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   [ Baseline and 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   [ Baseline and 12 Weeks ]

3.  Secondary:

Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second) at 6 Weeks   [ Baseline and 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   [ Day 1 (after first dose) ]

5.  Secondary:

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

6.  Secondary:

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

7.  Secondary:

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

8.  Secondary:

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

9.  Secondary:

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

11.  Secondary:

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

14.  Secondary:

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

15.  Secondary:

Change From Baseline in Peak FVC (Forced Vital Capacity) at Week 6   [ baseline and 6 Weeks (after first dose) ]

16.  Secondary:

Change From Baseline in Peak FVC (Forced Vital Capacity) at Week 12   [ Baseline and 12 Weeks ]

17.  Secondary:

FEV1 at 15 Minutes on Day 1   [ 15 minutes ]

18.  Secondary:

FEV1 at 30 Minutes on Day 1   [ 30 minutes ]

19.  Secondary:

FEV1 at 1 Hour on Day 1   [ 1 hour ]

20.  Secondary:

FEV1 at 2 Hours on Day 1   [ 2 hour ]

21.  Secondary:

FEV1 at 3 Hours on Day 1   [ 3 hour ]

22.  Secondary:

FEV1 at 4 Hours on Day 1   [ 4 hour ]

23.  Secondary:

FEV1 at 6 Hours on Day 1   [ 6 hours ]

24.  Secondary:

FEV1 at -10 Minutes at Week 6   [ 10 minutes before dosing ]

25.  Secondary:

FEV1 at 15 Minutes at Week 6   [ 15 minutes ]

26.  Secondary:

FEV1 at 30 Minutes at Week 6   [ 30 minutes ]

27.  Secondary:

FEV1 at 1 Hour at Week 6   [ 1 hour ]

28.  Secondary:

FEV1 at 2 Hours at Week 6   [ 2 hour ]

29.  Secondary:

FEV1 at 3 Hours at Week 6   [ 3 hour ]

30.  Secondary:

FEV1 at 4 Hours at Week 6   [ 4 hour ]

31.  Secondary:

FEV1 at 6 Hours at Week 6   [ 6 hour ]

32.  Secondary:

FEV1 at -10 Minutes at Week 12   [ 10 minutes before dosing ]

33.  Secondary:

FEV1 at 15 Minutes at Week 12   [ 15 minutes ]

34.  Secondary:

FEV1 at 30 Minutes at Week 12   [ 30 minutes ]

35.  Secondary:

FEV1 at 1 Hour at Week 12   [ 1 hour ]

36.  Secondary:

FEV1 at 2 Hours at Week 12   [ 2 hour ]

37.  Secondary:

FEV1 at 3 Hours at Week 12   [ 3 hour ]

38.  Secondary:

FEV1 at 4 Hours at Week 12   [ 4 hour ]

39.  Secondary:

FEV1 at 6 Hours at Week 12   [ 6 hour ]

40.  Secondary:

FVC at 15 Minutes on Day 1   [ 15 minutes ]

41.  Secondary:

FVC at 30 Minutes on Day 1   [ 30 minutes ]

42.  Secondary:

FVC at 1 Hour on Day 1   [ 1 hour ]

43.  Secondary:

FVC at 2 Hours on Day 1   [ 2 hour ]

44.  Secondary:

FVC at 3 Hours on Day 1   [ 3 hour ]

45.  Secondary:

FVC at 4 Hours on Day 1   [ 4 hour ]

46.  Secondary:

FVC at 6 Hours on Day 1   [ 6 hour ]

47.  Secondary:

FVC at -10 Minutes at Week 6   [ 10 minutes before dosing ]

48.  Secondary:

FVC at 15 Minutes at Week 6   [ 15 minutes ]

49.  Secondary:

FVC at 30 Minutes at Week 6   [ 30 minutes ]

50.  Secondary:

FVC at 1 Hour at Week 6   [ 1 hour ]

51.  Secondary:

FVC at 2 Hours at Week 6   [ 2 hour ]

52.  Secondary:

FVC at 3 Hours at Week 6   [ 3 hour ]

53.  Secondary:

FVC at 4 Hours at Week 6   [ 4 hour ]

54.  Secondary:

FVC at 6 Hours at Week 6   [ 6 hour ]

55.  Secondary:

FVC at -10 Minutes at Week 12   [ 10 minutes before dosing ]

56.  Secondary:

FVC at 15 Minutes at Week 12   [ 15 minutes ]

57.  Secondary:

FVC at 30 Minutes at Week 12   [ 30 minutes ]

58.  Secondary:

FVC at 1 Hour at Week 12   [ 1 hour ]

59.  Secondary:

FVC at 2 Hours at Week 12   [ 2 hour ]

60.  Secondary:

FVC at 3 Hours at Week 12   [ 3 hour ]

61.  Secondary:

FVC at 4 Hours at Week 12   [ 4 hour ]

62.  Secondary:

FVC at 6 Hours at Week 12   [ 6 hour ]

63.  Secondary:

Day Time Albuterol Use During Week 1   [ Week 1 ]

64.  Secondary:

Day Time Albuterol Use During Week 2   [ Week 2 ]

65.  Secondary:

Day Time Albuterol Use During Week 3   [ Week 3 ]

66.  Secondary:

Day Time Albuterol Use During Week 4   [ Week 4 ]

67.  Secondary:

Day Time Albuterol Use During Week 5   [ Week 5 ]

68.  Secondary:

Day Time Albuterol Use During Week 6   [ Week 6 ]

69.  Secondary:

Day Time Albuterol Use During Week 7   [ Week 7 ]

70.  Secondary:

Day Time Albuterol Use During Week 8   [ Week 8 ]

71.  Secondary:

Day Time Albuterol Use During Week 9   [ Week 9 ]

72.  Secondary:

Day Time Albuterol Use During Week 10   [ Week 10 ]

73.  Secondary:

Day Time Albuterol Use During Week 11   [ Week 11 ]

74.  Secondary:

Day Time Albuterol Use During Week 12   [ Week 12 ]

75.  Secondary:

Night Time Albuterol Use During Week 1   [ Week 1 ]

76.  Secondary:

Night Time Albuterol Use During Week 2   [ Week 2 ]

77.  Secondary:

Night Time Albuterol Use During Week 3   [ Week 3 ]

78.  Secondary:

Night Time Albuterol Use During Week 4   [ Week 4 ]

79.  Secondary:

Night Time Albuterol Use During Week 5   [ Week 5 ]

80.  Secondary:

Night Time Albuterol Use During Week 6   [ Week 6 ]

81.  Secondary:

Night Time Albuterol Use During Week 7   [ Week 7 ]

82.  Secondary:

Night Time Albuterol Use During Week 8   [ Week 8 ]

83.  Secondary:

Night Time Albuterol Use During Week 9   [ Week 9 ]

84.  Secondary:

Night Time Albuterol Use During Week 10   [ Week 10 ]

85.  Secondary:

Night Time Albuterol Use During Week 11   [ Week 11 ]

86.  Secondary:

Night Time Albuterol Use During Week 12   [ Week 12 ]

87.  Secondary:

Morning Peak Expiratory Flow Rate (PEFR) at Week 1   [ Week 1 ]

88.  Secondary:

Morning PEFR at Week 2   [ Week 2 ]

89.  Secondary:

Morning PEFR at Week 3   [ Week 3 ]

90.  Secondary:

Morning PEFR at Week 4   [ Week 4 ]

91.  Secondary:

Morning PEFR at Week 5   [ Week 5 ]

92.  Secondary:

Morning PEFR at Week 6   [ Week 6 ]

93.  Secondary:

Morning PEFR at Week 7   [ Week 7 ]

94.  Secondary:

Morning PEFR at Week 8   [ Week 8 ]

95.  Secondary:

Morning PEFR at Week 9   [ Week 9 ]

96.  Secondary:

Morning PEFR at Week 10   [ Week 10 ]

97.  Secondary:

Morning PEFR at Week 11   [ Week 11 ]

98.  Secondary:

Morning PEFR at Week 12   [ Week 12 ]

99.  Secondary:

Evening PEFR at Week 1   [ Week 1 ]

100.  Secondary:

Evening PEFR at Week 2   [ Week 2 ]

101.  Secondary:

Evening PEFR at Week 3   [ Week 3 ]

102.  Secondary:

Evening PEFR at Week 1   [ Week 4 ]

103.  Secondary:

Evening PEFR at Week 5   [ Week 5 ]

104.  Secondary:

Evening PEFR at Week 6   [ Week 6 ]

105.  Secondary:

Evening PEFR at Week 7   [ Week 7 ]

106.  Secondary:

Evening PEFR at Week 8   [ Week 8 ]

107.  Secondary:

Evening PEFR at Week 9   [ Week 9 ]

108.  Secondary:

Evening PEFR at Week 10   [ Week 10 ]

109.  Secondary:

Evening PEFR at Week 11   [ Week 11 ]

110.  Secondary:

Evening PEFR at Week 12   [ Week 12 ]

111.  Secondary:

Patient Global Evaluation   [ Week 6 ]

112.  Secondary:

Patient Global Evaluation   [ Week 12 ]

113.  Secondary:

Physician Global Evaluation   [ Week 6 ]

114.  Secondary:

Physician Global Evaluation   [ Week 12 ]