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Sponsored by: |
Sepracor, Inc. |
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Information provided by: | Sepracor, Inc. |
ClinicalTrials.gov Identifier: | NCT00667797 |
An analysis of the costs and outcomes associated with hospitalization and treatment of Levalbuterol versus Racemic Albuterol in subjects with Asthma and COPD.
Condition | Intervention | Phase |
---|---|---|
Asthma COPD |
Drug: levalbuterol HCl Drug: albuterol Sulfate |
Phase IV |
Study Type: | Interventional |
Study Design: | Health Services Research, Randomized, Open Label, Parallel Assignment |
Official Title: | Pharmacoeconomic Outcomes of Levalbuterol and Racemic Albuterol in Inpatients Requiring Nebulization (POLARIS) |
Enrollment: | 486 |
Study Start Date: | March 2003 |
Study Completion Date: | May 2005 |
Primary Completion Date: | May 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
levalbuterol 1.25 mg
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Drug: levalbuterol HCl
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.
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2: Active Comparator
Racemic albuterol 2.5 mg
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Drug: albuterol Sulfate
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.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Alabama | |
Birmingham, Alabama, United States | |
United States, California | |
Oakland, California, United States | |
Chula Vista, California, United States | |
United States, Colorado | |
Wheat Ridge, Colorado, United States | |
United States, Connecticut | |
Waterbury, Connecticut, United States | |
United States, District of Columbia | |
Washington, District of Columbia, United States | |
United States, Florida | |
Brandon, Florida, United States | |
United States, Iowa | |
Des Moines, Iowa, United States | |
United States, New Jersey | |
Johnson City, New Jersey, United States | |
United States, New York | |
Great Neck, New York, United States | |
Syracuse, New York, United States | |
United States, North Carolina | |
Chapel Hill, North Carolina, United States | |
Winston Salem, North Carolina, United States | |
United States, Oregon | |
Portland, Oregon, United States | |
United States, Pennsylvania | |
Pittsburg, Pennsylvania, United States | |
United States, Texas | |
San Antonio, Texas, United States | |
Houston, Texas, United States | |
United States, West Virginia | |
Morgantown, West Virginia, United States |
Responsible Party: | Sepracor ( Xopenex Medical Affairs Director ) |
Study ID Numbers: | 051-921 |
Study First Received: | April 24, 2008 |
Last Updated: | April 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00667797 History of Changes |
Health Authority: | United States: Institutional Review Board |
Asthma COPD chronic emphysema chronic bronchitis |
Emphysema Neurotransmitter Agents Adrenergic beta-Agonists Adrenergic Agents Bronchial Diseases Albuterol Anti-Asthmatic Agents Asthma Adrenergic Agonists Pulmonary Emphysema Bronchitis, Chronic |
Lung Diseases, Obstructive Hypersensitivity Respiratory Tract Diseases Lung Diseases Hypersensitivity, Immediate Bronchitis Peripheral Nervous System Agents Bronchodilator Agents Pulmonary Disease, Chronic Obstructive Respiratory Hypersensitivity |
Respiratory System Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Bronchial Diseases Adrenergic Agents Albuterol Physiological Effects of Drugs Reproductive Control Agents Adrenergic Agonists Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Tocolytic Agents |
Therapeutic Uses Immune System Diseases Adrenergic beta-Agonists Asthma Anti-Asthmatic Agents Pharmacologic Actions Autonomic Agents Lung Diseases Hypersensitivity, Immediate Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity Pulmonary Disease, Chronic Obstructive |