To investigate the efficacy and safety of OPC-6535 in COPD patients
- Conditions
- chronic obstructive pulmonary disease
- Registration Number
- JPRN-jRCT2080220742
- Lead Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Brief Summary
The results of this trial have established a treatment effect for OPC-6535 12.5 mg. There are no findings from this investigation that raise serious concerns about future administration of OPC-6535 to humans.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 772
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
-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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Trough FEV1<br><br>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 Outcome Measures
Name Time Method efficacy<br>symptom diary score , QOL, CT etc.<br><br>24 Month