Combivent® CFC Metered Dose Inhaler (MDI) in Moderate to Severe Asthma

Condition(s) targeted: Asthma

Intervention: Combivent® CFC MDI (Drug); Albuterol HFA MDI (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Boehringer Ingelheim Pharmaceuticals

Official(s) and/or principal investigator(s):
Boehringer Ingelheim Study Coordinator, Study Chair, Affiliation: Boehringer Ingelheim Pharmaceuticals

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.

Official title: A Single Dose, Randomized, Double-Blind Crossover Comparison of Combivent CFC MDI and Albuterol HFA MDI in Patients With Moderate to Severe Persistent Asthma and Persistent Symptoms Despite Treatement With Inhaled Corticosteroids

Study design: Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment

Primary outcome: FEV1 area under the curve (AUC) 0 to 6 hours Peak FEV1

Secondary outcome: FEV1 at each timepoint Peak FVC FVC at each timepoint FVC AUC 0-6 Adverse events Vital signs

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: - 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 - Exclusion

Criteria: - 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

Cooper Green Hospital, Birmingham, Alabama, United States

620 South 20th Street, NHB 104, Birmingham, Alabama, United States

Southern California Clinical Trials, Lakewood, California, United States

Boehringer Ingelheim Investigational Site, Palmdale, California, United States

Boehringer Ingelheim Investigational Site, Wheat Ridge, Colorado, United States

Norwalk Hospital, Norwalk, Connecticut, United States

Boehringer Ingelheim Investigational Site, Panama City, Florida, United States

University of Miami School of Medicine, Miami, Florida, United States

Boehringer Ingelheim Investigational Site, Coeur d'Arlene, Idaho, United States

Boehringer Ingelheim Investigational Site, River Forest, Illinois, United States

Boehringer Ingelheim Investigational Site, Olathe, Kansas, United States

LSU MC-Sheveport, Shreveport, Louisiana, United States

Boehringer Ingelheim Investigational Site, Auburn, Maine, United States

Johns Hopkins Asthma & Allergy, Baltimore, Maryland, United States

Brigham & Women's Hospital, Boston, Massachusetts, United States

Boehringer Ingelheim Investigational Site, Cherry Hill, New Jersey, United States

Boehringer Ingelheim Investigational Site, Berlin, New Jersey, United States

North Shore University Hospital, Manhasset, New York, United States

NYU School of Medicine, New York, New York, United States

Wake Forest University, Center for Human Genomics, Winston-Salem, North Carolina, United States

Division of Pulmonary & Critical Care Medicine, Durham, North Carolina, United States

Penn State University, Hershey Medical Center, Hershey, Pennsylvania, United States

Spartanburg Medical Research, Spartanburg, South Carolina, United States

Boehringer Ingelheim Investigational Site, Charleston, South Carolina, United States

Ben Taul General Hospital, Houston, Texas, United States

University of Texas Health Center at Tyler, Tyler, Texas, United States

University of Wisconsin Hospital, Madison, Wisconsin, United States

Starting date: November 2004
Ending date: August 2006
Last updated: April 3, 2008