Status:
TERMINATED
Pilot Study of Tetomilast in Chronic Obstructive Pulmonary Disease (COPD) Associated With Emphysema
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40-75 years
Phase:
PHASE2
Brief Summary
Phase 2a multicenter, randomized, double-blind, placebo-controlled study to assess the pharmacodynamics, efficacy, and safety of tetomilast in patients with emphysema.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT00874497
Start Date
March 1 2009
End Date
August 1 2015
Last Update
April 17 2017
Active Locations (15)
Enter a location and click search to find clinical trials sorted by distance.
1
UAB Lung Health Center
Birmingham, Alabama, United States, 35294
2
Los Angeles Biomedical Institute
Torrance, California, United States, 90502
3
Pulmonary Disease Specialist/PDS Research
Kissimmee, Florida, United States, 34741
4
Well Pharma Medical Research
Miami, Florida, United States, 33143