Study of Daily Dosing with Levalbuterol, Racemic Albuterol, and Placebo in Pediatric Subjects with Asthma

Condition	Treatment or Intervention	Phase
Asthma	Drug: Levalbuterol	Phase III

Ages Eligible for Study:  4 Years   -   11 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

• Subject’s parent/legal(p/l) guardian must give written informed consent
• Subject and subject’s p/l guardian must be willing and able to comply with the study procedures and visit schedules
• Subject, male or female, between the ages of 4 to 11 yrs
• Female subjects 8 yrs or older will have a negative serum pregnancy test
• Must have a documented diagnosis of asthma for a minimum of 6 months prior to Visit 1 (V1)
• At V1, must demonstrate a baseline FEV1 within >45% and <80% of predicted for their height (HT), age, gender, and race
• Following abstention from medications used to treat asthma, must demonstrate >12% reversibility of airflow obstruction within 15-30 minutes following inhalation of 180 µg 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 over-the-counter asthma medication for at least 6 mos. prior to V1
• Must be in good health with the exception of 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
• Subject’s p/l guardian must be able to complete the diary cards and medical event calendars reliably on a daily basis, understand dosing instructions and questionnaire completion, 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 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 9 AM
• Have travel commitments during the study that would interfere with trial measurements or compliance or both
• Have a history of hospitalization for asthma within 60 days prior to V1, or who is scheduled for in-patient hospitalization, including elective surgery during the course of 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
• Have currently diagnosed life-threatening asthma defined as a history of asthma episodes requiring intubation, associated with hypercapnia, respiratory arrest, or hypoxic seizures within 3 mos. prior to V1
• Have clinically significant abnormalities that may interfere with the metabolism or excretion of the study drug
• Have a history of cancer
• Subject with hyperthyroidism, diabetes, hypertension, cardiac diseases or seizure disorders that currently are not well controlled by medication or that may interfere with the successful completion of this protocol
• Have a history of substance abuse or drug abuse within 12 months preceding V1 or a positive urine drug screening at V1
• Have a documented history of bronchopulmonary aspergillosis or any form of allergic alveolitis
• Has suffered from a clinically significant upper or lower respiratory tract infection in the 2 wks 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 the study
• Have a history of cigarette smoking or use of any tobacco products
• Subject who is a relative of a staff member

Alabama
      Adolescent & Pediatric Associates, PC, Montgomery,  Alabama,  36116,  United States
Arkansas
      The Children's Clinic of Jonesboro, PA, Jonesboro,  Arkansas,  72401,  United States
California
      Southern California Research, Mission Viejo,  California,  92692,  United States
      CHOC, PSF, AMC Disision of Allergy, Asthma & Immunology, Orange,  California,  92868,  United States
      Clinical Trials of Orange County, Orange,  California,  92868,  United States
      Allergy & Asthma Medical Group of Diablo Valley, Inc., Walnut Creek,  California,  94598,  United States
      West Coast Clinical Trials, Inc., Signal Hill,  California,  90755,  United States
      Asthma, Allergy & Respiratory Care Center, Long Beach,  California,  90808,  United States
      Madera Family Medical Group, Madera,  California,  93637,  United States
      Integrated Research Group, Corona,  California,  92879,  United States
      Allergy Associates Medical Group, San Diego,  California,  92120,  United States
      Allergy & Asthma Specialists Medical Group, Huntington Beach,  California,  92647,  United States
Colorado
      National Jewish Medical & Research Center, Denver,  Colorado,  80206,  United States
      Asthma & Allergy Associates, Colorado Springs,  Colorado,  80907,  United States
Georgia
      Aeroallergy Research Laboratories of Savannah, Inc., Savannah,  Georgia,  31406,  United States
      The Allergy & Asthma Clinical Research Center, Lawrenceville,  Georgia,  30045,  United States
Kentucky
      Department of Pediatric Critical Care, Kosair Children's Hospital, Louisville,  Kentucky,  40202,  United States
Louisiana
      Dolby Providers, Inc, New Orleans,  Louisiana,  70127,  United States
      The Pediatric Clinic, Bogalusa,  Louisiana,  70429,  United States
      Doctor's Care, New Orleans,  Louisiana,  70122,  United States
Missouri
      Radiant Research, Bridgeton,  Missouri,  63044,  United States
New Jersey
      Essex-Morris Pediatric Group, Livingston,  New Jersey,  07960,  United States
      Summit Pediatric Pulmonology, Summit,  New Jersey,  07901,  United States
      Princeton Center for Clinical Research, Princeton,  New Jersey,  08540,  United States
New Mexico
      University of New Mexico, Health Sciences Center, Albuquerque,  New Mexico,  87131,  United States
New York
      Pulmonary Associates of Mobile, PC, Ithaca,  New York,  14850,  United States
North Carolina
      Regional Allergy & Asthma Consultants, PA, Asheville,  North Carolina,  28801,  United States
Ohio
      Pediatric Associates of Mt. Carmel, Cincinnati,  Ohio,  45245,  United States
      University Hospitals of Cleveland, Rainbow Babies & Children's Hospital, Cleveland,  Ohio,  44106,  United States
      Dr. Senders & Associates, University Heights,  Ohio,  44118,  United States
Oklahoma
      Sooner Clinical Research, Oklahoma City,  Oklahoma,  73112,  United States
Oregon
      Allergy & Asthma and Dermatology Research Center, Lake Oswego,  Oregon,  97035,  United States
      Clinical Research Institute of Southern Oregon, Medford,  Oregon,  97504,  United States
      Allergy Associates Research Center, Portland,  Oregon,  97213,  United States
Pennsylvania
      Bellevue Pediatric Association, Pittsburgh,  Pennsylvania,  15202,  United States
South Carolina
      Allergy & Asthma Consultants, Mt. Pleasant,  South Carolina,  29464,  United States
Tennessee
      Allergy, Asthma & Sinus Center, PC, Knoxville,  Tennessee,  37922,  United States
      Vanderbilt University ASAP Research, Nashville,  Tennessee,  37203,  United States
Texas
      Breath of Life Research Institute, Houston,  Texas,  77084,  United States
      Sun Research Institute, San Antonio,  Texas,  78205,  United States
      North Texas Institute for Clinical Trials, Fort Worth,  Texas,  76132,  United States
      Allergy & Asthma Associates, Houston,  Texas,  77054,  United States
      Pediatric Allergy/Immunology Associates, Dallas,  Texas,  75230,  United States
Virginia
      PI- Coor Clinical Research, LLC, Burke,  Virginia,  22015,  United States
Washington
      Allergy & Asthma Associates, Kirkland,  Washington,  98034,  United States

Study ID Numbers:  051-354
Record last reviewed:  June 2004
Last Updated:  October 13, 2004
Record first received:  December 9, 2003
ClinicalTrials.gov Identifier:  NCT00073814
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08