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

Tracking Information
First Received Date ^ICMJE	April 24, 2008
Last Updated Date	April 25, 2008
Start Date ^ICMJE	March 2003
Primary Completion Date	May 2005 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 25, 2008)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00667797 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 25, 2008)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Costs & Outcomes of Hospitalization/Treatment With Levalbuterol & Albuterol in Asthma or Chronic Obstructive Pulmonary Disease (COPD) Subjects
Official Title ^ICMJE	Pharmacoeconomic Outcomes of Levalbuterol and Racemic Albuterol in Inpatients Requiring Nebulization (POLARIS)
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.
Study Phase	Phase IV
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Health Services Research, Randomized, Open Label, Parallel Assignment
Condition ^ICMJE	Asthma COPD
Intervention ^ICMJE	Drug: levalbuterol HCl Drug: albuterol Sulfate
Study Arms / Comparison Groups	Experimental: levalbuterol 1.25 mg Active Comparator: Racemic albuterol 2.5 mg
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	486
Completion Date	May 2005
Primary Completion Date	May 2005 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00667797
Responsible Party	Xopenex Medical Affairs Director, Sepracor
Study ID Numbers ^ICMJE	051-921
Study Sponsor ^ICMJE	Sepracor, Inc.
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Sepracor, Inc.
Verification Date	April 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP