The primary objective of this study 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

• Must give written informed consent (IC) prior to participation in the study. For subjects 12 - 17 years of age, the IC must be signed parent or legal guardian. Females must sign the Women of Childbearing Potential Addendum
• Be willing and able to comply with the study procedures and visit schedules
• Male or female, at least 12 years of age
• Females 12-60 years of age must have a negative serum pregnancy test at Visit 1 (V1)
• Women of child bearing potential must be using an acceptable method of birth control
• Must have a documented diagnosis of asthma for a min. of 6 mos. prior to V1
• At V1, the subject must demonstrate a baseline FEV1 within >45% and <75% of predicted for their height, age, gender, and race
• Following abstention from medications used to treat asthma, subject must demonstrate >12% reversibility of airflow obstruction within 15-30 min. following inhalation of 180 µg (2 actuations, 90 µg ea.) 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 mos. prior to V1
• 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 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
• Subject who has participated in an investigational drug study within 30 days prior to V1, or who is currently participating in another clinical trial
• Schedule prevents him or her from taking the first daily dose of study medication and/or starting study visits before 9AM
• Subject who has travel commitments during the study that would interfere with trial measurements or compliance or both
• Subject who has a history of hospitalization for asthma within 45 days prior to V1, or who is scheduled for in-patient hospitalization during the trial
• Have 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 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
• Have a history of cancer (exception: basal cell carcinoma in remission)
• Have hyperthyroidism, diabetes, hypertension, cardiac diseases, or seizure disorders not well controlled by medication or that may interfere with the successful completion of this protocol
• Have a history of substance or drug abuse within 12 mos. preceding V1 or a positive urine drug screening at V1
• Have greater than 10 pack year history of cigarette smoking or use of any tobacco products within 6 mos. of V1
• Have a 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
• Have any clinically significant abnormal laboratory values
• Have a clinically significant abnormal 12-lead ECG that may jeopardize the subject’s ability to complete study
• Subject who is a staff member or relative of a staff member

Alabama
      Allergy & Asthma Center, LLC, Oxford,  Alabama,  36203,  United States
Arizona
      Alta Clinical Research, Tucson,  Arizona,  85745,  United States
California
      Southern California Research, Mission Viejo,  California,  92691,  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
      West Coast Clinical Trials, Signal Hill,  California,  90755,  United States
      Comprehensive Allergy Services, Oakland,  California,  94609,  United States
      Asthma, Allergy & Respiratory Care Center, Long Beach,  California,  90808,  United States
      Madera Family Medical Group, Madera,  California,  93637,  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., Walnut Creek,  California,  94598,  United States
      Allergy & Asthma Specialists Medical Group, Huntington Beach,  California,  92647,  United States
Colorado
      1st Allergy & Asthma Clinical Research Ctr, Thornton,  Colorado,  80233,  United States
Georgia
      Aeroallergy Research Laboratories of Savannah, Inc., Savannah,  Georgia,  31406,  United States
      The Allergy & Asthma Clinical Research Center, Conyers,  Georgia,  30013,  United States
      Watts Medical Research, Barnesville,  Georgia,  30204,  United States
Illinois
      Rush Presbyterian - St. Luke's Medical Center Rush University, Chicago,  Illinois,  60612,  United States
Indiana
      South Bend Clniic, South Bend,  Indiana,  46617,  United States
Louisiana
      Clinical Research Specialist, Metairie,  Louisiana,  70006,  United States
      Children's International Medical Research, Slidell,  Louisiana,  70458,  United States
      Doctor's Care, New Orleans,  Louisiana,  70122,  United States
Minnesota
      Clinical Research Institute, Minneapolis,  Minnesota,  55402,  United States
Missouri
      The Clinical Research Center, LLC, St. Louis,  Missouri,  63141,  United States
Nebraska
      Heartland Clinical Research Inc., Omaha,  Nebraska,  United States
      Asthma & Allergy Center PC, Papillion,  Nebraska,  68046,  United States
Nevada
      Office of Yekaterina Khronusova, MD, Las Vegas,  Nevada,  89119,  United States
New York
      Office or Richard Castaldo, MD, Tonawanda,  New York,  14150,  United States
      AAIR Research Center, Rochester,  New York,  14618,  United States
      Pulmonary Medical Research of NY, PLLC, Bay Shore,  New York,  11706,  United States
      Asthma & Allergy Associates PC, Cortland,  New York,  13046,  United States
North Carolina
      Piedmont Medical Research, Winston Salem,  North Carolina,  27103,  United States
      Charlotte Lung and Health Center, Charlotte,  North Carolina,  28207,  United States
      Albermarle Allergy & Asthma PC, Elizabeth City,  North Carolina,  27909,  United States
Ohio
      New Horizons Clinical Research, Inc., Cincinnati,  Ohio,  45241,  United States
Oklahoma
      Allergy, Asthma & Clinical Research Center, Oklahoma City,  Oklahoma,  73120,  United States
Oregon
      Allergy Associates Research Center, LLC, Portland,  Oregon,  97213,  United States
Pennsylvania
      Advanced Clinical Concepts, Temple,  Pennsylvania,  19560,  United States
      Valley Clinical Research Center, Easton,  Pennsylvania,  18045,  United States
South Carolina
      Allergy & Asthma Consultants, LLP, Mt. Pleasant,  South Carolina,  29464,  United States
      Allergic Disease & Asthma Center PA, Greenville,  South Carolina,  29607,  United States
Texas
      Breath of Life Research Institute, Houston,  Texas,  77084,  United States
      Lung Diagnostics, San Antonio,  Texas,  78229,  United States
      Breco Research, Houston,  Texas,  77024,  United States
      Allergy and Asthma Clinic of Central Texas, Austin,  Texas,  78749,  United States
      Research Across America, Dallas,  Texas,  75234,  United States
Virginia
      Pulmonary Associates of Richmond, inc., Richmond,  Virginia,  23225,  United States
      PI - Coor Clinical Research, LLC, Burke,  Virginia,  22015,  United States
Washington
      Rockwood Clinics, PS, Spokane,  Washington,  99220,  United States
Wisconsin
      Allergic Diseases, SC, West Allis,  Wisconsin,  53227,  United States
      Allergy, Asthma and Sinus Center F.C., Greenfield,  Wisconsin,  53228,  United States

Study ID Numbers:  051-355
Record last reviewed:  June 2004
Last Updated:  October 13, 2004
Record first received:  December 9, 2003
ClinicalTrials.gov Identifier:  NCT00073840
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08