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

Asthma Clinical Trial

— POLARIS  

Official title:

Pharmacoeconomic Outcomes of Levalbuterol and Racemic Albuterol in Inpatients Requiring Nebulization (POLARIS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00667797
• Other study ID #: 051-921
• Status: Completed
• Phase: Phase 4
• First received: April 24, 2008
• Last updated: February 21, 2012
• Start date: March 2003
• Est. completion date: May 2005

Study information

• Verified date: February 2012
• Source: Sunovion
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 486
• Est. completion date: May 2005
• Est. primary completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Asthma
• COPD
• Pulmonary Disease, Chronic Obstructive

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sunovion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint is the number of nebulizations, scheduled and rescue, required to treat the patient.		Daily for 14 days	Yes
Secondary	Hospital Length of Stay		Daily for 14 days	Yes
Secondary	Relapse Rate		Daily for 14 days	Yes
Secondary	Clinical Chest Assessment		Daily for 14 days	Yes
Secondary	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	Yes
Secondary	Disease Symptoms		Daily for 14 days	Yes
Secondary	Investigator and Subject Global Assessments		Daily for 14 days	Yes
Secondary	Discharge Location Classification		Daily for 14 days	Yes
Secondary	Concomitant Respiratory Medication Use		Daily and 30 days post discharge	Yes
Secondary	Total Hospital Costs		Daily for 14 days	Yes
Secondary	Cost of Respiratory Therapy Resources		Daily for 14 days	Yes
Secondary	Respiratory Medication Costs		Daily for 14 days	Yes
Secondary	Subject Satisfaction with Treatment		Daily for 14 days	Yes
Secondary	Subject General Well-being		Daily and 30 days post discharge	Yes