Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00359788
First received: August 1, 2006
Last updated: May 18, 2012
Last verified: May 2012
History of Changes
Results First Received: April 17, 2009  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Primary Purpose: Treatment
Condition: Pulmonary Disease, Chronic Obstructive
Interventions: Drug: tiotropium
Drug: Combivent (Ipratropium/Albuterol)

  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
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  



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
Tiotropium 18 mcg once daily
Combivent (Ipratropium/Albuterol) 2 actuations 4 times daily
Total Total of all reporting groups

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  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second) at 12 Weeks   [ Time Frame: Baseline and 12 Weeks ]
  Show Outcome Measure 1

2.  Primary:   Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) at 12 Weeks   [ Time Frame: Baseline and 12 Weeks ]
  Show Outcome Measure 2

3.  Secondary:   Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second) at 6 Weeks   [ Time Frame: Baseline and 6 Weeks ]
  Show Outcome Measure 3

4.  Secondary:   Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) on Day 1   [ Time Frame: Day 1 (after first dose) ]
  Show Outcome Measure 4

5.  Secondary:   Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) at Week 6   [ Time Frame: Baseline and week 6 ]
  Show Outcome Measure 5

6.  Secondary:   Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) on Day 1   [ Time Frame: Day 1 ]
  Show Outcome Measure 6

7.  Secondary:   Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) at Week 6   [ Time Frame: Baseline and 6 weeks ]
  Show Outcome Measure 7

8.  Secondary:   Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) at Week 12   [ Time Frame: Baseline and 12 weeks ]
  Show Outcome Measure 8

9.  Secondary:   Change From Baseline in Trough FVC (Forced Vital Capacity) at 12 Weeks   [ Time Frame: Baseline and 12 weeks ]
  Show Outcome Measure 9

10.  Secondary:   Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) at 12 Weeks   [ Time Frame: Baseline and 12 Weeks ]
  Show Outcome Measure 10

11.  Secondary:   Change From Baseline in Trough FVC (Forced Vital Capacity) at 6 Weeks   [ Time Frame: Baseline and 6 weeks ]
  Show Outcome Measure 11

12.  Secondary:   Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) on Day 1   [ Time Frame: Day 1 ]
  Show Outcome Measure 12

13.  Secondary:   Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) at 6 Weeks   [ Time Frame: Baseline and 6 Weeks ]
  Show Outcome Measure 13

14.  Secondary:   Change From Baseline in Peak FVC (Forced Vital Capacity) on Day 1   [ Time Frame: Day 1 ]
  Show Outcome Measure 14

15.  Secondary:   Change From Baseline in Peak FVC (Forced Vital Capacity) at Week 6   [ Time Frame: baseline and 6 Weeks (after first dose) ]
  Show Outcome Measure 15

16.  Secondary:   Change From Baseline in Peak FVC (Forced Vital Capacity) at Week 12   [ Time Frame: Baseline and 12 Weeks ]
  Show Outcome Measure 16

17.  Secondary:   FEV1 at 15 Minutes on Day 1   [ Time Frame: 15 minutes ]
  Show Outcome Measure 17

18.  Secondary:   FEV1 at 30 Minutes on Day 1   [ Time Frame: 30 minutes ]
  Show Outcome Measure 18

19.  Secondary:   FEV1 at 1 Hour on Day 1   [ Time Frame: 1 hour ]
  Show Outcome Measure 19

20.  Secondary:   FEV1 at 2 Hours on Day 1   [ Time Frame: 2 hour ]
  Show Outcome Measure 20

21.  Secondary:   FEV1 at 3 Hours on Day 1   [ Time Frame: 3 hour ]
  Show Outcome Measure 21

22.  Secondary:   FEV1 at 4 Hours on Day 1   [ Time Frame: 4 hour ]
  Show Outcome Measure 22

23.  Secondary:   FEV1 at 6 Hours on Day 1   [ Time Frame: 6 hours ]
  Show Outcome Measure 23

24.  Secondary:   FEV1 at -10 Minutes at Week 6   [ Time Frame: 10 minutes before dosing ]
  Show Outcome Measure 24

25.  Secondary:   FEV1 at 15 Minutes at Week 6   [ Time Frame: 15 minutes ]
  Show Outcome Measure 25

26.  Secondary:   FEV1 at 30 Minutes at Week 6   [ Time Frame: 30 minutes ]
  Show Outcome Measure 26

27.  Secondary:   FEV1 at 1 Hour at Week 6   [ Time Frame: 1 hour ]
  Show Outcome Measure 27

28.  Secondary:   FEV1 at 2 Hours at Week 6   [ Time Frame: 2 hour ]
  Show Outcome Measure 28

29.  Secondary:   FEV1 at 3 Hours at Week 6   [ Time Frame: 3 hour ]
  Show Outcome Measure 29

30.  Secondary:   FEV1 at 4 Hours at Week 6   [ Time Frame: 4 hour ]
  Show Outcome Measure 30

31.  Secondary:   FEV1 at 6 Hours at Week 6   [ Time Frame: 6 hour ]
  Show Outcome Measure 31

32.  Secondary:   FEV1 at -10 Minutes at Week 12   [ Time Frame: 10 minutes before dosing ]
  Show Outcome Measure 32

33.  Secondary:   FEV1 at 15 Minutes at Week 12   [ Time Frame: 15 minutes ]
  Show Outcome Measure 33

34.  Secondary:   FEV1 at 30 Minutes at Week 12   [ Time Frame: 30 minutes ]
  Show Outcome Measure 34

35.  Secondary:   FEV1 at 1 Hour at Week 12   [ Time Frame: 1 hour ]
  Show Outcome Measure 35

36.  Secondary:   FEV1 at 2 Hours at Week 12   [ Time Frame: 2 hour ]
  Show Outcome Measure 36

37.  Secondary:   FEV1 at 3 Hours at Week 12   [ Time Frame: 3 hour ]
  Show Outcome Measure 37

38.  Secondary:   FEV1 at 4 Hours at Week 12   [ Time Frame: 4 hour ]
  Show Outcome Measure 38

39.  Secondary:   FEV1 at 6 Hours at Week 12   [ Time Frame: 6 hour ]
  Show Outcome Measure 39

40.  Secondary:   FVC at 15 Minutes on Day 1   [ Time Frame: 15 minutes ]
  Show Outcome Measure 40

41.  Secondary:   FVC at 30 Minutes on Day 1   [ Time Frame: 30 minutes ]
  Show Outcome Measure 41

42.  Secondary:   FVC at 1 Hour on Day 1   [ Time Frame: 1 hour ]
  Show Outcome Measure 42

43.  Secondary:   FVC at 2 Hours on Day 1   [ Time Frame: 2 hour ]
  Show Outcome Measure 43

44.  Secondary:   FVC at 3 Hours on Day 1   [ Time Frame: 3 hour ]
  Show Outcome Measure 44

45.  Secondary:   FVC at 4 Hours on Day 1   [ Time Frame: 4 hour ]
  Show Outcome Measure 45

46.  Secondary:   FVC at 6 Hours on Day 1   [ Time Frame: 6 hour ]
  Show Outcome Measure 46

47.  Secondary:   FVC at -10 Minutes at Week 6   [ Time Frame: 10 minutes before dosing ]
  Show Outcome Measure 47

48.  Secondary:   FVC at 15 Minutes at Week 6   [ Time Frame: 15 minutes ]
  Show Outcome Measure 48

49.  Secondary:   FVC at 30 Minutes at Week 6   [ Time Frame: 30 minutes ]
  Show Outcome Measure 49

50.  Secondary:   FVC at 1 Hour at Week 6   [ Time Frame: 1 hour ]
  Show Outcome Measure 50

51.  Secondary:   FVC at 2 Hours at Week 6   [ Time Frame: 2 hour ]
  Show Outcome Measure 51

52.  Secondary:   FVC at 3 Hours at Week 6   [ Time Frame: 3 hour ]
  Show Outcome Measure 52

53.  Secondary:   FVC at 4 Hours at Week 6   [ Time Frame: 4 hour ]
  Show Outcome Measure 53

54.  Secondary:   FVC at 6 Hours at Week 6   [ Time Frame: 6 hour ]
  Show Outcome Measure 54

55.  Secondary:   FVC at -10 Minutes at Week 12   [ Time Frame: 10 minutes before dosing ]
  Show Outcome Measure 55

56.  Secondary:   FVC at 15 Minutes at Week 12   [ Time Frame: 15 minutes ]
  Show Outcome Measure 56

57.  Secondary:   FVC at 30 Minutes at Week 12   [ Time Frame: 30 minutes ]
  Show Outcome Measure 57

58.  Secondary:   FVC at 1 Hour at Week 12   [ Time Frame: 1 hour ]
  Show Outcome Measure 58

59.  Secondary:   FVC at 2 Hours at Week 12   [ Time Frame: 2 hour ]
  Show Outcome Measure 59

60.  Secondary:   FVC at 3 Hours at Week 12   [ Time Frame: 3 hour ]
  Show Outcome Measure 60

61.  Secondary:   FVC at 4 Hours at Week 12   [ Time Frame: 4 hour ]
  Show Outcome Measure 61

62.  Secondary:   FVC at 6 Hours at Week 12   [ Time Frame: 6 hour ]
  Show Outcome Measure 62

63.  Secondary:   Day Time Albuterol Use During Week 1   [ Time Frame: Week 1 ]
  Show Outcome Measure 63

64.  Secondary:   Day Time Albuterol Use During Week 2   [ Time Frame: Week 2 ]
  Show Outcome Measure 64

65.  Secondary:   Day Time Albuterol Use During Week 3   [ Time Frame: Week 3 ]
  Show Outcome Measure 65

66.  Secondary:   Day Time Albuterol Use During Week 4   [ Time Frame: Week 4 ]
  Show Outcome Measure 66

67.  Secondary:   Day Time Albuterol Use During Week 5   [ Time Frame: Week 5 ]
  Show Outcome Measure 67

68.  Secondary:   Day Time Albuterol Use During Week 6   [ Time Frame: Week 6 ]
  Show Outcome Measure 68

69.  Secondary:   Day Time Albuterol Use During Week 7   [ Time Frame: Week 7 ]
  Show Outcome Measure 69

70.  Secondary:   Day Time Albuterol Use During Week 8   [ Time Frame: Week 8 ]
  Show Outcome Measure 70

71.  Secondary:   Day Time Albuterol Use During Week 9   [ Time Frame: Week 9 ]
  Show Outcome Measure 71

72.  Secondary:   Day Time Albuterol Use During Week 10   [ Time Frame: Week 10 ]
  Show Outcome Measure 72

73.  Secondary:   Day Time Albuterol Use During Week 11   [ Time Frame: Week 11 ]
  Show Outcome Measure 73

74.  Secondary:   Day Time Albuterol Use During Week 12   [ Time Frame: Week 12 ]
  Show Outcome Measure 74

75.  Secondary:   Night Time Albuterol Use During Week 1   [ Time Frame: Week 1 ]
  Show Outcome Measure 75

76.  Secondary:   Night Time Albuterol Use During Week 2   [ Time Frame: Week 2 ]
  Show Outcome Measure 76

77.  Secondary:   Night Time Albuterol Use During Week 3   [ Time Frame: Week 3 ]
  Show Outcome Measure 77

78.  Secondary:   Night Time Albuterol Use During Week 4   [ Time Frame: Week 4 ]
  Show Outcome Measure 78

79.  Secondary:   Night Time Albuterol Use During Week 5   [ Time Frame: Week 5 ]
  Show Outcome Measure 79

80.  Secondary:   Night Time Albuterol Use During Week 6   [ Time Frame: Week 6 ]
  Show Outcome Measure 80

81.  Secondary:   Night Time Albuterol Use During Week 7   [ Time Frame: Week 7 ]
  Show Outcome Measure 81

82.  Secondary:   Night Time Albuterol Use During Week 8   [ Time Frame: Week 8 ]
  Show Outcome Measure 82

83.  Secondary:   Night Time Albuterol Use During Week 9   [ Time Frame: Week 9 ]
  Show Outcome Measure 83

84.  Secondary:   Night Time Albuterol Use During Week 10   [ Time Frame: Week 10 ]
  Show Outcome Measure 84

85.  Secondary:   Night Time Albuterol Use During Week 11   [ Time Frame: Week 11 ]
  Show Outcome Measure 85

86.  Secondary:   Night Time Albuterol Use During Week 12   [ Time Frame: Week 12 ]
  Show Outcome Measure 86

87.  Secondary:   Morning Peak Expiratory Flow Rate (PEFR) at Week 1   [ Time Frame: Week 1 ]
  Show Outcome Measure 87

88.  Secondary:   Morning PEFR at Week 2   [ Time Frame: Week 2 ]
  Show Outcome Measure 88

89.  Secondary:   Morning PEFR at Week 3   [ Time Frame: Week 3 ]
  Show Outcome Measure 89

90.  Secondary:   Morning PEFR at Week 4   [ Time Frame: Week 4 ]
  Show Outcome Measure 90

91.  Secondary:   Morning PEFR at Week 5   [ Time Frame: Week 5 ]
  Show Outcome Measure 91

92.  Secondary:   Morning PEFR at Week 6   [ Time Frame: Week 6 ]
  Show Outcome Measure 92

93.  Secondary:   Morning PEFR at Week 7   [ Time Frame: Week 7 ]
  Show Outcome Measure 93

94.  Secondary:   Morning PEFR at Week 8   [ Time Frame: Week 8 ]
  Show Outcome Measure 94

95.  Secondary:   Morning PEFR at Week 9   [ Time Frame: Week 9 ]
  Show Outcome Measure 95

96.  Secondary:   Morning PEFR at Week 10   [ Time Frame: Week 10 ]
  Show Outcome Measure 96

97.  Secondary:   Morning PEFR at Week 11   [ Time Frame: Week 11 ]
  Show Outcome Measure 97

98.  Secondary:   Morning PEFR at Week 12   [ Time Frame: Week 12 ]
  Show Outcome Measure 98

99.  Secondary:   Evening PEFR at Week 1   [ Time Frame: Week 1 ]
  Show Outcome Measure 99

100.  Secondary:   Evening PEFR at Week 2   [ Time Frame: Week 2 ]
  Show Outcome Measure 100

101.  Secondary:   Evening PEFR at Week 3   [ Time Frame: Week 3 ]
  Show Outcome Measure 101

102.  Secondary:   Evening PEFR at Week 1   [ Time Frame: Week 4 ]
  Show Outcome Measure 102

103.  Secondary:   Evening PEFR at Week 5   [ Time Frame: Week 5 ]
  Show Outcome Measure 103

104.  Secondary:   Evening PEFR at Week 6   [ Time Frame: Week 6 ]
  Show Outcome Measure 104

105.  Secondary:   Evening PEFR at Week 7   [ Time Frame: Week 7 ]
  Show Outcome Measure 105

106.  Secondary:   Evening PEFR at Week 8   [ Time Frame: Week 8 ]
  Show Outcome Measure 106

107.  Secondary:   Evening PEFR at Week 9   [ Time Frame: Week 9 ]
  Show Outcome Measure 107

108.  Secondary:   Evening PEFR at Week 10   [ Time Frame: Week 10 ]
  Show Outcome Measure 108

109.  Secondary:   Evening PEFR at Week 11   [ Time Frame: Week 11 ]
  Show Outcome Measure 109

110.  Secondary:   Evening PEFR at Week 12   [ Time Frame: Week 12 ]
  Show Outcome Measure 110

111.  Secondary:   Patient Global Evaluation   [ Time Frame: Week 6 ]
  Show Outcome Measure 111

112.  Secondary:   Patient Global Evaluation   [ Time Frame: Week 12 ]
  Show Outcome Measure 112

113.  Secondary:   Physician Global Evaluation   [ Time Frame: Week 6 ]
  Show Outcome Measure 113

114.  Secondary:   Physician Global Evaluation   [ Time Frame: Week 12 ]
  Show Outcome Measure 114


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Hide Other Adverse Events

Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

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

Other Adverse Events
    Tiotropium     Combivent (Ipratropium/Albuterol)  
Total, other (not including serious) adverse events      
# participants affected     14     13  
Respiratory, thoracic and mediastinal disorders      
Chronic Obstructive Pulmonary Disease exacerbations † 1    
# participants affected / at risk     14/173 (8.09%)     13/176 (7.39%)  
† Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 10.1



  More Information
  Hide More Information

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:
unchecked 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.
unchecked 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.


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, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00359788     History of Changes
Other Study ID Numbers: 205.325
Study First Received: August 1, 2006
Results First Received: April 17, 2009
Last Updated: May 18, 2012
Health Authority: United States: Food and Drug Administration