Efficacy and Safety of Levalbuterol in Chronic Obstructive Pulmonary Disease (COPD)

Inclusion Criteria: * Male and female subjects must be at least greater than or equal to 35 years of age at the time of consent. * Subjects must have a pre-established primary clinical diagnosis of COPD. * Subjects must have a baseline FEV1 less than or equal to 65% * Subjects must have a predicted and \>0.70 Liter * subject was taking steroids (inhaled, oral, or nasal), short-acting xanthines, or leukotrienes, the dose must have been stable for 30 days * Subjects must have a FEV1/forced vital capacity (FVC) less than or equal to 70% * Subjects must have a greater than or equal to 15 pack-year smoking history * Subjects must have a baseline medical research council (MRC) dyspnea scale score greater than or equal to 2 * Regular use of a prescribed therapy for control of COPD symptoms for 3 months prior to study entry. * No COPD exacerbations that have required an emergency room visit, hospital admission or intensive out-patient therapy within 1 month prior to study entry Exclusion Criteria: * Females who are pregnant or lactating. * Concurrent requirement of oxygen therapy * Known history of asthma, or any chronic respiratory disease other than COPD (not including chronic bronchitis or emphysema). * Diagnosis of cancer within 5 years prior to study entry with the exception of non-melanoma skin cancer. * Lung resection of more than one full lobe. * Use of intravenous, intra-articular or intramuscular corticosteroids within 30 days of study entry * History of upper or lower respiratory infection within 14 days of study entry. * Participation in an investigational drug study within 30 days of study entry.