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

Participant Flow:   Overall Study

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

Reporting Groups

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

Baseline Measures

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

1.  Primary:

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

2.  Primary:

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

3.  Primary:

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

4.  Secondary:

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

5.  Secondary:

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

6.  Secondary:

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

7.  Secondary:

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

8.  Secondary:

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

9.  Secondary:

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

10.  Secondary:

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

11.  Secondary:

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

12.  Secondary:

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

13.  Secondary:

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

14.  Secondary:

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

15.  Secondary:

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

16.  Secondary:

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

17.  Secondary:

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

18.  Secondary:

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

19.  Secondary:

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

20.  Secondary:

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

21.  Secondary:

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

22.  Secondary:

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

23.  Secondary:

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

24.  Secondary:

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

25.  Secondary:

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

26.  Secondary:

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

27.  Secondary:

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

28.  Secondary:

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

29.  Secondary:

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

30.  Secondary:

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

31.  Secondary:

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

32.  Secondary:

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

33.  Secondary:

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

34.  Secondary:

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

35.  Secondary:

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

36.  Secondary:

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

37.  Secondary:

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

38.  Secondary:

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

39.  Secondary:

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

40.  Secondary:

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

41.  Secondary:

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

42.  Secondary:

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

43.  Secondary:

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

44.  Secondary:

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

45.  Secondary:

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

46.  Secondary:

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

47.  Secondary:

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

48.  Secondary:

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

49.  Secondary:

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

50.  Secondary:

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

51.  Secondary:

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

52.  Secondary:

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

53.  Secondary:

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

54.  Secondary:

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

55.  Secondary:

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

56.  Secondary:

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

57.  Secondary:

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

58.  Secondary:

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

59.  Secondary:

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

60.  Secondary:

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

61.  Secondary:

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

62.  Secondary:

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

63.  Secondary:

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

64.  Secondary:

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

65.  Secondary:

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

66.  Secondary:

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

67.  Secondary:

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

68.  Secondary:

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

69.  Secondary:

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

70.  Secondary:

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

71.  Secondary:

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

72.  Secondary:

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

73.  Secondary:

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

74.  Secondary:

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

75.  Secondary:

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