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

Sumitomo Pharma

Status and phase

Completed

Phase 4

Conditions

Asthma

COPD

Treatments

Drug: albuterol Sulfate

Drug: levalbuterol HCl

Study type

Interventional

Funder types

Industry

Identifiers

NCT00667797

051-921

Details and patient eligibility

About

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

Full 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.

Enrollment

486 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.