A Phase 4 interventional study of levalbuterol HCl and albuterol Sulfate in Asthma and COPD, sponsored by Sumitomo Pharma America, Inc.. Completed at 18 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-02-22.
Sponsored by Sumitomo Pharma America, Inc. · Phase 4, Interventional, and Health services research
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.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 486 is above the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →Sumitomo Pharma America, Inc. is the lead sponsor of 176 studies on the registry; 5 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 20 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
levalbuterol 1.25 mg
Drug: levalbuterol HCl
Racemic albuterol 2.5 mg
Drug: albuterol Sulfate
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.
Also known as: Xopenex Inhalation Solution
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.
Also known as: Ventolin Inhalation Solution
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
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
This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.
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Sumitomo Pharma America, Inc.