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.

Condition	Treatment or Intervention	Phase
Asthma	Drug: Combivent® CFC MDI  Drug: Albuterol HFA MDI	Phase II Phase III

Further Study Details: 

Primary Outcomes: FEV1 area under the curve (AUC) 0 to 6 hours; Peak FEV1
Secondary Outcomes: FEV1 at each timepoint; Peak FVC; FVC at each timepoint; FVC AUC 0-6; Adverse events; Vital signs

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  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

Craig S. Conoscenti      (800) 344-4095  Ext. 4764    cconosce@rdg.boehringer-ingelheim.com

Alabama
      Jefferson Clinic, PC, Birmingham,  Alabama,  35233,  United States; Recruiting
California
      Southern California Clinical Trials, Lakewood,  California,  90712,  United States; Recruiting
      California Allergy & Asthma MDCL Group, Palmdale,  California,  93551,  United States; Recruiting
Colorado
      Pulmonary Research Consultants, Wheat Ridge,  Colorado,  80033,  United States; Recruiting
Connecticut
      Norwalk Hospital, Dept. of Pulmonary medecine, Norwalk,  Connecticut,  06856,  United States; Recruiting
Idaho
      Pulmonary Consultants of North idaho, Coeur D Alene,  Idaho,  83814,  United States; Recruiting
Kansas
      Consultants in Pulmonary Medecine, Olathe,  Kansas,  66061,  United States; Recruiting
Maryland
      Johns Hopkins Asthma and Allergy Center, Baltimore,  Maryland,  21224,  United States; Recruiting
Massachusetts
      Asthma Research Center, Boston,  Massachusetts,  02115,  United States; Recruiting
New York
      North Shore University Hospital, New Hyde Park,  New York,  11042,  United States; Recruiting
      NYU/Bellvue, New York,  New York,  10016,  United States; Not yet recruiting
Pennsylvania
      Penn State University of Hershey Medical Center, Hershey,  Pennsylvania,  17033,  United States; Recruiting
South Carolina
      Spartanburg Pharamceutical Research, Spartanburg,  South Carolina,  29307,  United States; Recruiting
      Lowcountry Lung and Critical Care P.C., Charleston,  South Carolina,  294063,  United States; Recruiting
Texas
      Ben Taub General Hospital, Houston,  Texas,  77030,  United States; Recruiting
Wisconsin
      University of Wisconson Hospital, Madison,  Wisconsin,  53792,  United States; Recruiting

Study ID Numbers:  BI - 1012.50
Record last reviewed:  March 2005
Last Updated:  March 14, 2005
Record first received:  November 12, 2004
ClinicalTrials.gov Identifier:  NCT00096616
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08