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Home > "S" Clinical Trials Conditions > Study of Daily Dosing with Levalbuterol, Racemic Albuterol, and Placebo in Pediatric Subjects with Asthma  Study of Daily Dosing with Levalbuterol, Racemic Albuterol, and Placebo in Pediatric Subjects with Asthma
Study of Daily Dosing with Levalbuterol, Racemic Albuterol, and Placebo in Pediatric Subjects with Asthma
For Condition: Asthma
Status: No longer recruiting
Sponsor(s): Sepracor, Inc. ,
Synopsis: Study of Daily Dosing with Levalbuterol, Racemic Albuterol, and Placebo in Pediatric Subjects with Asthma
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 4 Years/11 Years
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Madera Family Medical Group
Madera, California, 93637
United States
West Coast Clinical Trials, Inc.
Signal Hill, California, 90755
United States
Aeroallergy Research Laboratories of Savannah, Inc.
Savannah, Georgia, 31406
United States
Essex-Morris Pediatric Group
Livingston, New Jersey, 07960
United States
National Jewish Medical & Research Center
Denver, Colorado, 80206
United States
Clinical Research Institute of Southern Oregon
Medforo, Oregon, 97504
United States
CHOC, PSF, AMC Disision of Allergy, Asthma & Immunology
Orange, California, 92868
United States
Asthma, Allergy & Respiratory Care Center
Long Beach, California, 90808
United States
Sun Research Institute
San Antonio, Texas, 78205
United States
Allergy Associates Research Center
Portland, Oregon, 97213
United States
Pulmonary Associates of Mobile, PC
Ithaca, New York, 14850
United States
Adolescent & Pediatric Associates, PC
Montgomery, Alabama, 36116
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
Allergy & Asthma Consultants
Mt. Pleasant, South Carolina, 29464
United States
University Hospitals of Cleveland, Rainbow Babies & Children's Hospital
Cleveland, Ohio, 44106
United States
Asthma & Allergy Associates
Colorado Springs, Colorado, 80907
United States
Allergy & Asthma and Dermatology Research Center
Lake Oswego, Oregon, 97035
United States
Allergy Associates Medical Group
San Diego, California, 92120
United States
Vanderbilt University ASAP Research
Nashville, Tennessee, 37203
United States
The Allergy & Asthma Clinical Research Center
Lawrenceville, Georgia, 30045
United States
Breath of Life Research Institute
Houston, Texas, 77084
United States
The Children's Clinic of Jonesboro, PA
Jonesboro, Arkansas, 72401
United States
Integrated Research Group
Corona, California, 92879
United States
The Pediatric Clinic
Bogalusa, Louisiana, 70429
United States
Princeton Center for Clinical Research
Princeton, New Jersey, 08540
United States
Radiant Research
Bridgeton, Missouri, 63044
United States
Dolby Providers, Inc
New Orleans, Louisiana, 70127
United States
Allergy & Asthma Associates
Kirkland, Washington, 98034
United States
Sooner Clinical Research
Oklahoma City, Oklahoma, 73112
United States
Regional Allergy & Asthma Consultants, PA
Asheville, North Carolina, 28801
United States
Pediatric Associates of Mt. Carmel
Cincinnati, Ohio, 45245
United States
Dr. Senders & Associates
University Heights, Ohio, 44118
United States
Allergy & Asthma Specialists Medical Group
Huntington Beach, California, 92647
United States
Allergy, Asthma & Sinus Center, PC
Knoxville, Tennessee, 37922
United States
Department of Pediatric Critical Care, Kosair Children's Hospital
Louisville, Kentucky, 40202
United States
PI- Coor Clinical Research, LLC
Burke, Virginia, 22015
United States
Bellevue Pediatric Association
Pittsburgh, Pennsylvania, 15202
United States
North Texas Institute for Clinical Trials
Ft. Worth, Texas, 76132
United States
Summit Pediatric Pulmonology
Summit, New Jersey, 07901
United States
Pediatric Allergy/Immunology Associates
Dallas, Texas, 75230
United States
University of New Mexico, Health Sciences Center
Albuquerque, New Mexico, 87131
United States
Allergy & Asthma Associates
Houston, Texas, 77054
United States
Doctor's Care
New Orleans, Louisiana, 70122
United States
Southern California Research
Mission Viejo, California, 92692
United States
Additional Information:
Study ID Numbers: 051-354;
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00073814
Other Asthma Studies:
1. Endotoxin and Bronchial Inflammation in Asthma
2. The Genetics of Environmental Asthma
3. Geographic Modeling of Traffic and Asthma Rates
4. NHLBI/NICHD Collaborative Studies of Asthma in Pregnancy
5. Self Management Education Asthma
Related Studies:
Other Asthma Clinical Trials
Other California Clinical Trials
Other Signal Hill Clinical Trials
Study of Daily Dosing with Levalbuterol, Racemic Albuterol, and Placebo in Pediatric Subjects with Asthma
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