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Costs & Outcomes of Hospitalization/Treatment With Levalbuterol & Albuterol in Asthma or Chronic Obstructive Pulmonary Disease (COPD) Subjects (POLARIS)

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ClinicalTrials.gov Identifier: NCT00667797
Recruitment Status : Completed
First Posted : April 28, 2008
Last Update Posted : February 22, 2012
Information provided by (Responsible Party):

Brief Summary:
An analysis of the costs and outcomes associated with hospitalization and treatment of Levalbuterol versus Racemic Albuterol in subjects with Asthma and COPD.

Condition or disease Intervention/treatment Phase
Asthma COPD Drug: levalbuterol HCl Drug: albuterol Sulfate Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 486 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Pharmacoeconomic Outcomes of Levalbuterol and Racemic Albuterol in Inpatients Requiring Nebulization (POLARIS)
Study Start Date : March 2003
Actual Primary Completion Date : May 2005
Actual Study Completion Date : May 2005

Arm Intervention/treatment
Experimental: 1
levalbuterol 1.25 mg
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.
Other Name: Xopenex Inhalation Solution

Active Comparator: 2
Racemic albuterol 2.5 mg
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.
Other Name: Ventolin Inhalation Solution

Primary Outcome Measures :
  1. The primary endpoint is the number of nebulizations, scheduled and rescue, required to treat the patient. [ Time Frame: Daily for 14 days ]

Secondary Outcome Measures :
  1. Hospital Length of Stay [ Time Frame: Daily for 14 days ]
  2. Relapse Rate [ Time Frame: Daily for 14 days ]
  3. Clinical Chest Assessment [ Time Frame: Daily for 14 days ]
  4. 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 ]
  5. Disease Symptoms [ Time Frame: Daily for 14 days ]
  6. Investigator and Subject Global Assessments [ Time Frame: Daily for 14 days ]
  7. Discharge Location Classification [ Time Frame: Daily for 14 days ]
  8. Concomitant Respiratory Medication Use [ Time Frame: Daily and 30 days post discharge ]
  9. Total Hospital Costs [ Time Frame: Daily for 14 days ]
  10. Cost of Respiratory Therapy Resources [ Time Frame: Daily for 14 days ]
  11. Respiratory Medication Costs [ Time Frame: Daily for 14 days ]
  12. Subject Satisfaction with Treatment [ Time Frame: Daily for 14 days ]
  13. Subject General Well-being [ Time Frame: Daily and 30 days post discharge ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male and female subjects must be at least greater than or equal to 18 years of age at the time of consent.
  • Subjects must have history of asthma or COPD for at least 6 months prior to hospitalization.
  • Subjects must have been hospitalized due to an exacerbation of their disease and required further treatment with a nebulized beta2-adrenergic agonist.
  • Subjects must have an oxygen saturation level greater than or equal to 90% with greater than or equal to 40% face mask supplemental oxygen.

Exclusion Criteria:

  • Subjects who are likely to be in the Intensive Care Unit (ICU) or Critical Care Unit (CCU).
  • Based upon history or physical exam in the ED or Clinic, subjects with known or suspected cause of pulmonary symptoms other than asthma or COPD, such as pneumonia, pulmonary embolism, cystic fibrosis, or angioedema. Subjects with CHF that are admitted with a primary admission diagnosis of COPD are not excluded.
  • Female subjects who are pregnant or breast feeding.
  • Subjects who have participated in an investigational drug study within 30 days of study entry or have previously participated in the current trial.
  • Subjects who are planning to receive elective surgical procedures during the 30 day period after hospital discharge.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00667797

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United States, Alabama
Birmingham, Alabama, United States
United States, California
Chula Vista, California, United States
Oakland, 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
Houston, Texas, United States
San Antonio, Texas, United States
United States, West Virginia
Morgantown, West Virginia, United States
Sponsors and Collaborators
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Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT00667797    
Other Study ID Numbers: 051-921
First Posted: April 28, 2008    Key Record Dates
Last Update Posted: February 22, 2012
Last Verified: February 2012
Keywords provided by Sunovion:
chronic emphysema
chronic bronchitis
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Pharmaceutical Solutions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action