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

Information source: Sunovion
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma; COPD

Intervention: levalbuterol HCl (Drug); albuterol Sulfate (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Sunovion


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

Clinical Details

Official title: Pharmacoeconomic Outcomes of Levalbuterol and Racemic Albuterol in Inpatients Requiring Nebulization (POLARIS)

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Primary outcome: The primary endpoint is the number of nebulizations, scheduled and rescue, required to treat the patient.

Secondary outcome:

Hospital Length of Stay

Relapse Rate

Clinical Chest Assessment

Pulmonary Function Test Data (FEV1, FVC, PEF, FEV1/FVC)

Disease Symptoms

Investigator and Subject Global Assessments

Discharge Location Classification

Concomitant Respiratory Medication Use

Total Hospital Costs

Cost of Respiratory Therapy Resources

Respiratory Medication Costs

Subject Satisfaction with Treatment

Subject General Well-being

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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


- 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


- 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.

Locations and Contacts

Birmingham, Alabama, United States

Chula Vista, California, United States

Oakland, California, United States

Wheat Ridge, Colorado, United States

Waterbury, Connecticut, United States

Washington, District of Columbia, United States

Brandon, Florida, United States

Des Moines, Iowa, United States

Johnson City, New Jersey, United States

Great Neck, New York, United States

Syracuse, New York, United States

Chapel Hill, North Carolina, United States

Winston Salem, North Carolina, United States

Portland, Oregon, United States

Pittsburg, Pennsylvania, United States

Houston, Texas, United States

San Antonio, Texas, United States

Morgantown, West Virginia, United States

Additional Information

Starting date: March 2003
Last updated: February 21, 2012

Page last updated: August 23, 2015

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