Combivent Respimat 1-year Safety Study in Patients With Chronic Obstructive Pulmonary Disease

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Boehringer Ingelheim Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT01019694

First received: November 16, 2009

Last updated: February 13, 2013

Last verified: February 2013

History of Changes

Results First Received: April 5, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Pulmonary Disease, Chronic Obstructive
Interventions:	Drug: Combivent CFC-MDI Drug: Combivent Respimat 20/100 mcg Drug: Atrovent HFA 42 mcg + Albuterol HFA 200 mcg

Participant Flow

Hide Participant Flow

Recruitment Details

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

Pre-Assignment Details

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

Reporting Groups

	Description
Combivent Respimat	ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
Combivent Inhalation Aerosol	ipratropium bromide and albuterol sulfate 36/206 mcg qid
Atrovent + Albuterol Aerosols	ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid

Participant Flow: Overall Study

	Combivent Respimat	Combivent Inhalation Aerosol	Atrovent + Albuterol Aerosols
STARTED	157 ^[1]	156 ^[1]	157 ^[1]
COMPLETED	133	118	110
NOT COMPLETED	24	38	47
Adverse Event	12	16	19
Protocol Violation	2	6	4
Lost to Follow-up	5	3	3
Withdrawal by Subject	4	6	12
Not treated	0	2	3
Other reason (not specified)	1	5	6

[1]	2 pats. in Comb. Inh. Aero. and 3 pats. in Atro+Alb not treated and excluded from the Treated Set

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Combivent Respimat	ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
Combivent Inhalation Aerosol	ipratropium bromide and albuterol sulfate 36/206 mcg qid
Atrovent + Albuterol Aerosols	ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
Total	Total of all reporting groups

Baseline Measures

	Combivent Respimat	Combivent Inhalation Aerosol	Atrovent + Albuterol Aerosols	Total
Number of Participants [units: participants]	157	154	154	465
Age [units: years] Mean ± Standard Deviation	63.0 ± 8.2	62.6 ± 8.9	63.0 ± 9.3	62.9 ± 8.8
Age, Customized [units: participants]
>= 40 to < 65 years	90	91	82	263
>= 65 to < 75 years	51	47	58	156
>= 75 years	16	16	14	46
Gender [units: participants]
Female	65	70	57	192
Male	92	84	97	273
Race/Ethnicity, Customized [units: participants]
American Indian or Alaskan Native	0	0	1	1
Black / African American	9	11	9	29
White	148	143	144	435
Height [units: centimeters] Mean ± Standard Deviation	170.6 ± 9.6	170.6 ± 10.4	171.1 ± 10.4	170.8 ± 10.1
Smoking History [units: participants]
Ex-smoker	83	61	79	223
Currently smokes	74	93	75	242
Smoking History (pack years) [units: pack years] Mean ± Standard Deviation	53.6 ± 24.5	53.6 ± 29.7	55.6 ± 25.4	54.3 ± 26.6
Chronic Obstructive Pulmonary Disease (COPD) Duration [units: years] Mean ± Standard Deviation	8.1 ± 6.7	7.3 ± 6.1	7.5 ± 5.8	7.6 ± 6.2

Outcome Measures

Hide All Outcome Measures

1. Primary:

Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 48 [ Time Frame: 48 weeks ]

Measure Type	Primary
Measure Title	Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 48
Measure Description	Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied).
Time Frame	48 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated Set is defined as all patients who were randomized and received study drug

Reporting Groups

	Description
Combivent Respimat	ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
Combivent Inhalation Aerosol	ipratropium bromide and albuterol sulfate 36/206 mcg qid
Atrovent + Albuterol Aerosols	ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid

Measured Values

	Combivent Respimat	Combivent Inhalation Aerosol	Atrovent + Albuterol Aerosols
Number of Participants Analyzed [units: participants]	134	125	110
Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 48 [units: unit on a scale] Least Squares Mean ± Standard Error	87.9 ± 1.27	78.3 ± 1.31	81.7 ± 1.37

Statistical Analysis 1 for Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 48

Groups ^[1]	Combivent Respimat vs. Combivent Inhalation Aerosol
Method ^[2]	Mixed Models Analysis
P Value ^[3]	< 0.0001
Mean Difference (Final Values) ^[4]	9.6
95% Confidence Interval	( 6.02 to 13.19 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Combivent Inhalation Aerosol
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[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.

Statistical Analysis 2 for Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 48

Groups ^[1]	Combivent Respimat vs. Atrovent + Albuterol Aerosols
Method ^[2]	Mixed Models Analysis
P Value ^[3]	0.0009
Mean Difference (Final Values) ^[4]	6.2
95% Confidence Interval	( 2.57 to 9.91 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[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.

2. Secondary:

Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 3 [ Time Frame: 3 weeks ]

Measure Type	Secondary
Measure Title	Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 3
Measure Description	Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied).
Time Frame	3 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated Set is defined as all patients who were randomized and received study drug

Reporting Groups

	Description
Combivent Respimat	ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
Combivent Inhalation Aerosol	ipratropium bromide and albuterol sulfate 36/206 mcg qid
Atrovent + Albuterol Aerosols	ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid

Measured Values

	Combivent Respimat	Combivent Inhalation Aerosol	Atrovent + Albuterol Aerosols
Number of Participants Analyzed [units: participants]	157	152	153
Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 3 [units: unit on a scale] Least Squares Mean ± Standard Error	84.7 ± 1.07	79.4 ± 1.09	77.3 ± 1.08

Statistical Analysis 1 for Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 3

Groups ^[1]	Combivent Respimat vs. Combivent Inhalation Aerosol
Method ^[2]	Mixed Models Analysis
P Value ^[3]	0.0006
Mean Difference (Final Values) ^[4]	5.3
95% Confidence Interval	( 2.29 to 8.28 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Combivent Inhalation Aerosol
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[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.

Statistical Analysis 2 for Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 3

Groups ^[1]	Combivent Respimat vs. Atrovent + Albuterol Aerosols
Method ^[2]	Mixed Models Analysis
P Value ^[3]	< 0.0001
Mean Difference (Final Values) ^[4]	7.4
95% Confidence Interval	( 4.41 to 10.39 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

3. Secondary:

Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 12 [ Time Frame: 12 weeks ]

Measure Type	Secondary
Measure Title	Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 12
Measure Description	Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied).
Time Frame	12 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated Set is defined as all patients who were randomized and received study drug

Reporting Groups

	Description
Combivent Respimat	ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
Combivent Inhalation Aerosol	ipratropium bromide and albuterol sulfate 36/206 mcg qid
Atrovent + Albuterol Aerosols	ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid

Measured Values

	Combivent Respimat	Combivent Inhalation Aerosol	Atrovent + Albuterol Aerosols
Number of Participants Analyzed [units: participants]	149	148	146
Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 12 [units: unit on a scale] Least Squares Mean ± Standard Error	85.9 ± 1.14	78.0 ± 1.15	76.3 ± 1.16

Statistical Analysis 1 for Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 12

Groups ^[1]	Combivent Respimat vs. Combivent Inhalation Aerosol
Method ^[2]	Mixed Models Analysis
P Value ^[3]	< 0.0001
Mean Difference (Final Values) ^[4]	7.9
95% Confidence Interval	( 4.71 to 11.09 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Combivent Inhalation Aerosol
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[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.

Statistical Analysis 2 for Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 12

Groups ^[1]	Combivent Respimat vs. Atrovent + Albuterol Aerosols
Method ^[2]	Mixed Models Analysis
P Value ^[3]	< 0.0001
Mean Difference (Final Values) ^[4]	9.6
95% Confidence Interval	( 6.44 to 12.83 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[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.

4. Secondary:

Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 24 [ Time Frame: 24 weeks ]

Measure Type	Secondary
Measure Title	Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 24
Measure Description	Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied).
Time Frame	24 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated Set is defined as all patients who were randomized and received study drug

Reporting Groups

	Description
Combivent Respimat	ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
Combivent Inhalation Aerosol	ipratropium bromide and albuterol sulfate 36/206 mcg qid
Atrovent + Albuterol Aerosols	ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid

Measured Values

	Combivent Respimat	Combivent Inhalation Aerosol	Atrovent + Albuterol Aerosols
Number of Participants Analyzed [units: participants]	142	142	130
Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 24 [units: unit on a scale] Least Squares Mean ± Standard Error	86.6 ± 1.15	77.5 ± 1.16	78.9 ± 1.19

Statistical Analysis 1 for Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 24

Groups ^[1]	Combivent Respimat vs. Combivent Inhalation Aerosol
Method ^[2]	Mixed Models Analysis
P Value ^[3]	< 0.0001
Mean Difference (Final Values) ^[4]	9.2
95% Confidence Interval	( 5.94 to 12.37 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Combivent Inhalation Aerosol
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[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.

Statistical Analysis 2 for Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 24

Groups ^[1]	Combivent Respimat vs. Atrovent + Albuterol Aerosols
Method ^[2]	Mixed Models Analysis
P Value ^[3]	< 0.0001
Mean Difference (Final Values) ^[4]	7.7
95% Confidence Interval	( 4.44 to 10.96 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[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.

5. Secondary:

Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 36 [ Time Frame: 36 weeks ]

Measure Type	Secondary
Measure Title	Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 36
Measure Description	Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied).
Time Frame	36 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated Set is defined as all patients who were randomized and received study drug

Reporting Groups

	Description
Combivent Respimat	ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
Combivent Inhalation Aerosol	ipratropium bromide and albuterol sulfate 36/206 mcg qid
Atrovent + Albuterol Aerosols	ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid

Measured Values

	Combivent Respimat	Combivent Inhalation Aerosol	Atrovent + Albuterol Aerosols
Number of Participants Analyzed [units: participants]	136	132	119
Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 36 [units: unit on a scale] Least Squares Mean ± Standard Error	88.2 ± 1.22	76.9 ± 1.24	80.5 ± 1.29

Statistical Analysis 1 for Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 36

Groups ^[1]	Combivent Respimat vs. Combivent Inhalation Aerosol
Method ^[2]	Mixed Models Analysis
P Value ^[3]	< 0.0001
Mean Difference (Final Values) ^[4]	11.3
95% Confidence Interval	( 7.90 to 14.76 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Combivent Inhalation Aerosol
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[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.

Statistical Analysis 2 for Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 36

Groups ^[1]	Combivent Respimat vs. Atrovent + Albuterol Aerosols
Method ^[2]	Mixed Models Analysis
P Value ^[3]	< 0.0001
Mean Difference (Final Values) ^[4]	7.7
95% Confidence Interval	( 4.23 to 11.23 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[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.

6. Secondary:

Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 3 [ Time Frame: 3 weeks ]

Measure Type	Secondary
Measure Title	Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 3
Measure Description	Patient satisfaction was assessed by asking: "Overall, how satisfied are you with your inhaler?". Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied).
Time Frame	3 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated Set is defined as all patients who were randomized and received study drug

Reporting Groups

	Description
Combivent Respimat	ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
Combivent Inhalation Aerosol	ipratropium bromide and albuterol sulfate 36/206 mcg qid
Atrovent + Albuterol Aerosols	ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid

Measured Values

	Combivent Respimat	Combivent Inhalation Aerosol	Atrovent + Albuterol Aerosols
Number of Participants Analyzed [units: participants]	157	152	153
Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 3 [units: unit on a scale] Least Squares Mean ± Standard Error	6.2 ± 0.08	6.1 ± 0.08	5.9 ± 0.08

Statistical Analysis 1 for Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 3

Groups ^[1]	Combivent Respimat vs. Combivent Inhalation Aerosol
Method ^[2]	Mixed Models Analysis
P Value ^[3]	0.1167
Mean Difference (Final Values) ^[4]	0.2
95% Confidence Interval	( -0.05 to 0.42 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Combivent Inhalation Aerosol
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[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.

Statistical Analysis 2 for Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 3

Groups ^[1]	Combivent Respimat vs. Atrovent + Albuterol Aerosols
Method ^[2]	Mixed Models Analysis
P Value ^[3]	0.0026
Mean Difference (Final Values) ^[4]	0.4
95% Confidence Interval	( 0.13 to 0.59 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[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.

7. Secondary:

Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 12 [ Time Frame: 12 weeks ]

Measure Type	Secondary
Measure Title	Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 12
Measure Description	Patient satisfaction was assessed by asking: "Overall, how satisfied are you with your inhaler?". Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied).
Time Frame	12 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated Set is defined as all patients who were randomized and received study drug

Reporting Groups

	Description
Combivent Respimat	ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
Combivent Inhalation Aerosol	ipratropium bromide and albuterol sulfate 36/206 mcg qid
Atrovent + Albuterol Aerosols	ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid

Measured Values

	Combivent Respimat	Combivent Inhalation Aerosol	Atrovent + Albuterol Aerosols
Number of Participants Analyzed [units: participants]	149	149	146
Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 12 [units: unit on a scale] Least Squares Mean ± Standard Error	6.2 ± 0.09	6.0 ± 0.09	5.8 ± 0.09

Statistical Analysis 1 for Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 12

Groups ^[1]	Combivent Respimat vs. Combivent Inhalation Aerosol
Method ^[2]	Mixed Models Analysis
P Value ^[3]	0.2826
Mean Difference (Final Values) ^[4]	0.1
95% Confidence Interval	( -0.11 to 0.38 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Combivent Inhalation Aerosol
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[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.

Statistical Analysis 2 for Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 12

Groups ^[1]	Combivent Respimat vs. Atrovent + Albuterol Aerosols
Method ^[2]	Mixed Models Analysis
P Value ^[3]	0.0013
Mean Difference (Final Values) ^[4]	0.4
95% Confidence Interval	( 0.16 to 0.66 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

8. Secondary:

Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 24 [ Time Frame: 24 weeks ]

Measure Type	Secondary
Measure Title	Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 24
Measure Description	Patient satisfaction was assessed by asking: "Overall, how satisfied are you with your inhaler?". Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied).
Time Frame	24 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated Set is defined as all patients who were randomized and received study drug

Reporting Groups

	Description
Combivent Respimat	ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
Combivent Inhalation Aerosol	ipratropium bromide and albuterol sulfate 36/206 mcg qid
Atrovent + Albuterol Aerosols	ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid

Measured Values

	Combivent Respimat	Combivent Inhalation Aerosol	Atrovent + Albuterol Aerosols
Number of Participants Analyzed [units: participants]	142	142	130
Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 24 [units: unit on a scale] Least Squares Mean ± Standard Error	6.3 ± 0.08	6.0 ± 0.08	5.8 ± 0.09

Statistical Analysis 1 for Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 24

Groups ^[1]	Combivent Respimat vs. Combivent Inhalation Aerosol
Method ^[2]	Mixed Models Analysis
P Value ^[3]	0.0023
Mean Difference (Final Values) ^[4]	0.4
95% Confidence Interval	( 0.13 to 0.59 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Combivent Inhalation Aerosol
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[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.

Statistical Analysis 2 for Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 24

Groups ^[1]	Combivent Respimat vs. Atrovent + Albuterol Aerosols
Method ^[2]	Mixed Models Analysis
P Value ^[3]	< 0.0001
Mean Difference (Final Values) ^[4]	0.5
95% Confidence Interval	( 0.25 to 0.71 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

9. Secondary:

Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 36 [ Time Frame: 36 weeks ]

Measure Type	Secondary
Measure Title	Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 36
Measure Description	Patient satisfaction was assessed by asking: "Overall, how satisfied are you with your inhaler?". Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied).
Time Frame	36 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated Set is defined as all patients who were randomized and received study drug

Reporting Groups

	Description
Combivent Respimat	ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
Combivent Inhalation Aerosol	ipratropium bromide and albuterol sulfate 36/206 mcg qid
Atrovent + Albuterol Aerosols	ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid

Measured Values

	Combivent Respimat	Combivent Inhalation Aerosol	Atrovent + Albuterol Aerosols
Number of Participants Analyzed [units: participants]	136	132	119
Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 36 [units: unit on a scale] Least Squares Mean ± Standard Error	6.4 ± 0.08	6.0 ± 0.09	5.9 ± 0.09

Statistical Analysis 1 for Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 36

Groups ^[1]	Combivent Respimat vs. Combivent Inhalation Aerosol
Method ^[2]	Mixed Models Analysis
P Value ^[3]	0.0006
Mean Difference (Final Values) ^[4]	0.4
95% Confidence Interval	( 0.18 to 0.65 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Combivent Inhalation Aerosol
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[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.

Statistical Analysis 2 for Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 36

Groups ^[1]	Combivent Respimat vs. Atrovent + Albuterol Aerosols
Method ^[2]	Mixed Models Analysis
P Value ^[3]	0.0004
Mean Difference (Final Values) ^[4]	0.4
95% Confidence Interval	( 0.20 to 0.68 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

10. Secondary:

Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 48 [ Time Frame: 48 weeks ]

Measure Type	Secondary
Measure Title	Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 48
Measure Description	Patient satisfaction was assessed by asking: "Overall, how satisfied are you with your inhaler?". Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied).
Time Frame	48 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated Set is defined as all patients who were randomized and received study drug

Reporting Groups

	Description
Combivent Respimat	ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
Combivent Inhalation Aerosol	ipratropium bromide and albuterol sulfate 36/206 mcg qid
Atrovent + Albuterol Aerosols	ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid

Measured Values

	Combivent Respimat	Combivent Inhalation Aerosol	Atrovent + Albuterol Aerosols
Number of Participants Analyzed [units: participants]	134	125	110
Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 48 [units: unit on a scale] Least Squares Mean ± Standard Error	6.3 ± 0.09	6.1 ± 0.09	6.0 ± 0.09

Statistical Analysis 1 for Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 48

Groups ^[1]	Combivent Respimat vs. Combivent Inhalation Aerosol
Method ^[2]	Mixed Models Analysis
P Value ^[3]	0.0673
Mean Difference (Final Values) ^[4]	0.2
95% Confidence Interval	( -0.02 to 0.47 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Combivent Inhalation Aerosol
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[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.

Statistical Analysis 2 for Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 48

Groups ^[1]	Combivent Respimat vs. Atrovent + Albuterol Aerosols
Method ^[2]	Mixed Models Analysis
P Value ^[3]	0.0245
Mean Difference (Final Values) ^[4]	0.3
95% Confidence Interval	( 0.04 to 0.54 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[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.

11. Secondary:

Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 3 [ Time Frame: 3 weeks ]

Measure Type	Secondary
Measure Title	Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 3
Measure Description	CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited).
Time Frame	3 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated Set is defined as all patients who were randomized and received study drug

Reporting Groups

	Description
Combivent Respimat	ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
Combivent Inhalation Aerosol	ipratropium bromide and albuterol sulfate 36/206 mcg qid
Atrovent + Albuterol Aerosols	ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid

Measured Values

	Combivent Respimat	Combivent Inhalation Aerosol	Atrovent + Albuterol Aerosols
Number of Participants Analyzed [units: participants]	157	152	153
Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 3 [units: unit on a scale] Least Squares Mean ± Standard Error	2.7 ± 0.07	2.7 ± 0.07	2.8 ± 0.07

Statistical Analysis 1 for Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 3

Groups ^[1]	Combivent Respimat vs. Combivent Inhalation Aerosol
Method ^[2]	Mixed Models Analysis
P Value ^[3]	0.5695
Mean Difference (Final Values) ^[4]	-0.1
95% Confidence Interval	( -0.24 to 0.13 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Combivent Inhalation Aerosol
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[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.

Statistical Analysis 2 for Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 3

Groups ^[1]	Combivent Respimat vs. Atrovent + Albuterol Aerosols
Method ^[2]	Mixed Models Analysis
P Value ^[3]	0.3093
Mean Difference (Final Values) ^[4]	-0.1
95% Confidence Interval	( -0.28 to 0.09 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[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.

12. Secondary:

Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 12 [ Time Frame: 12 weeks ]

Measure Type	Secondary
Measure Title	Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 12
Measure Description	CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited).
Time Frame	12 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated Set is defined as all patients who were randomized and received study drug

Reporting Groups

	Description
Combivent Respimat	ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
Combivent Inhalation Aerosol	ipratropium bromide and albuterol sulfate 36/206 mcg qid
Atrovent + Albuterol Aerosols	ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid

Measured Values

	Combivent Respimat	Combivent Inhalation Aerosol	Atrovent + Albuterol Aerosols
Number of Participants Analyzed [units: participants]	150	149	146
Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 12 [units: unit on a scale] Least Squares Mean ± Standard Error	2.8 ± 0.08	2.9 ± 0.08	2.8 ± 0.08

Statistical Analysis 1 for Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 12

Groups ^[1]	Combivent Respimat vs. Combivent Inhalation Aerosol
Method ^[2]	Mixed Models Analysis
P Value ^[3]	0.3578
Mean Difference (Final Values) ^[4]	-0.1
95% Confidence Interval	( -0.31 to 0.11 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Combivent Inhalation Aerosol
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[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.

Statistical Analysis 2 for Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 12

Groups ^[1]	Combivent Respimat vs. Atrovent + Albuterol Aerosols
Method ^[2]	Mixed Models Analysis
P Value ^[3]	0.7433
Mean Difference (Final Values) ^[4]	0.0
95% Confidence Interval	( -0.18 to 0.25 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[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.

13. Secondary:

Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 24 [ Time Frame: 24 weeks ]

Measure Type	Secondary
Measure Title	Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 24
Measure Description	CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited).
Time Frame	24 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated Set is defined as all patients who were randomized and received study drug

Reporting Groups

	Description
Combivent Respimat	ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
Combivent Inhalation Aerosol	ipratropium bromide and albuterol sulfate 36/206 mcg qid
Atrovent + Albuterol Aerosols	ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid

Measured Values

	Combivent Respimat	Combivent Inhalation Aerosol	Atrovent + Albuterol Aerosols
Number of Participants Analyzed [units: participants]	142	142	130
Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 24 [units: unit on a scale] Least Squares Mean ± Standard Error	2.7 ± 0.08	2.8 ± 0.08	2.8 ± 0.08

Statistical Analysis 1 for Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 24

Groups ^[1]	Combivent Respimat vs. Combivent Inhalation Aerosol
Method ^[2]	Mixed Models Analysis
P Value ^[3]	0.524
Mean Difference (Final Values) ^[4]	-0.1
95% Confidence Interval	( -0.29 to 0.15 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Combivent Inhalation Aerosol
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[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.

Statistical Analysis 2 for Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 24

Groups ^[1]	Combivent Respimat vs. Atrovent + Albuterol Aerosols
Method ^[2]	Mixed Models Analysis
P Value ^[3]	0.3171
Mean Difference (Final Values) ^[4]	-0.1
95% Confidence Interval	( -0.34 to 0.11 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[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.

14. Secondary:

Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 36 [ Time Frame: 36 weeks ]

Measure Type	Secondary
Measure Title	Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 36
Measure Description	CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited).
Time Frame	36 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated Set is defined as all patients who were randomized and received study drug

Reporting Groups

	Description
Combivent Respimat	ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
Combivent Inhalation Aerosol	ipratropium bromide and albuterol sulfate 36/206 mcg qid
Atrovent + Albuterol Aerosols	ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid

Measured Values

	Combivent Respimat	Combivent Inhalation Aerosol	Atrovent + Albuterol Aerosols
Number of Participants Analyzed [units: participants]	136	132	119
Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 36 [units: unit on a scale] Least Squares Mean ± Standard Error	2.7 ± 0.09	2.8 ± 0.09	2.7 ± 0.09

Statistical Analysis 1 for Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 36

Groups ^[1]	Combivent Respimat vs. Combivent Inhalation Aerosol
Method ^[2]	Mixed Models Analysis
P Value ^[3]	0.2499
Mean Difference (Final Values) ^[4]	-0.1
95% Confidence Interval	( -0.38 to 0.10 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Combivent Inhalation Aerosol
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[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.

Statistical Analysis 2 for Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 36

Groups ^[1]	Combivent Respimat vs. Atrovent + Albuterol Aerosols
Method ^[2]	Mixed Models Analysis
P Value ^[3]	0.6144
Mean Difference (Final Values) ^[4]	-0.1
95% Confidence Interval	( -0.31 to 0.18 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[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.

15. Secondary:

Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 48 [ Time Frame: 48 weeks ]

Measure Type	Secondary
Measure Title	Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 48
Measure Description	CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited).
Time Frame	48 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated Set is defined as all patients who were randomized and received study drug

Reporting Groups

	Description
Combivent Respimat	ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
Combivent Inhalation Aerosol	ipratropium bromide and albuterol sulfate 36/206 mcg qid
Atrovent + Albuterol Aerosols	ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid

Measured Values

	Combivent Respimat	Combivent Inhalation Aerosol	Atrovent + Albuterol Aerosols
Number of Participants Analyzed [units: participants]	134	125	110
Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 48 [units: unit on a scale] Least Squares Mean ± Standard Error	2.8 ± 0.09	2.7 ± 0.09	2.9 ± 0.09

Statistical Analysis 1 for Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 48

Groups ^[1]	Combivent Respimat vs. Combivent Inhalation Aerosol
Method ^[2]	Mixed Models Analysis
P Value ^[3]	0.5142
Mean Difference (Final Values) ^[4]	0.1
95% Confidence Interval	( -0.16 to 0.33 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Combivent Inhalation Aerosol
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[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.

Statistical Analysis 2 for Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 48

Groups ^[1]	Combivent Respimat vs. Atrovent + Albuterol Aerosols
Method ^[2]	Mixed Models Analysis
P Value ^[3]	0.2691
Mean Difference (Final Values) ^[4]	-0.1
95% Confidence Interval	( -0.39 to 0.11 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[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.

16. Secondary:

Physician's Global Evaluation at Week 3 [ Time Frame: 3 weeks ]

Measure Type	Secondary
Measure Title	Physician's Global Evaluation at Week 3
Measure Description	Physicians evaluated the patient's overall clinical condition on a scale ranging from "poor" (score 1 or 2) to "excellent" (score 7 or 8).
Time Frame	3 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated Set is defined as all patients who were randomized and received study drug

Reporting Groups

	Description
Combivent Respimat	ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
Combivent Inhalation Aerosol	ipratropium bromide and albuterol sulfate 36/206 mcg qid
Atrovent + Albuterol Aerosols	ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid

Measured Values

	Combivent Respimat	Combivent Inhalation Aerosol	Atrovent + Albuterol Aerosols
Number of Participants Analyzed [units: participants]	157	152	152
Physician's Global Evaluation at Week 3 [units: unit on a scale] Least Squares Mean ± Standard Error	5.0 ± 0.07	5.1 ± 0.07	5.1 ± 0.07

Statistical Analysis 1 for Physician's Global Evaluation at Week 3

Groups ^[1]	Combivent Respimat vs. Combivent Inhalation Aerosol
Method ^[2]	Mixed Models Analysis
P Value ^[3]	0.6236
Mean Difference (Final Values) ^[4]	0.0
95% Confidence Interval	( -0.23 to 0.14 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Combivent Inhalation Aerosol
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[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.

Statistical Analysis 2 for Physician's Global Evaluation at Week 3

Groups ^[1]	Combivent Respimat vs. Atrovent + Albuterol Aerosols
Method ^[2]	Mixed Models Analysis
P Value ^[3]	0.3342
Mean Difference (Final Values) ^[4]	-0.1
95% Confidence Interval	( -0.28 to 0.09 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[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.

17. Secondary:

Physician's Global Evaluation at Week 12 [ Time Frame: 12 weeks ]

Measure Type	Secondary
Measure Title	Physician's Global Evaluation at Week 12
Measure Description	Physicians evaluated the patient's overall clinical condition on a scale ranging from "poor" (score 1 or 2) to "excellent" (score 7 or 8).
Time Frame	12 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated Set is defined as all patients who were randomized and received study drug

Reporting Groups

	Description
Combivent Respimat	ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
Combivent Inhalation Aerosol	ipratropium bromide and albuterol sulfate 36/206 mcg qid
Atrovent + Albuterol Aerosols	ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid

Measured Values

	Combivent Respimat	Combivent Inhalation Aerosol	Atrovent + Albuterol Aerosols
Number of Participants Analyzed [units: participants]	150	148	146
Physician's Global Evaluation at Week 12 [units: unit on a scale] Least Squares Mean ± Standard Error	5.1 ± 0.08	5.2 ± 0.08	5.0 ± 0.08

Statistical Analysis 1 for Physician's Global Evaluation at Week 12

Groups ^[1]	Combivent Respimat vs. Combivent Inhalation Aerosol
Method ^[2]	Mixed Models Analysis
P Value ^[3]	0.1884
Mean Difference (Final Values) ^[4]	-0.1
95% Confidence Interval	( -0.36 to 0.07 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Combivent Inhalation Aerosol
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[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.

Statistical Analysis 2 for Physician's Global Evaluation at Week 12

Groups ^[1]	Combivent Respimat vs. Atrovent + Albuterol Aerosols
Method ^[2]	Mixed Models Analysis
P Value ^[3]	0.6978
Mean Difference (Final Values) ^[4]	0.0
95% Confidence Interval	( -0.17 to 0.26 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

18. Secondary:

Physician's Global Evaluation at Week 24 [ Time Frame: 24 weeks ]

Measure Type	Secondary
Measure Title	Physician's Global Evaluation at Week 24
Measure Description	Physicians evaluated the patient's overall clinical condition on a scale ranging from "poor" (score 1 or 2) to "excellent" (score 7 or 8).
Time Frame	24 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated Set is defined as all patients who were randomized and received study drug

Reporting Groups

	Description
Combivent Respimat	ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
Combivent Inhalation Aerosol	ipratropium bromide and albuterol sulfate 36/206 mcg qid
Atrovent + Albuterol Aerosols	ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid

Measured Values

	Combivent Respimat	Combivent Inhalation Aerosol	Atrovent + Albuterol Aerosols
Number of Participants Analyzed [units: participants]	142	142	130
Physician's Global Evaluation at Week 24 [units: unit on a scale] Least Squares Mean ± Standard Error	5.1 ± 0.08	5.2 ± 0.08	5.2 ± 0.08

Statistical Analysis 1 for Physician's Global Evaluation at Week 24

Groups ^[1]	Combivent Respimat vs. Combivent Inhalation Aerosol
Method ^[2]	Mixed Models Analysis
P Value ^[3]	0.4197
Mean Difference (Final Values) ^[4]	-0.1
95% Confidence Interval	( -0.32 to 0.13 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Combivent Inhalation Aerosol
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[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.

Statistical Analysis 2 for Physician's Global Evaluation at Week 24

Groups ^[1]	Combivent Respimat vs. Atrovent + Albuterol Aerosols
Method ^[2]	Mixed Models Analysis
P Value ^[3]	0.3949
Mean Difference (Final Values) ^[4]	-0.1
95% Confidence Interval	( -0.33 to 0.13 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

19. Secondary:

Physician's Global Evaluation at Week 36 [ Time Frame: 36 weeks ]

Measure Type	Secondary
Measure Title	Physician's Global Evaluation at Week 36
Measure Description	Physicians evaluated the patient's overall clinical condition on a scale ranging from "poor" (score 1 or 2) to "excellent" (score 7 or 8).
Time Frame	36 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated Set is defined as all patients who were randomized and received study drug

Reporting Groups

	Description
Combivent Respimat	ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
Combivent Inhalation Aerosol	ipratropium bromide and albuterol sulfate 36/206 mcg qid
Atrovent + Albuterol Aerosols	ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid

Measured Values

	Combivent Respimat	Combivent Inhalation Aerosol	Atrovent + Albuterol Aerosols
Number of Participants Analyzed [units: participants]	136	132	118
Physician's Global Evaluation at Week 36 [units: unit on a scale] Least Squares Mean ± Standard Error	5.1 ± 0.09	5.2 ± 0.09	5.2 ± 0.09

Statistical Analysis 1 for Physician's Global Evaluation at Week 36

Groups ^[1]	Combivent Respimat vs. Combivent Inhalation Aerosol
Method ^[2]	Mixed Models Analysis
P Value ^[3]	0.299
Mean Difference (Final Values) ^[4]	-0.1
95% Confidence Interval	( -0.38 to 0.12 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Combivent Inhalation Aerosol
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[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.

Statistical Analysis 2 for Physician's Global Evaluation at Week 36

Groups ^[1]	Combivent Respimat vs. Atrovent + Albuterol Aerosols
Method ^[2]	Mixed Models Analysis
P Value ^[3]	0.1404
Mean Difference (Final Values) ^[4]	-0.2
95% Confidence Interval	( -0.44 to 0.06 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

20. Secondary:

Physician's Global Evaluation at Week 48 [ Time Frame: 48 weeks ]

Measure Type	Secondary
Measure Title	Physician's Global Evaluation at Week 48
Measure Description	Physicians evaluated the patient's overall clinical condition on a scale ranging from "poor" (score 1 or 2) to "excellent" (score 7 or 8).
Time Frame	48 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated Set is defined as all patients who were randomized and received study drug

Reporting Groups

	Description
Combivent Respimat	ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
Combivent Inhalation Aerosol	ipratropium bromide and albuterol sulfate 36/206 mcg qid
Atrovent + Albuterol Aerosols	ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid

Measured Values

	Combivent Respimat	Combivent Inhalation Aerosol	Atrovent + Albuterol Aerosols
Number of Participants Analyzed [units: participants]	133	125	108
Physician's Global Evaluation at Week 48 [units: unit on a scale] Least Squares Mean ± Standard Error	5.2 ± 0.09	5.3 ± 0.09	5.1 ± 0.10

Statistical Analysis 1 for Physician's Global Evaluation at Week 48

Groups ^[1]	Combivent Respimat vs. Combivent Inhalation Aerosol
Method ^[2]	Mixed Models Analysis
P Value ^[3]	0.463
Mean Difference (Final Values) ^[4]	-0.1
95% Confidence Interval	( -0.36 to 0.16 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Combivent Inhalation Aerosol
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[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.

Statistical Analysis 2 for Physician's Global Evaluation at Week 48

Groups ^[1]	Combivent Respimat vs. Atrovent + Albuterol Aerosols
Method ^[2]	Mixed Models Analysis
P Value ^[3]	0.3824
Mean Difference (Final Values) ^[4]	0.1
95% Confidence Interval	( -0.15 to 0.38 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

21. Secondary:

Change From Baseline in FEV1 at Day 1 [ Time Frame: baseline, day 1 ]

Measure Type	Secondary
Measure Title	Change From Baseline in FEV1 at Day 1
Measure Description	Change from test-day baseline in Forced Expiratory Volume in 1 second (FEV1) at 1 hour post dose on test day 1.
Time Frame	baseline, day 1
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated Set is defined as all patients who were randomized and received study drug

Reporting Groups

	Description
Combivent Respimat	ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
Combivent Inhalation Aerosol	ipratropium bromide and albuterol sulfate 36/206 mcg qid
Atrovent + Albuterol Aerosols	ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid

Measured Values

	Combivent Respimat	Combivent Inhalation Aerosol	Atrovent + Albuterol Aerosols
Number of Participants Analyzed [units: participants]	157	154	154
Change From Baseline in FEV1 at Day 1 [units: liters] Least Squares Mean ± Standard Error	0.22 ± 0.15	0.21 ± 0.15	0.21 ± 0.15

Statistical Analysis 1 for Change From Baseline in FEV1 at Day 1

Groups ^[1]	Combivent Respimat vs. Combivent Inhalation Aerosol
Method ^[2]	Mixed Models Analysis
P Value ^[3]	0.8282
Mean Difference (Final Values) ^[4]	0.0
95% Confidence Interval	( -0.036 to 0.045 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Combivent Inhalation Aerosol
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[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.

Statistical Analysis 2 for Change From Baseline in FEV1 at Day 1

Groups ^[1]	Combivent Respimat vs. Atrovent + Albuterol Aerosols
Method ^[2]	Mixed Models Analysis
P Value ^[3]	0.6587
Mean Difference (Final Values) ^[4]	0.01
95% Confidence Interval	( -0.032 to 0.050 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[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.

22. Secondary:

Change From Baseline in FEV1 at Week 12 [ Time Frame: baseline, 12 weeks ]

Measure Type	Secondary
Measure Title	Change From Baseline in FEV1 at Week 12
Measure Description	Change from test-day baseline in Forced Expiratory Volume in 1 second (FEV1) at 1 hour post dose at Week 12
Time Frame	baseline, 12 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated Set is defined as all patients who were randomized and received study drug

Reporting Groups

	Description
Combivent Respimat	ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
Combivent Inhalation Aerosol	ipratropium bromide and albuterol sulfate 36/206 mcg qid
Atrovent + Albuterol Aerosols	ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid

Measured Values

	Combivent Respimat	Combivent Inhalation Aerosol	Atrovent + Albuterol Aerosols
Number of Participants Analyzed [units: participants]	145	144	136
Change From Baseline in FEV1 at Week 12 [units: liters] Least Squares Mean ± Standard Error	0.23 ± 0.16	0.19 ± 0.16	0.20 ± 0.17

Statistical Analysis 1 for Change From Baseline in FEV1 at Week 12

Groups ^[1]	Combivent Respimat vs. Combivent Inhalation Aerosol
Method ^[2]	Mixed Models Analysis
P Value ^[3]	0.1185
Mean Difference (Final Values) ^[4]	0.04
95% Confidence Interval	( -0.009 to 0.081 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Combivent Inhalation Aerosol
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[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.

Statistical Analysis 2 for Change From Baseline in FEV1 at Week 12

Groups ^[1]	Combivent Respimat vs. Atrovent + Albuterol Aerosols
Method ^[2]	Mixed Models Analysis
P Value ^[3]	0.2651
Mean Difference (Final Values) ^[4]	0.03
95% Confidence Interval	( -0.020 to 0.072 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[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.

23. Secondary:

Change From Baseline in FEV1 at Week 24 [ Time Frame: baseline, 24 weeks ]

Measure Type	Secondary
Measure Title	Change From Baseline in FEV1 at Week 24
Measure Description	Change from test-day baseline in Forced Expiratory Volume in 1 second (FEV1) at 1 hour post dose at Week 24
Time Frame	baseline, 24 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated Set is defined as all patients who were randomized and received study drug

Reporting Groups

	Description
Combivent Respimat	ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
Combivent Inhalation Aerosol	ipratropium bromide and albuterol sulfate 36/206 mcg qid
Atrovent + Albuterol Aerosols	ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid

Measured Values

	Combivent Respimat	Combivent Inhalation Aerosol	Atrovent + Albuterol Aerosols
Number of Participants Analyzed [units: participants]	138	134	124
Change From Baseline in FEV1 at Week 24 [units: liters] Least Squares Mean ± Standard Error	0.20 ± 0.16	0.21 ± 0.16	0.21 ± 0.17

Statistical Analysis 1 for Change From Baseline in FEV1 at Week 24

Groups ^[1]	Combivent Respimat vs. Combivent Inhalation Aerosol
Method ^[2]	Mixed Models Analysis
P Value ^[3]	0.5852
Mean Difference (Final Values) ^[4]	-0.01
95% Confidence Interval	( -0.058 to 0.033 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Combivent Inhalation Aerosol
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[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.

Statistical Analysis 2 for Change From Baseline in FEV1 at Week 24

Groups ^[1]	Combivent Respimat vs. Atrovent + Albuterol Aerosols
Method ^[2]	Mixed Models Analysis
P Value ^[3]	0.7242
Mean Difference (Final Values) ^[4]	-0.01
95% Confidence Interval	( -0.054 to 0.038 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[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.

24. Secondary:

Change From Baseline in FEV1 at Week 48 [ Time Frame: baseline, 48 weeks ]

Measure Type	Secondary
Measure Title	Change From Baseline in FEV1 at Week 48
Measure Description	Change from test-day baseline in Forced Expiratory Volume in 1 second (FEV1) at 1 hour post dose at Week 48
Time Frame	baseline, 48 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated Set is defined as all patients who were randomized and received study drug

Reporting Groups

	Description
Combivent Respimat	ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
Combivent Inhalation Aerosol	ipratropium bromide and albuterol sulfate 36/206 mcg qid
Atrovent + Albuterol Aerosols	ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid

Measured Values

	Combivent Respimat	Combivent Inhalation Aerosol	Atrovent + Albuterol Aerosols
Number of Participants Analyzed [units: participants]	133	121	108
Change From Baseline in FEV1 at Week 48 [units: liters] Least Squares Mean ± Standard Error	0.22 ± 0.19	0.16 ± 0.19	0.23 ± 0.20

Statistical Analysis 1 for Change From Baseline in FEV1 at Week 48

Groups ^[1]	Combivent Respimat vs. Combivent Inhalation Aerosol
Method ^[2]	Mixed Models Analysis
P Value ^[3]	0.0328
Mean Difference (Final Values) ^[4]	0.06
95% Confidence Interval	( 0.005 to 0.110 )

[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:
	Adjusted for baseline and baseline-by-test-day interaction
[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.

Statistical Analysis 2 for Change From Baseline in FEV1 at Week 48

Groups ^[1]	Combivent Respimat vs. Atrovent + Albuterol Aerosols
Method ^[2]	Mixed Models Analysis
P Value ^[3]	0.8896
Mean Difference (Final Values) ^[4]	-0.00
95% Confidence Interval	( -0.058 to 0.050 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[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.

25. Secondary:

Change From Baseline in FVC at Day 1 [ Time Frame: baseline, day 1 ]

Measure Type	Secondary
Measure Title	Change From Baseline in FVC at Day 1
Measure Description	Change from test-day baseline in Forced Vital Capacity (FVC) at 1 hour post dose on test day 1.
Time Frame	baseline, day 1
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated Set is defined as all patients who were randomized and received study drug

Reporting Groups

	Description
Combivent Respimat	ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
Combivent Inhalation Aerosol	ipratropium bromide and albuterol sulfate 36/206 mcg qid
Atrovent + Albuterol Aerosols	ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid

Measured Values

	Combivent Respimat	Combivent Inhalation Aerosol	Atrovent + Albuterol Aerosols
Number of Participants Analyzed [units: participants]	157	154	154
Change From Baseline in FVC at Day 1 [units: liters] Least Squares Mean ± Standard Error	0.37 ± 0.26	0.34 ± 0.27	0.36 ± 0.27

Statistical Analysis 1 for Change From Baseline in FVC at Day 1

Groups ^[1]	Combivent Respimat vs. Combivent Inhalation Aerosol
Method ^[2]	Mixed Models Analysis
P Value ^[3]	0.402
Mean Difference (Final Values) ^[4]	0.03
95% Confidence Interval	( -0.042 to 0.105 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Combivent Inhalation Aerosol
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[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.

Statistical Analysis 2 for Change From Baseline in FVC at Day 1

Groups ^[1]	Combivent Respimat vs. Atrovent + Albuterol Aerosols
Method ^[2]	Mixed Models Analysis
P Value ^[3]	0.659
Mean Difference (Final Values) ^[4]	0.02
95% Confidence Interval	( -0.057 to 0.090 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[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.

26. Secondary:

Change From Baseline in FVC at Week 12 [ Time Frame: baseline, 12 weeks ]

Measure Type	Secondary
Measure Title	Change From Baseline in FVC at Week 12
Measure Description	Change from test-day baseline in Forced Vital Capacity (FVC) at 1 hour post dose at Week 12
Time Frame	baseline, 12 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated Set is defined as all patients who were randomized and received study drug

Reporting Groups

	Description
Combivent Respimat	ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
Combivent Inhalation Aerosol	ipratropium bromide and albuterol sulfate 36/206 mcg qid
Atrovent + Albuterol Aerosols	ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid

Measured Values

	Combivent Respimat	Combivent Inhalation Aerosol	Atrovent + Albuterol Aerosols
Number of Participants Analyzed [units: participants]	145	144	136
Change From Baseline in FVC at Week 12 [units: liters] Least Squares Mean ± Standard Error	0.38 ± 0.27	0.31 ± 0.27	0.35 ± 0.27

Statistical Analysis 1 for Change From Baseline in FVC at Week 12

Groups ^[1]	Combivent Respimat vs. Combivent Inhalation Aerosol
Method ^[2]	Mixed Models Analysis
P Value ^[3]	0.0893
Mean Difference (Final Values) ^[4]	0.06
95% Confidence Interval	( -0.010 to 0.139 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Combivent Inhalation Aerosol
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[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.

Statistical Analysis 2 for Change From Baseline in FVC at Week 12

Groups ^[1]	Combivent Respimat vs. Atrovent + Albuterol Aerosols
Method ^[2]	Mixed Models Analysis
P Value ^[3]	0.5424
Mean Difference (Final Values) ^[4]	0.02
95% Confidence Interval	( -0.052 to 0.099 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[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.

27. Secondary:

Change From Baseline in FVC at Week 24 [ Time Frame: baseline, 24 weeks ]

Measure Type	Secondary
Measure Title	Change From Baseline in FVC at Week 24
Measure Description	Change from test-day baseline in Forced Vital Capacity (FVC) at 1 hour post dose at Week 24
Time Frame	baseline, 24 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated Set is defined as all patients who were randomized and received study drug

Reporting Groups

	Description
Combivent Respimat	ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
Combivent Inhalation Aerosol	ipratropium bromide and albuterol sulfate 36/206 mcg qid
Atrovent + Albuterol Aerosols	ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid

Measured Values

	Combivent Respimat	Combivent Inhalation Aerosol	Atrovent + Albuterol Aerosols
Number of Participants Analyzed [units: participants]	138	134	124
Change From Baseline in FVC at Week 24 [units: liters] Least Squares Mean ± Standard Error	0.33 ± 0.30	0.35 ± 0.30	0.35 ± 0.31

Statistical Analysis 1 for Change From Baseline in FVC at Week 24

Groups ^[1]	Combivent Respimat vs. Combivent Inhalation Aerosol
Method ^[2]	Mixed Models Analysis
P Value ^[3]	0.6396
Mean Difference (Final Values) ^[4]	-0.02
95% Confidence Interval	( -0.104 to 0.064 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Combivent Inhalation Aerosol
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[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.

Statistical Analysis 2 for Change From Baseline in FVC at Week 24

Groups ^[1]	Combivent Respimat vs. Atrovent + Albuterol Aerosols
Method ^[2]	Mixed Models Analysis
P Value ^[3]	0.6455
Mean Difference (Final Values) ^[4]	-0.02
95% Confidence Interval	( -0.106 to 0.066 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[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.

28. Secondary:

Change From Baseline in FVC at Week 48 [ Time Frame: baseline, 48 weeks ]

Measure Type	Secondary
Measure Title	Change From Baseline in FVC at Week 48
Measure Description	Change from test-day baseline in Forced Vital Capacity (FVC) at 1 hour post dose at Week 48
Time Frame	baseline, 48 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated Set is defined as all patients who were randomized and received study drug

Reporting Groups

	Description
Combivent Respimat	ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
Combivent Inhalation Aerosol	ipratropium bromide and albuterol sulfate 36/206 mcg qid
Atrovent + Albuterol Aerosols	ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid

Measured Values

	Combivent Respimat	Combivent Inhalation Aerosol	Atrovent + Albuterol Aerosols
Number of Participants Analyzed [units: participants]	133	121	108
Change From Baseline in FVC at Week 48 [units: liters] Least Squares Mean ± Standard Error	0.35 ± 0.32	0.30 ± 0.33	0.37 ± 0.34

Statistical Analysis 1 for Change From Baseline in FVC at Week 48

Groups ^[1]	Combivent Respimat vs. Combivent Inhalation Aerosol
Method ^[2]	Mixed Models Analysis
P Value ^[3]	0.2596
Mean Difference (Final Values) ^[4]	0.05
95% Confidence Interval	( -0.038 to 0.141 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Combivent Inhalation Aerosol
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[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.

Statistical Analysis 2 for Change From Baseline in FVC at Week 48

Groups ^[1]	Combivent Respimat vs. Atrovent + Albuterol Aerosols
Method ^[2]	Mixed Models Analysis
P Value ^[3]	0.6659
Mean Difference (Final Values) ^[4]	-0.02
95% Confidence Interval	( -0.112 to 0.071 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[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.

29. Secondary:

Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 3 [ Time Frame: 3 weeks ]

Measure Type	Secondary
Measure Title	Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 3
Measure Description	No text entered.
Time Frame	3 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated Set is defined as all patients who were randomized and received study drug

Reporting Groups

	Description
Combivent Respimat	ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
Combivent Inhalation Aerosol	ipratropium bromide and albuterol sulfate 36/206 mcg qid
Atrovent + Albuterol Aerosols	ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid

Measured Values

	Combivent Respimat	Combivent Inhalation Aerosol	Atrovent + Albuterol Aerosols
Number of Participants Analyzed [units: participants]	157	151	152
Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 3 [units: number of puffs] Least Squares Mean ± Standard Error	1.7 ± 0.10	1.8 ± 0.11	1.7 ± 0.11

Statistical Analysis 1 for Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 3

Groups ^[1]	Combivent Respimat vs. Combivent Inhalation Aerosol
Method ^[2]	Mixed Models Analysis
P Value ^[3]	0.476
Mean Difference (Final Values) ^[4]	-0.1
95% Confidence Interval	( -0.40 to 0.19 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Combivent Inhalation Aerosol
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[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.

Statistical Analysis 2 for Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 3

Groups ^[1]	Combivent Respimat vs. Atrovent + Albuterol Aerosols
Method ^[2]	Mixed Models Analysis
P Value ^[3]	0.6976
Mean Difference (Final Values) ^[4]	-0.1
95% Confidence Interval	( -0.35 to 0.23 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[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.

30. Secondary:

Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 12 [ Time Frame: 12 weeks ]

Measure Type	Secondary
Measure Title	Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 12
Measure Description	No text entered.
Time Frame	12 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated Set is defined as all patients who were randomized and received study drug

Reporting Groups

	Description
Combivent Respimat	ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
Combivent Inhalation Aerosol	ipratropium bromide and albuterol sulfate 36/206 mcg qid
Atrovent + Albuterol Aerosols	ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid

Measured Values

	Combivent Respimat	Combivent Inhalation Aerosol	Atrovent + Albuterol Aerosols
Number of Participants Analyzed [units: participants]	147	149	145
Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 12 [units: number of puffs] Least Squares Mean ± Standard Error	1.9 ± 0.14	1.9 ± 0.14	1.7 ± 0.14

Statistical Analysis 1 for Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 12

Groups ^[1]	Combivent Respimat vs. Combivent Inhalation Aerosol
Method ^[2]	Mixed Models Analysis
P Value ^[3]	0.9506
Mean Difference (Final Values) ^[4]	-0.0
95% Confidence Interval	( -0.40 to 0.37 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Combivent Inhalation Aerosol
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[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.

Statistical Analysis 2 for Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 12

Groups ^[1]	Combivent Respimat vs. Atrovent + Albuterol Aerosols
Method ^[2]	Mixed Models Analysis
P Value ^[3]	0.2362
Mean Difference (Final Values) ^[4]	0.2
95% Confidence Interval	( -0.15 to 0.62 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[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.

31. Secondary:

Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 24 [ Time Frame: 24 weeks ]

Measure Type	Secondary
Measure Title	Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 24
Measure Description	No text entered.
Time Frame	24 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated Set is defined as all patients who were randomized and received study drug

Reporting Groups

	Description
Combivent Respimat	ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
Combivent Inhalation Aerosol	ipratropium bromide and albuterol sulfate 36/206 mcg qid
Atrovent + Albuterol Aerosols	ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid

Measured Values

	Combivent Respimat	Combivent Inhalation Aerosol	Atrovent + Albuterol Aerosols
Number of Participants Analyzed [units: participants]	142	143	129
Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 24 [units: number of puffs] Least Squares Mean ± Standard Error	2.1 ± 0.15	2.0 ± 0.15	1.6 ± 0.16

Statistical Analysis 1 for Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 24

Groups ^[1]	Combivent Respimat vs. Combivent Inhalation Aerosol
Method ^[2]	Mixed Models Analysis
P Value ^[3]	0.5645
Mean Difference (Final Values) ^[4]	0.1
95% Confidence Interval	( -0.30 to 0.54 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Combivent Inhalation Aerosol
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[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.

Statistical Analysis 2 for Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 24

Groups ^[1]	Combivent Respimat vs. Atrovent + Albuterol Aerosols
Method ^[2]	Mixed Models Analysis
P Value ^[3]	0.0163
Mean Difference (Final Values) ^[4]	0.5
95% Confidence Interval	( 0.10 to 0.95 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[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.

32. Secondary:

Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 36 [ Time Frame: 36 weeks ]

Measure Type	Secondary
Measure Title	Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 36
Measure Description	No text entered.
Time Frame	36 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated Set is defined as all patients who were randomized and received study drug

Reporting Groups

	Description
Combivent Respimat	ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
Combivent Inhalation Aerosol	ipratropium bromide and albuterol sulfate 36/206 mcg qid
Atrovent + Albuterol Aerosols	ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid

Measured Values

	Combivent Respimat	Combivent Inhalation Aerosol	Atrovent + Albuterol Aerosols
Number of Participants Analyzed [units: participants]	136	131	116
Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 36 [units: number of puffs] Least Squares Mean ± Standard Error	1.9 ± 0.15	2.1 ± 0.15	1.8 ± 0.16

Statistical Analysis 1 for Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 36

Groups ^[1]	Combivent Respimat vs. Combivent Inhalation Aerosol
Method ^[2]	Mixed Models Analysis
P Value ^[3]	0.4339
Mean Difference (Final Values) ^[4]	-0.2
95% Confidence Interval	( -0.60 to 0.26 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Combivent Inhalation Aerosol
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[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.

Statistical Analysis 2 for Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 36

Groups ^[1]	Combivent Respimat vs. Atrovent + Albuterol Aerosols
Method ^[2]	Mixed Models Analysis
P Value ^[3]	0.4886
Mean Difference (Final Values) ^[4]	0.2
95% Confidence Interval	( -0.28 to 0.59 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[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.

33. Secondary:

Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 48 [ Time Frame: 48 weeks ]

Measure Type	Secondary
Measure Title	Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 48
Measure Description	No text entered.
Time Frame	48 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated Set is defined as all patients who were randomized and received study drug

Reporting Groups

	Description
Combivent Respimat	ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
Combivent Inhalation Aerosol	ipratropium bromide and albuterol sulfate 36/206 mcg qid
Atrovent + Albuterol Aerosols	ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid

Measured Values

	Combivent Respimat	Combivent Inhalation Aerosol	Atrovent + Albuterol Aerosols
Number of Participants Analyzed [units: participants]	133	122	110
Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 48 [units: number of puffs] Least Squares Mean ± Standard Error	2.0 ± 0.16	2.1 ± 0.16	1.8 ± 0.16

Statistical Analysis 1 for Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 48

Groups ^[1]	Combivent Respimat vs. Combivent Inhalation Aerosol
Method ^[2]	Mixed Models Analysis
P Value ^[3]	0.7637
Mean Difference (Final Values) ^[4]	-0.1
95% Confidence Interval	( -0.50 to 0.37 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Combivent Inhalation Aerosol
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[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.

Statistical Analysis 2 for Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 48

Groups ^[1]	Combivent Respimat vs. Atrovent + Albuterol Aerosols
Method ^[2]	Mixed Models Analysis
P Value ^[3]	0.3755
Mean Difference (Final Values) ^[4]	0.2
95% Confidence Interval	( -0.24 to 0.65 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for baseline and baseline-by-test-day interaction
[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.

34. Secondary:

Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations [ Time Frame: 48 weeks ]

Measure Type	Secondary
Measure Title	Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
Measure Description	No text entered.
Time Frame	48 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated Set is defined as all patients who were randomized and received study drug

Reporting Groups

	Description
Combivent Respimat	ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
Combivent Inhalation Aerosol	ipratropium bromide and albuterol sulfate 36/206 mcg qid
Atrovent + Albuterol Aerosols	ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid

Measured Values

	Combivent Respimat	Combivent Inhalation Aerosol	Atrovent + Albuterol Aerosols
Number of Participants Analyzed [units: participants]	157	154	154
Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations [units: participants]
None	118	113	110
1 exacerbation	27	32	37
2 exacerbations	7	9	5
3 exacerbations	3	0	2
4 exacerbations	1	0	0
5 or more exacerbations	1	0	0

No statistical analysis provided for Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations

35. Secondary:

Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Leading to Hospitalization [ Time Frame: 48 weeks ]

Measure Type	Secondary
Measure Title	Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Leading to Hospitalization
Measure Description	No text entered.
Time Frame	48 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated Set is defined as all patients who were randomized and received study drug

Reporting Groups

	Description
Combivent Respimat	ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
Combivent Inhalation Aerosol	ipratropium bromide and albuterol sulfate 36/206 mcg qid
Atrovent + Albuterol Aerosols	ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid

Measured Values

	Combivent Respimat	Combivent Inhalation Aerosol	Atrovent + Albuterol Aerosols
Number of Participants Analyzed [units: participants]	157	154	154
Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Leading to Hospitalization [units: participants]
None	147	148	146
1 exacerbation	9	6	8
2 exacerbations	0	0	0
3 or more exacerbations	1	0	0

No statistical analysis provided for Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Leading to Hospitalization

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com

No publications provided

Responsible Party:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01019694 History of Changes
Other Study ID Numbers:	1012.62
Study First Received:	November 16, 2009
Results First Received:	April 5, 2012
Last Updated:	February 13, 2013
Health Authority:	United States: Food and Drug Administration

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