Clinical Trials

Clinical Trials

Ask a question about pulmonary clinical trials at the University of Louisville

Critical Care |    Interstitial Lung Disease/Pulmonary Fibrosis |    Pulmonary Artery Hypertension


Pulmonary

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 InvestigatorHiram Rivas, M.D.
Study Coordinator: Dena Shofner, RRT
Office: 502-852-7632
Email: dena.shofner@louisville.edu

COPD, Liberate, February 2014

Title: Lung Function Improvement after Bronchoscopic Lung Volume Reduction with Pulmonx Endobronchial Valves used in Treatment of Emphysema (LIBERATE STUDY)
U.S. Investigational Device Exemption (IDE) Clinical Investigational Plan #630-0012-B

Indication: GOLD stage 3 & 4 COPD.

Inclusion Criteria:

  • Male or female 40-75 years of age
  • Diagnosis of COPD stage 3 or 4
  • Ex-smoker > 4mos
  • Post Bronch FEV1 15-45%

Primary Investigator: Hiram Rivas, M.D.
Study Coordinator: Crissie DeSpirito, RN
Office: 502-852-0026
Email: crissie.despirito@louisville.edu


Critical Care

Study Investigators:
Dr. Mohamed Saad

Study Coordinators:
Karen Guilkey: 502-852-5443 / E-mail


  • Enteral Nutrition as Stress Ulcer Prophylaxis in Critically Ill Patients

Purpose
To determine if proton pump inhibitors plus enteral nutrition is superior to enteral nutrition alone as a stress ulcer prophylaxis strategy in critically ill patients in terms of incidence of overt and significant GI bleeding related to stress gastropathy.

Study Drug
Pantoprazole 40 mg IV daily and tube feed

Status
Active, recruiting

More information from clinicaltrials.gov

 

  • Diagnostic Value of Passive Leg Raise Induced Changes in Carotid Artery Flow Time to Predict Fluid Responsiveness in Critically Ill Patients

Sponsor
Investigator Initiated Clinical Trial

Purpose
To assess whether a passive leg raise induced increase in the carotid artery flow time measured by ultrasound can be used to predict fluid responsiveness in critically ill patients.

Study Drug
None

Status
Active, recruiting

 

  • Proportional-Assist-Ventilation Versus Volume-Assist-Control-Ventilation After Failed Spontaneous Breathing Trail: A Randomized Controlled Trial

Sponsor
Investigator Initiated Clinical Trial

Purpose
To compare Proportional assist ventilation mode to volume assist control ventilation mode in weaning from mechanical ventilation after a failed spontaneous breathing trail in critically ill mechanically ventilated patients.

Study Drug
None

Status
Active, recruiting

 

  • Outcome of Renal Function in Hepatorenal Syndrome Determined by Comparison of Target Mean Arterial Blood Pressure (MAP) of 65–70 mmHg Versus MAP ≥ 85 mmHg

Sponsor
Investigator Initiated Clinical Trial

Purpose
To investigate the difference in renal function outcome evidenced by change in creatinine level and urine output using higher MAP target (≥ 85 mmHg) versus lower MAP target (65–70 mmHg) in patients with hepatorenal syndrome on vasopressor therapy (Norepinephrine).

Study Drug
Norepinephrine is used as standard of care in both groups.

Status
Active, recruiting


Interstitial Lung Disease/Pulmonary Fibrosis

Study Coordinators:
Tamra Perez: 502-852-1358 / E-mail


  • FG 3019-049: A Phase 2, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Efficacy of FG-3019 in Subjects With Idiopathic Pulmonary Fibrosis

Purpose
To evaluate the safety and tolerability of FG-3019 in subjects with Idiopathic Pulmonary Fibrosis (IPF) and the efficacy of FG-3019 for attenuating fibrosis in these subjects.

Study Drug
Experimental; Study Drug (FG-3019) intravenous infusion every 3 weeks for a total of 16 infusions over 45 weeks

Status
Active, not recruiting

More information from clinicaltrials.gov

 

  • FG 3019-067: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of FG-3019 in Patients With Idiopathic Pulmonary Fibrosis

Purpose
To evaluate the safety and tolerability of FG-3019 in subjects with IPF, and the efficacy of FG-3019 in slowing the loss of forced vital capacity (FVC) and the progression of IPF in these subjects.

Study Drug
Experimental; FG-3019 or placebo by intravenous infusion every 3 weeks for a total of 16 infusions over 45 weeks

Status
Active, recruiting

More information from clinicaltrials.gov

 

  • BRAVE 3: Bronchial Sample Collection for a Novel Genomic Test – 3

Purpose
This is a specimen and data collection study that is being done to see if researchers can develop a better test by using genes found in the body to more accurately diagnose the different types of pulmonary fibrosis.

 

Status
Active, recruiting

  • PFF Registry

Sponsor: Pulmonary Fibrosis Foundation

Status: Draft stage

 

  • IPF PRO: Prospective Outcomes Registry of Subjects With Idiopathic Pulmonary Fibrosis

Purpose
This registry will collect data on the strategies used to achieve a diagnosis of Idiopathic Pulmonary Fibrosis (IPF) and the treatment and management efforts applied throughout study follow-up, clinical outcome events and patient reported outcome data. Blood samples will be collected periodically throughout the study for use in future research efforts.

Status
Active, recruiting

More information from clinicaltrials.gov


Pulmonary Artery Hypertension Trials

 

  • PAH QuERI: Pulmonary Arterial Hypertension (PAH) Quality Enhancement Research Initiative (QuERI) Extension Program

Purpose
This program intends to improve the management of pulmonary arterial hypertension (PAH) patients through an evidence-based approach aimed at achieving optimal World Health Organization (WHO) functional class (FC): 1. Improving FC III & IV patients to FC II, 2. Improving FC II patients to FC I, and 3. Maintaining FC II & FC I patients.

Status
Active, recruiting

More information from clinicaltrials.gov

 

  • BEAT: A multicenter, double-blind, randomized, placebo-controlled, Phase 3 study to assess the efficacy and safety of oral BPS-314d-MR added-on to treprostinil, inhaled (Tyvaso®) in subjects with pulmonary arterial hypertension

Purpose
The purpose of this study is to compare the effect of the oral investigational drug, Beraprost Sodium-314d-Modified Release (BPS 314d MR) to placebo in patients with PAH who are prescribed inhaled Tyvaso.

Study Drug
Experimental; Beraprost Sodium-314d-Modified Release (BPS 314d MR)

Status
Active, recruiting

More information from clinicaltrials.gov