An analysis of the costs and outcomes associated with hospitalization and treatment of Levalbuterol versus Racemic Albuterol in subjects with Asthma and COPD.
This was a randomized, open-label study evaluating clinical and pharmacoeconomic outcomes in hospitalized patients with asthma or COPD who have been admitted due to an exacerbation of their disease and required further treatment with a beta2-adrenergic agonist. Approximately 430 patients were randomized and enrolled. Patients were then followed during their hospitalization. Once discharged, patient status was assessed via telephone interview 30 days after discharge. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
486
Levalbuterol 1.25 mg will be prescribed every 6-8 hours, with standing orders for as needed PRN use. However, the prescribing physician may change the dose, frequency, and/or duration of levalbuterol administration at their discretion.
Racemic albuterol 2.5 mg will be prescribed per the standard of care used in the institution, with standing orders for as needed PRN use. However, the prescribing physician may change the dose, frequency, and/or duration of racemic albuterol administration at their discretion.
Unnamed facility
Birmingham, Alabama, United States
Unnamed facility
Chula Vista, California, United States
Unnamed facility
Oakland, California, United States
The primary endpoint is the number of nebulizations, scheduled and rescue, required to treat the patient.
Time frame: Daily for 14 days
Hospital Length of Stay
Time frame: Daily for 14 days
Relapse Rate
Time frame: Daily for 14 days
Clinical Chest Assessment
Time frame: Daily for 14 days
Pulmonary Function Test Data (FEV1, FVC, PEF, FEV1/FVC)
Time frame: Pre-dose each day and within 30 minutes after the initial dose of study medication on the first day
Disease Symptoms
Time frame: Daily for 14 days
Investigator and Subject Global Assessments
Time frame: Daily for 14 days
Discharge Location Classification
Time frame: Daily for 14 days
Concomitant Respiratory Medication Use
Time frame: Daily and 30 days post discharge
Total Hospital Costs
Time frame: Daily for 14 days
Cost of Respiratory Therapy Resources
Time frame: Daily for 14 days
Respiratory Medication Costs
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Unnamed facility
Wheat Ridge, Colorado, United States
Unnamed facility
Waterbury, Connecticut, United States
Unnamed facility
Washington D.C., District of Columbia, United States
Unnamed facility
Brandon, Florida, United States
Unnamed facility
Des Moines, Iowa, United States
Unnamed facility
Johnson City, New Jersey, United States
Unnamed facility
Great Neck, New York, United States
...and 8 more locations
Time frame: Daily for 14 days
Subject Satisfaction with Treatment
Time frame: Daily for 14 days
Subject General Well-being
Time frame: Daily and 30 days post discharge