A Study Designed to Evaluate ODSH in Subjects With Exacerbations of COPD

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary Disease

In brief

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.

Key facts

Study ID

NCT00457951

Run by

Jazz Pharmaceuticals

People needed

158

Starts

2007-04-01

Expected to finish

2009-10-01

Last updated by the study team

2021-12-02

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Pulmonary Consultants & Primary Care — Orange, California, United States
• Wellstar Kennestone Hospital — Marietta, Georgia, United States
• Louisiana State University Health Sciences Center in Shreveport — Shreveport, Louisiana, United States
• Washington Universtiy School of Medicine — St Louis, Missouri, United States
• The Oregon Clinic — Portland, Oregon, United States
• Temple University of the Commonwealth of Higher Education — Philadelphia, Pennsylvania, United States
• Methodist Hospital — Houston, Texas, United States
• Michael E. DeBakey VA Medical Center — Houston, Texas, United States
• University of Texas Health Care Center at Tyler — Tyler, Texas, United States
• Western Washington Medical Group — Everett, Washington, United States
• University Hospital Gasthuisberg — Leuven, Belgium
• CHU Liege Domain Universitaire du Sart Tilman — Liège, Belgium
• Cliniques Universiaries U.C.L. de Mont-Gondinne — Yvior, Belgium
• University of Alberta Hospital — Edmonton, Alberta, Canada
• Kelowna General Hospital — Kelowna, British Columbia, Canada
• Vancouver Coastal Health — Vancouver, British Columbia, Canada
• St. Boniface General Hospital — Winnipeg, Manitoba, Canada
• QE II Health Sciences Centre — Halifax, Nova Scotia, Canada
• Credit Valley Hospital, — Mississauga, Ontario, Canada
• The Ottawa Hospital, Civic Campus — Ottawa, Ontario, Canada
• University of Toronto — Toronto, Ontario, Canada
• Laval Hospital — Québec, Quebec, Canada
• Klinik Schillerhohe — Gerlingen, Germany
• Pneumologisches Forschungsinstitut GmbH — Großhansdorf, Germany
• Medizinsche Hochschule — Hanover, Germany

Full record on ClinicalTrials.gov

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