Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

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

Participant Flow:   Overall Study

	Tiotropium	Combivent (Ipratropium/Albuterol)
STARTED	173	176
COMPLETED	150	159
NOT COMPLETED	23	17
Adverse Event	11	10
Lack of Efficacy	1	2
Lost to Follow-up	3	2
Withdrawal by Subject	4	1
Protocol Violation	4	2

Reporting Groups

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

Baseline Measures

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

1.  Primary:

Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second) at 12 Weeks

2.  Primary:

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

3.  Secondary:

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

4.  Secondary:

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

5.  Secondary:

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

6.  Secondary:

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

7.  Secondary:

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

8.  Secondary:

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

9.  Secondary:

Change From Baseline in Trough FVC (Forced Vital Capacity) at 12 Weeks

10.  Secondary:

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

11.  Secondary:

Change From Baseline in Trough FVC (Forced Vital Capacity) at 6 Weeks

12.  Secondary:

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

13.  Secondary:

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

14.  Secondary:

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

15.  Secondary:

Change From Baseline in Peak FVC (Forced Vital Capacity) at Week 6

16.  Secondary:

Change From Baseline in Peak FVC (Forced Vital Capacity) at Week 12

17.  Secondary:

FEV1 at 15 Minutes on Day 1

18.  Secondary:

FEV1 at 30 Minutes on Day 1

19.  Secondary:

FEV1 at 1 Hour on Day 1

20.  Secondary:

FEV1 at 2 Hours on Day 1

21.  Secondary:

FEV1 at 3 Hours on Day 1

22.  Secondary:

FEV1 at 4 Hours on Day 1

23.  Secondary:

FEV1 at 6 Hours on Day 1

24.  Secondary:

FEV1 at -10 Minutes at Week 6

25.  Secondary:

FEV1 at 15 Minutes at Week 6

26.  Secondary:

FEV1 at 30 Minutes at Week 6

27.  Secondary:

FEV1 at 1 Hour at Week 6

28.  Secondary:

FEV1 at 2 Hours at Week 6

29.  Secondary:

FEV1 at 3 Hours at Week 6

30.  Secondary:

FEV1 at 4 Hours at Week 6

31.  Secondary:

FEV1 at 6 Hours at Week 6

32.  Secondary:

FEV1 at -10 Minutes at Week 12

33.  Secondary:

FEV1 at 15 Minutes at Week 12

34.  Secondary:

FEV1 at 30 Minutes at Week 12

35.  Secondary:

FEV1 at 1 Hour at Week 12

36.  Secondary:

FEV1 at 2 Hours at Week 12

37.  Secondary:

FEV1 at 3 Hours at Week 12

38.  Secondary:

FEV1 at 4 Hours at Week 12

39.  Secondary:

FEV1 at 6 Hours at Week 12

40.  Secondary:

FVC at 15 Minutes on Day 1

41.  Secondary:

FVC at 30 Minutes on Day 1

42.  Secondary:

FVC at 1 Hour on Day 1

43.  Secondary:

FVC at 2 Hours on Day 1

44.  Secondary:

FVC at 3 Hours on Day 1

45.  Secondary:

FVC at 4 Hours on Day 1

46.  Secondary:

FVC at 6 Hours on Day 1

47.  Secondary:

FVC at -10 Minutes at Week 6

48.  Secondary:

FVC at 15 Minutes at Week 6

49.  Secondary:

FVC at 30 Minutes at Week 6

50.  Secondary:

FVC at 1 Hour at Week 6

51.  Secondary:

FVC at 2 Hours at Week 6

52.  Secondary:

FVC at 3 Hours at Week 6

53.  Secondary:

FVC at 4 Hours at Week 6

54.  Secondary:

FVC at 6 Hours at Week 6

55.  Secondary:

FVC at -10 Minutes at Week 12

56.  Secondary:

FVC at 15 Minutes at Week 12

57.  Secondary:

FVC at 30 Minutes at Week 12

58.  Secondary:

FVC at 1 Hour at Week 12

59.  Secondary:

FVC at 2 Hours at Week 12

60.  Secondary:

FVC at 3 Hours at Week 12

61.  Secondary:

FVC at 4 Hours at Week 12

62.  Secondary:

FVC at 6 Hours at Week 12

63.  Secondary:

Day Time Albuterol Use During Week 1

64.  Secondary:

Day Time Albuterol Use During Week 2

65.  Secondary:

Day Time Albuterol Use During Week 3

66.  Secondary:

Day Time Albuterol Use During Week 4

67.  Secondary:

Day Time Albuterol Use During Week 5

68.  Secondary:

Day Time Albuterol Use During Week 6

69.  Secondary:

Day Time Albuterol Use During Week 7

70.  Secondary:

Day Time Albuterol Use During Week 8

71.  Secondary:

Day Time Albuterol Use During Week 9

72.  Secondary:

Day Time Albuterol Use During Week 10

73.  Secondary:

Day Time Albuterol Use During Week 11

74.  Secondary:

Day Time Albuterol Use During Week 12

75.  Secondary:

Night Time Albuterol Use During Week 1

76.  Secondary:

Night Time Albuterol Use During Week 2

77.  Secondary:

Night Time Albuterol Use During Week 3

78.  Secondary:

Night Time Albuterol Use During Week 4

79.  Secondary:

Night Time Albuterol Use During Week 5

80.  Secondary:

Night Time Albuterol Use During Week 6

81.  Secondary:

Night Time Albuterol Use During Week 7

82.  Secondary:

Night Time Albuterol Use During Week 8

83.  Secondary:

Night Time Albuterol Use During Week 9

84.  Secondary:

Night Time Albuterol Use During Week 10

85.  Secondary:

Night Time Albuterol Use During Week 11

86.  Secondary:

Night Time Albuterol Use During Week 12

87.  Secondary:

Morning Peak Expiratory Flow Rate (PEFR) at Week 1

88.  Secondary:

Morning PEFR at Week 2

89.  Secondary:

Morning PEFR at Week 3

90.  Secondary:

Morning PEFR at Week 4

91.  Secondary:

Morning PEFR at Week 5

92.  Secondary:

Morning PEFR at Week 6

93.  Secondary:

Morning PEFR at Week 7

94.  Secondary:

Morning PEFR at Week 8

95.  Secondary:

Morning PEFR at Week 9

96.  Secondary:

Morning PEFR at Week 10

97.  Secondary:

Morning PEFR at Week 11

98.  Secondary:

Morning PEFR at Week 12

99.  Secondary:

Evening PEFR at Week 1

100.  Secondary:

Evening PEFR at Week 2

101.  Secondary:

Evening PEFR at Week 3

102.  Secondary:

Evening PEFR at Week 1

103.  Secondary:

Evening PEFR at Week 5

104.  Secondary:

Evening PEFR at Week 6

105.  Secondary:

Evening PEFR at Week 7

106.  Secondary:

Evening PEFR at Week 8

107.  Secondary:

Evening PEFR at Week 9

108.  Secondary:

Evening PEFR at Week 10

109.  Secondary:

Evening PEFR at Week 11

110.  Secondary:

Evening PEFR at Week 12

111.  Secondary:

Patient Global Evaluation

112.  Secondary:

Patient Global Evaluation

113.  Secondary:

Physician Global Evaluation

114.  Secondary:

Physician Global Evaluation