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

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

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

Study Overview

• Status: Completed
• Conditions: Asthma; COPD
• Intervention / Treatment: Drug: levalbuterol HCl; Drug: albuterol Sulfate

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.

• Study Type: Interventional
• Enrollment (Actual): 486
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States
  • California
    • Chula Vista, California, United States
    • Oakland, California, United States
  • Colorado
    • Wheat Ridge, Colorado, United States
  • Connecticut
    • Waterbury, Connecticut, United States
  • District of Columbia
    • Washington, District of Columbia, United States
  • Florida
    • Brandon, Florida, United States
  • Iowa
    • Des Moines, Iowa, United States
  • New Jersey
    • Johnson City, New Jersey, United States
  • New York
    • Great Neck, New York, United States
    • Syracuse, New York, United States
  • North Carolina
    • Chapel Hill, North Carolina, United States
    • Winston Salem, North Carolina, United States
  • Oregon
    • Portland, Oregon, United States
  • Pennsylvania
    • Pittsburg, Pennsylvania, United States
  • Texas
    • Houston, Texas, United States
    • San Antonio, Texas, United States
  • West Virginia
    • Morgantown, West Virginia, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Ventolin Inhalation Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary endpoint is the number of nebulizations, scheduled and rescue, required to treat the patient.	Daily for 14 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Hospital Length of Stay	Daily for 14 days
Relapse Rate	Daily for 14 days
Clinical Chest Assessment	Daily for 14 days
Pulmonary Function Test Data (FEV1, FVC, PEF, FEV1/FVC)	Pre-dose each day and within 30 minutes after the initial dose of study medication on the first day
Disease Symptoms	Daily for 14 days
Investigator and Subject Global Assessments	Daily for 14 days
Discharge Location Classification	Daily for 14 days
Concomitant Respiratory Medication Use	Daily and 30 days post discharge
Total Hospital Costs	Daily for 14 days
Cost of Respiratory Therapy Resources	Daily for 14 days
Respiratory Medication Costs	Daily for 14 days
Subject Satisfaction with Treatment	Daily for 14 days
Subject General Well-being	Daily and 30 days post discharge

Collaborators and Investigators

• Sponsor: Sunovion

Study record dates

Study Major Dates

• Study Start: March 1, 2003
• Primary Completion (Actual): May 1, 2005
• Study Completion (Actual): May 1, 2005

Study Registration Dates

• First Submitted: April 24, 2008
• First Submitted That Met QC Criteria: April 25, 2008
• First Posted (Estimate): April 28, 2008

Study Record Updates

• Last Update Posted (Estimate): February 22, 2012
• Last Update Submitted That Met QC Criteria: February 21, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: Asthma; COPD; chronic bronchitis; chronic emphysema
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Reproductive Control Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Tocolytic Agents; Pharmaceutical Solutions; Albuterol
• Other Study ID Numbers: 051-921