Evaluation of the Long- Term Effects of Spiriva on Lung Function in COPD Patients
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00144339 |
Recruitment Status
:
Completed
First Posted
: September 5, 2005
Results First Posted
: August 17, 2009
Last Update Posted
: May 20, 2014
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Sponsor:
Boehringer Ingelheim
Information provided by:
Boehringer Ingelheim
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Study Type: | Interventional |
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Study Design: | Intervention Model: Parallel Assignment; Primary Purpose: Treatment |
Condition: |
Pulmonary Disease, Chronic Obstructive |
Interventions: |
Drug: tiotropium Drug: placebo |

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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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 |
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No text entered. |
Reporting Groups
Description | |
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Placebo | once daily |
Tiotropium Bromide Inhalation Capsules 18 mcg | once daily |
Participant Flow: Overall Study
Placebo | Tiotropium Bromide Inhalation Capsules 18 mcg | |
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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 |
Other | 58 | 60 |

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. |
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No text entered. |
Reporting Groups
Description | |
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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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Overall Participants Analyzed [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] |
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Female | 784 | 735 | 1519 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Male | 2222 | 2251 | 4473 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||

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 ] |
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 ] |
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. ] |
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 ] |
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 ] |
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 ] |
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 ] |
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 ] |
9. Secondary: | Rate of Decline of St George's Respiratory Questionnaire (SGRQ) Total Score [ Time Frame: From month 6 to 4 years ] |
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. ] |
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 ] |
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 ] |
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 ] |
14. Secondary: | Time to First Exacerbation [ Time Frame: From Day 1 to 4 years ] |
15. Secondary: | Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Patient Year [ Time Frame: Day 1 to 4 years ] |
16. Secondary: | Number and Percentage of Patients With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation [ Time Frame: Day 1 to 4 years ] |
17. Secondary: | Number of Exacerbation Days Per Patient Year [ Time Frame: Day 1 to 4 years ] |
18. Secondary: | Time to First COPD Exacerbation Leading to Hospitalization (for 25% Patients) [ Time Frame: Day 1 to 4 years ] |
19. Secondary: | Number and Percentage of Patients With at Least on COPD Exacerbation Leading to Hospitalization [ Time Frame: From Day 1 to 4 years ] |
20. Secondary: | Number of Exacerbation Leading to Hospitalization [ Time Frame: From Day 1 to 4 years ] |
21. Secondary: | Days of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Leading to Hospitalization [ Time Frame: From Day 1 to 4 years ] |
22. Secondary: | Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 1 [ Time Frame: Month 1 ] |
23. Secondary: | Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 1 [ Time Frame: Month 1 ] |
24. Secondary: | Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 6 [ Time Frame: Month 6 ] |
25. Secondary: | Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 6 [ Time Frame: Month 6 ] |
26. Secondary: | Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 12 [ Time Frame: Month 12 ] |
27. Secondary: | Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 12 [ Time Frame: Month 12 ] |
28. Secondary: | Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 18 [ Time Frame: Month 18 ] |
29. Secondary: | Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 18 [ Time Frame: Month 18 ] |
30. Secondary: | Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 24 [ Time Frame: Month 24 ] |
31. Secondary: | Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 24 [ Time Frame: Month 24 ] |
32. Secondary: | Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 30 [ Time Frame: Month 30 ] |
33. Secondary: | Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 30 [ Time Frame: Month 30 ] |
34. Secondary: | Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 36 [ Time Frame: Month 36 ] |
35. Secondary: | Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 36 [ Time Frame: Month 36 ] |
36. Secondary: | Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 42 [ Time Frame: Month 42 ] |
37. Secondary: | Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 42 [ Time Frame: Month 42 ] |
38. Secondary: | Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 48 [ Time Frame: Month 48 ] |
39. Secondary: | Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 48 [ Time Frame: Month 48 ] |
40. Secondary: | Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 1 [ Time Frame: Month 1 ] |
41. Secondary: | Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 1 [ Time Frame: Month 1 ] |
42. Secondary: | Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 6 [ Time Frame: Month 6 ] |
43. Secondary: | Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 6 [ Time Frame: Month 6 ] |
44. Secondary: | Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 12 [ Time Frame: Month 12 ] |
45. Secondary: | Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 12 [ Time Frame: Month 12 ] |
46. Secondary: | Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 18 [ Time Frame: Month 18 ] |
47. Secondary: | Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 18 [ Time Frame: Month 18 ] |
48. Secondary: | Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 24 [ Time Frame: Month 24 ] |
49. Secondary: | Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 24 [ Time Frame: Month 24 ] |
50. Secondary: | Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 30 [ Time Frame: Month 30 ] |
51. Secondary: | Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 30 [ Time Frame: Month 30 ] |
52. Secondary: | Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 36 [ Time Frame: Month 36 ] |
53. Secondary: | Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 36 [ Time Frame: Month 36 ] |
54. Secondary: | Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 42 [ Time Frame: Month 42 ] |
55. Secondary: | Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 42 [ Time Frame: Month 42 ] |
56. Secondary: | Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 48 [ Time Frame: Month 48 ] |
57. Secondary: | Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 48 [ Time Frame: Month 48 ] |
58. Secondary: | Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 1 [ Time Frame: Month 1 ] |
59. Secondary: | Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 1 [ Time Frame: Month 1 ] |
60. Secondary: | Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 6 [ Time Frame: Month 6 ] |
61. Secondary: | Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 6 [ Time Frame: Month 6 ] |
62. Secondary: | Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 12 [ Time Frame: Month 12 ] |
63. Secondary: | Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 12 [ Time Frame: Month 12 ] |
64. Secondary: | Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 18 [ Time Frame: Month 18 ] |
65. Secondary: | Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 18 [ Time Frame: Month 18 ] |
66. Secondary: | Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 24 [ Time Frame: Month 24 ] |
67. Secondary: | Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 24 [ Time Frame: Month 24 ] |
68. Secondary: | Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 30 [ Time Frame: Month 30 ] |
69. Secondary: | Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 30 [ Time Frame: Month 30 ] |
70. Secondary: | Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 36 [ Time Frame: Month 36 ] |
71. Secondary: | Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 36 [ Time Frame: Month 36 ] |
72. Secondary: | Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 42 [ Time Frame: Month 42 ] |
73. Secondary: | Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 42 [ Time Frame: Month 42 ] |
74. Secondary: | Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 48 [ Time Frame: Month 48 ] |
75. Secondary: | Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 48 [ Time Frame: Month 48 ] |
76. Secondary: | Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 6 [ Time Frame: Month 6 ] |
77. Secondary: | Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 12 [ Time Frame: Month 12 ] |
78. Secondary: | Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 18 [ Time Frame: Month 18 ] |
79. Secondary: | Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 24 [ Time Frame: Month 24 ] |
80. Secondary: | Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 30 [ Time Frame: Month 30 ] |
81. Secondary: | Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 36 [ Time Frame: Month 36 ] |
82. Secondary: | Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 42 [ Time Frame: Month 42 ] |
83. Secondary: | Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 48 [ Time Frame: Month 48 ] |
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 ] |
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 ] |
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 ] |
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 ] |

Measure Type | Secondary |
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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 |
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. |
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Reporting Groups
Description | |
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Placebo | Once daily |
Tiotropium Bromide Inhalation Capsules 18 mcg | Once daily |
Measured Values
Placebo | Tiotropium Bromide Inhalation Capsules 18 mcg | |
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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] |
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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 |
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Statistical Test Type [2] | Superiority or Other |
Statistical Method [3] | Log Rank |
P Value [4] | 0.2377 |
Hazard Ratio (HR) [5] | 0.88 |
95% Confidence Interval | 0.71 to 1.09 |
[1] | Additional details about the analysis, such as null hypothesis and power calculation: |
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[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |
No text entered. | |
[3] | Other relevant method information, such as adjustments or degrees of freedom: |
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[4] | 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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[5] | 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. 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 ] |
89. 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 ] |
90. 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 ] |
91. 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 ] |
92. 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 ] |
93. 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 ] |
94. 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 ] |
95. 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 ] |
96. 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 ] |
97. 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 ] |
98. 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 ] |
99. 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 ] |
100. 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 ] |
101. 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 ] |

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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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. |