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)
1 other identifier
interventional
486
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 asthma
Started Mar 2003
Typical duration for phase_4 asthma
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
April 24, 2008
CompletedFirst Posted
Study publicly available on registry
April 28, 2008
CompletedFebruary 22, 2012
February 1, 2012
2.2 years
April 24, 2008
February 21, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary endpoint is the number of nebulizations, scheduled and rescue, required to treat the patient.
Daily for 14 days
Secondary Outcomes (13)
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
- +8 more secondary outcomes
Study Arms (2)
1
EXPERIMENTALlevalbuterol 1.25 mg
2
ACTIVE COMPARATORRacemic albuterol 2.5 mg
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Chula Vista, California, United States
Unknown Facility
Oakland, California, United States
Unknown Facility
Wheat Ridge, Colorado, United States
Unknown Facility
Waterbury, Connecticut, United States
Unknown Facility
Washington D.C., District of Columbia, United States
Unknown Facility
Brandon, Florida, United States
Unknown Facility
Des Moines, Iowa, United States
Unknown Facility
Johnson City, New Jersey, United States
Unknown Facility
Great Neck, New York, United States
Unknown Facility
Syracuse, New York, United States
Unknown Facility
Chapel Hill, North Carolina, United States
Unknown Facility
Winston-Salem, North Carolina, United States
Unknown Facility
Portland, Oregon, United States
Unknown Facility
Pittsburgh, Pennsylvania, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Morgantown, West Virginia, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2008
First Posted
April 28, 2008
Study Start
March 1, 2003
Primary Completion
May 1, 2005
Study Completion
May 1, 2005
Last Updated
February 22, 2012
Record last verified: 2012-02