Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
ClinicalTrials.gov Identifier:
NCT00359788
First received: August 1, 2006
Last updated: May 7, 2014
Last verified: September 2013
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
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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
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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  



  Baseline Characteristics
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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.
No text entered.

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 ]

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 ]

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Measure Type Secondary
Measure Title FEV1 at 3 Hours at Week 12
Measure Description No text entered.
Time Frame 3 hour  
Safety Issue  

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.
Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

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

Measured Values
    Tiotropium     Combivent (Ipratropium/Albuterol)  
Number of Participants Analyzed  
[units: participants]
  152     158  
FEV1 at 3 Hours at Week 12  
[units: Liters]
Least Squares Mean ± Standard Error
  1.353  ± 0.021     1.333  ± 0.02  


Statistical Analysis 1 for FEV1 at 3 Hours at Week 12
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.4814
Mean Difference (Final Values) [4] 0.02
95% Confidence Interval ( -0.037 to 0.078 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.
[4] Other relevant estimation information:
  No text entered.



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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

102.  Secondary:   Evening PEFR at Week 4   [ Time Frame: Week 4 ]

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

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

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

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

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

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

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

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

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

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

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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information