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 ųg QID (manufacturing site A or B) III levalbuterol Placebo QID II levalbuterol Racemic Albuterol 180 ųg 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)
Allergy & Asthma Center, LLC
🇺🇸Oxford, Alabama, United States
Alta Clinical Research
🇺🇸Tucson, Arizona, United States
Integrated Research Group
🇺🇸Corona, California, United States
Radiant Research, Inc.
🇺🇸Encinitas, California, United States
Allergy & Asthma Specialists Medical Group
🇺🇸Huntington Beach, California, United States
Asthma, Allergy & Respiratory Care Center
🇺🇸Long Beach, California, United States
Allergy Research Foundation, Inc.
🇺🇸Los Angeles, California, United States
Madera Family Medical Group
🇺🇸Madera, California, United States
Southern California Research
🇺🇸Mission Viejo, California, United States
Comprehensive Allergy Services
🇺🇸Oakland, California, United States
Scroll for more (44 remaining)Allergy & Asthma Center, LLC🇺🇸Oxford, Alabama, United States