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Completed

NCT Number: NCT00359788

A Trial Comparing Treatment With Tiotropium Inhalation Capsules to Combivent Inhalation Aerosol in COPD Patients.

The objective of this study is to evaluate the efficacy and safety of 12 weeks treatment with tiotropium HandiHaler 18 micrograms (mcg) daily compared to Combivent Metered Dose Inhaler (MDI) Chlorofluorocarbon Inhalation Aerosol 2 actuations four times a day in Chronic Obstructive Pulmonary Disease (COPD) patients currently prescribed Combivent® MDI.

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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 4

Primary location

205.325.904 Boehringer Ingelheim Investigational Site, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) Age: greater than or equal to 40 years

  • Current or ex-smoker with a >= 10 pack-year smoking history
  • Use of Combivent® Metered Dose Inhaler (MDI)for >= 1 month prior to Visit 1

Spirometric criteria (determined at study visits):

  • Post-bronchodilator Forced Expiratory Volume in one second (FEV1) <= 70% (Visit 1)
  • Pre-bronchodilator FEV1 <= 65% of predicted and FEV1/Forced Vital Capacity (FVC) <= 70% (Visit 2)

Exclusion criteria

Clinical history of asthma

  • History of thoracotomy with pulmonary resection
  • History of Cystic Fibrosis, alpha 1 antitrypsin deficiency or interstitial lung disease
  • Daytime use of oxygen therapy for > 1 hour per day or if unable to abstain fr om using oxygen during Pulmonary Function Tests
  • Any respiratory tract infection or COPD exacerbation in 6 weeks prior to Visit 1
  • Recent history 6 months or less of Myocardial Infarction
  • Unstable or life-threatening cardiac arrhythmias
  • Hospitalization for Congestive Heart Failure during past year
  • Malignancy for which patient is receiving chemo or radiation therapy
  • Pregnant or nursing women
  • Known hypersensitivity to ipratropium or carrier substances, including related food products such as soybean, peanuts, or lactose
  • Use of SPIRIVA® 3 months prior to Visit 1
  • Symptomatic of prostatic hypertrophy or bladder neck obstruction
  • Known narrow- angle glaucoma
  • Participating in a pulmonary rehab program within 4 weeks of Visit 1

Treatment and study plan

Tiotropium

Drug

Combivent (Ipratropium/Albuterol)

Drug

Primary outcomes

  1. Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second) at 12 Weeks

    Time frame: Baseline and 12 Weeks

    Trough FEV1 is measured 10 minutes before drug administration

  2. Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) at 12 Weeks

    Time frame: Baseline and 12 Weeks

    Average hourly FEV1 AUC0-6 minus baseline FEV1

Secondary outcomes

  1. Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second) at 6 Weeks

    Time frame: Baseline and 6 Weeks

    Trough FEV1 is measured 10 minutes before drug administration

  2. Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) on Day 1

    Time frame: Day 1 (after first dose)

    Average hourly FEV1 AUC0-6 minus baseline FEV1

  3. Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) at Week 6

    Time frame: Baseline and week 6

    Average hourly FEV1 AUC0-6 minus baseline FEV1

  4. Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) on Day 1

    Time frame: Day 1

    Peak FEV1 is defined as the maximum FEV1 observed in the first three hours after dose of study medication

  5. Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) at Week 6

    Time frame: Baseline and 6 weeks

    Peak FEV1 is defined as the maximum FEV1 observed in the first three hours after dose of study medication

  6. Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) at Week 12

    Time frame: Baseline and 12 weeks

    Peak FEV1 is defined as the maximum FEV1 observed in the first three hours after dose of study medication

  7. Change From Baseline in Trough FVC (Forced Vital Capacity) at 12 Weeks

    Time frame: Baseline and 12 weeks

    Trough FVC is measured 10 minutes before drug administration

  8. Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) at 12 Weeks

    Time frame: Baseline and 12 Weeks

    Average hourly FVC AUC0-6 minus baseline FVC

  9. Change From Baseline in Trough FVC (Forced Vital Capacity) at 6 Weeks

    Time frame: Baseline and 6 weeks

    Trough FVC is measured 10 minutes before drug administration

  10. Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) on Day 1

    Time frame: Day 1

    Average hourly FVC AUC0-6 minus baseline FVC

  11. Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) at 6 Weeks

    Time frame: Baseline and 6 Weeks

    Average hourly FVC AUC0-6 minus baseline FVC

  12. Change From Baseline in Peak FVC (Forced Vital Capacity) on Day 1

    Time frame: Day 1

    Peak FVC is defined as the maximum FVC observed in the first three hours after dose of study medication

  13. Change From Baseline in Peak FVC (Forced Vital Capacity) at Week 6

    Time frame: baseline and 6 Weeks (after first dose)

    Peak FVC is defined as the maximum FVC observed in the first three hours after dose of study medication

  14. Change From Baseline in Peak FVC (Forced Vital Capacity) at Week 12

    Time frame: Baseline and 12 Weeks

    Peak FVC is defined as the maximum FVC observed in the first three hours after dose of study medication

  15. FEV1 at 15 Minutes on Day 1

    Time frame: 15 minutes

  16. FEV1 at 30 Minutes on Day 1

    Time frame: 30 minutes

  17. FEV1 at 1 Hour on Day 1

    Time frame: 1 hour

  18. FEV1 at 2 Hours on Day 1

    Time frame: 2 hour

  19. FEV1 at 3 Hours on Day 1

    Time frame: 3 hour

  20. FEV1 at 4 Hours on Day 1

    Time frame: 4 hour

  21. FEV1 at 6 Hours on Day 1

    Time frame: 6 hours

  22. FEV1 at -10 Minutes at Week 6

    Time frame: 10 minutes before dosing

  23. FEV1 at 15 Minutes at Week 6

    Time frame: 15 minutes

  24. FEV1 at 30 Minutes at Week 6

    Time frame: 30 minutes

  25. FEV1 at 1 Hour at Week 6

    Time frame: 1 hour

  26. FEV1 at 2 Hours at Week 6

    Time frame: 2 hour

  27. FEV1 at 3 Hours at Week 6

    Time frame: 3 hour

  28. FEV1 at 4 Hours at Week 6

    Time frame: 4 hour

  29. FEV1 at 6 Hours at Week 6

    Time frame: 6 hour

  30. FEV1 at -10 Minutes at Week 12

    Time frame: 10 minutes before dosing

  31. FEV1 at 15 Minutes at Week 12

    Time frame: 15 minutes

  32. FEV1 at 30 Minutes at Week 12

    Time frame: 30 minutes

  33. FEV1 at 1 Hour at Week 12

    Time frame: 1 hour

  34. FEV1 at 2 Hours at Week 12

    Time frame: 2 hour

  35. FEV1 at 3 Hours at Week 12

    Time frame: 3 hour

  36. FEV1 at 4 Hours at Week 12

    Time frame: 4 hour

  37. FEV1 at 6 Hours at Week 12

    Time frame: 6 hour

  38. FVC at 15 Minutes on Day 1

    Time frame: 15 minutes

  39. FVC at 30 Minutes on Day 1

    Time frame: 30 minutes

  40. FVC at 1 Hour on Day 1

    Time frame: 1 hour

  41. FVC at 2 Hours on Day 1

    Time frame: 2 hour

  42. FVC at 3 Hours on Day 1

    Time frame: 3 hour

  43. FVC at 4 Hours on Day 1

    Time frame: 4 hour

  44. FVC at 6 Hours on Day 1

    Time frame: 6 hour

  45. FVC at -10 Minutes at Week 6

    Time frame: 10 minutes before dosing

  46. FVC at 15 Minutes at Week 6

    Time frame: 15 minutes

  47. FVC at 30 Minutes at Week 6

    Time frame: 30 minutes

  48. FVC at 1 Hour at Week 6

    Time frame: 1 hour

  49. FVC at 2 Hours at Week 6

    Time frame: 2 hour

  50. FVC at 3 Hours at Week 6

    Time frame: 3 hour

  51. FVC at 4 Hours at Week 6

    Time frame: 4 hour

  52. FVC at 6 Hours at Week 6

    Time frame: 6 hour

  53. FVC at -10 Minutes at Week 12

    Time frame: 10 minutes before dosing

  54. FVC at 15 Minutes at Week 12

    Time frame: 15 minutes

  55. FVC at 30 Minutes at Week 12

    Time frame: 30 minutes

  56. FVC at 1 Hour at Week 12

    Time frame: 1 hour

  57. FVC at 2 Hours at Week 12

    Time frame: 2 hour

  58. FVC at 3 Hours at Week 12

    Time frame: 3 hour

  59. FVC at 4 Hours at Week 12

    Time frame: 4 hour

  60. FVC at 6 Hours at Week 12

    Time frame: 6 hour

  61. Day Time Albuterol Use During Week 1

    Time frame: Week 1

    Puffs of rescue albuterol used during the day in week 1

  62. Day Time Albuterol Use During Week 2

    Time frame: Week 2

    Puffs of rescue albuterol used during the day in week 2

  63. Day Time Albuterol Use During Week 3

    Time frame: Week 3

    Puffs of rescue albuterol used during the day in week 3

  64. Day Time Albuterol Use During Week 4

    Time frame: Week 4

    Puffs of rescue albuterol used during the day in week 4

  65. Day Time Albuterol Use During Week 5

    Time frame: Week 5

    Puffs of rescue albuterol used during the day in week 5

  66. Day Time Albuterol Use During Week 6

    Time frame: Week 6

    Puffs of rescue albuterol used during the day in week 6

  67. Day Time Albuterol Use During Week 7

    Time frame: Week 7

    Puffs of rescue albuterol used during the day in week 7

  68. Day Time Albuterol Use During Week 8

    Time frame: Week 8

    Puffs of rescue albuterol used during the day in week 8

  69. Day Time Albuterol Use During Week 9

    Time frame: Week 9

    Puffs of rescue albuterol used during the day in week 9

  70. Day Time Albuterol Use During Week 10

    Time frame: Week 10

    Puffs of rescue albuterol used during the day in week 10

  71. Day Time Albuterol Use During Week 11

    Time frame: Week 11

    Puffs of rescue albuterol used during the day in week 11

  72. Day Time Albuterol Use During Week 12

    Time frame: Week 12

    Puffs of rescue albuterol used during the day in week 12

  73. Night Time Albuterol Use During Week 1

    Time frame: Week 1

  74. Night Time Albuterol Use During Week 2

    Time frame: Week 2

    Puffs of rescue albuterol used during the night in week 2

  75. Night Time Albuterol Use During Week 3

    Time frame: Week 3

    Puffs of rescue albuterol used during the night in week 3

  76. Night Time Albuterol Use During Week 4

    Time frame: Week 4

    Puffs of rescue albuterol used during the night in week 4

  77. Night Time Albuterol Use During Week 5

    Time frame: Week 5

    Puffs of rescue albuterol used during the night in week 5

  78. Night Time Albuterol Use During Week 6

    Time frame: Week 6

    Puffs of rescue albuterol used during the night in week 6

  79. Night Time Albuterol Use During Week 7

    Time frame: Week 7

    Puffs of rescue albuterol used during the night in week 7

  80. Night Time Albuterol Use During Week 8

    Time frame: Week 8

    Puffs of rescue albuterol used during the night in week 8

  81. Night Time Albuterol Use During Week 9

    Time frame: Week 9

    Puffs of rescue albuterol used during the night in week 9

  82. Night Time Albuterol Use During Week 10

    Time frame: Week 10

    Puffs of rescue albuterol used during the night in week 10

  83. Night Time Albuterol Use During Week 11

    Time frame: Week 11

    Puffs of rescue albuterol used during the night in week 11

  84. Night Time Albuterol Use During Week 12

    Time frame: Week 12

    Puffs of rescue albuterol used during the night in week 12

  85. Morning Peak Expiratory Flow Rate (PEFR) at Week 1

    Time frame: Week 1

  86. Morning PEFR at Week 2

    Time frame: Week 2

    Weekly means for morning PEFR

  87. Morning PEFR at Week 3

    Time frame: Week 3

    Weekly means for morning PEFR

  88. Morning PEFR at Week 4

    Time frame: Week 4

    Weekly means for morning PEFR

  89. Morning PEFR at Week 5

    Time frame: Week 5

    Weekly means for morning PEFR

  90. Morning PEFR at Week 6

    Time frame: Week 6

    Weekly means for morning PEFR

  91. Morning PEFR at Week 7

    Time frame: Week 7

    Weekly means for morning PEFR

  92. Morning PEFR at Week 8

    Time frame: Week 8

    Weekly means for morning PEFR

  93. Morning PEFR at Week 9

    Time frame: Week 9

    Weekly means for morning PEFR

  94. Morning PEFR at Week 10

    Time frame: Week 10

    Weekly means for morning PEFR

  95. Morning PEFR at Week 11

    Time frame: Week 11

    Weekly means for morning PEFR

  96. Morning PEFR at Week 12

    Time frame: Week 12

    Weekly means for morning PEFR

  97. Evening PEFR at Week 1

    Time frame: Week 1

    Weekly means for evening PEFR

  98. Evening PEFR at Week 2

    Time frame: Week 2

    Weekly means for evening PEFR

  99. Evening PEFR at Week 3

    Time frame: Week 3

    Weekly means for evening PEFR

  100. Evening PEFR at Week 4

    Time frame: Week 4

    Weekly means for evening PEFR

  101. Evening PEFR at Week 5

    Time frame: Week 5

    Weekly means for evening PEFR

  102. Evening PEFR at Week 6

    Time frame: Week 6

    Weekly means for evening PEFR

  103. Evening PEFR at Week 7

    Time frame: Week 7

    Weekly means for evening PEFR

  104. Evening PEFR at Week 8

    Time frame: Week 8

    Weekly means for evening PEFR

  105. Evening PEFR at Week 9

    Time frame: Week 9

    Weekly means for evening PEFR

  106. Evening PEFR at Week 10

    Time frame: Week 10

    Weekly means for evening PEFR

  107. Evening PEFR at Week 11

    Time frame: Week 11

    Weekly means for evening PEFR

  108. Evening PEFR at Week 12

    Time frame: Week 12

    Weekly means for evening PEFR

  109. Patient Global Evaluation

    Time frame: Week 6

    The Patient Global Evaluation reflected the patient's opinion of their overall condition with respect to chronic obstructive pulmonary disease (COPD). The scale responses were: Poor (1,2). Fair (3,4), Good (5,6) and Excellent (7,8)

  110. Patient Global Evaluation

    Time frame: Week 12

    The Patient Global Evaluation reflected the patient's opinion of their overall condition with respect to COPD. The scale responses were: Poor (1,2). Fair (3,4), Good (5,6) and Excellent (7,8).

  111. Physician Global Evaluation

    Time frame: Week 6

    The Physician Global Evaluation reflected the physician's opinion of the patients overall condition with respect to COPD. The scale responses were: Poor (1,2). Fair (3,4), Good (5,6) and Excellent (7,8).

  112. Physician Global Evaluation

    Time frame: Week 12

    The Physician Global Evaluation reflected the physician's opinion of the patients overall condition with respect to COPD. The scale responses were: Poor (1,2). Fair (3,4), Good (5,6) and Excellent (7,8).

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

A Randomized, Double-blind, Parallel Group Trial Comparing 12 Weeks Treatment With Tiotropium 18 mcg Daily to Combivent MDI 2 Actuations Qid in COPD Patients Previously Prescribed Combivent MDI

Important dates

Study start
2006
Primary completion
2008
First posted
Aug 2, 2006
Registry last updated
May 16, 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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