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Completed

NCT Number: NCT00144339

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

The primary objective of this trial is to determine whether daily treatment with tiotropium (Spiriva®, Bromuro de Tiotropio®) inhalation capsule via HandiHaler® reduces the rate of decline in lung function over time in patients with COPD.

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

205.235.101, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Written informed consent.
  • Male or female patients 40 years of age or older.
  • Smoking history of at least 10 pack years.
  • Diagnosis of COPD with post bronchodilator FEV1 less than or equal to 70% of predicted normal and FEV1<70% of FVC and on stable respiratory medication.

Exclusion criteria

  • Significant diseases other than COPD which in the opinion of the investigator may put the patient at risk or influence the patients ability to participate.
  • Myocardial infarction in past 6 months.
  • Unstable or life threatening arrhythmia in past year.
  • Hospitalization for NYHA heart failure class III or IV in past year.
  • Active tuberculosis.
  • Asthma.
  • Pulmonary resection.
  • Malignancy treated with radiation or chemotherapy in past 5 years.
  • Respiratory infection in 4 weeks prior to screening.
  • Known hypersensitivity to anticholinergic drugs or components.
  • Known moderate to severe renal impairment.
  • Known narrow angle glaucoma.
  • Significant symptomatic BPH or bladder neck obstruction.
  • Need for oxygen therapy >12 hr/day.
  • Use of oral corticosteroids at unstable doses or >10 mg/day.

Treatment and study plan

Tiotropium

Drug

Placebo

Drug

Primary outcomes

  1. 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

    Rate of decline of forced expiratory volume in one second (FEV1) measured before the use of bronchodilators. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1.

  2. 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

    Rate of decline of forced expiratory volume in one second (FEV1) measured after bronchodilation. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1.

Secondary outcomes

  1. 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.

    Rate of decline of forced expiratory volume in one second (FEV1) measured before the use of bronchodilators. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1

  2. 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

    Rate of decline of forced expiratory volume in one second (FEV1) measured after the use of bronchodilators. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1

  3. Pre-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 30 to 4 Years

    Time frame: From day 30 to 4 years

    Rate of decline of forced vital capacity (FVC) measured before the use of bronchodilators. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC

  4. Post-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 30 to 4 Years

    Time frame: From day 30 to 4 years

    Rate of decline of forced vital capacity (FVC) measured after bronchodilation. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC

  5. Pre-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 30 to 4 Years

    Time frame: From day 30 to 4 years

    Rate of decline of slow vital capacity (SVC) measured before the use of bronchodilators. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC

  6. Post-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 30 to 4 Years

    Time frame: From day 30 to 4 years

    Rate of decline of slow vital capacity (SVC) measured after bronchodilation. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC

  7. Rate of Decline of St George's Respiratory Questionnaire (SGRQ) Total Score

    Time frame: From month 6 to 4 years

    SGRQ total score shows the impact of COPD on patient's health status, and expressed as a percentage of impairment with scale from 0 (best health status) to 100 (worst possible status). A negative rate of decline shows decreasing SGRQ total score (or improved health) over time, while a positive value shows increasing score (or worsen health).

  8. 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.

    Rate of decline of forced vital capacity (FVC) before bronchodilation. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC

  9. 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

    Rate of decline of forced vital capacity (FVC) after bronchodilation. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC

  10. 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

    Rate of decline slow vital capacity (SVC) before bronchodilation. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC

  11. 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

    Rate of decline of slow vital capacity (SVC) after bronchodilation. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC

  12. Time to First Exacerbation

    Time frame: From Day 1 to 4 years

    Chronic obstructive pulmonary disease (COPD) exacerbation

  13. Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Patient Year

    Time frame: Day 1 to 4 years

  14. Number and Percentage of Patients With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation

    Time frame: Day 1 to 4 years

  15. Number of Exacerbation Days Per Patient Year

    Time frame: Day 1 to 4 years

    Number of exacerbation days normalized by treatment exposure

  16. Time to First COPD Exacerbation Leading to Hospitalization (for 25% Patients)

    Time frame: Day 1 to 4 years

  17. Number and Percentage of Patients With at Least on COPD Exacerbation Leading to Hospitalization

    Time frame: From Day 1 to 4 years

  18. Number of Exacerbation Leading to Hospitalization

    Time frame: From Day 1 to 4 years

    Estimated number of exacerbations leading to hospitalizations per patient year

  19. Days of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Leading to Hospitalization

    Time frame: From Day 1 to 4 years

    Number of days with chronic obstructive pulmonary disease (COPD) exacerbation leading to hospitalization (normalized by treatment exposure)

  20. Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 1

    Time frame: Month 1

    Estimated FEV1 before bronchodilator at Month 1

  21. Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 1

    Time frame: Month 1

    Estimated forced expiratory volume in one second (FEV1) after bronchodilator at month 1

  22. Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 6

    Time frame: Month 6

    Estimated forced expiratory volume in one second (FEV1) before bronchodilator at month 6

  23. Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 6

    Time frame: Month 6

  24. Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 12

    Time frame: Month 12

  25. Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 12

    Time frame: Month 12

  26. Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 18

    Time frame: Month 18

  27. Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 18

    Time frame: Month 18

  28. Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 24

    Time frame: Month 24

  29. Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 24

    Time frame: Month 24

  30. Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 30

    Time frame: Month 30

  31. Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 30

    Time frame: Month 30

  32. Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 36

    Time frame: Month 36

  33. Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 36

    Time frame: Month 36

  34. Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 42

    Time frame: Month 42

  35. Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 42

    Time frame: Month 42

    Estimated FEV1 after bronchodilator at Month 42

  36. Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 48

    Time frame: Month 48

  37. Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 48

    Time frame: Month 48

  38. Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 1

    Time frame: Month 1

  39. Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 1

    Time frame: Month 1

  40. Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 6

    Time frame: Month 6

  41. Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 6

    Time frame: Month 6

  42. Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 12

    Time frame: Month 12

  43. Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 12

    Time frame: Month 12

  44. Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 18

    Time frame: Month 18

  45. Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 18

    Time frame: Month 18

  46. Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 24

    Time frame: Month 24

  47. Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 24

    Time frame: Month 24

  48. Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 30

    Time frame: Month 30

  49. Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 30

    Time frame: Month 30

  50. Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 36

    Time frame: Month 36

  51. Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 36

    Time frame: Month 36

  52. Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 42

    Time frame: Month 42

  53. Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 42

    Time frame: Month 42

  54. Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 48

    Time frame: Month 48

  55. Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 48

    Time frame: Month 48

  56. Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 1

    Time frame: Month 1

  57. Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 1

    Time frame: Month 1

  58. Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 6

    Time frame: Month 6

  59. Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 6

    Time frame: Month 6

  60. Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 12

    Time frame: Month 12

  61. Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 12

    Time frame: Month 12

  62. Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 18

    Time frame: Month 18

  63. Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 18

    Time frame: Month 18

  64. Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 24

    Time frame: Month 24

  65. Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 24

    Time frame: Month 24

  66. Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 30

    Time frame: Month 30

  67. Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 30

    Time frame: Month 30

  68. Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 36

    Time frame: Month 36

  69. Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 36

    Time frame: Month 36

  70. Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 42

    Time frame: Month 42

  71. Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 42

    Time frame: Month 42

  72. Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 48

    Time frame: Month 48

  73. Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 48

    Time frame: Month 48

  74. Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 6

    Time frame: Month 6

    • SGRQ total score summarizes the impact of COPD on overall patient's health status.
    • Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
    • The scale is continuous.
    • Rate of decline shows the yearly change of SGRQ total score.

  75. Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 12

    Time frame: Month 12

    • SGRQ total score summarizes the impact of COPD on overall patient's health status.
    • Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
    • The scale is continuous.
    • Rate of decline shows the yearly change of SGRQ total score.

  76. Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 18

    Time frame: Month 18

    • SGRQ total score summarizes the impact of COPD on overall patient's health status.
    • Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
    • The scale is continuous.
    • Rate of decline shows the yearly change of SGRQ total score.

  77. Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 24

    Time frame: Month 24

    • SGRQ total score summarizes the impact of COPD on overall patient's health status.
    • Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
    • The scale is continuous.
    • Rate of decline shows the yearly change of SGRQ total score.

  78. Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 30

    Time frame: Month 30

    • SGRQ total score summarizes the impact of COPD on overall patient's health status.
    • Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
    • The scale is continuous.
    • Rate of decline shows the yearly change of SGRQ total score.

  79. Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 36

    Time frame: Month 36

    • SGRQ total score summarizes the impact of COPD on overall patient's health status.
    • Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
    • The scale is continuous.
    • Rate of decline shows the yearly change of SGRQ total score.

  80. Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 42

    Time frame: Month 42

    • SGRQ total score summarizes the impact of COPD on overall patient's health status.
    • Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
    • The scale is continuous.
    • Rate of decline shows the yearly change of SGRQ total score.

  81. Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 48

    Time frame: Month 48

    • SGRQ total score summarizes the impact of COPD on overall patient's health status.
    • Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
    • The scale is continuous.
    • Rate of decline shows the yearly change of SGRQ total score.

  82. 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

    On-treatment defined as day 1 to completion of double blinded treatment plus 30 days

  83. 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

    All cause mortality vital status information was followed-up after discontinuation; vital status information up to 1470 days after the start of treatment was used.

  84. 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

    The primary cause of death was adjudicated by an external committee prior to unblinding; on-treatment defined as day 1 to completion of double blinded treatment plus 30 days

  85. 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

    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

Other outcomes

  1. Incidence Rate of Serious Adverse Event (System Organ Class = Cardiac Disorders)

    Time frame: Day 1 to completion of double blinded treatment plus 30 days

    Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.

  2. Incidence Rate of Serious Adverse Event (Preferred Term = Angina)

    Time frame: Day 1 to completion of double blinded treatment plus 30 days

    Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.

  3. Incidence Rate of Serious Adverse Event (Preferred Term = Atrial Fibrillation)

    Time frame: Day 1 to completion of double blinded treatment plus 30 days

    Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.

  4. Incidence Rate of Serious Adverse Event (Preferred Term = Cardiac Failure)

    Time frame: Day 1 to completion of double blinded treatment plus 30 days

    Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.

  5. Incidence Rate of Serious Adverse Event (Preferred Term = Cardiac Failure Congestive)

    Time frame: Day 1 to completion of double blinded treatment plus 30 days

    Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.

  6. Incidence Rate of Serious Adverse Event (Preferred Term = Coronary Artery Disease)

    Time frame: Day 1 to completion of double blinded treatment plus 30 days

    Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.

  7. Incidence Rate of Serious Adverse Event (Preferred Term = Myocardial Infarction)

    Time frame: Day 1 to completion of double blinded treatment plus 30 days

    Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.

  8. 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

    Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.

  9. Incidence Rate of Serious Adverse Event (Preferred Term = Bronchitis)

    Time frame: Day 1 to completion of double blinded treatment plus 30 days

    Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.

  10. 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

    Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.

  11. Incidence Rate of Serious Adverse Event (Preferred Term = Dyspnoea)

    Time frame: Day 1 to completion of double blinded treatment plus 30 days

    Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.

  12. Incidence Rate of Serious Adverse Event (Preferred Term = Pneumonia)

    Time frame: Day 1 to completion of double blinded treatment plus 30 days

    Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.

  13. Incidence Rate of Serious Adverse Event (Preferred Term = Respiratory Failure)

    Time frame: Day 1 to completion of double blinded treatment plus 30 days

    Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled, Parallel Group Trial Assessing the Rate of Decline of Lung Function With Tiotropium 18 mcg Inhalation Capsule Once Daily in Patients With Chronic Obstructive Pulmonary Disease (COPD).

Important dates

Study start
2002
Primary completion
2008
First posted
Sep 5, 2005
Registry last updated
May 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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