Long Term Safety Study of Levalbuterol and Racemic Albuterol in Subjects Twelve Years of Age and Older With Asthma
NCT ID: NCT00064389
Last Updated: 2012-02-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
746 participants
INTERVENTIONAL
2003-01-31
2005-07-31
Brief Summary
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Detailed Description
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This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
levalbuterol 90 mcg MDI QID
levalbuterol tartrate HFA MDI
levalbuterol MDI 90 mcg QID
2
racemic albuterol HFA MDI 180 mcg QID
racemic albuterol
racemic albuterol HFA MDI 180 mcg QID
Interventions
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levalbuterol tartrate HFA MDI
levalbuterol MDI 90 mcg QID
racemic albuterol
racemic albuterol HFA MDI 180 mcg QID
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Females 12-60 yrs must have a negative serum pregnancy test at study start
* Women of child bearing potential must use acceptable method of birth control throughout study
* Confirmed diagnosis of asthma minimum of 6 mos. prior to study start
* Have stable baseline asthma and have been using B-adrenergic agonist, and/or anti-asthma anti-inflammatory meds, and/or OTC asthma meds. \>6 mos. prior to study start
* In good health with exception of reversible airways disease and not suffering from any chronic condition that might affect their respiratory function
* Had chest X-ray w/in 12 mos. prior to randomization that is not diagnostic of pneumonia, atelectasis, pulmonary fibrotic disease, pneumothorax, chronic obstructive pulmonary disease etc.
* Subject rolling over from either Sepracor study 051-353 or 051-355 must have successfully completed the study
* Subject who is not immediately rolled over from Sepracor study 051-353 or 051-355 must wait \>30 days and will be regarded as a de novo subject
* Able to complete daily diary cards and medical event calendars reliably, understand dosing instructions, demonstrate how to use the MiniWright PEF meter. Minor subjects must have a parent/legal guardian assist them during the study with these activities
Exclusion Criteria
* Participated in investigational drug study w/in 30 days prior to study start, or currently participating in another clinical trial, other than Sepracor studies 051-353 or 051-355
* Subject who early terminated from Sepracor study 051-353 or 051-355
* Subject whose schedule prevents him or her from taking the first daily dose of study medication and/or starting study visits before 10 AM
* Have travel commitments during the study that would interfere with trial measurements and/or compliance
* History of hospitalization for asthma w/in 45 days prior to study start, or scheduled for in-patient hospitalization, including elective surgery during the trial
* Subject with 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 is contraindicated
* Subject with currently diagnosed life-threatening asthma
* 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 or may interfere with the successful completion of this protocol
* History of substance abuse or drug abuse within 12 months preceding V1
* Subject with \>10 pack/yr history of cigarette smoking or use of any tobacco products within 6 months of study start
* 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 study start
* Subject who is a staff member or relative of a staff member
12 Years
ALL
No
Sponsors
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Sumitomo Pharma America, Inc.
INDUSTRY
Responsible Party
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Locations
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Jefferson Clinic PC
Birmington, Alabama, United States
Pulmonary Associates Research Division
Mobile, Alabama, United States
Montgomery Pulmonary Consultants
Montgomery, Alabama, United States
Center of Research Excellence, LLC
Oxford, Alabama, United States
Lovelace Scientific Resources
Phoenix, Arizona, United States
Alta Clinical Research, LLC
Tucson, Arizona, United States
Integrated Research Group
Corona, California, United States
Northern California Research Corp
Fair Oaks, California, United States
Allergy, Asthma & Respiratory Care Center
Long Beach, California, United States
Madera Family Medical Group
Madera, California, United States
Clinical Trials of Orange County, Inc.
Orange, California, United States
Institute of Healthcare Assessment, Inc.
San Diego, California, United States
Westlake Medical Research, Inc.
Westlake Village, California, United States
Office of Constantine Falliers, MD
Denver, Colorado, United States
Office of Gary Richmond, MD
Fort Lauderdale, Florida, United States
CNS Clinical Trials
Fort Myers, Florida, United States
FPA Clinical Research
Kissimmee, Florida, United States
Orlando Clinic for Asthma & Respiratory Diseases
Longwood, Florida, United States
Allergy Sinus Asthma Research Institute
Miami, Florida, United States
Florida Center for Alergy & Asthma Research
Miami, Florida, United States
Orlando Clinical Research Center
Orlando, Florida, United States
Family Allergy & Asthma Center, PC
Atlanta, Georgia, United States
The Allergy & Asthma Clinic Research Center
Conyers, Georgia, United States
Aeroallergy Research
Savannah, Georgia, United States
Sneeze, Wheeze and Itch, LLC
Bloomington, Illinois, United States
Rush Presbyterian - St. Luke's Medical Center
Chicago, Illinois, United States
Children's Asthma Respiratory & Exercise Specialists
Glenview, Illinois, United States
Cardinal Respiratory, PC
Springfield, Illinois, United States
Clinical Research Center of Indiana
Indianapolis, Indiana, United States
South Bend Clinic
South Bend, Indiana, United States
Consultants in Pulmonary Medicine
Olathe, Kansas, United States
Heartland Research Associates
Wichita, Kansas, United States
Northshore Medical Research
Covington, Louisiana, United States
Institute for Asthma & Allergy, PC
Wheaton, Maryland, United States
Center for Clinical Research
Taunton, Massachusetts, United States
Henry Ford Hospital & Medical Centers
Detroit, Michigan, United States
Hurley Child and Adolescent Asthma Center
Flint, Michigan, United States
Clinical Research Institute
Minneapolis, Minnesota, United States
Allergy, Asthma, Immunology Services, LLC
Jefferson City, Missouri, United States
Midwest Chest Consultants, PC
Saint Charles, Missouri, United States
Washington University School of Medicine, Division of Allergy & Immunology
St Louis, Missouri, United States
Montana Medical Research, LLC
Missoula, Montana, United States
Allergy, Asthma & Immunology Associates, PC
Lincoln, Nebraska, United States
Heartland Clinical Research Inc.
Omaha, Nebraska, United States
Office of Meera Dewan, MD
Omaha, Nebraska, United States
Delaware Valley Institute for Clinical Research
Cherry Hill, New Jersey, United States
Clinical Research Center of Allergy & Asthma Consultants
Tinton Falls, New Jersey, United States
Lovelace Scientific Resources
Albuquerque, New Mexico, United States
Allergy & Asthma of Northern NM
Los Alamos, New Mexico, United States
Pulmonary Medical Research of NY
Bay Shore, New York, United States
Asthma & Allergy Associates, PC
Cortland, New York, United States
Office of Michael Marcus, MD
Staten Island, New York, United States
Office of Richard Castaldo
Tonawanda, New York, United States
Regional Allergy & Asthma Consultants
Asheville, North Carolina, United States
Charlotte Lung & Health Center
Charlotte, North Carolina, United States
Neem Research Group, Inc.
Charlotte, North Carolina, United States
Cornerstone Research Care
High Point, North Carolina, United States
Carolina MedTrials, LLC
Winston-Salem, North Carolina, United States
Allergy & Asthma Care Center
Fargo, North Dakota, United States
Sterling Research Group
Cincinnati, Ohio, United States
New Horizons Clinical Research
Cincinnati, Ohio, United States
Optimed Research LLC
Columbus, Ohio, United States
Allergy, Asthma & Clinical Research Center
Oklahoma City, Oklahoma, United States
Allergy, Asthma and Dermatology Research Center
Lake Oswego, Oregon, United States
Medford Medical Clinic, LLP
Medford, Oregon, United States
Bellevue Pediatric Associates
Bellevue, Pennsylvania, United States
Valley Clinical Research Center
Easton, Pennsylvania, United States
Allergy & Asthma Research of NJ, Inc.
Philadelphia, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Advanced Clinical Concepts
Shillington, Pennsylvania, United States
Neem Research Group of Charleston
Charleston, South Carolina, United States
Neem Research Group Inc.
Columbia, South Carolina, United States
Allergic Disease & Asthma Center, PA
Greenville, South Carolina, United States
Asthma Institute
Chattanooga, Tennessee, United States
The Allergy Associates
Knoxville, Tennessee, United States
Office of Constantine Saadeh
Amarillo, Texas, United States
Allergy & Asthma Clinical of Central Texas
Austin, Texas, United States
UTX Medical
Galveston, Texas, United States
Breco Research
Houston, Texas, United States
Breath of Life Research Institute
Houston, Texas, United States
Clinical Trials of North Houston
Houston, Texas, United States
Central Texas Health Research
New Braunfels, Texas, United States
Lung Diagnostics
San Antonio, Texas, United States
Hampton Roads Center for Clinical Research
Norfolk, Virginia, United States
Pulmonary Associates of Richmond Inc.
Richmond, Virginia, United States
Virginia Adult & Pediatric Allergy & Asthma PC
Richmond, Virginia, United States
National Clinical Research
Richmond, Virginia, United States
The Physician's Clinic of Spokane
Spokane, Washington, United States
Allergy, Asthma, and Sinus Center F.C.
Greenfield, Wisconsin, United States
Milwaukee Medical Clinic
Milwaukee, Wisconsin, United States
Allergic Diseases, S.C.
West Allis, Wisconsin, United States
Trial Management Group
Vancouver, British Columbia, Canada
St. Boniface General Hospital
Winnipeg, Manitoba, Canada
Clinical Research Group
Mississauga, Ontario, Canada
Niagara Clinical Research, Inc.
Niagara Falls, Ontario, Canada
Primary Care Lung Clinic
Toronto, Ontario, Canada
Countries
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Other Identifiers
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051-356
Identifier Type: -
Identifier Source: org_study_id
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