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Pilot Study of Tetomilast in Chronic Obstructive Pulmonary Disease (COPD) Associated With Emphysema | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

A Multi-center, Randomized, Double-blind, Placebo-controlled Pilot Study to Assess the Pharmacodynamics, Efficacy and Safety of 50 mg Tetomilast Administered as Oral Tablets in Patients With Chronic Obstructive Pulmonary Disease Associated With Emphysema THIS STUDY IS CLOSED TO ENROLLMENT AND NEW SITES

NCT00874497•Otsuka Pharmaceutical Development & Commercialization, Inc.

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

40 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.

Exclusion Criteria

•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.

Locations (15)

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

Key Dates

Start Date

March 1, 2009

Primary Completion Date

July 1, 2015

Completion Date

August 1, 2015

Last Updated

April 17, 2017

Enrollment

ACTUAL participants

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

tetomilast

DRUG

placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 17, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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