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Evaluation of the Long- Term Effects of Spiriva on Lung Function in COPD Patients

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00144339
First received: September 2, 2005
Last updated: July 10, 2012
Last verified: July 2012
History of Changes
Results First Received: February 21, 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: placebo

  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
09 Jan 2003 – 22 Feb 2008; 490 centers in 37 countries

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
Placebo once daily
Tiotropium Bromide Inhalation Capsules 18 Mcg once daily

Participant Flow:   Overall Study
    Placebo     Tiotropium Bromide Inhalation Capsules 18 Mcg  
STARTED     3006     2986  
COMPLETED     1648     1887  
NOT COMPLETED     1358     1099  



  Baseline Characteristics
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  Outcome Measures
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1.  Primary:   Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years   [ Time Frame: From day 30 to 4 years ]
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2.  Primary:   Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years   [ Time Frame: From day 30 to 4 years ]
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3.  Secondary:   Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment   [ Time Frame: Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days. ]
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4.  Secondary:   Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment   [ Time Frame: Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days ]
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5.  Secondary:   Pre-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 30 to 4 Years   [ Time Frame: From day 30 to 4 years ]
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6.  Secondary:   Post-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 30 to 4 Years   [ Time Frame: From day 30 to 4 years ]
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7.  Secondary:   Pre-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 30 to 4 Years   [ Time Frame: From day 30 to 4 years ]
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8.  Secondary:   Post-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 30 to 4 Years   [ Time Frame: From day 30 to 4 years ]
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9.  Secondary:   Rate of Decline of St George's Respiratory Questionnaire (SGRQ) Total Score   [ Time Frame: From month 6 to 4 years ]
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10.  Secondary:   Pre-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment   [ Time Frame: Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days. ]
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11.  Secondary:   Post-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment   [ Time Frame: Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days ]
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12.  Secondary:   Pre-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment   [ Time Frame: Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days ]
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13.  Secondary:   Post-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment   [ Time Frame: Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days ]
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14.  Secondary:   Time to First Exacerbation   [ Time Frame: From Day 1 to 4 years ]
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15.  Secondary:   Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Patient Year   [ Time Frame: Day 1 to 4 years ]
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16.  Secondary:   Number and Percentage of Patients With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation   [ Time Frame: Day 1 to 4 years ]
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17.  Secondary:   Number of Exacerbation Days Per Patient Year   [ Time Frame: Day 1 to 4 years ]
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18.  Secondary:   Number and Percentage of Patients With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Leading to Hospitalization   [ Time Frame: Day 1 to 4 years ]
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19.  Secondary:   Number and Percentage of Patients With Time to First Exacerbation Leading to Hospitalization   [ Time Frame: From Day 1 to 4 years ]
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20.  Secondary:   Number of Exacerbation Leading to Hospitalization   [ Time Frame: From Day 1 to 4 years ]
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21.  Secondary:   Days of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Leading to Hospitalization   [ Time Frame: From Day 1 to 4 years ]
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22.  Secondary:   Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 1   [ Time Frame: Month 1 ]
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23.  Secondary:   Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 1   [ Time Frame: Month 1 ]
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24.  Secondary:   Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 6   [ Time Frame: Month 6 ]
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25.  Secondary:   Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 6   [ Time Frame: Month 6 ]
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26.  Secondary:   Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 12   [ Time Frame: Month 12 ]
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27.  Secondary:   Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 12   [ Time Frame: Month 12 ]
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28.  Secondary:   Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 18   [ Time Frame: Month 18 ]
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29.  Secondary:   Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 18   [ Time Frame: Month 18 ]
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30.  Secondary:   Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 24   [ Time Frame: Month 24 ]
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31.  Secondary:   Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 24   [ Time Frame: Month 24 ]
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32.  Secondary:   Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 30   [ Time Frame: Month 30 ]
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33.  Secondary:   Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 30   [ Time Frame: Month 30 ]
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34.  Secondary:   Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 36   [ Time Frame: Month 36 ]
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35.  Secondary:   Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 36   [ Time Frame: Month 36 ]
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36.  Secondary:   Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 42   [ Time Frame: Month 42 ]
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37.  Secondary:   Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 42   [ Time Frame: Month 42 ]
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38.  Secondary:   Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 48   [ Time Frame: Month 48 ]
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39.  Secondary:   Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 48   [ Time Frame: Month 48 ]
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40.  Secondary:   Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 1   [ Time Frame: Month 1 ]
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41.  Secondary:   Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 1   [ Time Frame: Month 1 ]
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42.  Secondary:   Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 6   [ Time Frame: Month 6 ]
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43.  Secondary:   Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 6   [ Time Frame: Month 6 ]
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44.  Secondary:   Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 12   [ Time Frame: Month 12 ]
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45.  Secondary:   Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 12   [ Time Frame: Month 12 ]
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46.  Secondary:   Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 18   [ Time Frame: Month 18 ]
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47.  Secondary:   Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 18   [ Time Frame: Month 18 ]
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48.  Secondary:   Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 24   [ Time Frame: Month 24 ]
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49.  Secondary:   Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 24   [ Time Frame: Month 24 ]
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50.  Secondary:   Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 30   [ Time Frame: Month 30 ]
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51.  Secondary:   Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 30   [ Time Frame: Month 30 ]
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52.  Secondary:   Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 36   [ Time Frame: Month 36 ]
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53.  Secondary:   Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 36   [ Time Frame: Month 36 ]
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54.  Secondary:   Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 42   [ Time Frame: Month 42 ]
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55.  Secondary:   Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 42   [ Time Frame: Month 42 ]
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56.  Secondary:   Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 48   [ Time Frame: Month 48 ]
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57.  Secondary:   Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 48   [ Time Frame: Month 48 ]
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58.  Secondary:   Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 1   [ Time Frame: Month 1 ]
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59.  Secondary:   Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 1   [ Time Frame: Month 1 ]
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60.  Secondary:   Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 6   [ Time Frame: Month 6 ]
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61.  Secondary:   Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 6   [ Time Frame: Month 6 ]
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62.  Secondary:   Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 12   [ Time Frame: Month 12 ]
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63.  Secondary:   Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 12   [ Time Frame: Month 12 ]
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64.  Secondary:   Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 18   [ Time Frame: Month 18 ]
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65.  Secondary:   Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 18   [ Time Frame: Month 18 ]
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66.  Secondary:   Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 24   [ Time Frame: Month 24 ]
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67.  Secondary:   Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 24   [ Time Frame: Month 24 ]
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68.  Secondary:   Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 30   [ Time Frame: Month 30 ]
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69.  Secondary:   Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 30   [ Time Frame: Month 30 ]
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70.  Secondary:   Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 36   [ Time Frame: Month 36 ]
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71.  Secondary:   Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 36   [ Time Frame: Month 36 ]
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72.  Secondary:   Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 42   [ Time Frame: Month 42 ]
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73.  Secondary:   Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 42   [ Time Frame: Month 42 ]
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74.  Secondary:   Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 48   [ Time Frame: Month 48 ]
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75.  Secondary:   Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 48   [ Time Frame: Month 48 ]
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76.  Secondary:   Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 6   [ Time Frame: Month 6 ]
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77.  Secondary:   Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 12   [ Time Frame: Month 12 ]
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78.  Secondary:   Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 18   [ Time Frame: Month 18 ]
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79.  Secondary:   Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 24   [ Time Frame: Month 24 ]
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80.  Secondary:   Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 30   [ Time Frame: Month 30 ]
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81.  Secondary:   Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 36   [ Time Frame: Month 36 ]
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82.  Secondary:   Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 42   [ Time Frame: Month 42 ]
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83.  Secondary:   Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 48   [ Time Frame: Month 48 ]
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84.  Secondary:   Number and Percentage of Participants With All Cause Death and Time to Event Analysis (On-treatment)   [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days between Day 1 and 4 years plus 30 days ]
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85.  Secondary:   Number and Percentage of Participants With All Cause Death (Including Vital Status Follow-up, Cutoff at 1470 Days)   [ Time Frame: Day 1 to day 1470 ]
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86.  Secondary:   Number and Percentage of Participants With Lower Respiratory Death (On-treatment; Adjudicated Primary Cause)   [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days between Day 1 and 4 years plus 30 days ]
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87.  Secondary:   Number and Percentage of Participants With a Lower Respiratory Death (Adjudicated; Including Vital Status Follow-up, Cutoff at 1470 Days)   [ Time Frame: Day 1 to day 1470 ]
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88.  Post-Hoc:   Number and Percentage of Participants With All Cause Death (Including Vital Status Follow-up, Cutoff at 1440 Days)   [ Time Frame: Day 1 to day 1440 ]
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89.  Other Pre-specified:   Incidence Rate of Serious Adverse Event (System Organ Class = Cardiac Disorders)   [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days ]
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90.  Other Pre-specified:   Incidence Rate of Serious Adverse Event (Preferred Term = Angina)   [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days ]
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91.  Other Pre-specified:   Incidence Rate of Serious Adverse Event (Preferred Term = Atrial Fibrillation)   [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days ]
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92.  Other Pre-specified:   Incidence Rate of Serious Adverse Event (Preferred Term = Cardiac Failure)   [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days ]
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93.  Other Pre-specified:   Incidence Rate of Serious Adverse Event (Preferred Term = Cardiac Failure Congestive)   [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days ]
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94.  Other Pre-specified:   Incidence Rate of Serious Adverse Event (Preferred Term = Coronary Artery Disease)   [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days ]
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95.  Other Pre-specified:   Incidence Rate of Serious Adverse Event (Preferred Term = Myocardial Infarction)   [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days ]
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96.  Other Pre-specified:   Incidence Rate of Serious Adverse Event (System Organ Class = Lower Respiratory System Disorders)   [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days ]
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97.  Other Pre-specified:   Incidence Rate of Serious Adverse Event (Preferred Term = Bronchitis)   [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days ]
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98.  Other Pre-specified:   Incidence Rate of Serious Adverse Event (Preferred Term = Chronic Obstructive Pulmonary Disease (COPD) Exacerbation)   [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days ]
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99.  Other Pre-specified:   Incidence Rate of Serious Adverse Event (Preferred Term = Dyspnoea)   [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days ]
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100.  Other Pre-specified:   Incidence Rate of Serious Adverse Event (Preferred Term = Pneumonia)   [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days ]
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101.  Other Pre-specified:   Incidence Rate of Serious Adverse Event (Preferred Term = Respiratory Failure)   [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days ]
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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
Tio patients had significantly longer drug exposure,thus had increased chance of AE.Simple frequencies are biased for AE comparisons;exposure-adjusted incidence rates (IR) should be used. IR for serious AE(>1% patients) are in Outcome Measures.  


Results Point of Contact:  
Name/Title: Boehringer Ingelheim Pharmaceuticals
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


No publications provided by Boehringer Ingelheim Pharmaceuticals

Publications automatically indexed to this study:


Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00144339     History of Changes
Other Study ID Numbers: 205.235
Study First Received: September 2, 2005
Results First Received: February 21, 2009
Last Updated: July 10, 2012
Health Authority: Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10
Hungary: National Institute of Pharmacy, H-1051 Budapest
Lithuania: State Medicines Control Agency, LT-01132 Vilnius
Poland: Urzad Rejestracji Produktow Leczniczych, Wyrobow, Medycznych i Produktow Biobojczych
Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow
Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26
Slovenia: Agency for Medicinal Products, SI-1000 Ljubljana
Australia: Responsilble Ethics Committee
New Zealand: Multicentre Ethics Committee/Medsafe
Austria: Bundesamt für Sicherheit im Gesundheitswesen, A-1030 Vienna
Belgium: Federal Agency for Medicines and Health Products
United States: Food and Drug Administration
France: AFFSAPS
Hong Kong: Dept. of Health of Hong Kong
Italy: Comitato Etico Az. Osp. Univ. Pisana di Pisa
Malaysia: Ministry of Health, Malaysia
Norway: Norwegian Medicines Agency (Statens Legemiddelverk)
Portugal: INFARMED - National Authority of Medicines and Health Products, IP
Argentina: A.N.M.A.T. (Administracion Nacional de Medicamentos, Alimentos y Tecnología)
Taiwan: Department of Health, Executive Yuan, Taiwan
Philippines: Department of Health, Republic of the Philippines
Thailand: Ministry of Public Health
Finland: Finnish Medicines Agency
Singapore: Health Science Authority, Ministry of Health
Switzerland: Swissmedic
Turkey: Ministry of Health Central Ethics Committee
Great Britain: MHRA
South Africa: Medicines Control Council