Clinical Trials
Pulmonary
► COPD, Summit, November 2011
Title: A Clinical Outcomes Study to compare the effect of Fluticasone Furoate/Vilanterol Inhalation Powder 100/25mcg with placebo on Survival in Subjects with moderate Chronic Obstructive Pulmonary Disease (COPD) and a history of or at risk for cardiovascular disease.
Indication: Moderate COPD with history or risk of cardiovascular disease.
Inclusion Criteria:
- Male or Female 40 – 80 years of age
- Diagnosis of COPD with some form of cardiovascular disease
- FEV1/FVC ratio < .70
Primary Investigator: Rodney Folz, M.D., Ph.D.
Study Coordinator: Bryan Beatty, RRT, CPFT
Office: 502-852-1917
Email: bryan.beatty@louisville.edu
Critical Care
► Respiratory Failure & Multi-Organ Dysfunction, REDOXS© Study - Reducing Deaths due to Oxidative Stress, November 2011
Title: A Randomized Trial of Glutamine and Antioxidant Supplementation in Critically Ill Patients
Study Supplements: Glutamine and Antioxidants (Selenium, Beta-Carotene, Vitamins A, C, E, Zinc and Arginine) administered both parenterally and enterally.
Indication: Critically ill with 2 or more organ failures on mechanical ventilation
Inclusion Criteria:
- Mechanically ventilated adult patients (≥ 18 years old) admitted to the ICU.
- Patient also presents with 2 or more organ failures (Respiratory, Cardiovascular, Renal and/or Hematologic) related to their acute illness.
Primary Investigator: Mohamed Saad, M.D.
Study Coordinator: Crissie DeSpirito, RN
Office: 502-852-0026
Email: crissie.despirito@louisville.edu
Visit Clinical Trials.gov for information regarding this study
► Sepsis and ALI/ARDS Study, ALT-836, November 2011
Title: Efficacy and Safety Evaluation of ALT-836 in Patients with Sepsis and ALI/ARDS
Study Drug: ALT-836 an anti-tissue factor monoclonal antibody infused intravenously.
Indication: Sepsis and ALI/ARDS
Inclusion Criteria:
- Suspected or proven infection.
- Hypoxemia (PaO2/FiO2 taken after intubation is < 300mmHg).
- Bilateral infiltrates on a chest x-ray.
- Presence of at least 3 SIRS criteria.
Primary Investigator: Mohamed Saad, M.D.
Study Coordinator: Crissie DeSpirito, RN
Office: 502-852-0026
Email: crissie.despirito@louisville.edu
Visit Clinical Trials.gov for information regarding this study

