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
Summary
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 StayRelapse 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
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
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