Combivent® CFC Metered Dose Inhaler (MDI) in Moderate to Severe Asthma
- Conditions
- Asthma
- Registration Number
- NCT00096616
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The purpose of this study is to demonstrate the superior bronchodilator efficacy of inhaled Combivent® CFC MDI vs. Albuterol HFA MDI in moderate to severe asthma patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 113
- Patient greater than or equal to 18 years of age,
- non-smokers,
- diagnosed with asthma, with an FEV1 less than or equal to 70 percent of predicted normal,
- stable use of Beta agonist
- daily use of inhaled steroids for one year
- Patients with other significant diseases other than asthma, requiring oxygen,
- intubated within 5 years,
- asthma exacerbation within 6 weeks of trial,
- use of unstable doses (greater than 10 mg/day of prednisone or equivalent) of steroids,
- participating in another interventional trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method FEV1 area under the curve (AUC) 0 to 6 hours Peak FEV1
- Secondary Outcome Measures
Name Time Method FEV1 at each timepoint Peak FVC FVC at each timepoint FVC AUC 0-6 Adverse events Vital signs
Trial Locations
- Locations (18)
Ben Taul General Hospital
🇺🇸Houston, Texas, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
620 South 20th Street, NHB 104
🇺🇸Birmingham, Alabama, United States
Southern California Clinical Trials
🇺🇸Lakewood, California, United States
Johns Hopkins Asthma & Allergy
🇺🇸Baltimore, Maryland, United States
Norwalk Hospital
🇺🇸Norwalk, Connecticut, United States
Penn State University, Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
University of Wisconsin Hospital
🇺🇸Madison, Wisconsin, United States
Spartanburg Medical Research
🇺🇸Spartanburg, South Carolina, United States
NYU School of Medicine
🇺🇸New York, New York, United States
Boehringer Ingelheim Investigational Site
🇺🇸Charleston, South Carolina, United States
University of Miami School of Medicine
🇺🇸Miami, Florida, United States
LSU MC-Sheveport
🇺🇸Shreveport, Louisiana, United States
Brigham & Women's Hospital
🇺🇸Boston, Massachusetts, United States
Wake Forest University, Center for Human Genomics
🇺🇸Winston-Salem, North Carolina, United States
University of Texas Health Center at Tyler
🇺🇸Tyler, Texas, United States
Cooper Green Hospital
🇺🇸Birmingham, Alabama, United States
Division of Pulmonary & Critical Care Medicine
🇺🇸Durham, North Carolina, United States