Status:
COMPLETED
Costs & Outcomes of Hospitalization/Treatment With Levalbuterol & Albuterol in Asthma or Chronic Obstructive Pulmonary Disease (COPD) Subjects
Lead Sponsor:
Sumitomo Pharma America, Inc.
Conditions:
Asthma
COPD
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 an...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2005
Estimated Enrollment :
486 Patients enrolled
Trial Details
Trial ID
NCT00667797
Start Date
March 1 2003
End Date
May 1 2005
Last Update
February 22 2012
Active Locations (18)
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1
Birmingham, Alabama, United States
2
Chula Vista, California, United States
3
Oakland, California, United States
4
Wheat Ridge, Colorado, United States