Respimat® Combivent Trial in Chronic Obstructive Pulmonary Disease (COPD) - Study Results

Study Type:	Interventional
Condition:	Pulmonary Disease, Chronic Obstructive
Interventions:	Drug: Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI Drug: COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat Drug: Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
STARTED	486	491	483
COMPLETED	438	436	422
NOT COMPLETED	48	55	61

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg	Total
Number of Participants [units: participants]	486	491	483	1460
Age [units: years] Mean ± Standard Deviation	63.8 ± 8.7	64.2 ± 9.2	64.3 ± 8.6	64.1 ± 8.8
Gender [units: participants]
Female	170	169	166	505
Male	316	322	317	955

Outcome Measures

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1. Primary:

FEV1 AUC0-6 at Day 85 [ Before drug administration to 6 hours after drug administration on Day 85 ]

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2. Primary:

FEV1 AUC0-4 at Day 85 [ Before drug administration to 4 hours after drug administration on Day 85 ]

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3. Primary:

FEV1 AUC4-6 at Day 85 [ Between 4 hours and 6 hours after drug administration on Day 85 ]

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4. Secondary:

FEV1 AUC0-6 at Day 1 [ Before drug administration to 6 hours after drug administration on Day 1 ]

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5. Secondary:

FEV1 AUC0-6 at Day 29 [ Before drug administration to 6 hours after drug administration on Day 29 ]

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6. Secondary:

FEV1 AUC0-6 at Day 57 [ Before drug administration to 6 hours after drug administration on Day 57 ]

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7. Secondary:

FEV1 AUC0-4 at Day 1 [ Before drug administration to 4 hours after drug administration on Day 1 ]

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8. Secondary:

FEV1 AUC0-4 at Day 29 [ Before drug administration to 4 hours after drug administration on Day 29 ]

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9. Secondary:

FEV1 AUC0-4 at Day 57 [ Before drug administration to 4 hours after drug administration on Day 57 ]

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10. Secondary:

FEV1 AUC4-6 at Day 1 [ Between 4 hours and 6 hours after drug administration on Day 1 ]

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11. Secondary:

FEV1 AUC4-6 at Day 29 [ Between 4 hours and 6 hours after drug administration on Day 29 ]

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12. Secondary:

FEV1 AUC4-6 at Day 57 [ Between 4 hours and 6 hours after drug administration on Day 57 ]

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13. Secondary:

Peak FEV1 Response at Day 1 [ Within the first 2-hour post-treatment interval on Day 1 ]

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14. Secondary:

Peak FEV1 Response at Day 29 [ Within the first 2-hour post-treatment interval on Day 29 ]

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15. Secondary:

Peak FEV1 Response at Day 57 [ Within the first 2-hour post-treatment interval on Day 57 ]

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16. Secondary:

Peak FEV1 Response at Day 85 [ Within the first 2-hour post-treatment interval on Day 85 ]

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17. Secondary:

Peak FEV1 Response at Day 1 [ Within the first 2-hour post-treatment interval on Day 1 ]

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18. Secondary:

Peak FEV1 Response at Day 29 [ Within the first 2-hour post-treatment interval on Day 29 ]

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19. Secondary:

Peak FEV1 Response at Day 57 [ Within the first 2-hour post-treatment interval on Day 57 ]

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20. Secondary:

Peak FEV1 Response at Day 85 [ Within the first 2-hour post-treatment interval on Day 85 ]

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21. Secondary:

Time to Onset of Therapeutic FEV1 Response at Day 1 [ Within the first 2-hour post-treatment interval at Day 1 ]

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22. Secondary:

Time to Onset of Therapeutic FEV1 Response at Day 29 [ Within the first 2-hour post-treatment interval at Day 29 ]

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23. Secondary:

Time to Onset of Therapeutic FEV1 Response at Day 57 [ Within the first 2-hour post-treatment interval at Day 57 ]

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24. Secondary:

Time to Onset of Therapeutic FEV1 Response at Day 85 [ Within the first 2-hour post-treatment interval at Day 85 ]

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25. Secondary:

Duration of Therapeutic FEV1 Response at Day 1 [ During the 6-hour observation period after drug administration at Day 1 ]

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26. Secondary:

Duration of Therapeutic FEV1 Response at Day 29 [ During the 6-hour observation period after drug administration at Day 29 ]

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27. Secondary:

Duration of Therapeutic FEV1 Response at Day 57 [ During the 6-hour observation period after drug administration at Day 57 ]

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28. Secondary:

Duration of Therapeutic FEV1 Response at Day 85 [ During the 6-hour observation period after drug administration at Day 85 ]

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29. Secondary:

Time to Peak FEV1 Response at Day 1 [ Within the 6-hour post-treatment observation period at Day 1 ]

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30. Secondary:

Time to Peak FEV1 Response at Day 29 [ Within the 6-hour post-treatment observation period at Day 29 ]

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31. Secondary:

Time to Peak FEV1 Response at Day 57 [ Within the 6-hour post-treatment observation period at Day 57 ]

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32. Secondary:

Time to Peak FEV1 Response at Day 85 [ Within the 6-hour post-treatment observation period at Day 85 ]

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33. Secondary:

FVC AUC0-6 at Day 1 [ Before drug administration to 6 hours after drug administration at Day 1 ]

Show Outcome Measure 33

34. Secondary:

FVC AUC0-6 at Day 29 [ Before drug administration to 6 hours after drug administration at Day 29 ]

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35. Secondary:

FVC AUC0-6 at Day 57 [ Before drug administration to 6 hours after drug administration on Day 57 ]

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36. Secondary:

FVC AUC0-6 at Day 85 [ Before drug administration to 6 hours after drug administration on Day 85 ]

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37. Secondary:

FVC AUC0-4 at Day 1 [ Before drug administration to 4 hours after drug administration on Day 1 ]

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38. Secondary:

FVC AUC0-4 at Day 29 [ Before drug administration to 4 hours after drug administration on Day 29 ]

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39. Secondary:

FVC AUC0-4 at Day 57 [ Before drug administration to 4 hours after drug administration on Day 57 ]

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40. Secondary:

FVC AUC0-4 at Day 85 [ Before drug administration to 4 hours after drug administration on Day 85 ]

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41. Secondary:

FVC AUC4-6 at Day 1 [ Between 4 hours and 6 hours after drug administration on Day 1 ]

Show Outcome Measure 41

42. Secondary:

FVC AUC4-6 at Day 29 [ Between 4 hours and 6 hours after drug administration on Day 29 ]

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43. Secondary:

FVC AUC4-6 at Day 57 [ Between 4 hours and 6 hours after drug administration on Day 57 ]

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44. Secondary:

FVC AUC4-6 at Day 85 [ Between 4 hours and 6 hours after drug administration on Day 85 ]

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45. Secondary:

Peak FVC Response at Day 1 [ Within the first 2-hour post-treatment interval at Day 1 ]

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46. Secondary:

Peak FVC Response at Day 29 [ Within the first 2-hour post-treatment interval at Day 29 ]

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47. Secondary:

Peak FVC Response at Day 57 [ Within the first 2-hour post-treatment interval at Day 57 ]

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48. Secondary:

Peak FVC Response at Day 85 [ Within the first 2-hour post-treatment interval at Day 85 ]

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49. Secondary:

Peak FVC Response at Day 1 [ Within the first 2-hour post-treatment interval at Day 1 ]

Show Outcome Measure 49

50. Secondary:

Peak FVC Response at Day 29 [ Within the first 2-hour post-treatment interval at Day 29 ]

Show Outcome Measure 50

51. Secondary:

Peak FVC Response at Day 57 [ Within the first 2-hour post-treatment interval at Day 57 ]

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52. Secondary:

Peak FVC Response at Day 85 [ Within the first 2-hour post-treatment interval at Day 85 ]

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53. Secondary:

Rescue Medication Use on Pulmonary Test Day 1 [ During the 6-hour pulmonary function testing after drug administration on Day 1 ]

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54. Secondary:

Rescue Medication Use on Pulmonary Test Day 29 [ During the 6-hour pulmonary function testing after drug administration on Day 29 ]

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55. Secondary:

Rescue Medication Use on Pulmonary Test Day 57 [ During the 6-hour pulmonary function testing after drug administration on Day 57 ]

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56. Secondary:

Rescue Medication Use on Pulmonary Test Day 85 [ During the 6-hour pulmonary function testing after drug administration on Day 85 ]

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57. Secondary:

Night-time Rescue Medication Use [ During the 2-week baseline washout period and the 12-week treatment period ]

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58. Secondary:

Night-time Rescue Medication Use [ During the 2-week baseline washout period and the 12-week treatment period ]

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59. Secondary:

Daytime Rescue Medication Use [ During the 2-week baseline washout period and the 12-week treatment period ]

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60. Secondary:

Daytime Rescue Medication Use [ During the 2-week baseline washout period and the 12-week treatment period ]

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61. Secondary:

Night-time Symptom Score [ During the 2-week baseline washout period and the 12-week treatment period ]

Show Outcome Measure 61

62. Secondary:

Night-time Symptom Score [ During the 2-week baseline washout period and the 12-week treatment period ]

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63. Secondary:

Daytime Symptom Score [ During the 2-week baseline washout period and the 12-week treatment period ]

Show Outcome Measure 63

64. Secondary:

Daytime Symptom Score [ During the 2-week baseline washout period and the 12-week treatment period ]

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65. Secondary:

Trough Peak Expiratory Flow Rate (PEFR) [ During the 2-week baseline washout period and the 12-week treatment period and PEFR taken before administration of study medication ]

Show Outcome Measure 65

66. Secondary:

Trough PEFR [ During the 2-week baseline washout period and the 12-week treatment period and PEFR taken before administration of study medication ]

Show Outcome Measure 66

67. Secondary:

Physician's Global Evaluation Score on Pulmonary Function Testing Day 29 [ Prior to pulmonary function test on Day 29 ]

Show Outcome Measure 67

68. Secondary:

Physician's Global Evaluation Score on Pulmonary Function Testing Day 57 [ Prior to pulmonary function test on Day 57 ]

Show Outcome Measure 68

69. Secondary:

Physician's Global Evaluation Score on Pulmonary Function Testing Day 85 [ Prior to pulmonary function test on Day 85 ]

Show Outcome Measure 69

70. Secondary:

Physician's Global Evaluation Score on Pulmonary Function Testing Day 29 [ Prior to pulmonary function test on Day 29 ]

Show Outcome Measure 70

71. Secondary:

Physician's Global Evaluation Score on Pulmonary Function Testing Day 57 [ Prior to pulmonary function test on Day 57 ]

Show Outcome Measure 71

72. Secondary:

Physician's Global Evaluation Score on Pulmonary Function Testing Day 85 [ Prior to pulmonary function test on Day 85 ]

Show Outcome Measure 72

73. Secondary:

Chronic Obstructive Pulmonary Disease (COPD) Excerbation During the On-treatment Period [ During the 12-week on-treatment period ]

Show Outcome Measure 73

74. Secondary:

COPD Excerbation During the On-treatment Period [ During the 12-week on-treatment period ]

Show Outcome Measure 74

75. Secondary:

COPD Excerbation During the On-treatment Period [ During the 12-week on-treatment period ]

Show Outcome Measure 75

Serious Adverse Events

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Time Frame	No text entered.
Additional Description	No text entered.

Reporting Groups

	Description
COMBIVENT Respimat 20/100 Mcg	No text entered.
COMBIVENT CFC-MDI 36/206 Mcg	No text entered.
Ipratropium Respimat 20 Mcg	No text entered.

Serious Adverse Events

	COMBIVENT Respimat 20/100 Mcg	COMBIVENT CFC-MDI 36/206 Mcg	Ipratropium Respimat 20 Mcg
Total, serious adverse events
# participants affected	17	33	14
Cardiac disorders
Arteriosclerosis coronary artery ^†^A # participants affected / at risk	0/486 (0.00%)	1/491 (0.20%)	0/483 (0.00%)
Atrial Fibrillation ^†^A # participants affected / at risk	0/486 (0.00%)	1/491 (0.20%)	0/483 (0.00%)
Coronary artery disease ^†^A # participants affected / at risk	1/486 (0.21%)	0/491 (0.00%)	0/483 (0.00%)
Gastrointestinal disorders
Constipation ^†^A # participants affected / at risk	0/486 (0.00%)	1/491 (0.20%)	0/483 (0.00%)
Gastrointestinal haemorrhage ^†^A # participants affected / at risk	0/486 (0.00%)	1/491 (0.20%)	0/483 (0.00%)
Haemorrhoids ^†^A # participants affected / at risk	0/486 (0.00%)	1/491 (0.20%)	0/483 (0.00%)
Inguinal hernia ^†^A # participants affected / at risk	0/486 (0.00%)	1/491 (0.20%)	0/483 (0.00%)
General disorders
Chest pain ^†^A # participants affected / at risk	0/486 (0.00%)	0/491 (0.00%)	1/483 (0.21%)
Death ^†^A # participants affected / at risk	1/486 (0.21%)	0/491 (0.00%)	0/483 (0.00%)
Oedema peripheral ^†^A # participants affected / at risk	0/486 (0.00%)	0/491 (0.00%)	1/483 (0.21%)
Infections and infestations
Abscess limb ^†^A # participants affected / at risk	1/486 (0.21%)	0/491 (0.00%)	0/483 (0.00%)
Appendicitis ^†^A # participants affected / at risk	1/486 (0.21%)	0/491 (0.00%)	0/483 (0.00%)
Bronchitis ^†^A # participants affected / at risk	3/486 (0.62%)	2/491 (0.41%)	0/483 (0.00%)
Cellulitis ^†^A # participants affected / at risk	1/486 (0.21%)	0/491 (0.00%)	0/483 (0.00%)
Diverticulitis ^†^A # participants affected / at risk	1/486 (0.21%)	0/491 (0.00%)	0/483 (0.00%)
Infective exacerbation of chronic obstructive airways disease ^†^A # participants affected / at risk	1/486 (0.21%)	1/491 (0.20%)	0/483 (0.00%)
Lobar pneumonia ^†^A # participants affected / at risk	0/486 (0.00%)	2/491 (0.41%)	1/483 (0.21%)
Pneumonia ^†^A # participants affected / at risk	2/486 (0.41%)	3/491 (0.61%)	3/483 (0.62%)
Tracheobronchitis ^†^A # participants affected / at risk	1/486 (0.21%)	0/491 (0.00%)	0/483 (0.00%)
Injury, poisoning and procedural complications
Incisional hernia ^†^A # participants affected / at risk	1/486 (0.21%)	0/491 (0.00%)	0/483 (0.00%)
Injury ^†^A # participants affected / at risk	0/486 (0.00%)	1/491 (0.20%)	0/483 (0.00%)
Road traffic accident ^†^A # participants affected / at risk	0/486 (0.00%)	1/491 (0.20%)	0/483 (0.00%)
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion ^†^A # participants affected / at risk	0/486 (0.00%)	1/491 (0.20%)	0/483 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma ^†^A # participants affected / at risk	0/486 (0.00%)	0/491 (0.00%)	1/483 (0.21%)
Bladder cancer ^†^A # participants affected / at risk	0/486 (0.00%)	1/491 (0.20%)	0/483 (0.00%)
Brain cancer metastatic ^†^A # participants affected / at risk	0/486 (0.00%)	0/491 (0.00%)	1/483 (0.21%)
Colon cancer metastatic ^†^A # participants affected / at risk	0/486 (0.00%)	1/491 (0.20%)	0/483 (0.00%)
Lung adenocarcinoma ^†^A # participants affected / at risk	0/486 (0.00%)	1/491 (0.20%)	0/483 (0.00%)
Lung cancer metastatic ^†^A # participants affected / at risk	0/486 (0.00%)	2/491 (0.41%)	0/483 (0.00%)
Lung neoplasm ^†^A # participants affected / at risk	0/486 (0.00%)	1/491 (0.20%)	0/483 (0.00%)
Meningioma ^†^A # participants affected / at risk	0/486 (0.00%)	0/491 (0.00%)	1/483 (0.21%)
Metastases to liver ^†^A # participants affected / at risk	0/486 (0.00%)	1/491 (0.20%)	0/483 (0.00%)
Non-small cell lung cancer ^†^A # participants affected / at risk	0/486 (0.00%)	0/491 (0.00%)	1/483 (0.21%)
Prostate cancer ^†^A # participants affected / at risk	1/486 (0.21%)	0/491 (0.00%)	0/483 (0.00%)
Small cell carcinoma ^†^A # participants affected / at risk	0/486 (0.00%)	0/491 (0.00%)	1/483 (0.21%)
Squamous cell carcinoma ^†^A # participants affected / at risk	0/486 (0.00%)	1/491 (0.20%)	0/483 (0.00%)
Nervous system disorders
Cerebral cyst ^†^A # participants affected / at risk	0/486 (0.00%)	0/491 (0.00%)	1/483 (0.21%)
Loss of consciousness ^†^A # participants affected / at risk	0/486 (0.00%)	1/491 (0.20%)	0/483 (0.00%)
Syncope ^†^A # participants affected / at risk	0/486 (0.00%)	1/491 (0.20%)	0/483 (0.00%)
Respiratory, thoracic and mediastinal disorders
Aspiration ^†^A # participants affected / at risk	0/486 (0.00%)	1/491 (0.20%)	0/483 (0.00%)
Chronic obstructive pulmonary disease ^†^A # participants affected / at risk	10/486 (2.06%)	12/491 (2.44%)	8/483 (1.66%)
Dyspnoea ^†^A # participants affected / at risk	0/486 (0.00%)	2/491 (0.41%)	0/483 (0.00%)
Haemoptysis ^†^A # participants affected / at risk	0/486 (0.00%)	0/491 (0.00%)	1/483 (0.21%)
Pneumothorax ^†^A # participants affected / at risk	0/486 (0.00%)	1/491 (0.20%)	0/483 (0.00%)
Pulmonary embolism ^†^A # participants affected / at risk	0/486 (0.00%)	0/491 (0.00%)	1/483 (0.21%)
Respiratory failure ^†^A # participants affected / at risk	1/486 (0.21%)	0/491 (0.00%)	0/483 (0.00%)
Vascular disorders
Angiopathy ^†^A # participants affected / at risk	0/486 (0.00%)	1/491 (0.20%)	0/483 (0.00%)
Thrombophlebitis ^†^A # participants affected / at risk	0/486 (0.00%)	0/491 (0.00%)	1/483 (0.21%)

^†	Indicates events were collected by systematic assessment.
^A	Term from vocabulary, MedDRA 10.1

Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The FEV1 and FVC measurements at each observation time point were used to derive the primary and secondary efficacy endpoints and are not reported here. All statistical analyses for secondary endpoints are exploratory and the p-values are nominal.

Results Point of Contact:

Name/Title: Boehringer Ingelheim Pharmaceuticals
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 800-542-6257 Option 4
e-mail: clintriage.rdg@boehringer-ingelheim.com

No publications provided

Responsible Party:	Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers:	1012.56
Study First Received:	November 15, 2006
Results First Received:	April 3, 2009
Last Updated:	July 13, 2009
ClinicalTrials.gov Identifier:	NCT00400153 History of Changes
Health Authority:	Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow; Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine); New Zealand: Multicentre Ethics Committee/Medsafe; United States: Food and Drug Administration; France: AFSSAPS; Greece: National Organization for Medicines (EOF) National Ethics Committee; Argentina: A.N.M.A.T. (Administración Nacional de Medicamentos, Alimentos y Tecnología); Taiwan: Department of Health, Executive Yuan, Taiwan; Korea, Republic of: Korea Food and Drug Administration; Turkey: Ministry of Health Central Ethics Committee; Great Britain: MHRA; South Africa: MCC (Medicines Control Council)