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

February 21, 2012 updated by: Sunovion

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
486

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The primary endpoint is the number of nebulizations, scheduled and rescue, required to treat the patient.
Time Frame: Daily for 14 days
Daily for 14 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Hospital Length of Stay
Time Frame: Daily for 14 days
Daily for 14 days
Relapse Rate
Time Frame: Daily for 14 days
Daily for 14 days
Clinical Chest Assessment
Time Frame: Daily for 14 days
Daily for 14 days
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
Pre-dose each day and within 30 minutes after the initial dose of study medication on the first day
Disease Symptoms
Time Frame: Daily for 14 days
Daily for 14 days
Investigator and Subject Global Assessments
Time Frame: Daily for 14 days
Daily for 14 days
Discharge Location Classification
Time Frame: Daily for 14 days
Daily for 14 days
Concomitant Respiratory Medication Use
Time Frame: Daily and 30 days post discharge
Daily and 30 days post discharge
Total Hospital Costs
Time Frame: Daily for 14 days
Daily for 14 days
Cost of Respiratory Therapy Resources
Time Frame: Daily for 14 days
Daily for 14 days
Respiratory Medication Costs
Time Frame: Daily for 14 days
Daily for 14 days
Subject Satisfaction with Treatment
Time Frame: Daily for 14 days
Daily for 14 days
Subject General Well-being
Time Frame: Daily and 30 days post discharge
Daily and 30 days post discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sunovion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2003

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2005

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2005

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 24, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 28, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 22, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 051-921

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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