The primary objective is to investigate the efficacy of levalbuterol 90 ug (2 actuations, 45 ug each) versus placebo (2 actuations) in the treatment and prevention of bronchoconstriction in adolescent and adult subjects with asthma, with all treatments administered 4 times a day (QID).

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 (IC) prior to participation. Subjects 12 to 17 years of age, IC must be signed by the subject’s parent or legal guardian. Females sign the Women of Childbearing Potential Addendum
• Willing and able to comply with the study procedures and visit schedules
• Male or female, at least 12 years of age
• Female subjects 12-60 years of age must have a negative serum pregnancy test at Visit 1.
• Women of child bearing potential must be using an acceptable method of birth control
• Have a documented diagnosis of asthma for a minimum of 6 months prior to Visit 1
• At Visit 1, the subject must demonstrate a baseline FEV1 within >45% and <75% of predicted for their height (HT), age, gender, and race
• Following abstention from medications used to treat asthma, the subject must demonstrate >12% reversibility of airflow obstruction within 15-30 mins. following inhalation of racemic albuterol MDI
• Must have stable baseline asthma and have been using a B-adrenergic agonist, and/or anti-asthma anti-inflammatory medication, and/or OTC asthma medication for at least 6 months prior to Visit 1
• Must be in good health with the exception of their reversible airways disease and not suffering from any chronic condition that might affect their respiratory function
• Must have a chest X-ray that is not diagnostic of pneumonia, atelectasis, pulmonary fibrotic disease, pneumothorax, chronic obstructive pulmonary disease, etc.
• Must be able to complete the diary cards and medical event calendars reliably on a daily basis, understand dosing instructions, and demonstrate how to use the MiniWright PEF meter.

Exclusion Criteria

• Subject who is expected to require any disallowed medications
• Female subject who is pregnant or lactating
• Have participated in an investigational drug study within 30 days prior to Visit 1, or who is currently participating in another clinical trial
• Subject whose schedule prevents him or her from taking the first daily dose of study medication and/or starting study visits before 9 AM
• Subject who has travel commitments during the study that would interfere with trial measurements or compliance
• Have a history of hospitalization for asthma within 45 days prior to Visit 1, or who is scheduled for in-patient hospitalization, including elective surgery
• Have a known sensitivity to levalbuterol or racemic albuterol, or any excipients in any of these formulations
• Subject using any prescription drug with which albuterol sulfate administration 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
• History of substance abuse or drug abuse within 12 months preceding Visit 1
• Subject with greater than 10 pack year history of cigarette smoking or use of any tobacco products within 6 months of Visit 1
• 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 Visit 1
• Subject with any clinically significant abnormal laboratory values
• Subject with a clinically significant abnormal 12-lead ECG that would put the subject at risk for experiencing adverse cardiac effects
• Subject who is a staff member or relative of a staff member

Alabama
      Alabama Asthma and Allergy Center, Homewood,  Alabama,  35209,  United States
      MDC Research, Mobile,  Alabama,  36607,  United States
California
      Bensch Research Associates, Stockton,  California,  95207,  United States
      Allergy & Asthma Prevention & Treatment Center, San Diego,  California,  92131,  United States
      Allergy Research Foundation, Inc., Los Angeles,  California,  90025,  United States
      Clinical Trials of Orange County, Orange,  California,  92868,  United States
      Allergy & Asthma Assoc. of Santa Clara Valley Research Center, San Jose,  California,  95117,  United States
      Allergy, Asthma & Respiratory Care Center, Long Beach,  California,  90806,  United States
      Allergy & Asthma Medical Group & Research Center, San Diego,  California,  92123,  United States
      Integrated Research Group, Corona,  California,  92879,  United States
      Radiant Research, Inc., Encinitas,  California,  92024,  United States
      Allergy Associates Medical Group, San Diego,  California,  92120,  United States
      Allergy & Asthma Medical Group of Diablo Valley, Inc., Danville,  California,  94526,  United States
      Southern California Research Center, Viejo,  California,  92691,  United States
      Allergy & Asthma Specialists Medical Group, Huntington Beach,  California,  92647,  United States
Colorado
      Clinical Research Centers of Colorado PC, Englewood,  Colorado,  80112,  United States
      National Jewish Medical & Research Center, Denver,  Colorado,  80206,  United States
      Asthma & Allergy Associates, PC, Pueblo,  Colorado,  81001,  United States
Florida
      Office of Ronald Saff, Tallahassee,  Florida,  32308,  United States
Georgia
      Aeroallergy Research Laboratories of Savannah, Inc., Savannah,  Georgia,  31406,  United States
Hawaii
      Radiant Research Honolulu, Honolulu,  Hawaii,  96814,  United States
Indiana
      Clinical Research Center of Indiana, Indianapolis,  Indiana,  46208,  United States
Louisiana
      Northshore Medical Research, Slidell,  Louisiana,  70458,  United States
      Allergy & Asthma Care Specialists, Metairie,  Louisiana,  70006,  United States
Maryland
      University of Maryland School of Medicine, Baltimore,  Maryland,  United States
Massachusetts
      Northeast Medical Research Associates, Inc., N. Dartmouth,  Massachusetts,  02747,  United States
      PCHI, Needham,  Massachusetts,  02494,  United States
      Center for Clinical Research, Taunton,  Massachusetts,  02780,  United States
Michigan
      Henry Ford Health System, Detroit,  Michigan,  48202,  United States
Minnesota
      Clinical Research Institute, Minneapolis,  Minnesota,  55402,  United States
Mississippi
      Mississippi Asthma & Allergy Clinic, Jackson,  Mississippi,  United States
Missouri
      Office of Clinical Research, University of Missouri-Columbia, Columbia,  Missouri,  65212,  United States
      Division of Allergy & Immunology, Washington Univ School of Med, St. Louis,  Missouri,  63110,  United States
      The Clinical Research Center, LLC, St. Louis,  Missouri,  63141,  United States
      St. Louis University, St. Louis,  Missouri,  63110,  United States
      The Children's Mercy Hospital, Kansas City,  Missouri,  64108,  United States
New Jersey
      Pulmonary and Allergy Associates, Springfield,  New Jersey,  07081,  United States
      Princeton Center for Clinical Research, Princeton,  New Jersey,  08540,  United States
New York
      AAIR Research Center, Rochester,  New York,  14618,  United States
      PCCS, Albany,  New York,  12205,  United States
North Carolina
      Raleigh Pediatric Associates, Raleigh,  North Carolina,  27609,  United States
      Regional Allergy & Asthma Consultants, Asheville,  North Carolina,  28801,  United States
      Cornerstone Research Care, High Point,  North Carolina,  27262,  United States
Ohio
      Bernstein Clinical Research Center, LLC, Cincinnati,  Ohio,  45231,  United States
Oregon
      Allergy & Asthma Research, Eugene,  Oregon,  97401,  United States
      Allergy Associates Research Center, LLC, Portland,  Oregon,  97213,  United States
Pennsylvania
      University of Pittsburgh Division of Pulmonary, Pittsburgh,  Pennsylvania,  15213,  United States
      Temple University Hospital, Philadelphia,  Pennsylvania,  19140,  United States
      Asthma & Allergy Research Associates, Chester,  Pennsylvania,  19013,  United States
      Children's Hospital of Pittsburgh Division of Allergy, Immunology & Infectious Diseases, Pittsburgh,  Pennsylvania,  15213,  United States
South Carolina
      Allergy & Asthma Consultants, LLP, Mt. Pleasant,  South Carolina,  29464,  United States
      Radiant Research, Charleston,  South Carolina,  29407,  United States
      Office of Neil Kao, Greenville,  South Carolina,  29607,  United States
Texas
      Breath of Life Research Institute, Houston,  Texas,  77054,  United States
      Allergy & Asthma Center, Waco,  Texas,  United States
      Lung Diagnostics, San Antonio,  Texas,  United States
      North Texas Institute for Clinical Trials, Fort Worth,  Texas,  76132,  United States
      Allergy & Asthma Research Associates, Dallas,  Texas,  75231,  United States
      Office of Constantine Saadeh, Amarillo,  Texas,  79106,  United States
Virginia
      Children's Hospital of the Kings Daughters, Norfolk,  Virginia,  23507,  United States
      Pulmonary Associates of Richmond, Inc., Richmond,  Virginia,  23225,  United States
Washington
      ASTHMA, Inc., Seattle,  Washington,  98105,  United States
Wisconsin
      Allergic Diseases, SC, West Allis,  Wisconsin,  53227,  United States

Study ID Numbers:  051-353
Record last reviewed:  November 2004
Last Updated:  November 15, 2004
Record first received:  December 9, 2003
ClinicalTrials.gov Identifier:  NCT00073827
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08