To Investigate the Efficacy and Safety of OPC-6535 in Chronic Obstructive Pulmonary Disease (COPD) Patients

A Phase 2, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-arm, Dose-comparison Trial of OPC-6535 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

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

Inclusion Criteria:

• Age 40 to 75 years, inclusive, at the time informed consent is obtained
• Ability to provide own written informed consent
• Agree to use an appropriate method of contraception until 3 months after the last dose of the investigational medicinal product (IMP)
• A rating of 1 or higher on the Goddard scale in assessment of emphysema severity by chest CT scan at screening
• Ratio of forced expiratory volume in 1 second to forced vital capacity (FEV1/FVC) of less than 70% at screening
• Cigarette smoking history of at least 20 pack years at screening

Exclusion Criteria:

• Subjects with obstructive disorders due to bronchial asthma
• Subjects receiving long-term oxygen therapy
• Subjects with active tuberculosis or obvious bronchiectasis
• Complication of malignant tumor
• Uncontrolled cardiovascular, endocrine, blood, or nervous system disorders
• Uncontrolled condition with COPD exacerbation of level 2 or 3 within 8 weeks prior to the start of washout period (within 12 weeks prior to start of treatment period)