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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	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.

	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

	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.

	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

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2. Primary:

FEV1 AUC0-4 at Day 85

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3. Primary:

FEV1 AUC4-6 at Day 85

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4. Secondary:

FEV1 AUC0-6 at Day 1

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5. Secondary:

FEV1 AUC0-6 at Day 29

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6. Secondary:

FEV1 AUC0-6 at Day 57

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7. Secondary:

FEV1 AUC0-4 at Day 1

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8. Secondary:

FEV1 AUC0-4 at Day 29

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9. Secondary:

FEV1 AUC0-4 at Day 57

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10. Secondary:

FEV1 AUC4-6 at Day 1

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11. Secondary:

FEV1 AUC4-6 at Day 29

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12. Secondary:

FEV1 AUC4-6 at Day 57

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13. Secondary:

Peak FEV1 Response at Day 1

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14. Secondary:

Peak FEV1 Response at Day 29

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15. Secondary:

Peak FEV1 Response at Day 57

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16. Secondary:

Peak FEV1 Response at Day 85

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17. Secondary:

Peak FEV1 Response at Day 1

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18. Secondary:

Peak FEV1 Response at Day 29

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19. Secondary:

Peak FEV1 Response at Day 57

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20. Secondary:

Peak FEV1 Response at Day 85

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21. Secondary:

Time to Onset of Therapeutic FEV1 Response at Day 1

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22. Secondary:

Time to Onset of Therapeutic FEV1 Response at Day 29

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23. Secondary:

Time to Onset of Therapeutic FEV1 Response at Day 57

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24. Secondary:

Time to Onset of Therapeutic FEV1 Response at Day 85

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25. Secondary:

Duration of Therapeutic FEV1 Response at Day 1

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26. Secondary:

Duration of Therapeutic FEV1 Response at Day 29

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27. Secondary:

Duration of Therapeutic FEV1 Response at Day 57

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28. Secondary:

Duration of Therapeutic FEV1 Response at Day 85

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29. Secondary:

Time to Peak FEV1 Response at Day 1

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30. Secondary:

Time to Peak FEV1 Response at Day 29

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31. Secondary:

Time to Peak FEV1 Response at Day 57

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32. Secondary:

Time to Peak FEV1 Response at Day 85

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33. Secondary:

FVC AUC0-6 at Day 1

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34. Secondary:

FVC AUC0-6 at Day 29

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35. Secondary:

FVC AUC0-6 at Day 57

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36. Secondary:

FVC AUC0-6 at Day 85

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37. Secondary:

FVC AUC0-4 at Day 1

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38. Secondary:

FVC AUC0-4 at Day 29

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39. Secondary:

FVC AUC0-4 at Day 57

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40. Secondary:

FVC AUC0-4 at Day 85

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41. Secondary:

FVC AUC4-6 at Day 1

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42. Secondary:

FVC AUC4-6 at Day 29

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43. Secondary:

FVC AUC4-6 at Day 57

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44. Secondary:

FVC AUC4-6 at Day 85

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45. Secondary:

Peak FVC Response at Day 1

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46. Secondary:

Peak FVC Response at Day 29

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47. Secondary:

Peak FVC Response at Day 57

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48. Secondary:

Peak FVC Response at Day 85

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49. Secondary:

Peak FVC Response at Day 1

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50. Secondary:

Peak FVC Response at Day 29

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51. Secondary:

Peak FVC Response at Day 57

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52. Secondary:

Peak FVC Response at Day 85

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53. Secondary:

Rescue Medication Use on Pulmonary Test Day 1

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54. Secondary:

Rescue Medication Use on Pulmonary Test Day 29

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55. Secondary:

Rescue Medication Use on Pulmonary Test Day 57

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56. Secondary:

Rescue Medication Use on Pulmonary Test Day 85

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57. Secondary:

Night-time Rescue Medication Use

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58. Secondary:

Night-time Rescue Medication Use

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59. Secondary:

Daytime Rescue Medication Use

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60. Secondary:

Daytime Rescue Medication Use

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61. Secondary:

Night-time Symptom Score

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62. Secondary:

Night-time Symptom Score

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63. Secondary:

Daytime Symptom Score

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64. Secondary:

Daytime Symptom Score

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65. Secondary:

Trough Peak Expiratory Flow Rate (PEFR)

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66. Secondary:

Trough PEFR

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67. Secondary:

Physician's Global Evaluation Score on Pulmonary Function Testing Day 29

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68. Secondary:

Physician's Global Evaluation Score on Pulmonary Function Testing Day 57

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69. Secondary:

Physician's Global Evaluation Score on Pulmonary Function Testing Day 85

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70. Secondary:

Physician's Global Evaluation Score on Pulmonary Function Testing Day 29

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71. Secondary:

Physician's Global Evaluation Score on Pulmonary Function Testing Day 57

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72. Secondary:

Physician's Global Evaluation Score on Pulmonary Function Testing Day 85

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73. Secondary:

Chronic Obstructive Pulmonary Disease (COPD) Excerbation During the On-treatment Period

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74. Secondary:

COPD Excerbation During the On-treatment Period

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75. Secondary:

COPD Excerbation During the On-treatment Period

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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)