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

Otsuka

Status and phase: Completed; Phase 2

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: placebo; Drug: tetomilast (OPC-6535)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00917150

197-08-801

JapicCTI-090770

Details and patient eligibility

About

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

Enrollment: 771 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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771 participants in 4 patient groups, including a placebo group

OPC-6535 12.5mg

Experimental group

Treatment:

Drug: tetomilast (OPC-6535)

Drug: tetomilast (OPC-6535)

Drug: tetomilast (OPC-6535)

OPC-6535 25mg

Experimental group

Treatment:

Drug: tetomilast (OPC-6535)

Drug: tetomilast (OPC-6535)

Drug: tetomilast (OPC-6535)

OPC-6535 50mg

Experimental group

Treatment:

Drug: tetomilast (OPC-6535)

Drug: tetomilast (OPC-6535)

Drug: tetomilast (OPC-6535)

placebo

Placebo Comparator group

Treatment:

Drug: placebo