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

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

Detailed Description
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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.

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

Conditions
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Asthma, COPD

Intervention / Treatment
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* Drug: levalbuterol HCl
* Drug: albuterol Sulfate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>levalbuterol 1.25 mg | Drug: levalbuterol HCl<br>* 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.<br>* Other names: Xopenex Inhalation Solution;|
| Active Comparator: 2<br>Racemic albuterol 2.5 mg | Drug: albuterol Sulfate<br>* 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.<br>* Other names: Ventolin Inhalation Solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint is the number of nebulizations, scheduled and rescue, required to treat the patient. |  | Daily for 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Investigator and Subject Global Assessments |  | Daily for 14 days | 
| Discharge Location Classification |  | Daily for 14 days | 
| Concomitant Respiratory Medication Use |  | Daily and 30 days post discharge | 
| Total Hospital Costs |  | Daily for 14 days | 
| Cost of Respiratory Therapy Resources |  | Daily for 14 days | 
| Respiratory Medication Costs |  | Daily for 14 days | 
| Subject Satisfaction with Treatment |  | Daily for 14 days | 
| Subject General Well-being |  | Daily and 30 days post discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, COPD, chronic emphysema, chronic bronchitis