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A Trial Comparing Treatment With Tiotropium Inhalation Capsules to Combivent Inhalation Aerosol in COPD Patients.
This study has been completed.
Study NCT00359788   Information provided by Boehringer Ingelheim Pharmaceuticals
First Received: August 1, 2006   Last Updated: November 12, 2009   History of Changes
Study Type: Interventional
Study Design: Parallel Assignment
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
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
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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



  Outcome Measures
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1.  Primary:   Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second) at 12 Weeks   [ Baseline and 12 Weeks ]
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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 ]
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3.  Secondary:   Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second) at 6 Weeks   [ Baseline and 6 Weeks ]
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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) ]
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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 ]
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6.  Secondary:   Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) on Day 1   [ Day 1 ]
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7.  Secondary:   Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) at Week 6   [ Baseline and 6 weeks ]
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8.  Secondary:   Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) at Week 12   [ Baseline and 12 weeks ]
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9.  Secondary:   Change From Baseline in Trough FVC (Forced Vital Capacity) at 12 Weeks   [ Baseline and 12 weeks ]
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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 ]
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11.  Secondary:   Change From Baseline in Trough FVC (Forced Vital Capacity) at 6 Weeks   [ Baseline and 6 weeks ]
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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 ]
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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 ]
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14.  Secondary:   Change From Baseline in Peak FVC (Forced Vital Capacity) on Day 1   [ Day 1 ]
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15.  Secondary:   Change From Baseline in Peak FVC (Forced Vital Capacity) at Week 6   [ baseline and 6 Weeks (after first dose) ]
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16.  Secondary:   Change From Baseline in Peak FVC (Forced Vital Capacity) at Week 12   [ Baseline and 12 Weeks ]
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17.  Secondary:   FEV1 at 15 Minutes on Day 1   [ 15 minutes ]
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18.  Secondary:   FEV1 at 30 Minutes on Day 1   [ 30 minutes ]
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19.  Secondary:   FEV1 at 1 Hour on Day 1   [ 1 hour ]
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20.  Secondary:   FEV1 at 2 Hours on Day 1   [ 2 hour ]
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21.  Secondary:   FEV1 at 3 Hours on Day 1   [ 3 hour ]
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22.  Secondary:   FEV1 at 4 Hours on Day 1   [ 4 hour ]
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23.  Secondary:   FEV1 at 6 Hours on Day 1   [ 6 hours ]
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24.  Secondary:   FEV1 at -10 Minutes at Week 6   [ 10 minutes before dosing ]
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25.  Secondary:   FEV1 at 15 Minutes at Week 6   [ 15 minutes ]
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26.  Secondary:   FEV1 at 30 Minutes at Week 6   [ 30 minutes ]
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27.  Secondary:   FEV1 at 1 Hour at Week 6   [ 1 hour ]
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28.  Secondary:   FEV1 at 2 Hours at Week 6   [ 2 hour ]
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29.  Secondary:   FEV1 at 3 Hours at Week 6   [ 3 hour ]
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30.  Secondary:   FEV1 at 4 Hours at Week 6   [ 4 hour ]
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31.  Secondary:   FEV1 at 6 Hours at Week 6   [ 6 hour ]
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32.  Secondary:   FEV1 at -10 Minutes at Week 12   [ 10 minutes before dosing ]
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33.  Secondary:   FEV1 at 15 Minutes at Week 12   [ 15 minutes ]
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34.  Secondary:   FEV1 at 30 Minutes at Week 12   [ 30 minutes ]
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35.  Secondary:   FEV1 at 1 Hour at Week 12   [ 1 hour ]
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36.  Secondary:   FEV1 at 2 Hours at Week 12   [ 2 hour ]
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37.  Secondary:   FEV1 at 3 Hours at Week 12   [ 3 hour ]
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38.  Secondary:   FEV1 at 4 Hours at Week 12   [ 4 hour ]
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39.  Secondary:   FEV1 at 6 Hours at Week 12   [ 6 hour ]
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40.  Secondary:   FVC at 15 Minutes on Day 1   [ 15 minutes ]
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41.  Secondary:   FVC at 30 Minutes on Day 1   [ 30 minutes ]
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42.  Secondary:   FVC at 1 Hour on Day 1   [ 1 hour ]
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43.  Secondary:   FVC at 2 Hours on Day 1   [ 2 hour ]
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44.  Secondary:   FVC at 3 Hours on Day 1   [ 3 hour ]
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45.  Secondary:   FVC at 4 Hours on Day 1   [ 4 hour ]
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46.  Secondary:   FVC at 6 Hours on Day 1   [ 6 hour ]
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47.  Secondary:   FVC at -10 Minutes at Week 6   [ 10 minutes before dosing ]
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48.  Secondary:   FVC at 15 Minutes at Week 6   [ 15 minutes ]
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49.  Secondary:   FVC at 30 Minutes at Week 6   [ 30 minutes ]
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50.  Secondary:   FVC at 1 Hour at Week 6   [ 1 hour ]
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51.  Secondary:   FVC at 2 Hours at Week 6   [ 2 hour ]
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52.  Secondary:   FVC at 3 Hours at Week 6   [ 3 hour ]
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53.  Secondary:   FVC at 4 Hours at Week 6   [ 4 hour ]
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54.  Secondary:   FVC at 6 Hours at Week 6   [ 6 hour ]
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55.  Secondary:   FVC at -10 Minutes at Week 12   [ 10 minutes before dosing ]
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56.  Secondary:   FVC at 15 Minutes at Week 12   [ 15 minutes ]
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57.  Secondary:   FVC at 30 Minutes at Week 12   [ 30 minutes ]
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58.  Secondary:   FVC at 1 Hour at Week 12   [ 1 hour ]
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59.  Secondary:   FVC at 2 Hours at Week 12   [ 2 hour ]
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60.  Secondary:   FVC at 3 Hours at Week 12   [ 3 hour ]
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61.  Secondary:   FVC at 4 Hours at Week 12   [ 4 hour ]
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62.  Secondary:   FVC at 6 Hours at Week 12   [ 6 hour ]
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63.  Secondary:   Day Time Albuterol Use During Week 1   [ Week 1 ]
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64.  Secondary:   Day Time Albuterol Use During Week 2   [ Week 2 ]
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65.  Secondary:   Day Time Albuterol Use During Week 3   [ Week 3 ]
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66.  Secondary:   Day Time Albuterol Use During Week 4   [ Week 4 ]
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67.  Secondary:   Day Time Albuterol Use During Week 5   [ Week 5 ]
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68.  Secondary:   Day Time Albuterol Use During Week 6   [ Week 6 ]
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69.  Secondary:   Day Time Albuterol Use During Week 7   [ Week 7 ]
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Measure Type Secondary
Measure Title Day Time Albuterol Use During Week 7
Measure Description Puffs of rescue albuterol used during the day in week 7
Time Frame Week 7  
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] 		151 158
Day Time Albuterol Use During Week 7
[units: Puffs per day]
Least Squares Mean ± Standard Error 		1.313 ± 0.116 1.398 ± 0.114


Statistical Analysis 1 for Day Time Albuterol Use During Week 7
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.6048
Mean Difference (Final Values) [4] -0.085
95% Confidence Interval ( -0.408 to 0.238 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant 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:
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[4] Other relevant estimation information:
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70.  Secondary:   Day Time Albuterol Use During Week 8   [ Week 8 ]
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71.  Secondary:   Day Time Albuterol Use During Week 9   [ Week 9 ]
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72.  Secondary:   Day Time Albuterol Use During Week 10   [ Week 10 ]
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73.  Secondary:   Day Time Albuterol Use During Week 11   [ Week 11 ]
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74.  Secondary:   Day Time Albuterol Use During Week 12   [ Week 12 ]
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75.  Secondary:   Night Time Albuterol Use During Week 1   [ Week 1 ]
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76.  Secondary:   Night Time Albuterol Use During Week 2   [ Week 2 ]
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77.  Secondary:   Night Time Albuterol Use During Week 3   [ Week 3 ]
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78.  Secondary:   Night Time Albuterol Use During Week 4   [ Week 4 ]
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79.  Secondary:   Night Time Albuterol Use During Week 5   [ Week 5 ]
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80.  Secondary:   Night Time Albuterol Use During Week 6   [ Week 6 ]
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81.  Secondary:   Night Time Albuterol Use During Week 7   [ Week 7 ]
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82.  Secondary:   Night Time Albuterol Use During Week 8   [ Week 8 ]
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83.  Secondary:   Night Time Albuterol Use During Week 9   [ Week 9 ]
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84.  Secondary:   Night Time Albuterol Use During Week 10   [ Week 10 ]
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85.  Secondary:   Night Time Albuterol Use During Week 11   [ Week 11 ]
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86.  Secondary:   Night Time Albuterol Use During Week 12   [ Week 12 ]
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87.  Secondary:   Morning Peak Expiratory Flow Rate (PEFR) at Week 1   [ Week 1 ]
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88.  Secondary:   Morning PEFR at Week 2   [ Week 2 ]
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89.  Secondary:   Morning PEFR at Week 3   [ Week 3 ]
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90.  Secondary:   Morning PEFR at Week 4   [ Week 4 ]
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91.  Secondary:   Morning PEFR at Week 5   [ Week 5 ]
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92.  Secondary:   Morning PEFR at Week 6   [ Week 6 ]
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93.  Secondary:   Morning PEFR at Week 7   [ Week 7 ]
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94.  Secondary:   Morning PEFR at Week 8   [ Week 8 ]
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95.  Secondary:   Morning PEFR at Week 9   [ Week 9 ]
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96.  Secondary:   Morning PEFR at Week 10   [ Week 10 ]
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97.  Secondary:   Morning PEFR at Week 11   [ Week 11 ]
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98.  Secondary:   Morning PEFR at Week 12   [ Week 12 ]
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99.  Secondary:   Evening PEFR at Week 1   [ Week 1 ]
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100.  Secondary:   Evening PEFR at Week 2   [ Week 2 ]
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101.  Secondary:   Evening PEFR at Week 3   [ Week 3 ]
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102.  Secondary:   Evening PEFR at Week 1   [ Week 4 ]
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103.  Secondary:   Evening PEFR at Week 5   [ Week 5 ]
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104.  Secondary:   Evening PEFR at Week 6   [ Week 6 ]
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105.  Secondary:   Evening PEFR at Week 7   [ Week 7 ]
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106.  Secondary:   Evening PEFR at Week 8   [ Week 8 ]
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107.  Secondary:   Evening PEFR at Week 9   [ Week 9 ]
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108.  Secondary:   Evening PEFR at Week 10   [ Week 10 ]
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109.  Secondary:   Evening PEFR at Week 11   [ Week 11 ]
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110.  Secondary:   Evening PEFR at Week 12   [ Week 12 ]
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111.  Secondary:   Patient Global Evaluation   [ Week 6 ]
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112.  Secondary:   Patient Global Evaluation   [ Week 12 ]
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113.  Secondary:   Physician Global Evaluation   [ Week 6 ]
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114.  Secondary:   Physician Global Evaluation   [ Week 12 ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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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 ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 205.325
Study First Received: August 1, 2006
Results First Received: April 17, 2009
Last Updated: November 12, 2009
ClinicalTrials.gov Identifier: NCT00359788     History of Changes
Health Authority: United States: Food and Drug Administration





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