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.

Condition	Treatment or Intervention	Phase
Asthma	Drug: levalbuterol	Phase III

Ages Eligible for Study:  12 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

• Give written informed consent prior to participation. Females must sign Women of Childbearing Potential Addendum
• Willing and able to comply with study procedures and visit schedules
• Females 12-60 yrs must have a negative serum pregnancy test at Visit 1 (V1)
• Women of child bearing potential must use acceptable method of birth control throughout study
• Confirmed diagnosis of asthma minimum of 6 mos. prior to V1
• At V1, must demonstrate baseline FEV1 within >50% & <80% predicted for height/age/gender/race
• Following abstinence from asthma meds must demonstrate >12% reversibility of airflow obstruction within 15-30 mins. following inhalation racemic albuterol MDI
• 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 V1
• 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

• Subject who is expected to require any disallowed medications
• Female who is pregnant or lactating
• Participated in investigational drug study w/in 30 days prior to V1, 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 V1, 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
• Subject with clinically significant abnormalities that may interfere with the metabolism or excretion of the study drug
• 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 V1
• 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 V1
• Any clinically significant abnormal laboratory values
• Any clinically significant abnormal 12-lead ECG that may jeopardize the subject’s ability to complete the study
• Subject who is a staff member or relative of a staff member

Alabama
      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
Arizona
      Lovelace Scientific Resources, Phoenix,  Arizona,  85016,  United States
      Alta Clinical Research, LLC, Tucson,  Arizona,  85745,  United States
California
      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
Colorado
      Office of Constantine Falliers, MD, Denver,  Colorado,  80209,  United States
Florida
      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
Georgia
      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
Illinois
      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
Indiana
      Clinical Research Center of Indiana, Indianapolis,  Indiana,  46208,  United States
      South Bend Clinic, South Bend,  Indiana,  46617,  United States
Kansas
      Heartland Research Associates, Wichita,  Kansas,  67207,  United States
      Consultants in Pulmonary Medicine, Olathe,  Kansas,  66061,  United States
Louisiana
      Northshore Medical Research, Covington,  Louisiana,  70433,  United States
Maryland
      Institute for Asthma & Allergy, PC, Wheaton,  Maryland,  United States
Massachusetts
      Center for Clinical Research, Taunton,  Massachusetts,  02780,  United States
Michigan
      Henry Ford Hospital & Medical Centers, Detroit,  Michigan,  48202,  United States
      Hurley Child and Adolescent Asthma Center, Flint,  Michigan,  45832,  United States
Minnesota
      Clinical Research Institute, Minneapolis,  Minnesota,  55402,  United States
Missouri
      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
      Montana Medical Research, LLC, Missoula,  Montana,  59804,  United States
Nebraska
      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
New Jersey
      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
New Mexico
      Lovelace Scientific Resources, Albuquerque,  New Mexico,  87108,  United States
      Allergy & Asthma of Northern NM, Los Alamos,  New Mexico,  87544,  United States
New York
      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
North Carolina
      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
North Dakota
      Allergy & Asthma Care Center, Fargo,  North Dakota,  58104,  United States
Ohio
      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
Oklahoma
      Allergy, Asthma & Clinical Research Center, Oklahoma City,  Oklahoma,  73120,  United States
Oregon
      Medford Medical Clinic, LLP, Medford,  Oregon,  97504,  United States
      Allergy, Asthma and Dermatology Research Center, Lake Oswego,  Oregon,  97035,  United States
Pennsylvania
      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
South Carolina
      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
Tennessee
      The Allergy Associates, Knoxville,  Tennessee,  37917,  United States
      Asthma Institute, Chattanooga,  Tennessee,  37421,  United States
Texas
      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
      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
Washington
      The Physician's Clinic of Spokane, Spokane,  Washington,  99204,  United States
Wisconsin
      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
Canada, British Columbia
      Trial Management Group, Vancouver,  British Columbia,  V5K 1Z9,  Canada
Canada, Manitoba
      St. Boniface General Hospital, Winnipeg,  Manitoba,  R2H 2A6,  Canada
Canada, Ontario
      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

Study ID Numbers:  051-356
Record last reviewed:  January 2005
Last Updated:  January 21, 2005
Record first received:  July 8, 2003
ClinicalTrials.gov Identifier:  NCT00064389
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08