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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00917150
Recruitment Status : Completed
First Posted : June 10, 2009
Last Update Posted : June 10, 2014
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: tetomilast (OPC-6535) Drug: placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 771 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : March 2009
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Trough FEV1 [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. symptom diary score , QOL, CT etc. [ Time Frame: 24 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00917150

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
Kansai Region, et al., Japan
Korea, Republic of
Seoul, et al., Korea, Republic of
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.

Responsible Party: Otsuka Pharmaceutical Co., Ltd. Identifier: NCT00917150     History of Changes
Other Study ID Numbers: 197-08-801
First Posted: June 10, 2009    Key Record Dates
Last Update Posted: June 10, 2014
Last Verified: June 2014

Keywords provided by Otsuka Pharmaceutical Co., Ltd.:
chronic obstructive pulmonary disease

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases