Long Term Safety Study of Levalbuterol and Racemic Albuterol in Subjects Twelve Years of Age and Older With Asthma
- Conditions
- Asthma
- Interventions
- Registration Number
- NCT00064389
- Lead Sponsor
- Sumitomo Pharma America, Inc.
- Brief Summary
The purpose of this study is to evaluate the safety of levalbuterol as compared to racemic albuterol based on the frequencies of adverse events reporting during a 12-month period of chronic dosing of adolescent and adult subjects with asthma.
- Detailed Description
This was a randomized, open-label, active controlled, multicenter, parallel-group safety study in subjects 12 years of age and older with asthma. Subjects of appropriate age who completed the Phase III levalbuterol HFA MDI trials (Studies 051-353 or 051-355) were eligible to participate. Studies 051-353 and 051-355, both entitled "An Efficacy and Safety Study of Levalbuterol, Racemic Albuterol and Placebo in Subjects Twelve Years of Age and Older with Asthma" were multicenter, randomized, double-blind, placebo- and active-controlled, parallel-group studies of up to nine weeks in duration (a one-week single-blind placebo run in period followed by an eight-week double-blind treatment period). Subjects who completed Studies 051 353 and 051 355 but who were not immediately eligible to rollover into the current study could also participate but only after a 30-day washout. New subjects and subjects who participated in the Phase III trials who were not immediately eligible (ie, had a \>30-day washout) were considered to be de novo subjects.Study participation included 10 study visits over a 12 month period.
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
- 746
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 levalbuterol tartrate HFA MDI levalbuterol 90 mcg MDI QID 2 racemic albuterol racemic albuterol HFA MDI 180 mcg QID
- Primary Outcome Measures
Name Time Method incidence of post-randomization adverse events Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 22, 23, 26, 27, 30, 31, 34, 35, 38, 39, 43, 44, 47, 48, 52, 53
- Secondary Outcome Measures
Name Time Method rate of discontinuations due to adverse events Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 22, 23, 26, 27, 30, 31, 34, 35, 38, 39, 43, 44, 47, 48, 52, 53 time-to-selected adverse events (AEs with an incidence ≥5%) Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 22, 23, 26, 27, 30, 31, 34, 35, 38, 39, 43, 44, 47, 48, 52, 53 asthma attacks, asthma adverse events, and expanded-definition asthma events Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 22, 23, 26, 27, 30, 31, 34, 35, 38, 39, 43, 44, 47, 48, 52, 53 clinical laboratory values Weeks -1, 0, 10, 11, 26, 27, 43, 44, 52, 53 vital signs (blood pressure, heart rate, respiration rate, and body temperature) Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 26, 27, 34, 35, 43, 44, 52, 53 ECG parameters Weeks -1, 0, 1, 10, 11, 26, 27, 43, 44, 52, 53 physical examinations Weeks -1, 0, 26, 27, 52, 53 rescue medication, and daytime asthma control days Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 22, 23, 26, 27, 30, 31, 34, 35, 38, 39, 43, 44, 47, 48, 52, 53 FEV1, FVC, FEF25-75%, peak expiratory flow Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 26, 27, 34, 35, 43, 44, 52, 53 Asthma Quality of Life Questionnaire (AQLQ) Weeks 0, 26, 27, 52, 53 subject and physician global evaluations Weeks 26, 27, 52, 53 (S) and (R) albuterol plasma concentrations Weeks -1, 0, 10, 11, 26, 27, 43, 44, 52, 53 subject assessment of study inhaler device performance Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 22, 23, 26, 27, 30, 31, 34, 35, 38, 39, 43, 44, 47, 48, 52, 53
Trial Locations
- Locations (95)
Allergy & Asthma Research of NJ, Inc.
🇺🇸Philadelphia, Pennsylvania, United States
Primary Care Lung Clinic
🇨🇦Toronto, Ontario, Canada
Alta Clinical Research, LLC
🇺🇸Tucson, Arizona, United States
Neem Research Group Inc.
🇺🇸Columbia, South Carolina, United States
Allergic Disease & Asthma Center, PA
🇺🇸Greenville, South Carolina, United States
Allergy Sinus Asthma Research Institute
🇺🇸Miami, Florida, United States
Breco Research
🇺🇸Houston, Texas, United States
Florida Center for Alergy & Asthma Research
🇺🇸Miami, Florida, United States
Clinical Trials of North Houston
🇺🇸Houston, Texas, United States
Breath of Life Research Institute
🇺🇸Houston, Texas, United States
Institute of Healthcare Assessment, Inc.
🇺🇸San Diego, California, United States
Clinical Research Institute
🇺🇸Minneapolis, Minnesota, United States
New Horizons Clinical Research
🇺🇸Cincinnati, Ohio, United States
Consultants in Pulmonary Medicine
🇺🇸Olathe, Kansas, United States
Allergy & Asthma Care Center
🇺🇸Fargo, North Dakota, United States
St. Boniface General Hospital
🇨🇦Winnipeg, Manitoba, Canada
Henry Ford Hospital & Medical Centers
🇺🇸Detroit, Michigan, United States
Office of Constantine Falliers, MD
🇺🇸Denver, Colorado, United States
Heartland Clinical Research Inc.
🇺🇸Omaha, Nebraska, United States
Office of Meera Dewan, MD
🇺🇸Omaha, Nebraska, United States
Milwaukee Medical Clinic
🇺🇸Milwaukee, Wisconsin, United States
Lovelace Scientific Resources
🇺🇸Albuquerque, New Mexico, United States
Northern California Research Corp
🇺🇸Fair Oaks, California, United States
Jefferson Clinic PC
🇺🇸Birmington, Alabama, United States
Center of Research Excellence, LLC
🇺🇸Oxford, Alabama, United States
Clinical Research Center of Indiana
🇺🇸Indianapolis, Indiana, United States
Virginia Adult & Pediatric Allergy & Asthma PC
🇺🇸Richmond, Virginia, United States
Clinical Research Group
🇨🇦Mississauga, Ontario, Canada
Montgomery Pulmonary Consultants
🇺🇸Montgomery, Alabama, United States
Pulmonary Associates Research Division
🇺🇸Mobile, Alabama, United States
Madera Family Medical Group
🇺🇸Madera, California, United States
Clinical Trials of Orange County, Inc.
🇺🇸Orange, California, United States
Integrated Research Group
🇺🇸Corona, California, United States
Allergy, Asthma & Respiratory Care Center
🇺🇸Long Beach, California, United States
Office of Gary Richmond, MD
🇺🇸Ft. Lauderdale, Florida, United States
Westlake Medical Research, Inc.
🇺🇸Westlake Village, California, United States
FPA Clinical Research
🇺🇸Kissimmee, Florida, United States
Orlando Clinic for Asthma & Respiratory Diseases
🇺🇸Longwood, Florida, United States
CNS Clinical Trials
🇺🇸Ft. Myers, Florida, United States
Family Allergy & Asthma Center, PC
🇺🇸Atlanta, Georgia, United States
Aeroallergy Research
🇺🇸Savannah, Georgia, United States
The Allergy & Asthma Clinic Research Center
🇺🇸Conyers, Georgia, United States
Sneeze, Wheeze and Itch, LLC
🇺🇸Bloomington, Illinois, United States
Children's Asthma Respiratory & Exercise Specialists
🇺🇸Glenview, Illinois, United States
Rush Presbyterian - St. Luke's Medical Center
🇺🇸Chicago, Illinois, United States
South Bend Clinic
🇺🇸South Bend, Indiana, United States
Cardinal Respiratory, PC
🇺🇸Springfield, Illinois, United States
Northshore Medical Research
🇺🇸Covington, Louisiana, United States
Heartland Research Associates
🇺🇸Wichita, Kansas, United States
Institute for Asthma & Allergy, PC
🇺🇸Wheaton, Maryland, United States
Center for Clinical Research
🇺🇸Taunton, Massachusetts, United States
Hurley Child and Adolescent Asthma Center
🇺🇸Flint, Michigan, United States
Allergy, Asthma, Immunology Services, LLC
🇺🇸Jefferson City, Missouri, United States
Midwest Chest Consultants, PC
🇺🇸St. Charles, Missouri, United States
Washington University School of Medicine, Division of Allergy & Immunology
🇺🇸St. Louis, Missouri, United States
Montana Medical Research, LLC
🇺🇸Missoula, Montana, United States
Allergy, Asthma & Immunology Associates, PC
🇺🇸Lincoln, Nebraska, United States
Delaware Valley Institute for Clinical Research
🇺🇸Cherry Hill, New Jersey, United States
Clinical Research Center of Allergy & Asthma Consultants
🇺🇸Tinton Falls, New Jersey, United States
Asthma & Allergy Associates, PC
🇺🇸Cortland, New York, United States
Pulmonary Medical Research of NY
🇺🇸Bay Shore, New York, United States
Allergy & Asthma of Northern NM
🇺🇸Los Alamos, New Mexico, United States
Charlotte Lung & Health Center
🇺🇸Charlotte, North Carolina, United States
Office of Richard Castaldo
🇺🇸Tonawanda, New York, United States
Office of Michael Marcus, MD
🇺🇸Staten Island, New York, United States
Allergy, Asthma & Clinical Research Center
🇺🇸Oklahoma City, Oklahoma, United States
Neem Research Group, Inc.
🇺🇸Charlotte, North Carolina, United States
Allergy, Asthma and Dermatology Research Center
🇺🇸Lake Oswego, Oregon, United States
Regional Allergy & Asthma Consultants
🇺🇸Asheville, North Carolina, United States
Cornerstone Research Care
🇺🇸High Point, North Carolina, United States
Optimed Research LLC
🇺🇸Columbus, Ohio, United States
Sterling Research Group
🇺🇸Cincinnati, Ohio, United States
Bellevue Pediatric Associates
🇺🇸Bellevue, Pennsylvania, United States
Medford Medical Clinic, LLP
🇺🇸Medford, Oregon, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Valley Clinical Research Center
🇺🇸Easton, Pennsylvania, United States
Advanced Clinical Concepts
🇺🇸Shillington, Pennsylvania, United States
Asthma Institute
🇺🇸Chattanooga, Tennessee, United States
Office of Constantine Saadeh
🇺🇸Amarillo, Texas, United States
UTX Medical
🇺🇸Galveston, Texas, United States
The Allergy Associates
🇺🇸Knoxville, Tennessee, United States
Allergy & Asthma Clinical of Central Texas
🇺🇸Austin, Texas, United States
Pulmonary Associates of Richmond Inc.
🇺🇸Richmond, Virginia, United States
Central Texas Health Research
🇺🇸New Braunfels, Texas, United States
Lung Diagnostics
🇺🇸San Antonio, Texas, United States
Hampton Roads Center for Clinical Research
🇺🇸Norfolk, Virginia, United States
The Physician's Clinic of Spokane
🇺🇸Spokane, Washington, United States
Allergy, Asthma, and Sinus Center F.C.
🇺🇸Greenfield, Wisconsin, United States
Allergic Diseases, S.C.
🇺🇸West Allis, Wisconsin, United States
National Clinical Research
🇺🇸Richmond, Virginia, United States
Niagara Clinical Research, Inc.
🇨🇦Niagara Falls, Ontario, Canada
Orlando Clinical Research Center
🇺🇸Orlando, Florida, United States
Carolina MedTrials, LLC
🇺🇸Winston-Salem, North Carolina, United States
Neem Research Group of Charleston
🇺🇸Charleston, South Carolina, United States
Trial Management Group
🇨🇦Vancouver, British Columbia, Canada