Clinical Trials

Clinical Trials

Pulmonary

COPD, Pearl January 2014

Title: A Randomized, Double Blind (Test Products and Placebo), Chronic Dosing (24Weeks), Placebo-Controlled, Parallel Group, Multi Center Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD, Compared With Placebo and Spiriva® Handihaler® (Tiotropium Bromide 18 µg, Open Label) as an Active Control.

Indication: Mild to moderate COPD.

Inclusion Criteria:

  • Male or Female 40 – 80 years of age
  • Diagnosis of COPD
  • FEV1/FVC ratio < .80

Primary Investigator: Rodney Folz, M.D., Ph.D.
Study Coordinator: Carrie Becher, MPH
Office: 502-852-3184
Email: carrie.becher@louisville.edu

COPD, Ascent, February 2014

Title: Double-blind, Randomized, Placebo-controlled, Parallel-group, Phase IV Study to Evaluate the Effect of Aclidinium Bromide on Long-Term Cardiovascular Safety and COPD Exacerbations in Patients with Moderate to Very Severe COPD.

Indication: Moderate to severe COPD with cardiovascular disease.

Inclusion Criteria:

  • Male or Female >40 years of age
  • Diagnosis of COPD
  • FEV1/FVC ratio <.70

Primary Investigator: Rodney Folz, M.D., Ph.D.
Study Coordinator: Carrie Becher, MPH
Office: 502-852-3184
Email: carrie.becher@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