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

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)

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

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: tetomilast (OPC-6535); Drug: tetomilast (OPC-6535); Drug: tetomilast (OPC-6535); Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 771
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Central China Area, China
  • East China Area, China
  • North China Area, China
  • Northeast China Area, China
  • Northwest China Area, China
  • South China Area, China
  • Southwest China Area, China
• Japan
  • Kansai Region, Et Al., Japan
• Korea, Republic of
  • Seoul, Et Al., Korea, Republic of

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Otsuka Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: June 8, 2009
• First Submitted That Met QC Criteria: June 9, 2009
• First Posted (Estimate): June 10, 2009

Study Record Updates

• Last Update Posted (Actual): April 30, 2021
• Last Update Submitted That Met QC Criteria: April 5, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: COPD; emphysema; chronic obstructive pulmonary disease
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 197-08-801; JapicCTI-090770