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.
Inclusion Criteria
- Willing and able to comply with study procedures and visit schedules
- Females 12-60 yrs must have a negative serum pregnancy test at study start
- Women of child bearing potential must use acceptable method of birth control
throughout study
- Confirmed diagnosis of asthma minimum of 6 mos. prior to study start
- Have stable baseline asthma and have been using B-adrenergic agonist, and/or
anti-asthma anti-inflammatory meds, and/or OTC asthma meds. >6 mos. prior to study
start
- In good health with exception of reversible airways disease and not suffering from any
chronic condition that might affect their respiratory function
- Had chest X-ray w/in 12 mos. prior to randomization that is not diagnostic of
pneumonia, atelectasis, pulmonary fibrotic disease, pneumothorax, chronic obstructive
pulmonary disease etc.
- Subject rolling over from either Sepracor study 051-353 or 051-355 must have
successfully completed the study
- Subject who is not immediately rolled over from Sepracor study 051-353 or 051-355 must
wait >30 days and will be regarded as a de novo subject
- Able to complete daily diary cards and medical event calendars reliably, understand
dosing instructions, demonstrate how to use the MiniWright PEF meter. Minor subjects
must have a parent/legal guardian assist them during the study with these activities
Exclusion Criteria
- Female who is pregnant or lactating
- Participated in investigational drug study w/in 30 days prior to study start, or
currently participating in another clinical trial, other than Sepracor studies 051-353
or 051-355
- Subject who early terminated from Sepracor study 051-353 or 051-355
- Subject whose schedule prevents him or her from taking the first daily dose of study
medication and/or starting study visits before 10 AM
- Have travel commitments during the study that would interfere with trial measurements
and/or compliance
- History of hospitalization for asthma w/in 45 days prior to study start, or scheduled
for in-patient hospitalization, including elective surgery during the trial
- Subject with a known sensitivity to levalbuterol or racemic albuterol, or any of the
excipients contained in any of these formulations
- Subject using any prescription drug with which albuterol sulfate is contraindicated
- Subject with currently diagnosed life-threatening asthma
- History of cancer (exception: basal cell carcinoma in remission)
- Subject with hyperthyroidism, diabetes, hypertension, cardiac diseases or seizure
disorders that currently are not well controlled by medication or may interfere with
the successful completion of this protocol
- History of substance abuse or drug abuse within 12 months preceding V1
- Subject with >10 pack/yr history of cigarette smoking or use of any tobacco products
within 6 months of study start
- Documented history of bronchopulmonary aspergillosis or any form of allergic
alveolitis
- Have suffered from a clinically significant upper or lower respiratory tract infection
in the 2 weeks prior to study start
- Subject who is a staff member or relative of a staff member
Center of Research Excellence, LLC, Oxford, Alabama 36203, United States
Jefferson Clinic PC, Birmington, Alabama 35233, United States
Pulmonary Associates Research Division, Mobile, Alabama 36608, United States
Montgomery Pulmonary Consultants, Montgomery, Alabama 36111, United States
Lovelace Scientific Resources, Phoenix, Arizona 85016, United States
Alta Clinical Research, LLC, Tucson, Arizona 85745, United States
Trial Management Group, Vancouver, British Columbia V5K 1Z9, Canada
Institute of Healthcare Assessment, Inc., San Diego, California 92120, United States
Madera Family Medical Group, Madera, California 93637, United States
Integrated Research Group, Corona, California 92506, United States
Northern California Research Corp, Fair Oaks, California 95628, United States
Allergy, Asthma & Respiratory Care Center, Long Beach, California 90806, United States
Westlake Medical Research, Inc., Westlake Village, California 91361, United States
Clinical Trials of Orange County, Inc., Orange, California 92868, United States
Office of Constantine Falliers, MD, Denver, Colorado 80209, United States
Allergy Sinus Asthma Research Institute, Miami, Florida 33173, United States
Florida Center for Alergy & Asthma Research, Miami, Florida 33176, United States
Orlando Clinical Research Center, Orlando, Florida 32806, United States
CNS Clinical Trials, Ft. Myers, Florida 33907, United States
Office of Gary Richmond, MD, Ft. Lauderdale, Florida 33316, United States
Orlando Clinic for Asthma & Respiratory Diseases, Longwood, Florida 32750, United States
FPA Clinical Research, Kissimmee, Florida 34741, United States
Aeroallergy Research, Savannah, Georgia 31046, United States
Family Allergy & Asthma Center, PC, Atlanta, Georgia 30342, United States
The Allergy & Asthma Clinic Research Center, Conyers, Georgia 30013, United States
Rush Presbyterian - St. Luke's Medical Center, Chicago, Illinois 60612, United States
Cardinal Respiratory, PC, Springfield, Illinois, United States
Sneeze, Wheeze and Itch, LLC, Bloomington, Illinois 61761, United States
Children's Asthma Respiratory & Exercise Specialists, Glenview, Illinois 60025, United States
Clinical Research Center of Indiana, Indianapolis, Indiana 46208, United States
South Bend Clinic, South Bend, Indiana 46617, United States
Heartland Research Associates, Wichita, Kansas 67207, United States
Consultants in Pulmonary Medicine, Olathe, Kansas 66061, United States
Northshore Medical Research, Covington, Louisiana 70433, United States
St. Boniface General Hospital, Winnipeg, Manitoba R2H 2A6, Canada
Institute for Asthma & Allergy, PC, Wheaton, Maryland, United States
Center for Clinical Research, Taunton, Massachusetts 02780, United States
Henry Ford Hospital & Medical Centers, Detroit, Michigan 48202, United States
Hurley Child and Adolescent Asthma Center, Flint, Michigan 45832, United States
Clinical Research Institute, Minneapolis, Minnesota 55402, United States
Washington University School of Medicine, Division of Allergy & Immunology, St. Louis, Missouri 63110, United States
Allergy, Asthma, Immunology Services, LLC, Jefferson City, Missouri 65101, United States
Midwest Chest Consultants, PC, St. Charles, Missouri 63301, United States
Montana Medical Research, LLC, Missoula, Montana 59804, United States
Heartland Clinical Research Inc., Omaha, Nebraska 68134, United States
Office of Meera Dewan, MD, Omaha, Nebraska 68144, United States
Allergy, Asthma & Immunology Associates, PC, Lincoln, Nebraska 68505, United States
Clinical Research Center of Allergy & Asthma Consultants, Tinton Falls, New Jersey 07701, United States
Delaware Valley Institute for Clinical Research, Cherry Hill, New Jersey 08003, United States
Lovelace Scientific Resources, Albuquerque, New Mexico 87108, United States
Allergy & Asthma of Northern NM, Los Alamos, New Mexico 87544, United States
Office of Michael Marcus, MD, Staten Island, New York 10304, United States
Pulmonary Medical Research of NY, Bay Shore, New York 11706, United States
Asthma & Allergy Associates, PC, Cortland, New York 13045, United States
Office of Richard Castaldo, Tonawanda, New York 14150, United States
Regional Allergy & Asthma Consultants, Asheville, North Carolina 28801, United States
Cornerstone Research Care, High Point, North Carolina, United States
Carolina MedTrials, LLC, Winston-Salem, North Carolina 27103, United States
Charlotte Lung & Health Center, Charlotte, North Carolina 28207, United States
Neem Research Group, Inc., Charlotte, North Carolina 28262, United States
Allergy & Asthma Care Center, Fargo, North Dakota 58104, United States
New Horizons Clinical Research, Cincinnati, Ohio 45241, United States
Optimed Research LLC, Columbus, Ohio 43235, United States
Sterling Research Group, Cincinnati, Ohio 45219, United States
Allergy, Asthma & Clinical Research Center, Oklahoma City, Oklahoma 73120, United States
Primary Care Lung Clinic, Toronto, Ontario M6H 3M2, Canada
Niagara Clinical Research, Inc., Niagara Falls, Ontario L2E 7H1, Canada
Clinical Research Group, Mississauga, Ontario L5B 1N1, Canada
Medford Medical Clinic, LLP, Medford, Oregon 97504, United States
Allergy, Asthma and Dermatology Research Center, Lake Oswego, Oregon 97035, United States
Temple University Hospital, Philadelphia, Pennsylvania 19140, United States
Bellevue Pediatric Associates, Bellevue, Pennsylvania 15202, United States
Advanced Clinical Concepts, Shillington, Pennsylvania 19607, United States
Allergy & Asthma Research of NJ, Inc., Philadelphia, Pennsylvania 19115, United States
Valley Clinical Research Center, Easton, Pennsylvania 18045, United States
Neem Research Group of Charleston, Charleston, South Carolina 29407, United States
Neem Research Group Inc., Columbia, South Carolina 29201, United States
Allergic Disease & Asthma Center, PA, Greenville, South Carolina 29607, United States
The Allergy Associates, Knoxville, Tennessee 37917, United States
Asthma Institute, Chattanooga, Tennessee 37421, United States
Breath of Life Research Institute, Houston, Texas 77054, United States
Lung Diagnostics, San Antonio, Texas 78229, United States
Breco Research, Houston, Texas 77024, United States
UTX Medical, Galveston, Texas 00000, United States
Allergy & Asthma Clinical of Central Texas, Austin, Texas 78749, United States
Clinical Trials of North Houston, Houston, Texas 77070, United States
Central Texas Health Research, New Braunfels, Texas 78130, United States
Office of Constantine Saadeh, Amarillo, Texas 79106, United States
Virginia Adult & Pediatric Allergy & Asthma PC, Richmond, Virginia 23229, United States
National Clinical Research, Richmond, Virginia 23294, United States
Hampton Roads Center for Clinical Research, Norfolk, Virginia 23502, United States
Pulmonary Associates of Richmond Inc., Richmond, Virginia 23225, United States
The Physician's Clinic of Spokane, Spokane, Washington 99204, United States
Milwaukee Medical Clinic, Milwaukee, Wisconsin 53209, United States
Allergic Diseases, S.C., West Allis, Wisconsin 53227, United States
Allergy, Asthma, and Sinus Center F.C., Greenfield, Wisconsin 53228, United States
