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

• Status: Completed
• Trial end date: 2005-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunovion
• Treatments: Albuterol; Pharmaceutical Solutions

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.