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