Pilot Study of Tetomilast in Chronic Obstructive Pulmonary Disease (COPD) Associated With Emphysema (EMPHASIS)
This study is currently recruiting participants.
Verified December 2012 by Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT00874497
First received: March 31, 2009
Last updated: December 19, 2012
Last verified: December 2012
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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 | Recruiting |
| Torrance, California, United States, 90502 | |
| Contact: William W Stringer, MD stringer@ucla.edu | |
| Contact: Leticia Diaz 1-310 222 8200 ldiaz@labiomed.org | |
| Principal Investigator: William W Stringer, MD | |
| United States, Florida | |
| PAB Clinical Research | Withdrawn |
| Brandon, Florida, United States, 33511 | |
| University of Miami, School of Medicine | Recruiting |
| Miami, Florida, United States, 33136 | |
| Contact: Michael Campos, MD 305-243-2568 mcampos1@med.miami.edu | |
| Contact: Eliana Mendes 1-305 243 2568emendes emendes@med.miami.edu | |
| Principal Investigator: Michael Campos, MD | |
| 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 | Recruiting |
| Spartanburg, South Carolina, United States, 29303 | |
| Contact: Charles M Fogarty, MD 864-583-1556 | |
| Contact: Nicole Crockford 1-864 583 1556 ncrockford@medresearch.com | |
| Principal Investigator: Charles Fogarty, MD | |
| United States, Texas | |
| 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 | Recruiting |
| Tacoma, Washington, United States, 98405 | |
| Contact: James Taylor, MD 253-301-6850 jrtaylor1@qwest.net | |
| Contact: Darcie Cruz 253-301-6850 Darcie.Cruz@multicare.org | |
| Principal Investigator: James Taylor, MD | |
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: | December 19, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Emphysema Pulmonary Emphysema Lung Diseases Respiration Disorders |
Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Pathologic Processes Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 21, 2013