Study of Daily Dosing With Levalbuterol, Racemic Albuterol, and Placebo in Pediatric Subjects With Asthma
NCT ID: NCT00073814
Last Updated: 2012-02-22
Study Results
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Basic Information
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COMPLETED
PHASE3
80 participants
INTERVENTIONAL
2002-12-31
2003-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
levalbuterol MDI 90 mcg QID
Levalbuterol tartrate MDI
levalbuterol MDI 90 mcg QID
2
racemic albuterol MDI 190 mcg QID
racemic albuterol MDI
racemic albuterol MDI 180 mcg QID
3
Placebo MDI QID
Placebo
Placebo MDI QID
Interventions
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Levalbuterol tartrate MDI
levalbuterol MDI 90 mcg QID
racemic albuterol MDI
racemic albuterol MDI 180 mcg QID
Placebo
Placebo MDI QID
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 study start
* 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 study start
* 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
* Have participated in an investigational drug study within 30 days prior to study start, 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 study start, 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 study start
* 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 study start
* 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 study start
* Have a history of cigarette smoking or use of any tobacco products
* Subject who is a relative of a staff member
4 Years
11 Years
ALL
No
Sponsors
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Sumitomo Pharma America, Inc.
INDUSTRY
Responsible Party
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Locations
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Adolescent & Pediatric Associates, PC
Montgomery, Alabama, United States
The Children's Clinic of Jonesboro, PA
Jonesboro, Arkansas, United States
Integrated Research Group
Corona, California, United States
Allergy & Asthma Specialists Medical Group
Huntington Beach, California, United States
Asthma, Allergy & Respiratory Care Center
Long Beach, California, United States
Madera Family Medical Group
Madera, California, United States
Southern California Research
Mission Viejo, California, United States
CHOC, PSF, AMC Disision of Allergy, Asthma & Immunology
Orange, California, United States
Clinical Trials of Orange County
Orange, California, United States
Allergy Associates Medical Group
San Diego, California, United States
West Coast Clinical Trials, Inc.
Signal Hill, California, United States
Allergy & Asthma Medical Group of Diablo Valley, Inc.
Walnut Creek, California, United States
Asthma & Allergy Associates
Colorado Springs, Colorado, United States
National Jewish Medical & Research Center
Denver, Colorado, United States
The Allergy & Asthma Clinical Research Center
Lawrenceville, Georgia, United States
Aeroallergy Research Laboratories of Savannah, Inc.
Savannah, Georgia, United States
Department of Pediatric Critical Care, Kosair Children's Hospital
Louisville, Kentucky, United States
The Pediatric Clinic
Bogalusa, Louisiana, United States
Doctor's Care
New Orleans, Louisiana, United States
Dolby Providers, Inc
New Orleans, Louisiana, United States
Radiant Research
Bridgeton, Missouri, United States
Essex-Morris Pediatric Group
Livingston, New Jersey, United States
Princeton Center for Clinical Research
Princeton, New Jersey, United States
Summit Pediatric Pulmonology
Summit, New Jersey, United States
University of New Mexico, Health Sciences Center
Albuquerque, New Mexico, United States
Pulmonary Associates of Mobile, PC
Ithaca, New York, United States
Regional Allergy & Asthma Consultants, PA
Asheville, North Carolina, United States
Pediatric Associates of Mt. Carmel
Cincinnati, Ohio, United States
University Hospitals of Cleveland, Rainbow Babies & Children's Hospital
Cleveland, Ohio, United States
Dr. Senders & Associates
University Heights, Ohio, United States
Sooner Clinical Research
Oklahoma City, Oklahoma, United States
Allergy & Asthma and Dermatology Research Center
Lake Oswego, Oregon, United States
Clinical Research Institute of Southern Oregon
Medford, Oregon, United States
Allergy Associates Research Center
Portland, Oregon, United States
Bellevue Pediatric Association
Pittsburgh, Pennsylvania, United States
Allergy & Asthma Consultants
Mt. Pleasant, South Carolina, United States
Allergy, Asthma & Sinus Center, PC
Knoxville, Tennessee, United States
Vanderbilt University ASAP Research
Nashville, Tennessee, United States
Pediatric Allergy/Immunology Associates
Dallas, Texas, United States
North Texas Institute for Clinical Trials
Fort Worth, Texas, United States
Allergy & Asthma Associates
Houston, Texas, United States
Breath of Life Research Institute
Houston, Texas, United States
Sun Research Institute
San Antonio, Texas, United States
PI- Coor Clinical Research, LLC
Burke, Virginia, United States
Allergy & Asthma Associates
Kirkland, Washington, United States
Countries
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Other Identifiers
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051-354
Identifier Type: -
Identifier Source: org_study_id
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