chronic obstructive pulmonary disease
Conditions
Interventions
investigational material(s)
Generic name etc : OPC-6535
INN of investigational material : -
Therapeutic category code : 229 Other agents affecting respiratory organs
Dosage and Administration for Inve
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion 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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Trough FEV1 Measurement over time (from baseline over the 24-month treatment period) and change and percentage change from baseline to end of the treatment period (Month 24) | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy symptom diary score , QOL, CT etc. 24 Month | — |
Countries
Asia except Japan, Japan
Outcome results
None listed