Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
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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
ClinicalTrials.gov Identifier:
NCT00144339
First received: September 2, 2005
Last updated: May 15, 2014
Last verified: April 2014
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  
Adverse Event                 746                 627  
Protocol Violation                 75                 48  
Withdrawal by Subject                 403                 300  
Lost to Follow-up                 76                 64  
unknown                 58                 60  



  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
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily
Total Total of all reporting groups

Baseline Measures
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg     Total  
Number of Participants  
[units: participants]
 		  3006     2986     5992  
Age  
[units: years]
Mean ± Standard Deviation 		  64.52  ± 8.48     64.50  ± 8.41     64.51  ± 8.45  
Gender  
[units: participants]
 		     
Female     784     735     1519  
Male     2222     2251     4473  



  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:   Time to First COPD Exacerbation Leading to Hospitalization (for 25% Patients)   [ Time Frame: Day 1 to 4 years ]
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19.  Secondary:   Number and Percentage of Patients With at Least on COPD 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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Measure Type Secondary
Measure Title Number and Percentage of Participants With a Lower Respiratory Death (Adjudicated; Including Vital Status Follow-up, Cutoff at 1470 Days)
Measure Description The primary cause of death was adjudicated by an external committee prior to unblinding; vital status was information followed-up after discontinuation; vital status information up to 1470 days after the start of treatment was used
Time Frame Day 1 to day 1470  
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.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
 		  3006     2986  
Number and Percentage of Participants With a Lower Respiratory Death (Adjudicated; Including Vital Status Follow-up, Cutoff at 1470 Days)  
[units: Participants]
 		   
Number of patients with lower respiratory death     173     153  
Percentage patients with lower respiratory death     5.8     5.1  


Statistical Analysis 1 for Number and Percentage of Participants With a Lower Respiratory Death (Adjudicated; Including Vital Status Follow-up, Cutoff at 1470 Days)
Groups [1] All groups
Method [2] Log Rank
P Value [3] 0.2377
Hazard Ratio (HR) [4] 0.88
95% Confidence Interval ( 0.71 to 1.09 )
[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:
  No text entered.
[4] Other relevant estimation information:
  Cox regression; cut-off at 4 years plus 30 days; vital status form intended at 4 years; hazard ratio shown as tiotropium bromide vs. placebo



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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  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
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.


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