Study of Levalbuterol, Racemic Albuterol and Placebo in Subjects Twelve Years of Age and Older With Asthma
- Registration Number
- NCT00073840
- Lead Sponsor
- Sumitomo Pharma America, Inc.
- Brief Summary
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).
- Detailed Description
A double-blind, randomized, placebo- and active-controlled, multicenter, parallel-group trial of levalbuterol in subjects 12 years of age and older with asthma. Study participation will include one 1-week single-blind placebo run-in and an 8-week, randomized,double-blind, active-treatment period with four treatment groups. 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 386
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description I levalbuterol Levalbuterol 90 Ĺłg QID (manufacturing site A or B) III levalbuterol Placebo QID II levalbuterol Racemic Albuterol 180 Ĺłg QID
- Primary Outcome Measures
Name Time Method FEV1 (peak percent change from pre-dose averaged over the double-blind period). 8 weeks
- Secondary Outcome Measures
Name Time Method --FEV1 [area under the % change from pre-dose FEV1 curve] and FEV1 [area under the % change from study baseline FEV1 curve] 9 weeks
Trial Locations
- Locations (54)
Aeroallergy Research Laboratories of Savannah, Inc.
đşđ¸Savannah, Georgia, United States
Rush Presbyterian - St. Luke's Medical Center Rush University
đşđ¸Chicago, Illinois, United States
Research Across America
đşđ¸Dallas, Texas, United States
Allergy Associates Medical Group
đşđ¸San Diego, California, United States
Allergy & Asthma Medical Group & Research Center
đşđ¸San Diego, California, United States
Clinical Research Institute
đşđ¸Minneapolis, Minnesota, United States
New Horizons Clinical Research, Inc.
đşđ¸Cincinnati, Ohio, United States
Allergy & Asthma Center, LLC
đşđ¸Oxford, Alabama, United States
Madera Family Medical Group
đşđ¸Madera, California, United States
South Bend Clniic
đşđ¸South Bend, Indiana, United States
AAIR Research Center
đşđ¸Rochester, New York, United States
Allergy Research Foundation, Inc.
đşđ¸Los Angeles, California, United States
1st Allergy & Asthma Clinical Research Ctr
đşđ¸Thornton, Colorado, United States
Office or Richard Castaldo, MD
đşđ¸Tonawanda, New York, United States
Charlotte Lung and Health Center
đşđ¸Charlotte, North Carolina, United States
Integrated Research Group
đşđ¸Corona, California, United States
Radiant Research, Inc.
đşđ¸Encinitas, California, United States
Watts Medical Research
đşđ¸Barnesville, Georgia, United States
Allergy & Asthma Specialists Medical Group
đşđ¸Huntington Beach, California, United States
Breco Research
đşđ¸Houston, Texas, United States
Heartland Clinical Research Inc.
đşđ¸Omaha, Nebraska, United States
Breath of Life Research Institute
đşđ¸Houston, Texas, United States
Lung Diagnostics
đşđ¸San Antonio, Texas, United States
Allergy, Asthma and Sinus Center F.C.
đşđ¸Greenfield, Wisconsin, United States
Alta Clinical Research
đşđ¸Tucson, Arizona, United States
Asthma, Allergy & Respiratory Care Center
đşđ¸Long Beach, California, United States
Southern California Research
đşđ¸Mission Viejo, California, United States
Clinical Trials of Orange County
đşđ¸Orange, California, United States
Comprehensive Allergy Services
đşđ¸Oakland, California, United States
Allergy & Asthma Assoc. of Santa Clara Valley Research Center
đşđ¸San Jose, California, United States
West Coast Clinical Trials
đşđ¸Signal Hill, California, United States
Allergy & Asthma Medical Group of Diablo Valley, Inc.
đşđ¸Walnut Creek, California, United States
The Allergy & Asthma Clinical Research Center
đşđ¸Conyers, Georgia, United States
Clinical Research Specialist
đşđ¸Metairie, Louisiana, United States
The Clinical Research Center, LLC
đşđ¸St. Louis, Missouri, United States
Pulmonary Medical Research of NY, PLLC
đşđ¸Bay Shore, New York, United States
Allergy, Asthma & Clinical Research Center
đşđ¸Oklahoma City, Oklahoma, United States
Allergy Associates Research Center, LLC
đşđ¸Portland, Oregon, United States
Albermarle Allergy & Asthma PC
đşđ¸Elizabeth City, North Carolina, United States
Valley Clinical Research Center
đşđ¸Easton, Pennsylvania, United States
Advanced Clinical Concepts
đşđ¸Temple, Pennsylvania, United States
Allergic Disease & Asthma Center PA
đşđ¸Greenville, South Carolina, United States
Allergy and Asthma Clinic of Central Texas
đşđ¸Austin, Texas, United States
Pulmonary Associates of Richmond, inc.
đşđ¸Richmond, Virginia, United States
PI - Coor Clinical Research, LLC
đşđ¸Burke, Virginia, United States
Allergic Diseases, SC
đşđ¸West Allis, Wisconsin, United States
Allergy & Asthma Consultants, LLP
đşđ¸Mt. Pleasant, South Carolina, United States
Children's International Medical Research
đşđ¸Slidell, Louisiana, United States
Office of Yekaterina Khronusova, MD
đşđ¸Las Vegas, Nevada, United States
Doctor's Care
đşđ¸New Orleans, Louisiana, United States
Asthma & Allergy Center PC
đşđ¸Papillion, Nebraska, United States
Asthma & Allergy Associates PC
đşđ¸Cortland, New York, United States
Piedmont Medical Research
đşđ¸Winston-Salem, North Carolina, United States
Rockwood Clinics, PS
đşđ¸Spokane, Washington, United States