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

• Status: Terminated
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Criteria

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.