Costs & Outcomes of Hospitalization/Treatment With Levalbuterol & Albuterol in Asthma or Chronic Obstructive Pulmonary Disease (COPD) Subjects (POLARIS)
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|ClinicalTrials.gov Identifier: NCT00667797|
Recruitment Status : Completed
First Posted : April 28, 2008
Last Update Posted : February 22, 2012
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|Condition or disease||Intervention/treatment||Phase|
|Asthma COPD||Drug: levalbuterol HCl Drug: albuterol Sulfate||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||486 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Pharmacoeconomic Outcomes of Levalbuterol and Racemic Albuterol in Inpatients Requiring Nebulization (POLARIS)|
|Study Start Date :||March 2003|
|Actual Primary Completion Date :||May 2005|
|Actual Study Completion Date :||May 2005|
levalbuterol 1.25 mg
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.
Other Name: Xopenex Inhalation Solution
Active Comparator: 2
Racemic albuterol 2.5 mg
Drug: 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.
Other Name: Ventolin Inhalation Solution
- The primary endpoint is the number of nebulizations, scheduled and rescue, required to treat the patient. [ Time Frame: Daily for 14 days ]
- Hospital Length of Stay [ Time Frame: Daily for 14 days ]
- Relapse Rate [ Time Frame: Daily for 14 days ]
- Clinical Chest Assessment [ Time Frame: Daily for 14 days ]
- 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 ]
- Disease Symptoms [ Time Frame: Daily for 14 days ]
- Investigator and Subject Global Assessments [ Time Frame: Daily for 14 days ]
- Discharge Location Classification [ Time Frame: Daily for 14 days ]
- Concomitant Respiratory Medication Use [ Time Frame: Daily and 30 days post discharge ]
- Total Hospital Costs [ Time Frame: Daily for 14 days ]
- Cost of Respiratory Therapy Resources [ Time Frame: Daily for 14 days ]
- Respiratory Medication Costs [ Time Frame: Daily for 14 days ]
- Subject Satisfaction with Treatment [ Time Frame: Daily for 14 days ]
- Subject General Well-being [ Time Frame: Daily and 30 days post discharge ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00667797
|United States, Alabama|
|Birmingham, Alabama, United States|
|United States, California|
|Chula Vista, California, United States|
|Oakland, California, United States|
|United States, Colorado|
|Wheat Ridge, Colorado, United States|
|United States, Connecticut|
|Waterbury, Connecticut, United States|
|United States, District of Columbia|
|Washington, District of Columbia, United States|
|United States, Florida|
|Brandon, Florida, United States|
|United States, Iowa|
|Des Moines, Iowa, United States|
|United States, New Jersey|
|Johnson City, New Jersey, United States|
|United States, New York|
|Great Neck, New York, United States|
|Syracuse, New York, United States|
|United States, North Carolina|
|Chapel Hill, North Carolina, United States|
|Winston Salem, North Carolina, United States|
|United States, Oregon|
|Portland, Oregon, United States|
|United States, Pennsylvania|
|Pittsburg, Pennsylvania, United States|
|United States, Texas|
|Houston, Texas, United States|
|San Antonio, Texas, United States|
|United States, West Virginia|
|Morgantown, West Virginia, United States|
|Other Study ID Numbers:||
|First Posted:||April 28, 2008 Key Record Dates|
|Last Update Posted:||February 22, 2012|
|Last Verified:||February 2012|
Respiratory Tract Diseases
Lung Diseases, Obstructive
Immune System Diseases
Peripheral Nervous System Agents
Physiological Effects of Drugs
Respiratory System Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Molecular Mechanisms of Pharmacological Action