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Study Results
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Respimat® Combivent Trial in Chronic Obstructive Pulmonary Disease (COPD)
This study has been completed.
Study NCT00400153   Information provided by Boehringer Ingelheim Pharmaceuticals

First Received on November 15, 2006.   Last Updated on August 18, 2011   History of Changes
Results First Received: April 3, 2009  
Study Type: Interventional
Study Design: Primary Purpose: Treatment
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

  Participant Flow
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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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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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.

Participant Flow:   Overall Study
    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  



  Baseline Characteristics
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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.

Baseline Measures
    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   [ Time Frame: Before drug administration to 6 hours after drug administration on Day 85 ]
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2.  Primary:   FEV1 AUC0-4 at Day 85   [ Time Frame: Before drug administration to 4 hours after drug administration on Day 85 ]
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3.  Primary:   FEV1 AUC4-6 at Day 85   [ Time Frame: Between 4 hours and 6 hours after drug administration on Day 85 ]
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4.  Secondary:   FEV1 AUC0-6 at Day 1   [ Time Frame: Before drug administration to 6 hours after drug administration on Day 1 ]
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5.  Secondary:   FEV1 AUC0-6 at Day 29   [ Time Frame: Before drug administration to 6 hours after drug administration on Day 29 ]
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6.  Secondary:   FEV1 AUC0-6 at Day 57   [ Time Frame: Before drug administration to 6 hours after drug administration on Day 57 ]
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7.  Secondary:   FEV1 AUC0-4 at Day 1   [ Time Frame: Before drug administration to 4 hours after drug administration on Day 1 ]
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8.  Secondary:   FEV1 AUC0-4 at Day 29   [ Time Frame: Before drug administration to 4 hours after drug administration on Day 29 ]
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9.  Secondary:   FEV1 AUC0-4 at Day 57   [ Time Frame: Before drug administration to 4 hours after drug administration on Day 57 ]
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10.  Secondary:   FEV1 AUC4-6 at Day 1   [ Time Frame: Between 4 hours and 6 hours after drug administration on Day 1 ]
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11.  Secondary:   FEV1 AUC4-6 at Day 29   [ Time Frame: Between 4 hours and 6 hours after drug administration on Day 29 ]
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12.  Secondary:   FEV1 AUC4-6 at Day 57   [ Time Frame: Between 4 hours and 6 hours after drug administration on Day 57 ]
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13.  Secondary:   Peak FEV1 Response at Day 1   [ Time Frame: Within the first 2-hour post-treatment interval on Day 1 ]
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14.  Secondary:   Peak FEV1 Response at Day 29   [ Time Frame: Within the first 2-hour post-treatment interval on Day 29 ]
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15.  Secondary:   Peak FEV1 Response at Day 57   [ Time Frame: Within the first 2-hour post-treatment interval on Day 57 ]
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16.  Secondary:   Peak FEV1 Response at Day 85   [ Time Frame: Within the first 2-hour post-treatment interval on Day 85 ]
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17.  Secondary:   Peak FEV1 Response at Day 1   [ Time Frame: Within the first 2-hour post-treatment interval on Day 1 ]
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18.  Secondary:   Peak FEV1 Response at Day 29   [ Time Frame: Within the first 2-hour post-treatment interval on Day 29 ]
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19.  Secondary:   Peak FEV1 Response at Day 57   [ Time Frame: Within the first 2-hour post-treatment interval on Day 57 ]
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20.  Secondary:   Peak FEV1 Response at Day 85   [ Time Frame: 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   [ Time Frame: 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   [ Time Frame: 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   [ Time Frame: 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   [ Time Frame: 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   [ Time Frame: 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   [ Time Frame: 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   [ Time Frame: 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   [ Time Frame: 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   [ Time Frame: 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   [ Time Frame: 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   [ Time Frame: 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   [ Time Frame: Within the 6-hour post-treatment observation period at Day 85 ]
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33.  Secondary:   FVC AUC0-6 at Day 1   [ Time Frame: Before drug administration to 6 hours after drug administration at Day 1 ]
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34.  Secondary:   FVC AUC0-6 at Day 29   [ Time Frame: Before drug administration to 6 hours after drug administration at Day 29 ]
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35.  Secondary:   FVC AUC0-6 at Day 57   [ Time Frame: Before drug administration to 6 hours after drug administration on Day 57 ]
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36.  Secondary:   FVC AUC0-6 at Day 85   [ Time Frame: Before drug administration to 6 hours after drug administration on Day 85 ]
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37.  Secondary:   FVC AUC0-4 at Day 1   [ Time Frame: Before drug administration to 4 hours after drug administration on Day 1 ]
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38.  Secondary:   FVC AUC0-4 at Day 29   [ Time Frame: Before drug administration to 4 hours after drug administration on Day 29 ]
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39.  Secondary:   FVC AUC0-4 at Day 57   [ Time Frame: Before drug administration to 4 hours after drug administration on Day 57 ]
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40.  Secondary:   FVC AUC0-4 at Day 85   [ Time Frame: Before drug administration to 4 hours after drug administration on Day 85 ]
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41.  Secondary:   FVC AUC4-6 at Day 1   [ Time Frame: Between 4 hours and 6 hours after drug administration on Day 1 ]
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42.  Secondary:   FVC AUC4-6 at Day 29   [ Time Frame: Between 4 hours and 6 hours after drug administration on Day 29 ]
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43.  Secondary:   FVC AUC4-6 at Day 57   [ Time Frame: Between 4 hours and 6 hours after drug administration on Day 57 ]
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44.  Secondary:   FVC AUC4-6 at Day 85   [ Time Frame: Between 4 hours and 6 hours after drug administration on Day 85 ]
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45.  Secondary:   Peak FVC Response at Day 1   [ Time Frame: Within the first 2-hour post-treatment interval at Day 1 ]
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46.  Secondary:   Peak FVC Response at Day 29   [ Time Frame: Within the first 2-hour post-treatment interval at Day 29 ]
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47.  Secondary:   Peak FVC Response at Day 57   [ Time Frame: Within the first 2-hour post-treatment interval at Day 57 ]
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48.  Secondary:   Peak FVC Response at Day 85   [ Time Frame: Within the first 2-hour post-treatment interval at Day 85 ]
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49.  Secondary:   Peak FVC Response at Day 1   [ Time Frame: Within the first 2-hour post-treatment interval at Day 1 ]
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50.  Secondary:   Peak FVC Response at Day 29   [ Time Frame: Within the first 2-hour post-treatment interval at Day 29 ]
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51.  Secondary:   Peak FVC Response at Day 57   [ Time Frame: Within the first 2-hour post-treatment interval at Day 57 ]
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52.  Secondary:   Peak FVC Response at Day 85   [ Time Frame: 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   [ Time Frame: 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   [ Time Frame: 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   [ Time Frame: 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   [ Time Frame: During the 6-hour pulmonary function testing after drug administration on Day 85 ]
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57.  Secondary:   Night-time Rescue Medication Use   [ Time Frame: During the 2-week baseline washout period and the 12-week treatment period ]
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58.  Secondary:   Night-time Rescue Medication Use   [ Time Frame: During the 2-week baseline washout period and the 12-week treatment period ]
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59.  Secondary:   Daytime Rescue Medication Use   [ Time Frame: During the 2-week baseline washout period and the 12-week treatment period ]
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60.  Secondary:   Daytime Rescue Medication Use   [ Time Frame: During the 2-week baseline washout period and the 12-week treatment period ]
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61.  Secondary:   Night-time Symptom Score   [ Time Frame: During the 2-week baseline washout period and the 12-week treatment period ]
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62.  Secondary:   Night-time Symptom Score   [ Time Frame: During the 2-week baseline washout period and the 12-week treatment period ]
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63.  Secondary:   Daytime Symptom Score   [ Time Frame: During the 2-week baseline washout period and the 12-week treatment period ]
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64.  Secondary:   Daytime Symptom Score   [ Time Frame: 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)   [ Time Frame: During the 2-week baseline washout period and the 12-week treatment period and PEFR taken before administration of study medication ]
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66.  Secondary:   Trough PEFR   [ Time Frame: During the 2-week baseline washout period and the 12-week treatment period and PEFR taken before administration of study medication ]
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67.  Secondary:   Physician's Global Evaluation Score on Pulmonary Function Testing Day 29   [ Time Frame: Prior to pulmonary function test on Day 29 ]
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68.  Secondary:   Physician's Global Evaluation Score on Pulmonary Function Testing Day 57   [ Time Frame: Prior to pulmonary function test on Day 57 ]
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69.  Secondary:   Physician's Global Evaluation Score on Pulmonary Function Testing Day 85   [ Time Frame: Prior to pulmonary function test on Day 85 ]
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70.  Secondary:   Physician's Global Evaluation Score on Pulmonary Function Testing Day 29   [ Time Frame: Prior to pulmonary function test on Day 29 ]
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71.  Secondary:   Physician's Global Evaluation Score on Pulmonary Function Testing Day 57   [ Time Frame: Prior to pulmonary function test on Day 57 ]
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72.  Secondary:   Physician's Global Evaluation Score on Pulmonary Function Testing Day 85   [ Time Frame: Prior to pulmonary function test on Day 85 ]
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73.  Secondary:   Chronic Obstructive Pulmonary Disease (COPD) Excerbation During the On-treatment Period   [ Time Frame: During the 12-week on-treatment period ]
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74.  Secondary:   COPD Excerbation During the On-treatment Period   [ Time Frame: During the 12-week on-treatment period ]
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75.  Secondary:   COPD Excerbation During the On-treatment Period   [ Time Frame: During the 12-week on-treatment period ]
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  Serious Adverse Events
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  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:
unchecked 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.
unchecked 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.


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 by Boehringer Ingelheim Pharmaceuticals

Publications automatically indexed to this study:
Zuwallack R, De Salvo MC, Kaelin T, Bateman ED, Park CS, Abrahams R, Fakih F, Sachs P, Pudi K, Zhao Y, Wood CC; Combivent Respimat Inhaler Study Group. Efficacy and safety of ipratropium bromide/albuterol delivered via Respimat inhaler versus MDI. Respir Med. 2010 Aug;104(8):1179-88. Epub 2010 Feb 20.


Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00400153     History of Changes
Other Study ID Numbers: 1012.56
Study First Received: November 15, 2006
Results First Received: April 3, 2009
Last Updated: August 18, 2011
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)





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