Back to resultsCosts & Outcomes of Hospitalization/Treatment With Levalbuterol & Albuterol in Asthma or Chronic Obstructive Pulmonary Disease (COPD) Subjects (POLARIS)
Primary Purpose
Asthma, COPD
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
levalbuterol HCl
albuterol Sulfate
Sponsored by
About this trial
This is an interventional health services research trial for Asthma focused on measuring Asthma, COPD, chronic emphysema, chronic bronchitis
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
levalbuterol 1.25 mg
Racemic albuterol 2.5 mg
Outcomes
Primary Outcome Measures
The primary endpoint is the number of nebulizations, scheduled and rescue, required to treat the patient.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00667797
First Posted
April 24, 2008
Last Updated
February 21, 2012
Sponsor
Sumitomo Pharma America, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00667797
Brief Title
Costs & Outcomes of Hospitalization/Treatment With Levalbuterol & Albuterol in Asthma or Chronic Obstructive Pulmonary Disease (COPD) Subjects
Acronym
POLARIS
Official Title
Pharmacoeconomic Outcomes of Levalbuterol and Racemic Albuterol in Inpatients Requiring Nebulization (POLARIS)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
May 2005 (Actual)
Study Completion Date
May 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sumitomo Pharma America, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, COPD
Keywords
Asthma, COPD, chronic emphysema, chronic bronchitis
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
486 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
levalbuterol 1.25 mg
Arm Title
2
Arm Type
Active Comparator
Arm Description
Racemic albuterol 2.5 mg
Intervention Type
Drug
Intervention Name(s)
levalbuterol HCl
Other Intervention Name(s)
Xopenex Inhalation Solution
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
albuterol Sulfate
Other Intervention Name(s)
Ventolin Inhalation Solution
Intervention Description
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.
Primary Outcome Measure Information:
Title
The primary endpoint is the number of nebulizations, scheduled and rescue, required to treat the patient.
Time Frame
Daily for 14 days
Secondary Outcome Measure Information:
Title
Hospital Length of Stay
Time Frame
Daily for 14 days
Title
Relapse Rate
Time Frame
Daily for 14 days
Title
Clinical Chest Assessment
Time Frame
Daily for 14 days
Title
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
Title
Disease Symptoms
Time Frame
Daily for 14 days
Title
Investigator and Subject Global Assessments
Time Frame
Daily for 14 days
Title
Discharge Location Classification
Time Frame
Daily for 14 days
Title
Concomitant Respiratory Medication Use
Time Frame
Daily and 30 days post discharge
Title
Total Hospital Costs
Time Frame
Daily for 14 days
Title
Cost of Respiratory Therapy Resources
Time Frame
Daily for 14 days
Title
Respiratory Medication Costs
Time Frame
Daily for 14 days
Title
Subject Satisfaction with Treatment
Time Frame
Daily for 14 days
Title
Subject General Well-being
Time Frame
Daily and 30 days post discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
City
Chula Vista
State/Province
California
Country
United States
City
Oakland
State/Province
California
Country
United States
City
Wheat Ridge
State/Province
Colorado
Country
United States
City
Waterbury
State/Province
Connecticut
Country
United States
City
Washington
State/Province
District of Columbia
Country
United States
City
Brandon
State/Province
Florida
Country
United States
City
Des Moines
State/Province
Iowa
Country
United States
City
Johnson City
State/Province
New Jersey
Country
United States
City
Great Neck
State/Province
New York
Country
United States
City
Syracuse
State/Province
New York
Country
United States
City
Chapel Hill
State/Province
North Carolina
Country
United States
City
Winston Salem
State/Province
North Carolina
Country
United States
City
Portland
State/Province
Oregon
Country
United States
City
Pittsburg
State/Province
Pennsylvania
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Morgantown
State/Province
West Virginia
Country
United States
12. IPD Sharing Statement
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Costs & Outcomes of Hospitalization/Treatment With Levalbuterol & Albuterol in Asthma or Chronic Obstructive Pulmonary Disease (COPD) Subjects
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