Study of Levalbuterol, Racemic Albuterol and Placebo in Subjects Twelve Years of Age and Older With Asthma
- Conditions
- Asthma
- Interventions
- Registration Number
- NCT00073827
- Lead Sponsor
- Sumitomo Pharma America, Inc.
- Brief Summary
The primary purpose of this study was to investigate the efficacy of levalbuterol compared to a placebo and compared to albuterol in the treatment and prevention of bronchoconstriction in adolescent and adult subjects with asthma, with all treatments administered 4 times a day (QID).
- Detailed Description
This was a Phase III, multicenter, randomized, double-blind, placebo- and active-controlled, parallel-group study of up to 9 weeks in duration. Seven days of QID single-blind placebo administration (via MDI) was followed by 56 days of QID double-blind active treatment. Following the run-in period, each subject was randomized to one of the following three treatments: levalbuterol HFA MDI 90 mcg (2 actuations of 45 mcg), racemic albuterol HFA MDI 180 mcg (2 actuations of 90 mcg), or placebo (2 actuations). Subjects were randomized in a 2:1:1 ratio of levalbuterol to racemic albuterol to placebo. In order to maintain blinding of the device, a placebo dose was administered with each treatment. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 445
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 levalbuterol tartrate MDI levalbuterol MDI 90 mcg QID 2 racemic albuterol MDI racemic albuterol MDI 180 mcg QID 3 Placebo Placebo MDI QID
- Primary Outcome Measures
Name Time Method percent change in FEV1 from visit predose averaged over the 8-week double-blind period Weeks 0, 4, 8
- Secondary Outcome Measures
Name Time Method area under the FEV1 percent change curve from visit pre-dose and from study baseline curves averaged over the double-blind period Weeks 0, 4, 8 peak percent change in FEV1 from study baseline Weeks 0, 4, 8 peak change in FEV1 from visit predose Weeks 0, 4, 8 peak percent of predicted FEV1 Weeks 0, 4, 8 area under the FEV1 curve (AUC) Weeks 0, 4, 8 peak change and peak percent change in FEF25-75% from visit predose Weeks 0, 4, 8 peak change and peak percent change in FVC from visit predose Weeks 0, 4, 8
Trial Locations
- Locations (63)
Clinical Research Centers of Colorado PC
🇺🇸Englewood, Colorado, United States
University of Maryland School of Medicine
🇺🇸Baltimore, Maryland, United States
Princeton Center for Clinical Research
🇺🇸Princeton, New Jersey, United States
Asthma & Allergy Associates, PC
🇺🇸Pueblo, Colorado, United States
Regional Allergy & Asthma Consultants
🇺🇸Asheville, North Carolina, United States
Allergy Research Foundation, Inc.
🇺🇸Los Angeles, California, United States
Children's Hospital of Pittsburgh Division of Allergy, Immunology & Infectious Diseases
🇺🇸Pittsburgh, Pennsylvania, United States
University of Pittsburgh Division of Pulmonary
🇺🇸Pittsburgh, Pennsylvania, United States
ASTHMA, Inc.
🇺🇸Seattle, Washington, United States
Clinical Research Center of Indiana
🇺🇸Indianapolis, Indiana, United States
Breath of Life Research Institute
🇺🇸Houston, Texas, United States
Allergy, Asthma & Respiratory Care Center
🇺🇸Long Beach, California, United States
MDC Research
🇺🇸Mobile, Alabama, United States
Allergy & Asthma Medical Group of Diablo Valley, Inc.
🇺🇸Danville, California, United States
Radiant Research, Inc.
🇺🇸Encinitas, California, United States
Allergy & Asthma Specialists Medical Group
🇺🇸Huntington Beach, California, United States
Office of Ronald Saff
🇺🇸Tallahassee, Florida, United States
The Clinical Research Center, LLC
🇺🇸St. Louis, Missouri, United States
Allergy & Asthma Research Associates
🇺🇸Dallas, Texas, United States
Office of Constantine Saadeh
🇺🇸Amarillo, Texas, United States
Clinical Trials of Orange County
🇺🇸Orange, California, United States
Alabama Asthma and Allergy Center
🇺🇸Homewood, Alabama, United States
Integrated Research Group
🇺🇸Corona, California, United States
Aeroallergy Research Laboratories of Savannah, Inc.
🇺🇸Savannah, Georgia, United States
Allergy & Asthma Assoc. of Santa Clara Valley Research Center
🇺🇸San Jose, California, United States
Southern California Research Center
🇺🇸Viejo, California, United States
Bensch Research Associates
🇺🇸Stockton, California, United States
Radiant Research Honolulu
🇺🇸Honolulu, Hawaii, United States
Northshore Medical Research
🇺🇸Slidell, Louisiana, United States
Mississippi Asthma & Allergy Clinic
🇺🇸Jackson, Mississippi, United States
Allergy & Asthma Care Specialists
🇺🇸Metairie, Louisiana, United States
PCHI
🇺🇸Needham, Massachusetts, United States
Northeast Medical Research Associates, Inc.
🇺🇸N. Dartmouth, Massachusetts, United States
PCCS
🇺🇸Albany, New York, United States
Center for Clinical Research
🇺🇸Taunton, Massachusetts, United States
Division of Allergy & Immunology, Washington Univ School of Med
🇺🇸St. Louis, Missouri, United States
Office of Clinical Research, University of Missouri-Columbia
🇺🇸Columbia, Missouri, United States
AAIR Research Center
🇺🇸Rochester, New York, United States
Pulmonary and Allergy Associates
🇺🇸Springfield, New Jersey, United States
Allergy & Asthma Research
🇺🇸Eugene, Oregon, United States
Raleigh Pediatric Associates
🇺🇸Raleigh, North Carolina, United States
Cornerstone Research Care
🇺🇸High Point, North Carolina, United States
Asthma & Allergy Research Associates
🇺🇸Chester, Pennsylvania, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Office of Neil Kao
🇺🇸Greenville, South Carolina, United States
Allergy & Asthma Consultants, LLP
🇺🇸Mt. Pleasant, South Carolina, United States
Children's Hospital of the Kings Daughters
🇺🇸Norfolk, Virginia, United States
Allergy & Asthma Center
🇺🇸Waco, Texas, United States
North Texas Institute for Clinical Trials
🇺🇸Fort Worth, Texas, United States
Allergic Diseases, SC
🇺🇸West Allis, Wisconsin, United States
Pulmonary Associates of Richmond, Inc.
🇺🇸Richmond, Virginia, United States
St. Louis University
🇺🇸St. Louis, Missouri, United States
Allergy Associates Medical Group
🇺🇸San Diego, California, United States
Allergy & Asthma Medical Group & Research Center
🇺🇸San Diego, California, United States
Allergy & Asthma Prevention & Treatment Center
🇺🇸San Diego, California, United States
National Jewish Medical & Research Center
🇺🇸Denver, Colorado, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Clinical Research Institute
🇺🇸Minneapolis, Minnesota, United States
The Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States
Bernstein Clinical Research Center, LLC
🇺🇸Cincinnati, Ohio, United States
Allergy Associates Research Center, LLC
🇺🇸Portland, Oregon, United States
Lung Diagnostics
🇺🇸San Antonio, Texas, United States
Radiant Research
🇺🇸Charleston, South Carolina, United States