.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

39. Secondary:

FVC AUC0-4 at Day 57 [ Before drug administration to 4 hours after drug administration on Day 57 ]

Measure Type	Secondary
Measure Title	FVC AUC0-4 at Day 57
Measure Description	Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 57
Time Frame	Before drug administration to 4 hours after drug administration on Day 57
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set for Pulmonary Function Test Data

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	474	482	468
FVC AUC0-4 at Day 57 [units: liters] Least Squares Mean ± Standard Error	0.361 ± 0.015	0.380 ± 0.015	0.264 ± 0.015

Statistical Analysis 1 for FVC AUC0-4 at Day 57

Groups ^[1]	COMBIVENT Respimat 20/100 Mcg vs. Ipratropium Respimat 20 Mcg
Method ^[2]	ANCOVA
P Value ^[3]	< 0.0001
Mean Difference (Final Values) ^[4]	0.097
Standard Error of the mean	± 0.021
95% Confidence Interval	( 0.056 to 0.138 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis is purely exploratory.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

40. Secondary:

FVC AUC0-4 at Day 85 [ Before drug administration to 4 hours after drug administration on Day 85 ]

Measure Type	Secondary
Measure Title	FVC AUC0-4 at Day 85
Measure Description	Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 85
Time Frame	Before drug administration to 4 hours after drug administration on Day 85
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set for Pulmonary Function Test Data

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	474	482	468
FVC AUC0-4 at Day 85 [units: liters] Least Squares Mean ± Standard Error	0.359 ± 0.015	0.359 ± 0.015	0.265 ± 0.015

Statistical Analysis 1 for FVC AUC0-4 at Day 85

Groups ^[1]	COMBIVENT Respimat 20/100 Mcg vs. Ipratropium Respimat 20 Mcg
Method ^[2]	ANCOVA
P Value ^[3]	< 0.0001
Mean Difference (Final Values) ^[4]	0.094
Standard Error of the mean	± 0.021
95% Confidence Interval	( 0.054 to 0.135 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis is purely exploratory.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

41. Secondary:

FVC AUC4-6 at Day 1 [ Between 4 hours and 6 hours after drug administration on Day 1 ]

Measure Type	Secondary
Measure Title	FVC AUC4-6 at Day 1
Measure Description	Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 1
Time Frame	Between 4 hours and 6 hours after drug administration on Day 1
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set for Pulmonary Function Test Data 4-6 hours

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	447	449	427
FVC AUC4-6 at Day 1 [units: liters] Least Squares Mean ± Standard Error	0.2 ± 0.017	0.221 ± 0.017	0.156 ± 0.018

Statistical Analysis 1 for FVC AUC4-6 at Day 1

Groups ^[1]	COMBIVENT Respimat 20/100 Mcg vs. Ipratropium Respimat 20 Mcg
Non-Inferiority/Equivalence Test ^[2]	Yes
Method ^[3]	ANCOVA
P Value ^[4]	0.0688
Mean Difference (Final Values) ^[5]	0.043
Standard Error of the mean	± 0.024
95% Confidence Interval	( -0.003 to 0.09 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	This analysis is purely exploratory. Non-inferiority margin is not established.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

42. Secondary:

FVC AUC4-6 at Day 29 [ Between 4 hours and 6 hours after drug administration on Day 29 ]

Measure Type	Secondary
Measure Title	FVC AUC4-6 at Day 29
Measure Description	Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 29
Time Frame	Between 4 hours and 6 hours after drug administration on Day 29
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set for Pulmonary Function Test Data 4-6 hours

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	447	449	427
FVC AUC4-6 at Day 29 [units: liters] Least Squares Mean ± Standard Error	0.137 ± 0.017	0.180 ± 0.017	0.156 ± 0.017

Statistical Analysis 1 for FVC AUC4-6 at Day 29

Groups ^[1]	COMBIVENT Respimat 20/100 Mcg vs. Ipratropium Respimat 20 Mcg
Non-Inferiority/Equivalence Test ^[2]	Yes
Method ^[3]	ANCOVA
P Value ^[4]	0.3895
Mean Difference (Final Values) ^[5]	-0.02
Standard Error of the mean	± 0.023
95% Confidence Interval	( -0.064 to 0.025 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	This analysis is purely exploratory. Non-inferiority margin is not established.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

43. Secondary:

FVC AUC4-6 at Day 57 [ Between 4 hours and 6 hours after drug administration on Day 57 ]

Measure Type	Secondary
Measure Title	FVC AUC4-6 at Day 57
Measure Description	Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 57
Time Frame	Between 4 hours and 6 hours after drug administration on Day 57
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set for Pulmonary Function Test Data 4-6 hours

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	447	449	427
FVC AUC4-6 at Day 57 [units: liters] Least Squares Mean ± Standard Error	0.128 ± 0.016	0.147 ± 0.016	0.13 ± 0.017

Statistical Analysis 1 for FVC AUC4-6 at Day 57

Groups ^[1]	COMBIVENT Respimat 20/100 Mcg vs. Ipratropium Respimat 20 Mcg
Non-Inferiority/Equivalence Test ^[2]	Yes
Method ^[3]	ANCOVA
P Value ^[4]	0.959
Mean Difference (Final Values) ^[5]	-0.001
Standard Error of the mean	± 0.022
95% Confidence Interval	( -0.045 to 0.042 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	This analysis is purely exploratory. Non-inferiority margin is not established.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

44. Secondary:

FVC AUC4-6 at Day 85 [ Between 4 hours and 6 hours after drug administration on Day 85 ]

Measure Type	Secondary
Measure Title	FVC AUC4-6 at Day 85
Measure Description	Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 85
Time Frame	Between 4 hours and 6 hours after drug administration on Day 85
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set for Pulmonary Function Test Data 4-6 hours

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	447	449	427
FVC AUC4-6 at Day 85 [units: liters] Least Squares Mean ± Standard Error	0.117 ± 0.017	0.130 ± 0.017	0.124 ± 0.017

Statistical Analysis 1 for FVC AUC4-6 at Day 85

Groups ^[1]	COMBIVENT Respimat 20/100 Mcg vs. Ipratropium Respimat 20 Mcg
Non-Inferiority/Equivalence Test ^[2]	Yes
Method ^[3]	ANCOVA
P Value ^[4]	0.7652
Mean Difference (Final Values) ^[5]	-0.007
Standard Error of the mean	± 0.023
95% Confidence Interval	( -0.053 to 0.039 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	This analysis is purely exploratory. Non-inferiority margin is not established.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

45. Secondary:

Peak FVC Response at Day 1 [ Within the first 2-hour post-treatment interval at Day 1 ]

Measure Type	Secondary
Measure Title	Peak FVC Response at Day 1
Measure Description	Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 1
Time Frame	Within the first 2-hour post-treatment interval at Day 1
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set for Pulmonary Function Test Data

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	474	482	468
Peak FVC Response at Day 1 [units: liters] Least Squares Mean ± Standard Error	0.6 ± 0.017	0.612 ± 0.017	0.479 ± 0.017

Statistical Analysis 1 for Peak FVC Response at Day 1

Groups ^[1]	COMBIVENT Respimat 20/100 Mcg vs. COMBIVENT CFC-MDI 36/206 Mcg
Non-Inferiority/Equivalence Test ^[2]	Yes
Method ^[3]	ANCOVA
P Value ^[4]	0.6244
Mean Difference (Final Values) ^[5]	-0.011
Standard Error of the mean	± 0.023
95% Confidence Interval	( -0.057 to 0.034 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	This analysis is purely exploratory. Non-inferiority margin is not established.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

46. Secondary:

Peak FVC Response at Day 29 [ Within the first 2-hour post-treatment interval at Day 29 ]

Measure Type	Secondary
Measure Title	Peak FVC Response at Day 29
Measure Description	Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 29
Time Frame	Within the first 2-hour post-treatment interval at Day 29
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set for Pulmonary Function Test Data

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	474	482	468
Peak FVC Response at Day 29 [units: liters] Least Squares Mean ± Standard Error	0.594 ± 0.017	0.591 ± 0.017	0.465 ± 0.017

Statistical Analysis 1 for Peak FVC Response at Day 29

Groups ^[1]	COMBIVENT Respimat 20/100 Mcg vs. COMBIVENT CFC-MDI 36/206 Mcg
Non-Inferiority/Equivalence Test ^[2]	Yes
Method ^[3]	ANCOVA
P Value ^[4]	0.873
Mean Difference (Final Values) ^[5]	0.004
Standard Error of the mean	± 0.023
95% Confidence Interval	( -0.041 to 0.049 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	This analysis is purely exploratory. Non-inferiority margin is not established.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

47. Secondary:

Peak FVC Response at Day 57 [ Within the first 2-hour post-treatment interval at Day 57 ]

Measure Type	Secondary
Measure Title	Peak FVC Response at Day 57
Measure Description	Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 57
Time Frame	Within the first 2-hour post-treatment interval at Day 57
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set for Pulmonary Function Test Data

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	474	482	468
Peak FVC Response at Day 57 [units: liters] Least Squares Mean ± Standard Error	0.562 ± 0.017	0.577 ± 0.017	0.445 ± 0.017

Statistical Analysis 1 for Peak FVC Response at Day 57

Groups ^[1]	COMBIVENT Respimat 20/100 Mcg vs. COMBIVENT CFC-MDI 36/206 Mcg
Non-Inferiority/Equivalence Test ^[2]	Yes
Method ^[3]	ANCOVA
P Value ^[4]	0.5294
Mean Difference (Final Values) ^[5]	-0.015
Standard Error of the mean	± 0.023
95% Confidence Interval	( -0.06 to 0.031 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	This analysis is purely exploratory. Non-inferiority margin is not established.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

48. Secondary:

Peak FVC Response at Day 85 [ Within the first 2-hour post-treatment interval at Day 85 ]

Measure Type	Secondary
Measure Title	Peak FVC Response at Day 85
Measure Description	Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 85
Time Frame	Within the first 2-hour post-treatment interval at Day 85
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set for Pulmonary Function Test Data

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	474	482	468
Peak FVC Response at Day 85 [units: liters] Least Squares Mean ± Standard Error	0.575 ± 0.017	0.562 ± 0.017	0.449 ± 0.017

Statistical Analysis 1 for Peak FVC Response at Day 85

Groups ^[1]	COMBIVENT Respimat 20/100 Mcg vs. COMBIVENT CFC-MDI 36/206 Mcg
Non-Inferiority/Equivalence Test ^[2]	Yes
Method ^[3]	ANCOVA
P Value ^[4]	0.563
Mean Difference (Final Values) ^[5]	0.013
Standard Error of the mean	± 0.023
95% Confidence Interval	( -0.032 to 0.058 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	This analysis is purely exploratory. Non-inferiority margin is not established.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

49. Secondary:

Peak FVC Response at Day 1 [ Within the first 2-hour post-treatment interval at Day 1 ]

Measure Type	Secondary
Measure Title	Peak FVC Response at Day 1
Measure Description	Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 1
Time Frame	Within the first 2-hour post-treatment interval at Day 1
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set for Pulmonary Function Test Data

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	474	482	468
Peak FVC Response at Day 1 [units: liters] Least Squares Mean ± Standard Error	0.6 ± 0.017	0.612 ± 0.017	0.479 ± 0.017

Statistical Analysis 1 for Peak FVC Response at Day 1

Groups ^[1]	COMBIVENT Respimat 20/100 Mcg vs. Ipratropium Respimat 20 Mcg
Method ^[2]	ANCOVA
P Value ^[3]	< 0.0001
Mean Difference (Final Values) ^[4]	0.121
Standard Error of the mean	± 0.024
95% Confidence Interval	( 0.075 to 0.167 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis is purely exploratory.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

50. Secondary:

Peak FVC Response at Day 29 [ Within the first 2-hour post-treatment interval at Day 29 ]

Measure Type	Secondary
Measure Title	Peak FVC Response at Day 29
Measure Description	Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 29
Time Frame	Within the first 2-hour post-treatment interval at Day 29
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set for Pulmonary Function Test Data

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	474	482	468
Peak FVC Response at Day 29 [units: liters] Least Squares Mean ± Standard Error	0.594 ± 0.017	0.591 ± 0.017	0.465 ± 0.017

Statistical Analysis 1 for Peak FVC Response at Day 29

Groups ^[1]	COMBIVENT Respimat 20/100 Mcg vs. Ipratropium Respimat 20 Mcg
Method ^[2]	ANCOVA
P Value ^[3]	< 0.0001
Mean Difference (Final Values) ^[4]	0.129
Standard Error of the mean	± 0.023
95% Confidence Interval	( 0.084 to 0.174 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis is purely exploratory.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

51. Secondary:

Peak FVC Response at Day 57 [ Within the first 2-hour post-treatment interval at Day 57 ]

Measure Type	Secondary
Measure Title	Peak FVC Response at Day 57
Measure Description	Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 57
Time Frame	Within the first 2-hour post-treatment interval at Day 57
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set for Pulmonary Function Test Data

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	474	482	468
Peak FVC Response at Day 57 [units: liters] Least Squares Mean ± Standard Error	0.562 ± 0.017	0.577 ± 0.017	0.445 ± 0.017

Statistical Analysis 1 for Peak FVC Response at Day 57

Groups ^[1]	COMBIVENT Respimat 20/100 Mcg vs. Ipratropium Respimat 20 Mcg
Method ^[2]	ANCOVA
P Value ^[3]	< 0.0001
Mean Difference (Final Values) ^[4]	0.118
Standard Error of the mean	± 0.023
95% Confidence Interval	( 0.072 to 0.163 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis is purely exploratory.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

52. Secondary:

Peak FVC Response at Day 85 [ Within the first 2-hour post-treatment interval at Day 85 ]

Measure Type	Secondary
Measure Title	Peak FVC Response at Day 85
Measure Description	Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 85
Time Frame	Within the first 2-hour post-treatment interval at Day 85
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set for Pulmonary Function Test Data

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	474	482	468
Peak FVC Response at Day 85 [units: liters] Least Squares Mean ± Standard Error	0.575 ± 0.017	0.562 ± 0.017	0.449 ± 0.017

Statistical Analysis 1 for Peak FVC Response at Day 85

Groups ^[1]	COMBIVENT Respimat 20/100 Mcg vs. Ipratropium Respimat 20 Mcg
Method ^[2]	ANCOVA
P Value ^[3]	< 0.0001
Mean Difference (Final Values) ^[4]	0.126
Standard Error of the mean	± 0.023
95% Confidence Interval	( 0.081 to 0.171 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis is purely exploratory.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

53. Secondary:

Rescue Medication Use on Pulmonary Test Day 1 [ During the 6-hour pulmonary function testing after drug administration on Day 1 ]

Measure Type	Secondary
Measure Title	Rescue Medication Use on Pulmonary Test Day 1
Measure Description	Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 1
Time Frame	During the 6-hour pulmonary function testing after drug administration on Day 1
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated Set

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	486	491	483
Rescue Medication Use on Pulmonary Test Day 1 [units: patients]	8	9	7

No statistical analysis provided for Rescue Medication Use on Pulmonary Test Day 1

54. Secondary:

Rescue Medication Use on Pulmonary Test Day 29 [ During the 6-hour pulmonary function testing after drug administration on Day 29 ]

Measure Type	Secondary
Measure Title	Rescue Medication Use on Pulmonary Test Day 29
Measure Description	Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 29
Time Frame	During the 6-hour pulmonary function testing after drug administration on Day 29
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated Set

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	486	491	483
Rescue Medication Use on Pulmonary Test Day 29 [units: patients]	10	7	7

No statistical analysis provided for Rescue Medication Use on Pulmonary Test Day 29

55. Secondary:

Rescue Medication Use on Pulmonary Test Day 57 [ During the 6-hour pulmonary function testing after drug administration on Day 57 ]

Measure Type	Secondary
Measure Title	Rescue Medication Use on Pulmonary Test Day 57
Measure Description	Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 57
Time Frame	During the 6-hour pulmonary function testing after drug administration on Day 57
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated Set

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	486	491	483
Rescue Medication Use on Pulmonary Test Day 57 [units: patients]	7	7	6

No statistical analysis provided for Rescue Medication Use on Pulmonary Test Day 57

56. Secondary:

Rescue Medication Use on Pulmonary Test Day 85 [ During the 6-hour pulmonary function testing after drug administration on Day 85 ]

Measure Type	Secondary
Measure Title	Rescue Medication Use on Pulmonary Test Day 85
Measure Description	Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 85
Time Frame	During the 6-hour pulmonary function testing after drug administration on Day 85
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated Set

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	486	491	483
Rescue Medication Use on Pulmonary Test Day 85 [units: patients]	5	7	10

No statistical analysis provided for Rescue Medication Use on Pulmonary Test Day 85

57. Secondary:

Night-time Rescue Medication Use [ During the 2-week baseline washout period and the 12-week treatment period ]

Measure Type	Secondary
Measure Title	Night-time Rescue Medication Use
Measure Description	The mean number of puffs of rescue medication used during the night-time per week during the entire study (including baseline and on-treatment period)
Time Frame	During the 2-week baseline washout period and the 12-week treatment period
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set for Diary Data

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	471	467	454
Night-time Rescue Medication Use [units: puffs] Least Squares Mean ± Standard Error	0.977 ± 0.047	0.977 ± 0.047	0.997 ± 0.048

Statistical Analysis 1 for Night-time Rescue Medication Use

Groups ^[1]	COMBIVENT Respimat 20/100 Mcg vs. COMBIVENT CFC-MDI 36/206 Mcg
Non-Inferiority/Equivalence Test ^[2]	Yes
Method ^[3]	ANCOVA
P Value ^[4]	0.9943
Mean Difference (Final Values) ^[5]	-0.00045
Standard Error of the mean	± 0.06396
95% Confidence Interval	( -0.1259 to 0.125 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	This analysis is purely exploratory. Non-inferiority margin is not established.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

58. Secondary:

Night-time Rescue Medication Use [ During the 2-week baseline washout period and the 12-week treatment period ]

Measure Type	Secondary
Measure Title	Night-time Rescue Medication Use
Measure Description	The mean number of puffs of rescue medication used during the night-time per week during the entire study (including baseline and on-treatment period)
Time Frame	During the 2-week baseline washout period and the 12-week treatment period
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set for Diary Data

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	471	467	454
Night-time Rescue Medication Use [units: puffs] Least Squares Mean ± Standard Error	0.977 ± 0.047	0.977 ± 0.047	0.997 ± 0.048

Statistical Analysis 1 for Night-time Rescue Medication Use

Groups ^[1]	COMBIVENT Respimat 20/100 Mcg vs. Ipratropium Respimat 20 Mcg
Method ^[2]	ANCOVA
P Value ^[3]	0.7569
Mean Difference (Final Values) ^[4]	-0.01995
Standard Error of the mean	± 0.06441
95% Confidence Interval	( -0.1463 to 0.1064 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis is purely exploratory.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

59. Secondary:

Daytime Rescue Medication Use [ During the 2-week baseline washout period and the 12-week treatment period ]

Measure Type	Secondary
Measure Title	Daytime Rescue Medication Use
Measure Description	The mean number of puffs of rescue medication used during the daytime per week during the entire study (including baseline and on-treatment period)
Time Frame	During the 2-week baseline washout period and the 12-week treatment period
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set for Diary Data

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	453	458	438
Daytime Rescue Medication Use [units: puffs] Least Squares Mean ± Standard Error	2.3 ± 0.089	2.191 ± 0.089	2.456 ± 0.09

Statistical Analysis 1 for Daytime Rescue Medication Use

Groups ^[1]	COMBIVENT Respimat 20/100 Mcg vs. COMBIVENT CFC-MDI 36/206 Mcg
Non-Inferiority/Equivalence Test ^[2]	Yes
Method ^[3]	ANCOVA
P Value ^[4]	0.3659
Mean Difference (Final Values) ^[5]	0.1091
Standard Error of the mean	± 0.1206
95% Confidence Interval	( -0.1276 to 0.3458 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	This analysis is purely exploratory. Non-inferiority margin is not established.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

60. Secondary:

Daytime Rescue Medication Use [ During the 2-week baseline washout period and the 12-week treatment period ]

Measure Type	Secondary
Measure Title	Daytime Rescue Medication Use
Measure Description	The mean number of puffs of rescue medication used during the daytime per week during the entire study (including baseline and on-treatment period)
Time Frame	During the 2-week baseline washout period and the 12-week treatment period
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set for Diary Data

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	453	458	438
Daytime Rescue Medication Use [units: puffs] Least Squares Mean ± Standard Error	2.3 ± 0.089	2.191 ± 0.089	2.456 ± 0.09

Statistical Analysis 1 for Daytime Rescue Medication Use

Groups ^[1]	COMBIVENT Respimat 20/100 Mcg vs. Ipratropium Respimat 20 Mcg
Method ^[2]	ANCOVA
P Value ^[3]	0.203
Mean Difference (Final Values) ^[4]	-0.1554
Standard Error of the mean	± 0.122
95% Confidence Interval	( -0.3947 to 0.08395 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis is purely exploratory.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

61. Secondary:

Night-time Symptom Score [ During the 2-week baseline washout period and the 12-week treatment period ]

Measure Type	Secondary
Measure Title	Night-time Symptom Score
Measure Description	The weekly mean night-time symptom score per week during the entire study (including baseline and on-treatment period)
Time Frame	During the 2-week baseline washout period and the 12-week treatment period
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set for Diary Data

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	471	467	454
Night-time Symptom Score [units: unit] Least Squares Mean ± Standard Error	0.922 ± 0.023	0.914 ± 0.024	0.857 ± 0.024

Statistical Analysis 1 for Night-time Symptom Score

Groups ^[1]	COMBIVENT Respimat 20/100 Mcg vs. COMBIVENT CFC-MDI 36/206 Mcg
Non-Inferiority/Equivalence Test ^[2]	Yes
Method ^[3]	ANCOVA
P Value ^[4]	0.809
Mean Difference (Final Values) ^[5]	0.007734
Standard Error of the mean	± 0.03199
95% Confidence Interval	( -0.05503 to 0.0705 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	This analysis is purely exploratory. Non-inferiority margin is not established.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

62. Secondary:

Night-time Symptom Score [ During the 2-week baseline washout period and the 12-week treatment period ]

Measure Type	Secondary
Measure Title	Night-time Symptom Score
Measure Description	The weekly mean night-time symptom score per week during the entire study (including baseline and on-treatment period)
Time Frame	During the 2-week baseline washout period and the 12-week treatment period
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set for Diary Data

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	471	467	454
Night-time Symptom Score [units: unit] Least Squares Mean ± Standard Error	0.922 ± 0.023	0.914 ± 0.024	0.857 ± 0.024

Statistical Analysis 1 for Night-time Symptom Score

Groups ^[1]	COMBIVENT Respimat 20/100 Mcg vs. Ipratropium Respimat 20 Mcg
Method ^[2]	ANCOVA
P Value ^[3]	0.044
Mean Difference (Final Values) ^[4]	0.06501
Standard Error of the mean	± 0.03225
95% Confidence Interval	( 0.001746 to 0.1283 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis is purely exploratory.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

63. Secondary:

Daytime Symptom Score [ During the 2-week baseline washout period and the 12-week treatment period ]

Measure Type	Secondary
Measure Title	Daytime Symptom Score
Measure Description	The weekly mean daytime symptom score per week during the entire study (including baseline and on-treatment period)
Time Frame	During the 2-week baseline washout period and the 12-week treatment period
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set for Diary Data

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	452	456	437
Daytime Symptom Score [units: unit] Least Squares Mean ± Standard Error	1.015 ± 0.022	1.002 ± 0.022	0.999 ± 0.022

Statistical Analysis 1 for Daytime Symptom Score

Groups ^[1]	COMBIVENT Respimat 20/100 Mcg vs. COMBIVENT CFC-MDI 36/206 Mcg
Non-Inferiority/Equivalence Test ^[2]	Yes
Method ^[3]	ANCOVA
P Value ^[4]	0.6674
Mean Difference (Final Values) ^[5]	0.0129
Standard Error of the mean	± 0.03002
95% Confidence Interval	( -0.04598 to 0.07179 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	This analysis is purely exploratory. Non-inferiority margin is not established.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

64. Secondary:

Daytime Symptom Score [ During the 2-week baseline washout period and the 12-week treatment period ]

Measure Type	Secondary
Measure Title	Daytime Symptom Score
Measure Description	The weekly mean daytime symptom score per week during the entire study (including baseline and on-treatment period)
Time Frame	During the 2-week baseline washout period and the 12-week treatment period
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set for Diary Data

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	452	456	437
Daytime Symptom Score [units: unit] Least Squares Mean ± Standard Error	1.015 ± 0.022	1.002 ± 0.022	0.999 ± 0.022

Statistical Analysis 1 for Daytime Symptom Score

Groups ^[1]	COMBIVENT Respimat 20/100 Mcg vs. Ipratropium Respimat 20 Mcg
Method ^[2]	ANCOVA
P Value ^[3]	0.604
Mean Difference (Final Values) ^[4]	0.01573
Standard Error of the mean	± 0.03033
95% Confidence Interval	( -0.04376 to 0.07523 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis is purely exploratory.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

65. Secondary:

Trough Peak Expiratory Flow Rate (PEFR) [ During the 2-week baseline washout period and the 12-week treatment period and PEFR taken before administration of study medication ]

Measure Type	Secondary
Measure Title	Trough Peak Expiratory Flow Rate (PEFR)
Measure Description	The weekly mean trough PEFR during the entire study (including baseline and on-treatment period)
Time Frame	During the 2-week baseline washout period and the 12-week treatment period and PEFR taken before administration of study medication
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set for Diary Data

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	441	444	426
Trough Peak Expiratory Flow Rate (PEFR) [units: liters/min] Least Squares Mean ± Standard Error	191.95 ± 1.51	190.290 ± 1.526	189.51 ± 1.551

Statistical Analysis 1 for Trough Peak Expiratory Flow Rate (PEFR)

Groups ^[1]	COMBIVENT Respimat 20/100 Mcg vs. COMBIVENT CFC-MDI 36/206 Mcg
Non-Inferiority/Equivalence Test ^[2]	Yes
Method ^[3]	ANCOVA
P Value ^[4]	0.4238
Mean Difference (Final Values) ^[5]	1.6526
Standard Error of the mean	± 2.0653
95% Confidence Interval	( -2.3995 to 5.7047 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	This analysis is purely exploratory. Non-inferiority margin is not established.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

66. Secondary:

Trough PEFR [ During the 2-week baseline washout period and the 12-week treatment period and PEFR taken before administration of study medication ]

Measure Type	Secondary
Measure Title	Trough PEFR
Measure Description	The weekly mean trough PEFR during the entire study (including baseline and on-treatment period)
Time Frame	During the 2-week baseline washout period and the 12-week treatment period and PEFR taken before administration of study medication
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set for Diary Data

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	441	444	426
Trough PEFR [units: liters/min] Least Squares Mean ± Standard Error	191.95 ± 1.51	190.290 ± 1.526	189.51 ± 1.551

Statistical Analysis 1 for Trough PEFR

Groups ^[1]	COMBIVENT Respimat 20/100 Mcg vs. Ipratropium Respimat 20 Mcg
Method ^[2]	ANCOVA
P Value ^[3]	0.2431
Mean Difference (Final Values) ^[4]	2.4376
Standard Error of the mean	± 2.0874
95% Confidence Interval	( -1.6578 to 6.533 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis is purely exploratory.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

67. Secondary:

Physician's Global Evaluation Score on Pulmonary Function Testing Day 29 [ Prior to pulmonary function test on Day 29 ]

Measure Type	Secondary
Measure Title	Physician's Global Evaluation Score on Pulmonary Function Testing Day 29
Measure Description	Physician's Global Evaluation score is based on the need for concomitant medication, number and severity of exacerbations since the last visit, severity of cough, ability to exercise, amount of wheezing, etc.
Time Frame	Prior to pulmonary function test on Day 29
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated Set

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	480	487	481
Physician's Global Evaluation Score on Pulmonary Function Testing Day 29 [units: score] Least Squares Mean ± Standard Error	4.936 ± 0.041	4.859 ± 0.041	4.99 ± 0.041

Statistical Analysis 1 for Physician's Global Evaluation Score on Pulmonary Function Testing Day 29

Groups ^[1]	COMBIVENT Respimat 20/100 Mcg vs. COMBIVENT CFC-MDI 36/206 Mcg
Non-Inferiority/Equivalence Test ^[2]	Yes
Method ^[3]	ANCOVA
P Value ^[4]	0.173
Mean Difference (Final Values) ^[5]	0.077
Standard Error of the mean	± 0.056
95% Confidence Interval	( -0.034 to 0.187 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	This analysis is purely exploratory. Non-inferiority margin is not established.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

68. Secondary:

Physician's Global Evaluation Score on Pulmonary Function Testing Day 57 [ Prior to pulmonary function test on Day 57 ]

Measure Type	Secondary
Measure Title	Physician's Global Evaluation Score on Pulmonary Function Testing Day 57
Measure Description	Physician's Global Evaluation score is based on the need for concomitant medication, number and severity of exacerbations since the last visit, severity of cough, ability to exercise, amount of wheezing, etc.
Time Frame	Prior to pulmonary function test on Day 57
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated Set

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	480	487	481
Physician's Global Evaluation Score on Pulmonary Function Testing Day 57 [units: score] Least Squares Mean ± Standard Error	4.971 ± 0.045	4.965 ± 0.045	5.04 ± 0.046

Statistical Analysis 1 for Physician's Global Evaluation Score on Pulmonary Function Testing Day 57

Groups ^[1]	COMBIVENT Respimat 20/100 Mcg vs. COMBIVENT CFC-MDI 36/206 Mcg
Non-Inferiority/Equivalence Test ^[2]	Yes
Method ^[3]	ANCOVA
P Value ^[4]	0.924
Mean Difference (Final Values) ^[5]	0.006
Standard Error of the mean	± 0.062
95% Confidence Interval	( -0.115 to 0.127 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	This analysis is purely exploratory. Non-inferiority margin is not established.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

69. Secondary:

Physician's Global Evaluation Score on Pulmonary Function Testing Day 85 [ Prior to pulmonary function test on Day 85 ]

Measure Type	Secondary
Measure Title	Physician's Global Evaluation Score on Pulmonary Function Testing Day 85
Measure Description	Physician's Global Evaluation score is based on the need for concomitant medication, number and severity of exacerbations since the last visit, severity of cough, ability to exercise, amount of wheezing, etc.
Time Frame	Prior to pulmonary function test on Day 85
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated Set

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	480	487	481
Physician's Global Evaluation Score on Pulmonary Function Testing Day 85 [units: score] Least Squares Mean ± Standard Error	5.115 ± 0.048	5.018 ± 0.048	5.097 ± 0.048

Statistical Analysis 1 for Physician's Global Evaluation Score on Pulmonary Function Testing Day 85

Groups ^[1]	COMBIVENT Respimat 20/100 Mcg vs. COMBIVENT CFC-MDI 36/206 Mcg
Non-Inferiority/Equivalence Test ^[2]	Yes
Method ^[3]	ANCOVA
P Value ^[4]	0.139
Mean Difference (Final Values) ^[5]	0.097
Standard Error of the mean	± 0.065
95% Confidence Interval	( -0.031 to 0.225 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	This analysis is purely exploratory. Non-inferiority margin is not established.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

70. Secondary:

Physician's Global Evaluation Score on Pulmonary Function Testing Day 29 [ Prior to pulmonary function test on Day 29 ]

Measure Type	Secondary
Measure Title	Physician's Global Evaluation Score on Pulmonary Function Testing Day 29
Measure Description	Physician's Global Evaluation score is based on the need for concomitant medication, number and severity of exacerbations since the last visit, severity of cough, ability to exercise, amount of wheezing, etc.
Time Frame	Prior to pulmonary function test on Day 29
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated Set

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	480	487	481
Physician's Global Evaluation Score on Pulmonary Function Testing Day 29 [units: score] Least Squares Mean ± Standard Error	4.936 ± 0.041	4.859 ± 0.041	4.99 ± 0.041

Statistical Analysis 1 for Physician's Global Evaluation Score on Pulmonary Function Testing Day 29

Groups ^[1]	COMBIVENT Respimat 20/100 Mcg vs. Ipratropium Respimat 20 Mcg
Method ^[2]	ANCOVA
P Value ^[3]	0.336
Mean Difference (Final Values) ^[4]	-0.054
Standard Error of the mean	± 0.056
95% Confidence Interval	( -0.165 to 0.056 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis is purely exploratory.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

71. Secondary:

Physician's Global Evaluation Score on Pulmonary Function Testing Day 57 [ Prior to pulmonary function test on Day 57 ]

Measure Type	Secondary
Measure Title	Physician's Global Evaluation Score on Pulmonary Function Testing Day 57
Measure Description	Physician's Global Evaluation score is based on the need for concomitant medication, number and severity of exacerbations since the last visit, severity of cough, ability to exercise, amount of wheezing, etc.
Time Frame	Prior to pulmonary function test on Day 57
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated Set

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	480	487	481
Physician's Global Evaluation Score on Pulmonary Function Testing Day 57 [units: score] Least Squares Mean ± Standard Error	4.971 ± 0.045	4.965 ± 0.045	5.04 ± 0.046

Statistical Analysis 1 for Physician's Global Evaluation Score on Pulmonary Function Testing Day 57

Groups ^[1]	COMBIVENT Respimat 20/100 Mcg vs. Ipratropium Respimat 20 Mcg
Method ^[2]	ANCOVA
P Value ^[3]	0.266
Mean Difference (Final Values) ^[4]	-0.069
Standard Error of the mean	± 0.062
95% Confidence Interval	( -0.19 to 0.053 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis is purely exploratory.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

72. Secondary:

Physician's Global Evaluation Score on Pulmonary Function Testing Day 85 [ Prior to pulmonary function test on Day 85 ]

Measure Type	Secondary
Measure Title	Physician's Global Evaluation Score on Pulmonary Function Testing Day 85
Measure Description	Physician's Global Evaluation score is based on the need for concomitant medication, number and severity of exacerbations since the last visit, severity of cough, ability to exercise, amount of wheezing, etc.
Time Frame	Prior to pulmonary function test on Day 85
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated Set

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	480	487	481
Physician's Global Evaluation Score on Pulmonary Function Testing Day 85 [units: score] Least Squares Mean ± Standard Error	5.115 ± 0.048	5.018 ± 0.048	5.097 ± 0.048

Statistical Analysis 1 for Physician's Global Evaluation Score on Pulmonary Function Testing Day 85

Groups ^[1]	COMBIVENT Respimat 20/100 Mcg vs. Ipratropium Respimat 20 Mcg
Method ^[2]	ANCOVA
P Value ^[3]	0.788
Mean Difference (Final Values) ^[4]	0.018
Standard Error of the mean	± 0.066
95% Confidence Interval	( -0.111 to 0.146 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis is purely exploratory.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

73. Secondary:

Chronic Obstructive Pulmonary Disease (COPD) Excerbation During the On-treatment Period [ During the 12-week on-treatment period ]

Measure Type	Secondary
Measure Title	Chronic Obstructive Pulmonary Disease (COPD) Excerbation During the On-treatment Period
Measure Description	COPD excerbation is defined as an increase or new onset of more than one of the following respiratory symptoms (cough, sputum, sputum purulence, wheezing, dyspnea, and chest tightness) having a duration of three or more days requiring treatment with an antibiotic and/or systemic steroids with or without hospital admission.
Time Frame	During the 12-week on-treatment period
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated Set

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	486	491	483
Chronic Obstructive Pulmonary Disease (COPD) Excerbation During the On-treatment Period [units: Percentage of patients]	14.81	13.03	10.35

No statistical analysis provided for Chronic Obstructive Pulmonary Disease (COPD) Excerbation During the On-treatment Period

74. Secondary:

COPD Excerbation During the On-treatment Period [ During the 12-week on-treatment period ]

Measure Type	Secondary
Measure Title	COPD Excerbation During the On-treatment Period
Measure Description	COPD excerbation is defined as an increase or new onset of more than one of the following respiratory symptoms (cough, sputum, sputum purulence, wheezing, dyspnea, and chest tightness) having a duration of three or more days requiring treatment with an antibiotic and/or systemic steroids with or without hospital admission.
Time Frame	During the 12-week on-treatment period
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated Set

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	486	491	483
COPD Excerbation During the On-treatment Period [units: Mean COPD exacerbation rate/patient year]	0.76	0.69	0.53

No statistical analysis provided for COPD Excerbation During the On-treatment Period

75. Secondary:

COPD Excerbation During the On-treatment Period [ During the 12-week on-treatment period ]

Measure Type	Secondary
Measure Title	COPD Excerbation During the On-treatment Period
Measure Description	COPD excerbation is defined as an increase or new onset of more than one of the following respiratory symptoms (cough, sputum, sputum purulence, wheezing, dyspnea, and chest tightness) having a duration of three or more days requiring treatment with an antibiotic and/or systemic steroids with or without hospital admission.
Time Frame	During the 12-week on-treatment period
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated Set

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Measured Values

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Number of Participants Analyzed [units: participants]	486	491	483
COPD Excerbation During the On-treatment Period [units: Percentage of patients]	3.27	2.93	2.13

No statistical analysis provided for COPD Excerbation During the On-treatment Period

Responsible Party:	Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers:	1012.56
Study First Received:	November 15, 2006
Results First Received:	April 3, 2009
Last Updated:	July 13, 2009
ClinicalTrials.gov Identifier:	NCT00400153 History of Changes
Health Authority:	Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow; Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine); New Zealand: Multicentre Ethics Committee/Medsafe; United States: Food and Drug Administration; France: AFSSAPS; Greece: National Organization for Medicines (EOF) National Ethics Committee; Argentina: A.N.M.A.T. (Administración Nacional de Medicamentos, Alimentos y Tecnología); Taiwan: Department of Health, Executive Yuan, Taiwan; Korea, Republic of: Korea Food and Drug Administration; Turkey: Ministry of Health Central Ethics Committee; Great Britain: MHRA; South Africa: MCC (Medicines Control Council)