Pilot Study of Tetomilast in Chronic Obstructive Pulmonary Disease (COPD) Associated With Emphysema

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary Disease

In brief

Phase 2a multicenter, randomized, double-blind, placebo-controlled study to assess the pharmacodynamics, efficacy, and safety of tetomilast in patients with emphysema.

Key facts

Study ID

NCT00874497

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

84

Starts

2009-03-01

Expected to finish

2015-08-01

Last updated by the study team

2017-04-17

Who can join

Age: 40 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, 40-75 yrs old,inclusive.
• 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.

You may not qualify if…

• Patients with asthma, active tuberculosis or bronchiectasis.
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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