Conditions: Chronic Obstructive Pulmonary Disease
Keywords: chronic obstructive pulmonary disease COPD emphysema
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 771
Healthy volunteers: no

Brief summary:
To investigate the efficacy and safety of OPC-6535 in COPD patients, using the measurement of trough FEV1 over time as the primary endpoint.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None

Interventions: intervention 1: tetomilast (OPC-6535) intervention 2: tetomilast (OPC-6535) intervention 3: tetomilast (OPC-6535) intervention 4: placebo
Intervention descriptions: intervention 1: oral administration of 12.5mg OPC-6535, once daily for 24months intervention 2: oral administration of 25mg OPC-6535, once daily for 24months intervention 3: oral administration of 50 mg OPC-6535, once daily for 24months intervention 4: oral administration of placebo, once daily for 24months

Protocol document: