Long Term Safety Study of Levalbuterol and Racemic Albuterol in Subjects Twelve Years of Age and Older With Asthma
- Conditions
- Asthma
- Interventions
- Registration Number
- NCT00064389
- Lead Sponsor
- Sumitomo Pharma America, Inc.
- Brief Summary
The purpose of this study is to evaluate the safety of levalbuterol as compared to racemic albuterol based on the frequencies of adverse events reporting during a 12-month period of chronic dosing of adolescent and adult subjects with asthma.
- Detailed Description
This was a randomized, open-label, active controlled, multicenter, parallel-group safety study in subjects 12 years of age and older with asthma. Subjects of appropriate age who completed the Phase III levalbuterol HFA MDI trials (Studies 051-353 or 051-355) were eligible to participate. Studies 051-353 and 051-355, both entitled "An Efficacy and Safety Study of Levalbuterol, Racemic Albuterol and Placebo in Subjects Twelve Years of Age and Older with Asthma" were multicenter, randomized, double-blind, placebo- and active-controlled, parallel-group studies of up to nine weeks in duration (a one-week single-blind placebo run in period followed by an eight-week double-blind treatment period). Subjects who completed Studies 051 353 and 051 355 but who were not immediately eligible to rollover into the current study could also participate but only after a 30-day washout. New subjects and subjects who participated in the Phase III trials who were not immediately eligible (ie, had a \>30-day washout) were considered to be de novo subjects.Study participation included 10 study visits over a 12 month period.
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
- 746
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 levalbuterol tartrate HFA MDI levalbuterol 90 mcg MDI QID 2 racemic albuterol racemic albuterol HFA MDI 180 mcg QID
- Primary Outcome Measures
Name Time Method incidence of post-randomization adverse events Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 22, 23, 26, 27, 30, 31, 34, 35, 38, 39, 43, 44, 47, 48, 52, 53
- Secondary Outcome Measures
Name Time Method rate of discontinuations due to adverse events Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 22, 23, 26, 27, 30, 31, 34, 35, 38, 39, 43, 44, 47, 48, 52, 53 time-to-selected adverse events (AEs with an incidence ≥5%) Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 22, 23, 26, 27, 30, 31, 34, 35, 38, 39, 43, 44, 47, 48, 52, 53 asthma attacks, asthma adverse events, and expanded-definition asthma events Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 22, 23, 26, 27, 30, 31, 34, 35, 38, 39, 43, 44, 47, 48, 52, 53 clinical laboratory values Weeks -1, 0, 10, 11, 26, 27, 43, 44, 52, 53 vital signs (blood pressure, heart rate, respiration rate, and body temperature) Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 26, 27, 34, 35, 43, 44, 52, 53 ECG parameters Weeks -1, 0, 1, 10, 11, 26, 27, 43, 44, 52, 53 physical examinations Weeks -1, 0, 26, 27, 52, 53 rescue medication, and daytime asthma control days Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 22, 23, 26, 27, 30, 31, 34, 35, 38, 39, 43, 44, 47, 48, 52, 53 FEV1, FVC, FEF25-75%, peak expiratory flow Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 26, 27, 34, 35, 43, 44, 52, 53 Asthma Quality of Life Questionnaire (AQLQ) Weeks 0, 26, 27, 52, 53 subject and physician global evaluations Weeks 26, 27, 52, 53 (S) and (R) albuterol plasma concentrations Weeks -1, 0, 10, 11, 26, 27, 43, 44, 52, 53 subject assessment of study inhaler device performance Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 22, 23, 26, 27, 30, 31, 34, 35, 38, 39, 43, 44, 47, 48, 52, 53
Trial Locations
- Locations (95)
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
🇺🇸Albuquerque, New Mexico, 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
Scroll for more (85 remaining)Jefferson Clinic PC🇺🇸Birmington, Alabama, United States