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

• Status: Completed
• Trial end date: 2003-03-01
• Target enrollment: 0
• Participant gender: All

Summary

To investigate the efficacy and safety of repeated dosing of Levalbuterol over 6 weeks of treatment in COPD.

• Phase: Phase 3
• 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 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.