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

This study is currently recruiting participants.
Verified November 2013 by Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT00874497
First received: March 31, 2009
Last updated: November 21, 2013
Last verified: November 2013
  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

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 ]

Estimated Enrollment: 100
Study Start Date: March 2009
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: September 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00874497

Contacts
Contact: Kathy Waters 919-533-3153 kathy.waters@incresearch.com

Locations
United States, Alabama
UAB Lung Health Center Recruiting
Birmingham, Alabama, United States, 35294
Contact: Don Davis    205-996-6601    drdbeat@uab.edu   
Principal Investigator: Mark Dransfield, MD         
United States, Arizona
Pulmonary Associates, PA Withdrawn
Phoenix, Arizona, United States, 85006
United States, California
Los Angeles Biomedical Institute Completed
Torrance, California, United States, 90502
United States, Florida
PAB Clinical Research Withdrawn
Brandon, Florida, United States, 33511
Pulmonary Disease Specialist/PDS Research Recruiting
Kissimmee, Florida, United States, 34741
Contact: Thomas O'Brien, MD    407-624-4831    PI@PDS-CFSC.com   
Contact: Derrica Robinson    407-933-1221    drobinson@PDS-CFSC.Com   
Well Pharma Medical Research Recruiting
Miami, Florida, United States, 33143
Contact: Manuel Suarez, MD    305-665-4818    msuarez@wpharma.com   
Contact: Martha Ballmajo    305 665-4818 ext 114    mballmajo@wpharma.com   
University of Miami, School of Medicine Withdrawn
Miami, Florida, United States, 33136
Florida Premier Research Institute Recruiting
Winter Park, Florida, United States, 32789
Contact: Faisal Fakih, MD    407-215-1809    Ffakih@fpcresearch.com   
Contact: Juan Carlos Olaya    407-740-8078 ext 246    jolaya@fpcresearch.com   
United States, Georgia
Georgia Clinical Research Withdrawn
Austell, Georgia, United States, 30106
United States, Illinois
llinois Lung Institute Completed
Peoria, Illinois, United States, 61606
United States, Kentucky
University of Louisville, Pulmonary Division Recruiting
Louisville, Kentucky, United States, 40202
Contact: Crissie DeSpirito    502-852-0026    crissie.despirito@louisville.edu   
Principal Investigator: Rodney Folz, MD         
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Stephen L Rennard, MD       srennard@unmc.edu   
Contact: Sandra Talbott    (402) 559-6365    stalbott@unmc.edu   
Principal Investigator: Stephen I Rennard, MD         
United States, Pennsylvania
Temple University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Francis Cordova, MD    215-707-3332    francis.cordova@tuhs.temple.edu   
Contact: Sylvia Johnson    1-215 707 4679    sylvia.johnson@tuhs.temple.edu   
Principal Investigator: Francis Cordova, MD         
United States, South Carolina
Spartanburg Medical Research Active, not recruiting
Spartanburg, South Carolina, United States, 29303
United States, Texas
Texas Institute of Chest and Sleep Disorders, PA Recruiting
Houston, Texas, United States, 77034
Contact: Alex Lechin, MD    281-517-0550    dralexlechin@gmail.com   
Contact: Heather Hughes    281-517-0550 ext 405    heatherh@dmclinicalresearch.com   
Diagnostics Research Group Recruiting
San Antonio, Texas, United States, 78229
Contact: John R Holcomb, MD    210-692-7157      
Contact: Kathleen Canty    1-210 692 7157    kcanty@dxrg.com   
Principal Investigator: John R Holcomb, MD         
United States, Virginia
Pulmonary Associates of Richmond Recruiting
Richmond, Virginia, United States, 23225
Contact: James C Hey, MD    804-272-3231      
Contact: Laura Lincoln    1-804 272 3231    llincoln@paraccess.com   
Principal Investigator: James C Hey, MD         
United States, Washington
Multicare Pulmonary Specialist Active, not recruiting
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: November 21, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Emphysema
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 20, 2014