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

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Criteria

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)