Status:
TERMINATED
A Study Designed to Evaluate ODSH in Subjects With Exacerbations of COPD
Lead Sponsor:
Jazz Pharmaceuticals
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether ODSH, when added to conventional treatment, is more effective in treating COPD exacerbations than conventional therapy alone.
Detailed Description
The management of acute exacerbations of COPD today is qualitatively the same as it was 40 years ago: bronchodilators, corticosteroids, and antibiotics. Because of the prominent pathophysiological rol...
Eligibility Criteria
Inclusion
- Male and female patients (40 years of age or older) with an established diagnosis of COPD based upon medical history who are being admitted to the hospital to treat an exacerbation of COPD;
- Normal prothrombin time and activated partial thromboplastin time; Platelet count; hemoglobin and hematocrit
Exclusion
- Certain diseases such as:
- asthma;
- left heart failure or pulmonary embolism;
- lung cancer;
- pneumonia
- liver or kidney disease
- blood clotting disorder
- Positive HIV or hepatitis tests
- GI bleeding, physical trauma with bleeding, any disease with bleeding within 60 days of study entry
- Certain medications such as:
- Plavix®
- Warfarin
- Heparin therapy
- Certain antibiotics
- Exacerbations that are too severe (requiring intubation and mechanical ventilation)
- Women of child-bearing potential, pregnancy or breast-feeding
- Unable or unwilling to provide informed consent and follow study procedures.
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT00457951
Start Date
April 1 2007
End Date
October 1 2009
Last Update
December 2 2021
Active Locations (38)
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1
Pulmonary Consultants & Primary Care
Orange, California, United States, 92868
2
Wellstar Kennestone Hospital
Marietta, Georgia, United States, 30060
3
Louisiana State University Health Sciences Center in Shreveport
Shreveport, Louisiana, United States, 71130
4
Washington Universtiy School of Medicine
St Louis, Missouri, United States, 63110