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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:
ClinicalTrials.gov Identifier:
NCT00818454
First Posted: January 7, 2009
Last Update Posted: February 14, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Boehringer Ingelheim
Results First Submitted: September 21, 2010  
Study Type: Interventional
Study Design: Intervention Model: Crossover Assignment;   Primary Purpose: Treatment
Condition: Asthma
Interventions: Drug: Combivent CFC MDI
Drug: Albuterol HFA MDI
Drug: Respimat Combivent

  Participant Flow
  Hide Participant Flow

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 
Overall Participants Analyzed 
[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


  Limitations and Caveats
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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
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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.


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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00818454     History of Changes
Other Study ID Numbers: 1012.57
57948
First Submitted: January 6, 2009
First Posted: January 7, 2009
Results First Submitted: September 21, 2010
Results First Posted: November 23, 2010
Last Update Posted: February 14, 2014