Study of Daily Dosing With Levalbuterol, Racemic Albuterol, and Placebo in Pediatric Subjects With Asthma
- Conditions
- Asthma
- Interventions
- Registration Number
- NCT00073814
- Lead Sponsor
- Sumitomo Pharma America, Inc.
- Brief Summary
Study of Daily Dosing with Levalbuterol, Racemic Albuterol, and Placebo in Pediatric Subjects with Asthma
- Detailed Description
This was a Phase III, double-blind, randomized, placebo- and active-controlled, multicenter, parallel-group study of up to 6 weeks in duration. Seven days of QID single-blind, placebo administration (via HFA MDI) was followed by 28 days of QID, double-blind treatment. A follow-up visit was required only for subjects who had, in the opinion of the investigator, a clinically significant finding at Visit 6 /ET that would put the subject at risk. A final follow up phone evaluation was conducted 7 days after the completion of Visit 6/ET. 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
- 80
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 Placebo Placebo MDI QID 1 Levalbuterol tartrate MDI levalbuterol MDI 90 mcg QID 2 racemic albuterol MDI racemic albuterol MDI 190 mcg QID
- Primary Outcome Measures
Name Time Method was peak percent change in FEV1 from visit predose averaged over the double-blind period Week 0, 2, 4
- Secondary Outcome Measures
Name Time Method peak change in FEV1 from visit predose to each visit Week 0, 2, 4 time to peak change Week 0, 2, 4 peak percent of predicted FEV1 at each visit and over the double-blind period Week 0, 2, 4 area under the FEV1 percent change from predose curve at each visit Week 0, 2, 4 percent of predicted FEV1 AUC at each visit Week 0, 2, 4 percent change in predose FEV1 from study baseline at each visit Week 0, 2, 4 number and percent of responders Week 0, 2, 4 time to onset of response and duration of response Week 0, 2, 4 under the FEV1 percent change from visit predose curve averaged over the double-blind period Week 0, 2, 4 peak change and peak percent change in FEV1 from visit predose to each visit Week 0, 2, 4 area under the FEV1 percent change from study baseline curve at each visit and averaged over the double-blind period Week 0, 2, 4 peak percent change in FEV1 from study baseline over the double blind period Week 0, 2, 4
Trial Locations
- Locations (44)
The Children's Clinic of Jonesboro, PA
🇺🇸Jonesboro, Arkansas, United States
Madera Family Medical Group
🇺🇸Madera, California, United States
Bellevue Pediatric Association
🇺🇸Pittsburgh, Pennsylvania, United States
North Texas Institute for Clinical Trials
🇺🇸Fort Worth, Texas, United States
West Coast Clinical Trials, Inc.
🇺🇸Signal Hill, California, United States
University of New Mexico, Health Sciences Center
🇺🇸Albuquerque, New Mexico, United States
PI- Coor Clinical Research, LLC
🇺🇸Burke, Virginia, United States
Allergy & Asthma Medical Group of Diablo Valley, Inc.
🇺🇸Walnut Creek, California, United States
Dolby Providers, Inc
🇺🇸New Orleans, Louisiana, United States
Dr. Senders & Associates
🇺🇸University Heights, Ohio, United States
Adolescent & Pediatric Associates, PC
🇺🇸Montgomery, Alabama, United States
Regional Allergy & Asthma Consultants, PA
🇺🇸Asheville, North Carolina, United States
The Pediatric Clinic
🇺🇸Bogalusa, Louisiana, United States
Allergy & Asthma Consultants
🇺🇸Mt. Pleasant, South Carolina, United States
Pediatric Allergy/Immunology Associates
🇺🇸Dallas, Texas, United States
Pulmonary Associates of Mobile, PC
🇺🇸Ithaca, New York, United States
Clinical Research Institute of Southern Oregon
🇺🇸Medford, Oregon, United States
University Hospitals of Cleveland, Rainbow Babies & Children's Hospital
🇺🇸Cleveland, Ohio, United States
Breath of Life Research Institute
🇺🇸Houston, Texas, United States
Allergy Associates Medical Group
🇺🇸San Diego, California, United States
Pediatric Associates of Mt. Carmel
🇺🇸Cincinnati, Ohio, United States
Vanderbilt University ASAP Research
🇺🇸Nashville, Tennessee, United States
Sun Research Institute
🇺🇸San Antonio, Texas, United States
Allergy & Asthma Specialists Medical Group
🇺🇸Huntington Beach, California, United States
Integrated Research Group
🇺🇸Corona, California, United States
Asthma, Allergy & Respiratory Care Center
🇺🇸Long Beach, California, United States
Southern California Research
🇺🇸Mission Viejo, California, United States
Clinical Trials of Orange County
🇺🇸Orange, California, United States
CHOC, PSF, AMC Disision of Allergy, Asthma & Immunology
🇺🇸Orange, California, United States
Asthma & Allergy Associates
🇺🇸Colorado Springs, Colorado, United States
Aeroallergy Research Laboratories of Savannah, Inc.
🇺🇸Savannah, Georgia, United States
The Allergy & Asthma Clinical Research Center
🇺🇸Lawrenceville, Georgia, United States
Princeton Center for Clinical Research
🇺🇸Princeton, New Jersey, United States
Doctor's Care
🇺🇸New Orleans, Louisiana, United States
Essex-Morris Pediatric Group
🇺🇸Livingston, New Jersey, United States
Summit Pediatric Pulmonology
🇺🇸Summit, New Jersey, United States
Allergy & Asthma and Dermatology Research Center
🇺🇸Lake Oswego, Oregon, United States
Allergy, Asthma & Sinus Center, PC
🇺🇸Knoxville, Tennessee, United States
Allergy & Asthma Associates
🇺🇸Kirkland, Washington, United States
National Jewish Medical & Research Center
🇺🇸Denver, Colorado, United States
Department of Pediatric Critical Care, Kosair Children's Hospital
🇺🇸Louisville, Kentucky, United States
Allergy Associates Research Center
🇺🇸Portland, Oregon, United States
Sooner Clinical Research
🇺🇸Oklahoma City, Oklahoma, United States
Radiant Research
🇺🇸Bridgeton, Missouri, United States