4 Week 2 Way Crossover Double Blind Treatment Phase With Combivent CFC Versus Albuterol Followed by a 4 Week Open Label Combivent Respimat When All Drugs Are Used for Symptom Relief as Needed in Pts With Moderate to Severe Asthma

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00818454
First received: January 6, 2009
Last updated: January 21, 2014
Last verified: January 2014
Results First Received: September 21, 2010  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Primary Purpose: Treatment
Condition: Asthma
Interventions: Drug: Combivent CFC MDI
Drug: Albuterol HFA MDI
Drug: Respimat Combivent

  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
  • Crossover Part of the Study (Treatment Period 1)
  • Crossover Part of the Study (Washout Period of 1 Week)
  • Crossover Part of the Study (Treatment Period 2)
  • Parallel Part of the Study Following Second Randomization (Treatment Period 3)

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Albuterol HFA First, Then Combivent CFC Albuterol Hydrofluoroalkene, Combivent Chlorofluorocarbon
Combivent CFC First, Then Albuterol HFA Combivent Chlorofluorocarbon, Albuterol Hydrofluoroalkene
Placebo Respimat Placebo Respimat (matching Combivent Respimat)
Combivent Respimat Combivent Respimat (contains the effective dose of albuterol)

Participant Flow for 4 periods

Period 1:   Treatment Period 1
    Albuterol HFA First, Then Combivent CFC     Combivent CFC First, Then Albuterol HFA     Placebo Respimat     Combivent Respimat  
STARTED     115     111     0     0  
COMPLETED     112     110     0     0  
NOT COMPLETED     3     1     0     0  
Adverse Event                 0                 1                 0                 0  
not specified                 3                 0                 0                 0  

Period 2:   Washout Period of 1 Week
    Albuterol HFA First, Then Combivent CFC     Combivent CFC First, Then Albuterol HFA     Placebo Respimat     Combivent Respimat  
STARTED     112     110     0     0  
COMPLETED     108     107     0     0  
NOT COMPLETED     4     3     0     0  
Adverse Event                 1                 1                 0                 0  
Protocol Violation                 2                 0                 0                 0  
not specified                 1                 2                 0                 0  

Period 3:   Treatment Period 2
    Albuterol HFA First, Then Combivent CFC     Combivent CFC First, Then Albuterol HFA     Placebo Respimat     Combivent Respimat  
STARTED     108     107     0     0  
COMPLETED     106     106     0     0  
NOT COMPLETED     2     1     0     0  
not specified                 2                 1                 0                 0  

Period 4:   Treatment Period 3
    Albuterol HFA First, Then Combivent CFC     Combivent CFC First, Then Albuterol HFA     Placebo Respimat     Combivent Respimat  
STARTED     0     0     26     139  
COMPLETED     0     0     26     138  
NOT COMPLETED     0     0     0     1  
Adverse Event                 0                 0                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Entire Study Population Participants randomized to crossover part at randomization 1

Baseline Measures
    Entire Study Population  
Number of Participants  
[units: participants]
  226  
Age  
[units: Years]
Mean ± Standard Deviation
  47.1  ± 13.7  
Gender  
[units: Participants]
 
Female     130  
Male     96  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     11  
Not Hispanic or Latino     215  
Unknown or Not Reported     0  
Race/Ethnicity, Customized  
[units: Participants]
 
Amer. Ind./Alaska Nat     1  
Asian     2  
Black/African Amer.     44  
Hawaiian/Pacif. Isle     5  
White     174  
Body mass index  
[units: Kilograms per square meter]
Mean ± Standard Deviation
  31.1  ± 6.7  
Smoking history  
[units: Participants]
 
Never smoked     163  
Ex-smoker     63  
Currently smokes     0  
Alcohol history  
[units: Participants]
 
Non drinker     76  
Drinks - no interference     150  
Drinks - possible interference     0  
Height  
[units: Centimeters]
Mean ± Standard Deviation
  169.9  ± 11.0  
Weight  
[units: Kilograms]
Mean ± Standard Deviation
  89.9  ± 21.0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   FEV1 AUC0-6 Response (Crossover Part of the Study)   [ Time Frame: Test day baseline and test day FEV1 AUC 0-6, after 4 weeks ]

2.  Primary:   Peak FEV1 Response (Crossover Part of the Study)   [ Time Frame: Test day baseline and test day peak FEV1, after 4 weeks ]

3.  Secondary:   Mini Asthma Quality of Life Questionnaire (Crossover Part of the Study)   [ Time Frame: Baseline, 4 weeks ]

4.  Secondary:   Asthma Control Questionnaire (Crossover Part of the Study)   [ Time Frame: Baseline, 4 weeks ]

5.  Secondary:   Puffs Study Medication Used During Day (Crossover Part of the Study)   [ Time Frame: Baseline, 4 weeks ]

6.  Secondary:   Puffs Study Medication Used During Night (Crossover Part of the Study)   [ Time Frame: Baseline, 4 weeks ]

7.  Secondary:   Puffs Open-label Albuterol Used During Day (Crossover Part of the Study)   [ Time Frame: Baseline, 4 weeks ]

8.  Secondary:   Puffs Open-label Albuterol Used During Night (Crossover Part of the Study)   [ Time Frame: Baseline, 4 weeks ]

9.  Secondary:   FEV1 AUC0-6 Response (Parallel Part of the Study)   [ Time Frame: Test day baseline and test day FEV1 AUC 0-6, after 4 weeks ]

10.  Secondary:   Peak FEV1 Response   [ Time Frame: Test day baseline and test day peak FEV1, after 4 weeks ]


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.  


Results Point of Contact:  
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


No publications provided


Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00818454     History of Changes
Other Study ID Numbers: 1012.57, 57948
Study First Received: January 6, 2009
Results First Received: September 21, 2010
Last Updated: January 21, 2014
Health Authority: United States: Food and Drug Administration