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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

771 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2014-04-30

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.

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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

oral administration of 12.5mg OPC-6535, once daily for 24months

Intervention Type DRUG

tetomilast (OPC-6535)

oral administration of 25mg OPC-6535, once daily for 24months

Intervention Type DRUG

tetomilast (OPC-6535)

oral administration of 50 mg OPC-6535, once daily for 24months

Intervention Type DRUG

placebo

oral administration of placebo, once daily for 24months

Intervention Type DRUG

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)

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No