Clinical trial NCT00667797: Costs & Outcomes of Hospitalization/Treatment With Levalbuterol & Albuterol in Asthma or Chronic Obstructive Pulmonary Disease (COPD) Subjects
Official title: Pharmacoeconomic Outcomes of Levalbuterol and Racemic Albuterol in Inpatients Requiring Nebulization (POLARIS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
COPD
Keywords: Asthma
COPD
chronic emphysema
chronic bronchitis
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2008-04-28
Enrollment: 486
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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 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.

Primary outcomes:
measure: The primary endpoint is the number of nebulizations, scheduled and rescue, required to treat the patient.
timeFrame: Daily for 14 days
Secondary outcomes:
measure: Hospital Length of Stay
timeFrame: Daily for 14 days
measure: Relapse Rate
timeFrame: Daily for 14 days
measure: Clinical Chest Assessment
timeFrame: Daily for 14 days
measure: Pulmonary Function Test Data (FEV1, FVC, PEF, FEV1/FVC)
timeFrame: Pre-dose each day and within 30 minutes after the initial dose of study medication on the first day
measure: Disease Symptoms
timeFrame: Daily for 14 days
measure: Investigator and Subject Global Assessments
timeFrame: Daily for 14 days
measure: Discharge Location Classification
timeFrame: Daily for 14 days
measure: Concomitant Respiratory Medication Use
timeFrame: Daily and 30 days post discharge
measure: Total Hospital Costs
timeFrame: Daily for 14 days
measure: Cost of Respiratory Therapy Resources
timeFrame: Daily for 14 days
measure: Respiratory Medication Costs
timeFrame: Daily for 14 days
measure: Subject Satisfaction with Treatment
timeFrame: Daily for 14 days
measure: Subject General Well-being
timeFrame: Daily and 30 days post discharge
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Chula Vista
country: United States
state: California
city: Oakland
country: United States
state: California
city: Wheat Ridge
country: United States
state: Colorado
city: Waterbury
country: United States
state: Connecticut
city: Washington
country: United States
state: District of Columbia
city: Brandon
country: United States
state: Florida
city: Des Moines
country: United States
state: Iowa
city: Johnson City
country: United States
state: New Jersey
city: Great Neck
country: United States
state: New York
city: Syracuse
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Winston Salem
country: United States
state: North Carolina
city: Portland
country: United States
state: Oregon
city: Pittsburg
country: United States
state: Pennsylvania
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Morgantown
country: United States
state: West Virginia
Study officials:
References: