A Trial Comparing Treatment With Tiotropium Inhalation Capsules to Combivent Inhalation Aerosol in COPD Patients. - Study Results

Study Type:	Interventional
Study Design:	Parallel Assignment
Condition:	Pulmonary Disease, Chronic Obstructive
Interventions:	Drug: tiotropium Drug: Combivent (Ipratropium/Albuterol)

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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	Tiotropium	Combivent (Ipratropium/Albuterol)
STARTED	173	176
COMPLETED	150	159
NOT COMPLETED	23	17
Adverse Event	11	10
Lack of Efficacy	1	2
Lost to Follow-up	3	2
Withdrawal by Subject	4	1
Protocol Violation	4	2

	Tiotropium	Combivent (Ipratropium/Albuterol)	Total
Number of Participants [units: participants]	173	176	349
Age [units: years] Mean ± Standard Deviation	64.7 ± 7.7	65.4 ± 8	65.1 ± 7.8
Gender [units: participants]
Female	20	13	33
Male	153	163	316

Measure Type	Primary
Measure Title	Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second) at 12 Weeks
Measure Description	Trough FEV1 is measured 10 minutes before drug administration
Time Frame	Baseline and 12 Weeks
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	152	158
Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second) at 12 Weeks [units: Liters] Least Squares Mean ± Standard Error	0.081 ± 0.018	-0.025 ± 0.018

No statistical analysis provided for Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second) at 12 Weeks

Measure Type	Primary
Measure Title	Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) at 12 Weeks
Measure Description	Average hourly FEV1 AUC0-6 minus baseline FEV1
Time Frame	Baseline and 12 Weeks
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	152	158
Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) at 12 Weeks [units: Liters] Least Squares Mean ± Standard Error	0.187 ± 0.019	0.167 ± 0.018

Statistical Analysis 1 for Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) at 12 Weeks

Groups ^[1]	All groups
Non-Inferiority/Equivalence Test ^[2]	Yes
Method ^[3]	ANCOVA
P Value ^[4]	0.0042
Mean Difference (Final Values) ^[5]	0.02
95% Confidence Interval	( -0.032 to 0.072 )

[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 = 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.

Measure Type	Secondary
Measure Title	Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second) at 6 Weeks
Measure Description	Trough FEV1 is measured 10 minutes before drug administration
Time Frame	Baseline and 6 Weeks
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	152	158
Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second) at 6 Weeks [units: Liters] Least Squares Mean ± Standard Error	0.11 ± 0.017	-0.036 ± 0.017

Statistical Analysis 1 for Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second) at 6 Weeks

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0001
Mean Difference (Final Values) ^[4]	0.145
95% Confidence Interval	( 0.098 to 0.193 )

[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.

Measure Type	Secondary
Measure Title	Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) on Day 1
Measure Description	Average hourly FEV1 AUC0-6 minus baseline FEV1
Time Frame	Day 1 (after first dose)
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	152	158
Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) on Day 1 [units: Liters] Least Squares Mean ± Standard Error	0.132 ± 0.012	0.211 ± 0.012

Statistical Analysis 1 for Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) on Day 1

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0001
Mean Difference (Final Values) ^[4]	-0.08
95% Confidence Interval	( -0.114 to -0.046 )

[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.

Measure Type	Secondary
Measure Title	Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) at Week 6
Measure Description	Average hourly FEV1 AUC0-6 minus baseline FEV1
Time Frame	Baseline and week 6
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	152	158
Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) at Week 6 [units: Liters] Least Squares Mean ± Standard Error	0.207 ± 0.019	0.153 ± 0.018

Statistical Analysis 1 for Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) at Week 6

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0447
Mean Difference (Final Values) ^[4]	0.054
95% Confidence Interval	( 0.001 to 0.106 )

[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.

Measure Type	Secondary
Measure Title	Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) on Day 1
Measure Description	Peak FEV1 is defined as the maximum FEV1 observed in the first three hours after dose of study medication
Time Frame	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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	152	158
Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) on Day 1 [units: Liters] Least Squares Mean ± Standard Error	0.232 ± 0.014	0.364 ± 0.014

Statistical Analysis 1 for Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) on Day 1

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0001
Mean Difference (Final Values) ^[4]	-0.131
95% Confidence Interval	( -0.171 to -0.092 )

[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.

Measure Type	Secondary
Measure Title	Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) at Week 6
Measure Description	Peak FEV1 is defined as the maximum FEV1 observed in the first three hours after dose of study medication
Time Frame	Baseline and 6 weeks
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	152	158
Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) at Week 6 [units: Liters] Least Squares Mean ± Standard Error	0.204 ± 0.014	0.356 ± 0.013

Statistical Analysis 1 for Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) at Week 6

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0001
Mean Difference (Final Values) ^[4]	-0.152
95% Confidence Interval	( -0.19 to -0.113 )

[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.

Measure Type	Secondary
Measure Title	Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) at Week 12
Measure Description	Peak FEV1 is defined as the maximum FEV1 observed in the first three hours after dose of study medication
Time Frame	Baseline and 12 weeks
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	152	158
Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) at Week 12 [units: Liters] Least Squares Mean ± Standard Error	0.209 ± 0.015	0.342 ± 0.015

Statistical Analysis 1 for Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) at Week 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0001
Mean Difference (Final Values) ^[4]	-0.133
95% Confidence Interval	( -0.175 to -0.091 )

[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.

Measure Type	Secondary
Measure Title	Change From Baseline in Trough FVC (Forced Vital Capacity) at 12 Weeks
Measure Description	Trough FVC is measured 10 minutes before drug administration
Time Frame	Baseline and 12 weeks
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	152	158
Change From Baseline in Trough FVC (Forced Vital Capacity) at 12 Weeks [units: Liters] Least Squares Mean ± Standard Error	0.225 ± 0.039	0.051 ± 0.038

Statistical Analysis 1 for Change From Baseline in Trough FVC (Forced Vital Capacity) at 12 Weeks

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0015
Mean Difference (Final Values) ^[4]	0.175
95% Confidence Interval	( 0.067 to 0.283 )

[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.

Measure Type	Secondary
Measure Title	Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) at 12 Weeks
Measure Description	Average hourly FVC AUC0-6 minus baseline FVC
Time Frame	Baseline and 12 Weeks
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	152	158
Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) at 12 Weeks [units: Liters] Least Squares Mean ± Standard Error	0.443 ± 0.037	0.432 ± 0.036

Statistical Analysis 1 for Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) at 12 Weeks

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.835
Mean Difference (Final Values) ^[4]	0.011
95% Confidence Interval	( -0.092 to 0.114 )

[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.

Measure Type	Secondary
Measure Title	Change From Baseline in Trough FVC (Forced Vital Capacity) at 6 Weeks
Measure Description	Trough FVC is measured 10 minutes before drug administration
Time Frame	Baseline and 6 weeks
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	152	158
Change From Baseline in Trough FVC (Forced Vital Capacity) at 6 Weeks [units: Liters] Least Squares Mean ± Standard Error	0.258 ± 0.036	-0.02 ± 0.035

Statistical Analysis 1 for Change From Baseline in Trough FVC (Forced Vital Capacity) at 6 Weeks

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0001
Mean Difference (Final Values) ^[4]	0.278
95% Confidence Interval	( 0.178 to 0.379 )

[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.

Measure Type	Secondary
Measure Title	Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) on Day 1
Measure Description	Average hourly FVC AUC0-6 minus baseline FVC
Time Frame	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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	152	158
Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) on Day 1 [units: Liters] Least Squares Mean ± Standard Error	0.327 ± 0.028	0.484 ± 0.028

Statistical Analysis 1 for Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) on Day 1

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0001
Mean Difference (Final Values) ^[4]	-0.157
95% Confidence Interval	( -0.236 to -0.078 )

[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.

Measure Type	Secondary
Measure Title	Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) at 6 Weeks
Measure Description	Average hourly FVC AUC0-6 minus baseline FVC
Time Frame	Baseline and 6 Weeks
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	152	158
Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) at 6 Weeks [units: Liters] Least Squares Mean ± Standard Error	0.464 ± 0.035	0.425 ± 0.035

Statistical Analysis 1 for Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) at 6 Weeks

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.4386
Mean Difference (Final Values) ^[4]	0.039
95% Confidence Interval	( -0.059 to 0.137 )

[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.

Measure Type	Secondary
Measure Title	Change From Baseline in Peak FVC (Forced Vital Capacity) on Day 1
Measure Description	Peak FVC is defined as the maximum FVC observed in the first three hours after dose of study medication
Time Frame	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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	152	158
Change From Baseline in Peak FVC (Forced Vital Capacity) on Day 1 [units: Liters] Least Squares Mean ± Standard Error	0.542 ± 0.033	0.824 ± 0.032

Statistical Analysis 1 for Change From Baseline in Peak FVC (Forced Vital Capacity) on Day 1

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0001
Mean Difference (Final Values) ^[4]	-0.282
95% Confidence Interval	( -0.374 to -0.191 )

[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.

Measure Type	Secondary
Measure Title	Change From Baseline in Peak FVC (Forced Vital Capacity) at Week 6
Measure Description	Peak FVC is defined as the maximum FVC observed in the first three hours after dose of study medication
Time Frame	baseline and 6 Weeks (after first dose)
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	152	158
Change From Baseline in Peak FVC (Forced Vital Capacity) at Week 6 [units: Liters] Least Squares Mean ± Standard Error	0.43 ± 0.031	0.791 ± 0.031

Statistical Analysis 1 for Change From Baseline in Peak FVC (Forced Vital Capacity) at Week 6

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0001
Mean Difference (Final Values) ^[4]	-0.361
95% Confidence Interval	( -0.449 to -0.274 )

[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.

Measure Type	Secondary
Measure Title	Change From Baseline in Peak FVC (Forced Vital Capacity) at Week 12
Measure Description	Peak FVC is defined as the maximum FVC observed in the first three hours after dose of study medication
Time Frame	Baseline and 12 Weeks
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	152	158
Change From Baseline in Peak FVC (Forced Vital Capacity) at Week 12 [units: Liters] Least Squares Mean ± Standard Error	0.418 ± 0.032	0.703 ± 0.032

Statistical Analysis 1 for Change From Baseline in Peak FVC (Forced Vital Capacity) at Week 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0001
Mean Difference (Final Values) ^[4]	-0.286
95% Confidence Interval	( -0.375 to -0.196 )

[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.

Measure Type	Secondary
Measure Title	FEV1 at 15 Minutes on Day 1
Measure Description	No text entered.
Time Frame	15 minutes
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	152	158
FEV1 at 15 Minutes on Day 1 [units: Liters] Least Squares Mean ± Standard Error	1.214 ± 0.012	1.389 ± 0.011

Statistical Analysis 1 for FEV1 at 15 Minutes on Day 1

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0001
Mean Difference (Final Values) ^[4]	-0.175
95% Confidence Interval	( -0.207 to -0.142 )

[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.

Measure Type	Secondary
Measure Title	FEV1 at 30 Minutes on Day 1
Measure Description	No text entered.
Time Frame	30 minutes
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	152	158
FEV1 at 30 Minutes on Day 1 [units: Liters] Least Squares Mean ± Standard Error	1.261 ± 0.013	1.429 ± 0.013

Statistical Analysis 1 for FEV1 at 30 Minutes on Day 1

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0001
Mean Difference (Final Values) ^[4]	-0.168
95% Confidence Interval	( -0.205 to -0.131 )

[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.

Measure Type	Secondary
Measure Title	FEV1 at 1 Hour on Day 1
Measure Description	No text entered.
Time Frame	1 hour
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	152	158
FEV1 at 1 Hour on Day 1 [units: Liters] Least Squares Mean ± Standard Error	1.272 ± 0.014	1.455 ± 0.014

Statistical Analysis 1 for FEV1 at 1 Hour on Day 1

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0001
Mean Difference (Final Values) ^[4]	-0.182
95% Confidence Interval	( -0.221 to -0.143 )

[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.

Measure Type	Secondary
Measure Title	FEV1 at 2 Hours on Day 1
Measure Description	No text entered.
Time Frame	2 hour
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	152	158
FEV1 at 2 Hours on Day 1 [units: Least Squares Mean] Least Squares Mean ± Standard Error	1.293 ± 0.014	1.43 ± 0.014

Statistical Analysis 1 for FEV1 at 2 Hours on Day 1

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0001
Mean Difference (Final Values) ^[4]	-0.136
95% Confidence Interval	( -0.175 to -0.097 )

[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.

Measure Type	Secondary
Measure Title	FEV1 at 3 Hours on Day 1
Measure Description	No text entered.
Time Frame	3 hour
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	152	158
FEV1 at 3 Hours on Day 1 [units: Liters] Least Squares Mean ± Standard Error	1.29 ± 0.015	1.375 ± 0.014

Statistical Analysis 1 for FEV1 at 3 Hours on Day 1

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0001
Mean Difference (Final Values) ^[4]	-0.084
95% Confidence Interval	( -0.125 to -0.044 )

[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.

Measure Type	Secondary
Measure Title	FEV1 at 4 Hours on Day 1
Measure Description	No text entered.
Time Frame	4 hour
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	152	158
FEV1 at 4 Hours on Day 1 [units: Liters] Least Squares Mean ± Standard Error	1.284 ± 0.015	1.319 ± 0.015

Statistical Analysis 1 for FEV1 at 4 Hours on Day 1

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0997
Mean Difference (Final Values) ^[4]	-0.035
95% Confidence Interval	( -0.076 to 0.007 )

[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.

Measure Type	Secondary
Measure Title	FEV1 at 6 Hours on Day 1
Measure Description	No text entered.
Time Frame	6 hours
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	152	158
FEV1 at 6 Hours on Day 1 [units: Liters] Least Squares Mean ± Standard Error	1.269 ± 0.016	1.233 ± 0.015

Statistical Analysis 1 for FEV1 at 6 Hours on Day 1

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.101
Mean Difference (Final Values) ^[4]	0.037
95% Confidence Interval	( -0.007 to 0.08 )

[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.

Measure Type	Secondary
Measure Title	FEV1 at -10 Minutes at Week 6
Measure Description	No text entered.
Time Frame	10 minutes before dosing
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	152	158
FEV1 at -10 Minutes at Week 6 [units: Liters] Least Squares Mean ± Standard Error	1.254 ± 0.017	1.108 ± 0.017

Statistical Analysis 1 for FEV1 at -10 Minutes at Week 6

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0001
Mean Difference (Final Values) ^[4]	0.145
95% Confidence Interval	( 0.098 to 0.193 )

[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.

Measure Type	Secondary
Measure Title	FEV1 at 15 Minutes at Week 6
Measure Description	No text entered.
Time Frame	15 minutes
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	152	158
FEV1 at 15 Minutes at Week 6 [units: Liters] Least Squares Mean ± Standard Error	1.3 ± 0.019	1.355 ± 0.019

Statistical Analysis 1 for FEV1 at 15 Minutes at Week 6

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0411
Mean Difference (Final Values) ^[4]	-0.055
95% Confidence Interval	( -0.108 to -0.002 )

[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.

Measure Type	Secondary
Measure Title	FEV1 at 30 Minutes at Week 6
Measure Description	No text entered.
Time Frame	30 minutes
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	152	158
FEV1 at 30 Minutes at Week 6 [units: Liters] Least Squares Mean ± Standard Error	1.328 ± 0.02	1.388 ± 0.02

Statistical Analysis 1 for FEV1 at 30 Minutes at Week 6

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0354
Mean Difference (Final Values) ^[4]	-0.06
95% Confidence Interval	( -0.116 to -0.004 )

[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.

Measure Type	Secondary
Measure Title	FEV1 at 1 Hour at Week 6
Measure Description	No text entered.
Time Frame	1 hour
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	152	158
FEV1 at 1 Hour at Week 6 [units: Liters] Least Squares Mean ± Standard Error	1.343 ± 0.021	1.405 ± 0.021

Statistical Analysis 1 for FEV1 at 1 Hour at Week 6

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.041
Mean Difference (Final Values) ^[4]	-0.062
95% Confidence Interval	( -0.121 to -0.003 )

[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.

Measure Type	Secondary
Measure Title	FEV1 at 2 Hours at Week 6
Measure Description	No text entered.
Time Frame	2 hour
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	152	158
FEV1 at 2 Hours at Week 6 [units: Liters] Least Squares Mean ± Standard Error	1.364 ± 0.021	1.382 ± 0.02

Statistical Analysis 1 for FEV1 at 2 Hours at Week 6

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.5387
Mean Difference (Final Values) ^[4]	0.018
95% Confidence Interval	( -0.076 to 0.04 )

[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.

Measure Type	Secondary
Measure Title	FEV1 at 3 Hours at Week 6
Measure Description	No text entered.
Time Frame	3 hour
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	152	158
FEV1 at 3 Hours at Week 6 [units: Liters] Least Squares Mean ± Standard Error	1.371 ± 0.021	1.31 ± 0.02

Statistical Analysis 1 for FEV1 at 3 Hours at Week 6

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0372
Mean Difference (Final Values) ^[4]	0.061
95% Confidence Interval	( 0.004 to 0.118 )

[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.

Measure Type	Secondary
Measure Title	FEV1 at 4 Hours at Week 6
Measure Description	No text entered.
Time Frame	4 hour
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	152	158
FEV1 at 4 Hours at Week 6 [units: Liters] Least Squares Mean ± Standard Error	1.369 ± 0.02	1.247 ± 0.02

Statistical Analysis 1 for FEV1 at 4 Hours at Week 6

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0001
Mean Difference (Final Values) ^[4]	0.121
95% Confidence Interval	( 0.066 to 0.177 )

[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.

Measure Type	Secondary
Measure Title	FEV1 at 6 Hours at Week 6
Measure Description	No text entered.
Time Frame	6 hour
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	152	158
FEV1 at 6 Hours at Week 6 [units: Liters] Least Squares Mean ± Standard Error	1.33 ± 0.019	1.168 ± 0.019

Statistical Analysis 1 for FEV1 at 6 Hours at Week 6

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0001
Mean Difference (Final Values) ^[4]	0.162
95% Confidence Interval	( 0.108 to 0.216 )

[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.

Measure Type	Secondary
Measure Title	FEV1 at -10 Minutes at Week 12
Measure Description	No text entered.
Time Frame	10 minutes before dosing
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	152	158
FEV1 at -10 Minutes at Week 12 [units: Liters] Least Squares Mean ± Standard Error	1.225 ± 0.018	1.119 ± 0.018

Statistical Analysis 1 for FEV1 at -10 Minutes at Week 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0001
Mean Difference (Final Values) ^[4]	0.106
95% Confidence Interval	( 0.055 to 0.157 )

[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.

Measure Type	Secondary
Measure Title	FEV1 at 15 Minutes at Week 12
Measure Description	No text entered.
Time Frame	15 minutes
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	152	158
FEV1 at 15 Minutes at Week 12 [units: Liters] Least Squares Mean ± Standard Error	1.268 ± 0.019	1.351 ± 0.019

Statistical Analysis 1 for FEV1 at 15 Minutes at Week 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0023
Mean Difference (Final Values) ^[4]	-0.083
95% Confidence Interval	( -0.136 to -0.03 )

[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.

Measure Type	Secondary
Measure Title	FEV1 at 30 Minutes at Week 12
Measure Description	No text entered.
Time Frame	30 minutes
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	152	158
FEV1 at 30 Minutes at Week 12 [units: Liters] Least Squares Mean ± Standard Error	1.306 ± 0.02	1.393 ± 0.019

Statistical Analysis 1 for FEV1 at 30 Minutes at Week 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0019
Mean Difference (Final Values) ^[4]	-0.087
95% Confidence Interval	( -0.142 to -0.033 )

[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.

Measure Type	Secondary
Measure Title	FEV1 at 1 Hour at Week 12
Measure Description	No text entered.
Time Frame	1 hour
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	152	158
FEV1 at 1 Hour at Week 12 [units: Liters] Least Squares Mean ± Standard Error	1.327 ± 0.02	1.41 ± 0.02

Statistical Analysis 1 for FEV1 at 1 Hour at Week 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0044
Mean Difference (Final Values) ^[4]	-0.083
95% Confidence Interval	( -0.139 to -0.026 )

[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.

Measure Type	Secondary
Measure Title	FEV1 at 2 Hours at Week 12
Measure Description	No text entered.
Time Frame	2 hour
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	152	158
FEV1 at 2 Hours at Week 12 [units: Liters] Least Squares Mean ± Standard Error	1.353 ± 0.021	1.398 ± 0.02

Statistical Analysis 1 for FEV1 at 2 Hours at Week 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.1182
Mean Difference (Final Values) ^[4]	-0.046
95% Confidence Interval	( -0.103 to 0.012 )

[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.

Measure Type	Secondary
Measure Title	FEV1 at 3 Hours at Week 12
Measure Description	No text entered.
Time Frame	3 hour
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	152	158
FEV1 at 3 Hours at Week 12 [units: Liters] Least Squares Mean ± Standard Error	1.353 ± 0.021	1.333 ± 0.02

Statistical Analysis 1 for FEV1 at 3 Hours at Week 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.4814
Mean Difference (Final Values) ^[4]	0.02
95% Confidence Interval	( -0.037 to 0.078 )

[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.

Measure Type	Secondary
Measure Title	FEV1 at 4 Hours at Week 12
Measure Description	No text entered.
Time Frame	4 hour
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	152	158
FEV1 at 4 Hours at Week 12 [units: Liters] Least Squares Mean ± Standard Error	1.337 ± 0.02	1.263 ± 0.019

Statistical Analysis 1 for FEV1 at 4 Hours at Week 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.008
Mean Difference (Final Values) ^[4]	0.074
95% Confidence Interval	( 0.019 to 0.129 )

[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.

Measure Type	Secondary
Measure Title	FEV1 at 6 Hours at Week 12
Measure Description	No text entered.
Time Frame	6 hour
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	152	158
FEV1 at 6 Hours at Week 12 [units: Liters] Least Squares Mean ± Standard Error	1.318 ± 0.019	1.182 ± 0.019

Statistical Analysis 1 for FEV1 at 6 Hours at Week 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0001
Mean Difference (Final Values) ^[4]	0.136
95% Confidence Interval	( 0.082 to 0.19 )

[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.

Measure Type	Secondary
Measure Title	FVC at 15 Minutes on Day 1
Measure Description	No text entered.
Time Frame	15 minutes
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	152	158
FVC at 15 Minutes on Day 1 [units: Liters] Least Squares Mean ± Standard Error	2.938 ± 0.036	3.308 ± 0.035

Statistical Analysis 1 for FVC at 15 Minutes on Day 1

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0001
Mean Difference (Final Values) ^[4]	-0.37
95% Confidence Interval	( -0.449 to -0.29 )

[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.

Measure Type	Secondary
Measure Title	FVC at 30 Minutes on Day 1
Measure Description	No text entered.
Time Frame	30 minutes
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	152	158
FVC at 30 Minutes on Day 1 [units: Liters] Least Squares Mean ± Standard Error	3.044 ± 0.03	3.4 ± 0.03

Statistical Analysis 1 for FVC at 30 Minutes on Day 1

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0001
Mean Difference (Final Values) ^[4]	-0.356
95% Confidence Interval	( -0.44 to -0.272 )

[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.

Measure Type	Secondary
Measure Title	FVC at 1 Hour on Day 1
Measure Description	No text entered.
Time Frame	1 hour
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	152	158
FVC at 1 Hour on Day 1 [units: Liters] Least Squares Mean ± Standard Error	3.087 ± 0.033	3.444 ± 0.033

Statistical Analysis 1 for FVC at 1 Hour on Day 1

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0001
Mean Difference (Final Values) ^[4]	-0.357
95% Confidence Interval	( -0.451 to -0.264 )

[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.

Measure Type	Secondary
Measure Title	FVC at 2 Hours on Day 1
Measure Description	No text entered.
Time Frame	2 hour
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	152	158
FVC at 2 Hours on Day 1 [units: Liters] Least Squares Mean ± Standard Error	3.103 ± 0.033	3.388 ± 0.032

Statistical Analysis 1 for FVC at 2 Hours on Day 1

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0001
Mean Difference (Final Values) ^[4]	-0.285
95% Confidence Interval	( -0.376 to -0.194 )

[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.

Measure Type	Secondary
Measure Title	FVC at 3 Hours on Day 1
Measure Description	No text entered.
Time Frame	3 hour
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	152	158
FVC at 3 Hours on Day 1 [units: Liters] Least Squares Mean ± Standard Error	3.091 ± 0.033	3.261 ± 0.032

Statistical Analysis 1 for FVC at 3 Hours on Day 1

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0003
Mean Difference (Final Values) ^[4]	-0.17
95% Confidence Interval	( -0.261 to -0.079 )

[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.

Measure Type	Secondary
Measure Title	FVC at 4 Hours on Day 1
Measure Description	No text entered.
Time Frame	4 hour
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	152	158
FVC at 4 Hours on Day 1 [units: Liters] Least Squares Mean ± Standard Error	3.087 ± 0.034	3.136 ± 0.033

Statistical Analysis 1 for FVC at 4 Hours on Day 1

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.2992
Mean Difference (Final Values) ^[4]	-0.05
95% Confidence Interval	( -0.143 to 0.044 )

[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.

Measure Type	Secondary
Measure Title	FVC at 6 Hours on Day 1
Measure Description	No text entered.
Time Frame	6 hour
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	152	158
FVC at 6 Hours on Day 1 [units: Liters] Least Squares Mean ± Standard Error	3.053 ± 0.034	2.972 ± 0.034

Statistical Analysis 1 for FVC at 6 Hours on Day 1

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0984
Mean Difference (Final Values) ^[4]	0.081
95% Confidence Interval	( -0.015 to 0.177 )

[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.

Measure Type	Secondary
Measure Title	FVC at -10 Minutes at Week 6
Measure Description	No text entered.
Time Frame	10 minutes before dosing
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	152	158
FVC at -10 Minutes at Week 6 [units: Liters] Least Squares Mean ± Standard Error	3 ± 0.036	2.722 ± 0.035

Statistical Analysis 1 for FVC at -10 Minutes at Week 6

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0001
Mean Difference (Final Values) ^[4]	0.278
95% Confidence Interval	( 0.178 to 0.379 )

[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.

Measure Type	Secondary
Measure Title	FVC at 15 Minutes at Week 6
Measure Description	No text entered.
Time Frame	15 minutes
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	152	158
FVC at 15 Minutes at Week 6 [units: Liters] Least Squares Mean ± Standard Error	3.09 ± 0.037	3.279 ± 0.036

Statistical Analysis 1 for FVC at 15 Minutes at Week 6

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0004
Mean Difference (Final Values) ^[4]	-0.189
95% Confidence Interval	( -0.293 to -0.086 )

[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.

Measure Type	Secondary
Measure Title	FVC at 30 Minutes at Week 6
Measure Description	No text entered.
Time Frame	30 minutes
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	152	158
FVC at 30 Minutes at Week 6 [units: Liters] Least Squares Mean ± Standard Error	3.158 ± 0.039	3.362 ± 0.039

Statistical Analysis 1 for FVC at 30 Minutes at Week 6

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0003
Mean Difference (Final Values) ^[4]	-0.204
95% Confidence Interval	( -0.314 to -0.095 )

[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.

Measure Type	Secondary
Measure Title	FVC at 1 Hour at Week 6
Measure Description	No text entered.
Time Frame	1 hour
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	152	158
FVC at 1 Hour at Week 6 [units: Liters] Least Squares Mean ± Standard Error	3.206 ± 0.04	3.388 ± 0.039

Statistical Analysis 1 for FVC at 1 Hour at Week 6

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.012
Mean Difference (Final Values) ^[4]	-0.1832
95% Confidence Interval	( -0.293 to -0.072 )

[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.

Measure Type	Secondary
Measure Title	FVC at 2 Hours at Week 6
Measure Description	No text entered.
Time Frame	2 hour
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	152	158
FVC at 2 Hours at Week 6 [units: Liters] Least Squares Mean ± Standard Error	3.227 ± 0.039	3.338 ± 0.038

Statistical Analysis 1 for FVC at 2 Hours at Week 6

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.044
Mean Difference (Final Values) ^[4]	-0.097
95% Confidence Interval	( -0.219 to 0.003 )

[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.

Measure Type	Secondary
Measure Title	FVC at 3 Hours at Week 6
Measure Description	No text entered.
Time Frame	3 hour
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	152	158
FVC at 3 Hours at Week 6 [units: Liters] Least Squares Mean ± Standard Error	3.235 ± 0.039	3.185 ± 0.038

Statistical Analysis 1 for FVC at 3 Hours at Week 6

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.3634
Mean Difference (Final Values) ^[4]	0.05
95% Confidence Interval	( -0.058 to 0.158 )

[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.

Measure Type	Secondary
Measure Title	FVC at 4 Hours at Week 6
Measure Description	No text entered.
Time Frame	4 hour
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	152	158
FVC at 4 Hours at Week 6 [units: Liters] Least Squares Mean ± Standard Error	3.23 ± 0.039	3.068 ± 0.038

Statistical Analysis 1 for FVC at 4 Hours at Week 6

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0032
Mean Difference (Final Values) ^[4]	0.163
95% Confidence Interval	( 0.055 to 0.27 )

[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.

Measure Type	Secondary
Measure Title	FVC at 6 Hours at Week 6
Measure Description	No text entered.
Time Frame	6 hour
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	152	158
FVC at 6 Hours at Week 6 [units: Liters] Least Squares Mean ± Standard Error	3.155 ± 0.037	2.914 ± 0.036

Statistical Analysis 1 for FVC at 6 Hours at Week 6

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0001
Mean Difference (Final Values) ^[4]	0.275
95% Confidence Interval	( 0.173 to 0.378 )

[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.

Measure Type	Secondary
Measure Title	FVC at -10 Minutes at Week 12
Measure Description	No text entered.
Time Frame	10 minutes before dosing
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	152	158
FVC at -10 Minutes at Week 12 [units: Liters] Least Squares Mean ± Standard Error	2.967 ± 0.039	2.792 ± 0.038

Statistical Analysis 1 for FVC at -10 Minutes at Week 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0015
Mean Difference (Final Values) ^[4]	0.175
95% Confidence Interval	( 0.067 to 0.283 )

[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.

Measure Type	Secondary
Measure Title	FVC at 15 Minutes at Week 12
Measure Description	No text entered.
Time Frame	15 minutes
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	152	158
FVC at 15 Minutes at Week 12 [units: Liters] Least Squares Mean ± Standard Error	3.069 ± 0.037	3.263 ± 0.036

Statistical Analysis 1 for FVC at 15 Minutes at Week 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0002
Mean Difference (Final Values) ^[4]	-0.193
95% Confidence Interval	( -0.296 to -0.091 )

[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.

Measure Type	Secondary
Measure Title	FVC at 30 Minutes at Week 12
Measure Description	No text entered.
Time Frame	30 minutes
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	152	158
FVC at 30 Minutes at Week 12 [units: Liters] Least Squares Mean ± Standard Error	3.143 ± 0.039	3.358 ± 0.038

Statistical Analysis 1 for FVC at 30 Minutes at Week 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0001
Mean Difference (Final Values) ^[4]	-0.215
95% Confidence Interval	( -0.323 to -0.108 )

[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.

Measure Type	Secondary
Measure Title	FVC at 1 Hour at Week 12
Measure Description	No text entered.
Time Frame	1 hour
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	152	158
FVC at 1 Hour at Week 12 [units: Liters] Least Squares Mean ± Standard Error	3.177 ± 0.04	3.375 ± 0.039

Statistical Analysis 1 for FVC at 1 Hour at Week 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0006
Mean Difference (Final Values) ^[4]	-0.198
95% Confidence Interval	( -0.309 to -0.086 )

[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.

Measure Type	Secondary
Measure Title	FVC at 2 Hours at Week 12
Measure Description	No text entered.
Time Frame	2 hour
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	152	158
FVC at 2 Hours at Week 12 [units: Liters] Least Squares Mean ± Standard Error	3.231 ± 0.04	3.328 ± 0.04

Statistical Analysis 1 for FVC at 2 Hours at Week 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0896
Mean Difference (Final Values) ^[4]	-0.097
95% Confidence Interval	( -0.21 to 0.015 )

[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.

Measure Type	Secondary
Measure Title	FVC at 3 Hours at Week 12
Measure Description	No text entered.
Time Frame	3 hour
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	152	158
FVC at 3 Hours at Week 12 [units: Liters] Least Squares Mean ± Standard Error	3.226 ± 0.04	3.218 ± 0.039

Statistical Analysis 1 for FVC at 3 Hours at Week 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.8937
Mean Difference (Final Values) ^[4]	0.008
95% Confidence Interval	( -0.103 to 0.118 )

[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.

Measure Type	Secondary
Measure Title	FVC at 4 Hours at Week 12
Measure Description	No text entered.
Time Frame	4 hour
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	152	158
FVC at 4 Hours at Week 12 [units: Liters] Least Squares Mean ± Standard Error	3.199 ± 0.04	3.074 ± 0.039

Statistical Analysis 1 for FVC at 4 Hours at Week 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0269
Mean Difference (Final Values) ^[4]	0.125
95% Confidence Interval	( 0.014 to 0.236 )

[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.

Measure Type	Secondary
Measure Title	FVC at 6 Hours at Week 12
Measure Description	No text entered.
Time Frame	6 hour
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	152	158
FVC at 6 Hours at Week 12 [units: Liters] Least Squares Mean ± Standard Error	3.155 ± 0.04	2.932 ± 0.04

Statistical Analysis 1 for FVC at 6 Hours at Week 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0001
Mean Difference (Final Values) ^[4]	0.223
95% Confidence Interval	( 0.111 to 0.335 )

[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.

Measure Type	Secondary
Measure Title	Day Time Albuterol Use During Week 1
Measure Description	Puffs of rescue albuterol used during the day in week 1
Time Frame	Week 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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	151	158
Day Time Albuterol Use During Week 1 [units: Puffs per day] Least Squares Mean ± Standard Error	1.175 ± 0.084	1.217 ± 0.082

Statistical Analysis 1 for Day Time Albuterol Use During Week 1

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.7196
Mean Difference (Final Values) ^[4]	-0.042
95% Confidence Interval	( -0.275 to 0.19 )

[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.

Measure Type	Secondary
Measure Title	Day Time Albuterol Use During Week 2
Measure Description	Puffs of rescue albuterol used during the day in week 2
Time Frame	Week 2
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	151	158
Day Time Albuterol Use During Week 2 [units: Puffs per day] Least Squares Mean ± Standard Error	1.24 ± 0.099	1.309 ± 0.096

Statistical Analysis 1 for Day Time Albuterol Use During Week 2

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.6189
Mean Difference (Final Values) ^[4]	-0.069
95% Confidence Interval	( -0.343 to 0.205 )

[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.

Measure Type	Secondary
Measure Title	Day Time Albuterol Use During Week 3
Measure Description	Puffs of rescue albuterol used during the day in week 3
Time Frame	Week 3
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	151	158
Day Time Albuterol Use During Week 3 [units: Puffs per day] Least Squares Mean ± Standard Error	1.337 ± 0.104	1.41 ± 0.101

Statistical Analysis 1 for Day Time Albuterol Use During Week 3

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.6197
Mean Difference (Final Values) ^[4]	-0.073
95% Confidence Interval	( -0.36 to 0.215 )

[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.

Measure Type	Secondary
Measure Title	Day Time Albuterol Use During Week 4
Measure Description	Puffs of rescue albuterol used during the day in week 4
Time Frame	Week 4
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	151	158
Day Time Albuterol Use During Week 4 [units: Puffs per day] Least Squares Mean ± Standard Error	1.287 ± 0.107	1.399 ± 0.104

Statistical Analysis 1 for Day Time Albuterol Use During Week 4

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.4582
Mean Difference (Final Values) ^[4]	-0.112
95% Confidence Interval	( -0.408 to 0.184 )

[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.

Measure Type	Secondary
Measure Title	Day Time Albuterol Use During Week 5
Measure Description	Puffs of rescue albuterol used during the day in week 5
Time Frame	Week 5
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	151	158
Day Time Albuterol Use During Week 5 [units: Puffs per day] Least Squares Mean ± Standard Error	1.275 ± 0.11	1.345 ± 0.107

Statistical Analysis 1 for Day Time Albuterol Use During Week 5

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.6538
Mean Difference (Final Values) ^[4]	-0.07
95% Confidence Interval	( -0.376 to 0.236 )

[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.

Measure Type	Secondary
Measure Title	Day Time Albuterol Use During Week 6
Measure Description	Puffs of rescue albuterol used during the day in week 6
Time Frame	Week 6
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	151	158
Day Time Albuterol Use During Week 6 [units: Puffs per day] Least Squares Mean ± Standard Error	1.259 ± 0.126	1.405 ± 0.123

Statistical Analysis 1 for Day Time Albuterol Use During Week 6

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.4145
Mean Difference (Final Values) ^[4]	-0.145
95% Confidence Interval	( -0.495 to 0.205 )

[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.

Measure Type	Secondary
Measure Title	Day Time Albuterol Use During Week 7
Measure Description	Puffs of rescue albuterol used during the day in week 7
Time Frame	Week 7
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	151	158
Day Time Albuterol Use During Week 7 [units: Puffs per day] Least Squares Mean ± Standard Error	1.313 ± 0.116	1.398 ± 0.114

Statistical Analysis 1 for Day Time Albuterol Use During Week 7

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.6048
Mean Difference (Final Values) ^[4]	-0.085
95% Confidence Interval	( -0.408 to 0.238 )

[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.

Measure Type	Secondary
Measure Title	Day Time Albuterol Use During Week 8
Measure Description	Puffs of rescue albuterol used during the day in week 8
Time Frame	Week 8
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	151	158
Day Time Albuterol Use During Week 8 [units: Puffs per day] Least Squares Mean ± Standard Error	1.301 ± 0.119	1.471 ± 0.117

Statistical Analysis 1 for Day Time Albuterol Use During Week 8

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.3137
Mean Difference (Final Values) ^[4]	-0.17
95% Confidence Interval	( -0.503 to 0.162 )

[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.

Measure Type	Secondary
Measure Title	Day Time Albuterol Use During Week 9
Measure Description	Puffs of rescue albuterol used during the day in week 9
Time Frame	Week 9
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	151	158
Day Time Albuterol Use During Week 9 [units: Puffs per day] Least Squares Mean ± Standard Error	1.369 ± 0.12	1.43 ± 0.117

Statistical Analysis 1 for Day Time Albuterol Use During Week 9

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.7195
Mean Difference (Final Values) ^[4]	-0.061
95% Confidence Interval	( -0.395 to 0.273 )

[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.

Measure Type	Secondary
Measure Title	Day Time Albuterol Use During Week 10
Measure Description	Puffs of rescue albuterol used during the day in week 10
Time Frame	Week 10
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	151	158
Day Time Albuterol Use During Week 10 [units: Puffs per day] Least Squares Mean ± Standard Error	1.351 ± 0.116	1.394 ± 0.114

Statistical Analysis 1 for Day Time Albuterol Use During Week 10

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.7947
Mean Difference (Final Values) ^[4]	-0.043
95% Confidence Interval	( -0.367 to 0.282 )

[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.

Measure Type	Secondary
Measure Title	Day Time Albuterol Use During Week 11
Measure Description	Puffs of rescue albuterol used during the day in week 11
Time Frame	Week 11
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	151	158
Day Time Albuterol Use During Week 11 [units: Puffs per day] Least Squares Mean ± Standard Error	1.352 ± 0.127	1.445 ± 0.124

Statistical Analysis 1 for Day Time Albuterol Use During Week 11

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.6049
Mean Difference (Final Values) ^[4]	-0.093
95% Confidence Interval	( -0.446 to 0.26 )

[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.

Measure Type	Secondary
Measure Title	Day Time Albuterol Use During Week 12
Measure Description	Puffs of rescue albuterol used during the day in week 12
Time Frame	Week 12
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	151	158
Day Time Albuterol Use During Week 12 [units: Puffs per day] Least Squares Mean ± Standard Error	1.361 ± 0.139	1.409 ± 0.137

Statistical Analysis 1 for Day Time Albuterol Use During Week 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.8109
Mean Difference (Final Values) ^[4]	-0.047
95% Confidence Interval	( -0.437 to 0.342 )

[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.

Measure Type	Secondary
Measure Title	Night Time Albuterol Use During Week 1
Measure Description	No text entered.
Time Frame	Week 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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	143	157
Night Time Albuterol Use During Week 1 [units: Puffs per night] Least Squares Mean ± Standard Error	3.493 ± 0.259	2.966 ± 0.248

Statistical Analysis 1 for Night Time Albuterol Use During Week 1

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.1471
Mean Difference (Final Values) ^[4]	0.527
95% Confidence Interval	( -0.186 to 1.24 )

[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.

Measure Type	Secondary
Measure Title	Night Time Albuterol Use During Week 2
Measure Description	Puffs of rescue albuterol used during the night in week 2
Time Frame	Week 2
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	143	157
Night Time Albuterol Use During Week 2 [units: Puffs per night] Least Squares Mean ± Standard Error	3.269 ± 0.19	3.004 ± 0.182

Statistical Analysis 1 for Night Time Albuterol Use During Week 2

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.3192
Mean Difference (Final Values) ^[4]	0.265
95% Confidence Interval	( -0.258 to 0.788 )

[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.

Measure Type	Secondary
Measure Title	Night Time Albuterol Use During Week 3
Measure Description	Puffs of rescue albuterol used during the night in week 3
Time Frame	Week 3
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	143	157
Night Time Albuterol Use During Week 3 [units: Puffs per night] Least Squares Mean ± Standard Error	3.282 ± 0.187	2.931 ± 0.18

Statistical Analysis 1 for Night Time Albuterol Use During Week 3

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.182
Mean Difference (Final Values) ^[4]	0.351
95% Confidence Interval	( -0.165 to 0.867 )

[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.

Measure Type	Secondary
Measure Title	Night Time Albuterol Use During Week 4
Measure Description	Puffs of rescue albuterol used during the night in week 4
Time Frame	Week 4
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	143	157
Night Time Albuterol Use During Week 4 [units: Puffs per night] Least Squares Mean ± Standard Error	3.285 ± 0.193	2.921 ± 0.184

Statistical Analysis 1 for Night Time Albuterol Use During Week 4

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.1777
Mean Difference (Final Values) ^[4]	0.363
95% Confidence Interval	( -0.166 to 0.893 )

[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.

Measure Type	Secondary
Measure Title	Night Time Albuterol Use During Week 5
Measure Description	Puffs of rescue albuterol used during the night in week 5
Time Frame	Week 5
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	143	157
Night Time Albuterol Use During Week 5 [units: Puffs per night] Least Squares Mean ± Standard Error	3.152 ± 0.194	2.789 ± 0.185

Statistical Analysis 1 for Night Time Albuterol Use During Week 5

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.1805
Mean Difference (Final Values) ^[4]	0.363
95% Confidence Interval	( -0.169 to 0.895 )

[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.

Measure Type	Secondary
Measure Title	Night Time Albuterol Use During Week 6
Measure Description	Puffs of rescue albuterol used during the night in week 6
Time Frame	Week 6
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	143	157
Night Time Albuterol Use During Week 6 [units: Puffs per night] Least Squares Mean ± Standard Error	3.178 ± 0.197	2.806 ± 0.188

Statistical Analysis 1 for Night Time Albuterol Use During Week 6

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.1777
Mean Difference (Final Values) ^[4]	0.372
95% Confidence Interval	( -0.17 to 0.913 )

[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.

Measure Type	Secondary
Measure Title	Night Time Albuterol Use During Week 7
Measure Description	Puffs of rescue albuterol used during the night in week 7
Time Frame	Week 7
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	143	157
Night Time Albuterol Use During Week 7 [units: Puffs per night] Least Squares Mean ± Standard Error	3.156 ± 0.201	2.966 ± 0.193

Statistical Analysis 1 for Night Time Albuterol Use During Week 7

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.5725
Mean Difference (Final Values) ^[4]	0.159
95% Confidence Interval	( -0.395 to 0.714 )

[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.

Measure Type	Secondary
Measure Title	Night Time Albuterol Use During Week 8
Measure Description	Puffs of rescue albuterol used during the night in week 8
Time Frame	Week 8
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	143	157
Night Time Albuterol Use During Week 8 [units: Puffs per night] Least Squares Mean ± Standard Error	3.104 ± 0.207	2.983 ± 0.198

Statistical Analysis 1 for Night Time Albuterol Use During Week 8

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.6765
Mean Difference (Final Values) ^[4]	0.121
95% Confidence Interval	( -0.449 to 0.69 )

[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.

Measure Type	Secondary
Measure Title	Night Time Albuterol Use During Week 9
Measure Description	Puffs of rescue albuterol used during the night in week 9
Time Frame	Week 9
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	143	157
Night Time Albuterol Use During Week 9 [units: Puffs per night] Least Squares Mean ± Standard Error	3.254 ± 0.208	3.006 ± 0.198

Statistical Analysis 1 for Night Time Albuterol Use During Week 9

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.3943
Mean Difference (Final Values) ^[4]	0.247
95% Confidence Interval	( -0.323 to 0.818 )

[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.

Measure Type	Secondary
Measure Title	Night Time Albuterol Use During Week 10
Measure Description	Puffs of rescue albuterol used during the night in week 10
Time Frame	Week 10
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	143	157
Night Time Albuterol Use During Week 10 [units: Puffs per night] Least Squares Mean ± Standard Error	3.199 ± 0.203	2.909 ± 0.196

Statistical Analysis 1 for Night Time Albuterol Use During Week 10

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.3091
Mean Difference (Final Values) ^[4]	0.291
95% Confidence Interval	( -0.271 to 0.852 )

[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.

Measure Type	Secondary
Measure Title	Night Time Albuterol Use During Week 11
Measure Description	Puffs of rescue albuterol used during the night in week 11
Time Frame	Week 11
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	143	157
Night Time Albuterol Use During Week 11 [units: Puffs per night] Least Squares Mean ± Standard Error	3.224 ± 0.214	2.907 ± 0.205

Statistical Analysis 1 for Night Time Albuterol Use During Week 11

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.2911
Mean Difference (Final Values) ^[4]	0.317
95% Confidence Interval	( -0.273 to 0.907 )

[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.

Measure Type	Secondary
Measure Title	Night Time Albuterol Use During Week 12
Measure Description	Puffs of rescue albuterol used during the night in week 12
Time Frame	Week 12
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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	143	157
Night Time Albuterol Use During Week 12 [units: Puffs per night] Least Squares Mean ± Standard Error	3.178 ± 0.238	3.069 ± 0.229

Statistical Analysis 1 for Night Time Albuterol Use During Week 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.7458
Mean Difference (Final Values) ^[4]	0.108
95% Confidence Interval	( -0.549 to 0.766 )

[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.

Measure Type	Secondary
Measure Title	Morning Peak Expiratory Flow Rate (PEFR) at Week 1
Measure Description	No text entered.
Time Frame	Week 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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Reporting Groups

	Description
Tiotropium	18 mcg once daily
Combivent (Ipratropium/Albuterol)	2 actuations 4 times daily

Measured Values

	Tiotropium	Combivent (Ipratropium/Albuterol)
Number of Participants Analyzed [units: participants]	150	157
Morning Peak Expiratory Flow Rate (PEFR) at Week 1 [units: Liters/minute] Least Squares Mean ± Standard Error	205.8 ± 2.1	195.1 ± 2.059

Statistical Analysis 1 for Morning Peak Expiratory Flow Rate (PEFR) at Week 1

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0004
Mean Difference (Final Values) ^[4]	10.698
95% Confidence Interval	( 4.836 to 16.56 )

[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.

Measure Type	Secondary
Measure Title	Morning PEFR at Week 2
Measure Description	Weekly means for morning PEFR
Time Frame	Week 2
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.