Study To Assess Efficacy and Safety of Oglemilast in Patients With Chronic Obstructive Pulmonary Disease (COPD)

• Status: Completed
• Trial end date: 2009-05-15
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the safety and efficacy of a range of oglemilast doses. The study will be 14 weeks in duration. All patients meeting the eligibility criteria will be randomized to one of three doses of oglemilast or placebo.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Forest Laboratories

Criteria

Inclusion Criteria:

• Presence of COPD as defined by GOLD criteria (2006); post-bronchodilator FEV1/FVC <70%, and post-bronchodilator FEV1 >30% and < 80% predicted

• Current or former cigarette smoker

Exclusion Criteria:

• Long-term oxygen use of > 15 hours a day

• Symptoms consistent with a significant asthmatic component (e.g. atopic disease, allergic symptoms)

• Any COPD exacerbations within 30 days prior to study entry or during run-in

• History of chronic or recurrent gastrointestinal disorder associated with bleeding in previous 12 months

• Presence of clinical significant pulmonary disease other than COPD