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

Sponsor:	Sunovion
Information provided by:	Sunovion
ClinicalTrials.gov Identifier:	NCT00667797

Purpose

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

Condition	Intervention	Phase
Asthma COPD	Drug: levalbuterol HCl Drug: albuterol Sulfate	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research
Official Title:	Pharmacoeconomic Outcomes of Levalbuterol and Racemic Albuterol in Inpatients Requiring Nebulization (POLARIS)

Resource links provided by NLM:

MedlinePlus related topics: Asthma COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Albuterol Levalbuterol hydrochloride Albuterol sulfate Levalbuterol tartrate

U.S. FDA Resources

Further study details as provided by Sunovion:

Primary Outcome Measures:

The primary endpoint is the number of nebulizations, scheduled and rescue, required to treat the patient. [ Time Frame: Daily for 14 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Hospital Length of Stay [ Time Frame: Daily for 14 days ] [ Designated as safety issue: Yes ]
Relapse Rate [ Time Frame: Daily for 14 days ] [ Designated as safety issue: Yes ]
Clinical Chest Assessment [ Time Frame: Daily for 14 days ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
Disease Symptoms [ Time Frame: Daily for 14 days ] [ Designated as safety issue: Yes ]
Investigator and Subject Global Assessments [ Time Frame: Daily for 14 days ] [ Designated as safety issue: Yes ]
Discharge Location Classification [ Time Frame: Daily for 14 days ] [ Designated as safety issue: Yes ]
Concomitant Respiratory Medication Use [ Time Frame: Daily and 30 days post discharge ] [ Designated as safety issue: Yes ]
Total Hospital Costs [ Time Frame: Daily for 14 days ] [ Designated as safety issue: Yes ]
Cost of Respiratory Therapy Resources [ Time Frame: Daily for 14 days ] [ Designated as safety issue: Yes ]
Respiratory Medication Costs [ Time Frame: Daily for 14 days ] [ Designated as safety issue: Yes ]
Subject Satisfaction with Treatment [ Time Frame: Daily for 14 days ] [ Designated as safety issue: Yes ]
Subject General Well-being [ Time Frame: Daily and 30 days post discharge ] [ Designated as safety issue: Yes ]

Enrollment:	486
Study Start Date:	March 2003
Study Completion Date:	May 2005
Primary Completion Date:	May 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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 Name: Ventolin Inhalation Solution

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00667797

Locations

United States, Alabama

Birmingham, Alabama, United States
United States, California

Chula Vista, California, United States

Oakland, California, United States
United States, Colorado

Wheat Ridge, Colorado, United States
United States, Connecticut

Waterbury, Connecticut, United States
United States, District of Columbia

Washington, District of Columbia, United States
United States, Florida

Brandon, Florida, United States
United States, Iowa

Des Moines, Iowa, United States
United States, New Jersey

Johnson City, New Jersey, United States
United States, New York

Great Neck, New York, United States

Syracuse, New York, United States
United States, North Carolina

Chapel Hill, North Carolina, United States

Winston Salem, North Carolina, United States
United States, Oregon

Portland, Oregon, United States
United States, Pennsylvania

Pittsburg, Pennsylvania, United States
United States, Texas

Houston, Texas, United States

San Antonio, Texas, United States
United States, West Virginia

Morgantown, West Virginia, United States

Sponsors and Collaborators

Sunovion

More Information

No publications provided

Responsible Party:	Xopenex Medical Affairs Director, Sunovion Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:	NCT00667797 History of Changes
Other Study ID Numbers:	051-921
Study First Received:	April 24, 2008
Last Updated:	November 1, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by Sunovion:

Asthma
COPD
chronic emphysema
chronic bronchitis

Additional relevant MeSH terms:

Asthma
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Albuterol
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs

Pharmacologic Actions
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on February 12, 2012