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

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

Official Title
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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)

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Drug: tetomilast (OPC-6535)
* Drug: tetomilast (OPC-6535)
* Drug: tetomilast (OPC-6535)
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OPC-6535 12.5mg<br> | Drug: tetomilast (OPC-6535)<br>* oral administration of 12.5mg OPC-6535, once daily for 24months<br>|
| Experimental: OPC-6535 25mg<br> | Drug: tetomilast (OPC-6535)<br>* oral administration of 25mg OPC-6535, once daily for 24months<br>|
| Experimental: OPC-6535 50mg<br> | Drug: tetomilast (OPC-6535)<br>* oral administration of 50 mg OPC-6535, once daily for 24months<br>|
| Placebo Comparator: placebo<br> | Drug: placebo<br>* oral administration of placebo, once daily for 24months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trough Forced Expiratory Volume in 1 Second (FEV1) Change From Baseline to 24 Months | Measurement over time (from baseline over the 24-month treatment period) and change from baseline to end of the treatment period. | Baseline, 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline at 24 Months in Total Symptom Diary Score | Subjects were required to keep a symptom diary throughout the entire trial period from the start of investigational medicinal product (IMP) administration in the washout period until the end of the treatment period. Assessment items included scores for shortness of breath, cough, and sputum, IMP compliance, use of salbutamol and respiratory symptom medications, and smoking status. Subjects recorded a score of between 0 and 3, with 0 indicating no symptoms and 3 indicating a high level of symptoms, for each domain. | Baseline, 24 months | 
| Change From Baseline at 24 Months in St. George's Respiratory Questionnaire (SGRQ) Total Score | The SGRQ is a self-administered questionnaire designed to measure and quantify the impact of chronic respiratory disease on health-related quality of life (QOL) and well-being in three domains: symptoms, activity, and impact on daily life. The SGRQ was completed by each subject prior to IMP administration at baseline and at Month 6, Month 12, Month 18, and Month 24 (end of treatment). A weighted score based on population norms for each dimension and total was evaluated. Scores were expressed as a percentage of overall impairment where 100 represented worst possible health status and 0 indicated best possible health status. Scores were calculated when less than 24% of the item scores were missing, otherwise the scores were set to missing. Where there were multiple answers for a question, the worst case was used. | Baseline, 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic obstructive pulmonary disease, COPD, emphysema