Pilot Study of Tetomilast in Chronic Obstructive Pulmonary Disease (COPD) Associated With Emphysema
NCT ID: NCT00874497
Last Updated: 2017-04-17
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
84 participants
INTERVENTIONAL
2009-03-31
2015-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1 Tetomilast
tetomilast
Oral tetomilast 25 mg once daily for 2 weeks followed by 50 mg once daily for 2 years.
2 Placebo
placebo
Placebo for 104 weeks (2 years)
Interventions
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tetomilast
Oral tetomilast 25 mg once daily for 2 weeks followed by 50 mg once daily for 2 years.
placebo
Placebo for 104 weeks (2 years)
Eligibility Criteria
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Inclusion Criteria
* Rating of greater than or equal to 1 on the Goddard scale in assessment of emphysema severity by HRCT.
* FEV1: FVC greater than 70% predicted.
* At least 1 documented COPD exacerbation within the past year but not within 8 weeks of randomization.
* Current or former smokers with a cigarette smoking history of at least 20 pack-years (or equivalent) and whose smoking status has not changed 60 days prior to screening.
Exclusion Criteria
* A respiratory tract infection within 30 days prior to the screening visit.
* Any malignancy within the last 5 years with the exception of non-melanomatous skin cancer.
* Uncontrolled cardiovascular, endocrine, blood, or nervous system disorders.
* Uncontrolled condition with COPD exacerbation of level 2 or 3 in the 8-week period prior to randomization.
* Systemic use of corticosteroids or other immunosuppressive agents within 30 days of the screening visit.
* Subjects taking anticoagulants.
40 Years
75 Years
ALL
No
Sponsors
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Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY
Responsible Party
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Locations
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UAB Lung Health Center
Birmingham, Alabama, United States
Los Angeles Biomedical Institute
Torrance, California, United States
Pulmonary Disease Specialist/PDS Research
Kissimmee, Florida, United States
Well Pharma Medical Research
Miami, Florida, United States
Florida Premier Research Institute
Winter Park, Florida, United States
Georgia Clinical Research
Austell, Georgia, United States
Illinios Lung Institute
Peoria, Illinois, United States
University of Louisville, Pulmonary Division
Louisville, Kentucky, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Spartanburg Medical Research
Spartanburg, South Carolina, United States
Texas Institute of Chest and Sleep Disorders, PA
Houston, Texas, United States
Diagnostics Research Group
San Antonio, Texas, United States
Pulmonary Associates of Richmond
Richmond, Virginia, United States
Multicare Pulmonary Specialist
Tacoma, Washington, United States
Countries
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Other Identifiers
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197-08-250
Identifier Type: -
Identifier Source: org_study_id
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