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
Interstitial Lung Disease
► Title: Prednisone, Azathioprine, N-Acetylcysteine A Study That Evaluates Response in Idiopathic Pulmonary Fibrosis (PANTHER-IPF)
Status: CURRENTLY ENROLLING
Study Drug: N-Acetylcysteine(NAC) vs. placebo.
Indication: Idiopathic Pulmonary Fibrosis
Inclusion Criteria:
- Male or female 35-85 years of age.
- Diagnosis of definite Idiopathic Pulmonary Fibrosis (IPF).
- Forced Vital Capacity (FVC) ≥50% of predicted.
- Lung Diffusion Capacity (DLCO) ≥ 35% of predicted.
- Smoking is allowed.
Primary Investigator: Jesse Roman, M.D.; Rafael Perez, M.D.
Study Coordinator: Tamra Perez, RN
Office: 502-852-1358
Email: tamra.perez@louisville.edu
Visit Clinical Trials.gov for information regarding this study
Sub Study to PANTHER
Title: Oxidant Stress: Is it a biomarker of disease progression and response to therapy?
Inclusion Criteria:
- Subjects that are enrolled into PANTHER-IPF study
Principal Investigators: Jesse Roman, M.D.; Rafael Perez, M.D.
Study Coordinator: Tamra Perez, RN
Office: 502-852-1358
Email: tamra.perez@louisville.edu
► Title: A Randomized, Double-Blind, Placebo Controlled, Phase 3
Study of the Efficacy and Safety of Pirfenidone in Patients with
Idiopathic Pulmonary Fibrosis
Status: CURRENTLY ENROLLING
Study Drug: Pirfenidone vs. placebo.
Indication: Idiopathic Pulmonary Fibrosis
Inclusion Criteria:
- Male or female 40-80 years of age.
- Forced Vital Capacity (FVC) >50% of predicted.
- Lung Diffusion Capacity (DLCO) > 30% of predicted.
- FEV1/FVC >0.8.
- Smoking is Prohibited.
Primary Investigators: Jesse Roman, M.D.; Rafael Perez, M.D.; J. Shaun Smith, D.O.
Study Coordinator: Heidi Wilson, SC
Office: 502-852-0560
Email: heidi.wilson@louisville.edu
Visit Clinical Trials.gov for information regarding this study
► Title: A Phase 2, Sequential, Ascending Dose Study To Characterize The Safety, Tolerability, Pharmacokinetic And Biological Activity Of CC-930 In Idiopathic Pulmonary Fibrosis (IPF)
Status: No New Enrollments at this time
Study Drug: CC-930.
Indication: Idiopathic Pulmonary Fibrosis
Inclusion Criteria:
- Male or female >50 years of age.
- Diagnosis of definite Idiopathic Pulmonary Fibrosis (IPF).
- Forced Vital Capacity (FVC) >50 % of predicted.
- Lung Diffusion Capacity (DLCO) > 25% of predicted.
- Smoking is prohibited.
Primary Investigators: Rafael Perez, M.D.; J. Shaun Smith, D.O.
Study Coordinator: Tamra Perez, RN
Office: 502-852-1358
Email: tamra.perez@louisville.edu
Visit Clinical Trials.gov for information regarding this study
► Title: A Phase 1, Open Label, Multi-Dose Study to Evaluate the Safety, Tolerability, and Biologic Effects of Three Doses of IW001 in Patients with Idiopathic Pulmonary Fibrosis (IPF)
Status: No New Enrollments at this time
Study Drug: CC-930.
Indication: Idiopathic Pulmonary Fibrosis
Inclusion Criteria:
- Male or female 35-75 years of age inclusive.
- Diagnosis of definite Idiopathic Pulmonary Fibrosis (IPF).
- Forced Vital Capacity (FVC) >50% of predicted.
- Lung Diffusion Capacity (DLCO) > 35% of predicted.
- Smoking is prohibited (3 month washout).
Primary Investigators: Rafael Perez, M.D.; Jesse Roman, M.D.
Study Coordinator: Tamra Perez, RN
Office: 502-852-1358
Email: tamra.perez@louisville.edu
Visit Clinical Trials.gov for information regarding this study
► Title: Safety,Tolerability, and Efficacy Study of Idiopathic Pulmonary Fibrosis (FGCL-3019-049)
Status: CURRENTLY RECRUITING
Study Drug: FG 3019.
Indication: Idiopathic Pulmonary Fibrosis
Inclusion Criteria:
- Age 35 to 80 years
- Clinical diagnosis of IPF by high resolution computed tomography (HRCT) scan (and in some cases by surgical lung biopsy) and reduced lung function (forced vital capacity).
- History of IPF of 5 years' duration or less.
- Evidence of progression of IPF within the last 3 to 12 months before enrollment.
- Women
of childbearing potential, and men, must be willing to use a medically
acceptable method of contraception during the trial and 3 months after
the study.
Primary Investigators: Rafael Perez, M.D.; Jesse Roman, M.D.
Study Coordinator: Tamra Perez, RN
Office: 502-852-0560
Email: heidi.wilson@louisville.edu
Visit Clinical Trials.gov for information regarding this study
