Pilot Study of Tetomilast in Chronic Obstructive Pulmonary Disease (COPD) Associated With Emphysema

A Multi-center, Randomized, Double-blind, Placebo-controlled Pilot Study to Assess the Pharmacodynamics, Efficacy and Safety of 50 mg Tetomilast Administered as Oral Tablets in Patients With Chronic Obstructive Pulmonary Disease Associated With Emphysema THIS STUDY IS CLOSED TO ENROLLMENT AND NEW SITES

Phase 2a multicenter, randomized, double-blind, placebo-controlled study to assess the pharmacodynamics, efficacy, and safety of tetomilast in patients with emphysema.

Inclusion Criteria:

• Male or female, 40-75 yrs old,inclusive.
• Rating of greater than or equal to 1 on the Goddard scale in assessment of emphysema severity by HRCT.
• FEV1: FVC greater than 70% predicted.
• At least 1 documented COPD exacerbation within the past year but not within 8 weeks of randomization.
• Current or former smokers with a cigarette smoking history of at least 20 pack-years (or equivalent) and whose smoking status has not changed 60 days prior to screening.

Exclusion Criteria:

• Patients with asthma, active tuberculosis or bronchiectasis.
• A respiratory tract infection within 30 days prior to the screening visit.
• Any malignancy within the last 5 years with the exception of non-melanomatous skin cancer.
• Uncontrolled cardiovascular, endocrine, blood, or nervous system disorders.
• Uncontrolled condition with COPD exacerbation of level 2 or 3 in the 8-week period prior to randomization.
• Systemic use of corticosteroids or other immunosuppressive agents within 30 days of the screening visit.
• Subjects taking anticoagulants.