The primary goal of this trial is to compare the efficacy and safety of COMBIVENT CFC MDI with albuterol HFA MDI, the current standard reliever medication in asthma. In the first cross-over part of the study (Treatment Phases 1 and 2) the marketed product, COMBIVENT CFC MDI will be used. In the second, parallel group part of the trial (Treatment Phase 3) COMBIVENT RESPIMAT will be tested for acute bronchodilator efficacy in a blinded manner at the clinic visits. During the third 4-week treatment phase open label COMBIVENT RESPIMAT will be used for symptom relief as needed.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Enrollment
226
1012.57.121 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
1012.57.144 Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
1012.57.145 Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
1012.57.124 Boehringer Ingelheim Investigational Site
Palmdale, California, United States
1012.57.137 Boehringer Ingelheim Investigational Site
San Diego, California, United States
FEV1 AUC0-6 Response (Crossover Part of the Study)
Change from baseline after 4 weeks in Forced Expiratory Volume Area Under (FEV1 AUC) the Curve from 0 to 6 hours.
Time frame: Test day baseline and test day FEV1 AUC 0-6, after 4 weeks
Peak FEV1 Response (Crossover Part of the Study)
Change from baseline after 4 weeks in peak Forced Expiratory Volume response
Time frame: Test day baseline and test day peak FEV1, after 4 weeks
Mini Asthma Quality of Life Questionnaire (Crossover Part of the Study)
Change from baseline after 4 weeks in Mini-AQLQ score. Worst score - 1 (most severe), best score - 7 (less severe)
Time frame: Baseline, 4 weeks
Asthma Control Questionnaire (Crossover Part of the Study)
Change from baseline after 4 weeks in ACQ score. Worst score - 6(most severe), best score - 0 (no symptoms)
Time frame: Baseline, 4 weeks
Puffs Study Medication Used During Day (Crossover Part of the Study)
Change from baseline in weekly mean of puffs of blinded study medication (albuterol HFA or combivent CFC) used during day
Time frame: Baseline, 4 weeks
Puffs Study Medication Used During Night (Crossover Part of the Study)
Change from baseline in weekly mean of puffs of blinded study medication (albuterol HFA or combivent CFC) used during night
Time frame: Baseline, 4 weeks
Puffs Open-label Albuterol Used During Day (Crossover Part of the Study)
Change from baseline in weekly mean of puffs of open-label albuterol used during day
Time frame: Baseline, 4 weeks
Puffs Open-label Albuterol Used During Night (Crossover Part of the Study)
Change from baseline in weekly mean of puffs of open-label albuterol used during night
Time frame: Baseline, 4 weeks
FEV1 AUC0-6 Response (Parallel Part of the Study)
Change from baseline after 4 weeks in Forced Expiratory Volume Area Under the Curve from 0 to 6 hours
Time frame: Test day baseline and test day FEV1 AUC 0-6, after 4 weeks
Peak FEV1 Response
Change from baseline after 4 weeks in peak Forced Expiratory Volume response
Time frame: Test day baseline and test day peak FEV1, after 4 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
1012.57.130 Boehringer Ingelheim Investigational Site
Stockton, California, United States
1012.57.134 Boehringer Ingelheim Investigational Site
Centennial, Colorado, United States
1012.57.151 Boehringer Ingelheim Investigational Site
Wheat Ridge, Colorado, United States
1012.57.119 Boehringer Ingelheim Investigational Site
Panama City, Florida, United States
1012.57.149 Boehringer Ingelheim Investigational Site
Winter Park, Florida, United States
...and 31 more locations