Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Otsuka Pharmaceutical Co., Ltd.
Age
40–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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)
Clareo Health | To Investigate the Efficacy and Safety of OPC-6535 in Chronic Obstructive Pulmonary Disease (COPD) Patients
