search
Back to results

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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
tetomilast (OPC-6535)
tetomilast (OPC-6535)
tetomilast (OPC-6535)
placebo
Sponsored by
Otsuka Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring chronic obstructive pulmonary disease, COPD, emphysema

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

OPC-6535 12.5mg

OPC-6535 25mg

OPC-6535 50mg

placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
June 8, 2009
Last Updated
April 5, 2021
Sponsor
Otsuka Pharmaceutical Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT00917150
Brief Title
To Investigate the Efficacy and Safety of OPC-6535 in Chronic Obstructive Pulmonary Disease (COPD) Patients
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
chronic obstructive pulmonary disease, COPD, emphysema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
771 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OPC-6535 12.5mg
Arm Type
Experimental
Arm Title
OPC-6535 25mg
Arm Type
Experimental
Arm Title
OPC-6535 50mg
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
tetomilast (OPC-6535)
Intervention Description
oral administration of 12.5mg OPC-6535, once daily for 24months
Intervention Type
Drug
Intervention Name(s)
tetomilast (OPC-6535)
Intervention Description
oral administration of 25mg OPC-6535, once daily for 24months
Intervention Type
Drug
Intervention Name(s)
tetomilast (OPC-6535)
Intervention Description
oral administration of 50 mg OPC-6535, once daily for 24months
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
oral administration of placebo, once daily for 24months
Primary Outcome Measure Information:
Title
Trough Forced Expiratory Volume in 1 Second (FEV1) Change From Baseline to 24 Months
Description
Measurement over time (from baseline over the 24-month treatment period) and change from baseline to end of the treatment period.
Time Frame
Baseline, 24 months
Secondary Outcome Measure Information:
Title
Change From Baseline at 24 Months in Total Symptom Diary Score
Description
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.
Time Frame
Baseline, 24 months
Title
Change From Baseline at 24 Months in St. George's Respiratory Questionnaire (SGRQ) Total Score
Description
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.
Time Frame
Baseline, 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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)
Facility Information:
City
Central China Area
Country
China
City
East China Area
Country
China
City
North China Area
Country
China
City
Northeast China Area
Country
China
City
Northwest China Area
Country
China
City
South China Area
Country
China
City
Southwest China Area
Country
China
City
Kansai Region, Et Al.
Country
Japan
City
Seoul, Et Al.
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs