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

This study has been terminated.
(Sponsor Terminated)
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT00874497
First received: March 31, 2009
Last updated: August 6, 2015
Last verified: August 2015
  Purpose

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


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: tetomilast
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

Primary Outcome Measures:
  • The change in trough forced expiratory volume in 1 second (FEV1) and the rate of change in the 20th percentile of lung density voxels using High Resolution Computed Tomography (HRCT) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent change in trough FEV1 [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 84
Study Start Date: March 2009
Study Completion Date: August 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Tetomilast Drug: tetomilast
Oral tetomilast 25 mg once daily for 2 weeks followed by 50 mg once daily for 2 years.
Placebo Comparator: 2 Placebo Drug: placebo
Placebo for 104 weeks (2 years)

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00874497

Locations
United States, Alabama
UAB Lung Health Center
Birmingham, Alabama, United States, 35294
United States, California
Los Angeles Biomedical Institute
Torrance, California, United States, 90502
United States, Florida
Pulmonary Disease Specialist/PDS Research
Kissimmee, Florida, United States, 34741
Well Pharma Medical Research
Miami, Florida, United States, 33143
Florida Premier Research Institute
Winter Park, Florida, United States, 32789
United States, Georgia
Georgia Clinical Research
Austell, Georgia, United States, 30106
United States, Illinois
Illinios Lung Institute
Peoria, Illinois, United States, 61606
United States, Kentucky
University of Louisville, Pulmonary Division
Louisville, Kentucky, United States, 40202
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, Pennsylvania
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
United States, South Carolina
Spartanburg Medical Research
Spartanburg, South Carolina, United States, 29303
United States, Texas
Texas Institute of Chest and Sleep Disorders, PA
Houston, Texas, United States, 77034
Diagnostics Research Group
San Antonio, Texas, United States, 78229
United States, Virginia
Pulmonary Associates of Richmond
Richmond, Virginia, United States, 23225
United States, Washington
Multicare Pulmonary Specialist
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
  More Information

No publications provided

Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT00874497     History of Changes
Other Study ID Numbers: 197-08-250
Study First Received: March 31, 2009
Last Updated: August 6, 2015
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 01, 2015