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/Pulmonary Fibrosis


  • 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

 

  • PIPF 016: A Randomized, Double-Blind, Placebo Controlled, Phase 3 Study of the Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (ASCEND Trial)

Purpose
The study objectives are to confirm the treatment effect of pirfenidone compared with placebo on change in percent predicted forced vital capacity (%FVC) in patients with idiopathic pulmonary fibrosis (IPF), and to confirm the safety of treatment with pirfenidone compared with placebo in patients with IPF.

Study Drug
Experimental Drug; Pirfenidone or Placebo, total daily dose of 2403 mg/ day, given as 3 divided doses 3 times per day.

Status
Completed, awaiting results

More information from clinicaltrials.gov

 

  • PIPF 012: An Open-Label Extension Study of the Long Term Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Purpose
This is an open-label, extension study for patients with IPF who complete a qualifying InterMune clinical trial of pirfenidone. The purpose of this study is to obtain additional safety data for pirfenidone 2403 mg/day in patients with IPF who complete a qualifying InterMune clinical trial of pirfenidone.

Status
Active, not recruiting

More information from clinicaltrials.gov

 

  • RANIER STUDY: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of Simtuzumab (GS-6624) in Subjects With Idiopathic Pulmonary Fibrosis (IPF)

Purpose
The purpose of this study is to determine if Simtuzumab (GS-6624) is safe and effective in treating Idiopathic Pulmonary Fibrosis

Study Drug
Experimental; Simtuzumab (GS-6624) or Placebo,125 mg/mL, single dose vials, subcutaneous self-injection, once weekly

Status
Active, recruiting

More information from clinicaltrials.gov

 

  • BMS IM136003 IPF Study: Safety and Efficacy of a Lysophosphatidic Acid Receptor Antagonist in Idiopathic Pulmonary Fibrosis

Purpose
The purpose of this study is to determine if study drug (BMS-986020) dose of 600 mg once daily or 600 mg twice daily for 26 weeks compared with placebo will reduce the decline in forced vital capacity (FVC) and will be well tolerated in subjects with idiopathic pulmonary fibrosis (IPF).

Study Drug
Experimental; BMS 986020 and/or placebo, 600 mg tablets, taken by mouth, twice daily, 26 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
Not yet recruiting

  • A double blind randomized placebo controlled trial evaluating the effect of oral nintedanib 150 mg twice daily on high resolution computerized tomography quantitative lung fibrosis score, lung function, six minute walk test distance and St. George's Respiratory Questionnaire after twelve months of treatment in patients with Idiopathic Pulmonary Fibrosis with continued evaluations over a period of up to eighteen month

Purpose
To assess the effect of nintedanib 150mg BID on the progression of IPF measured by using HRCT, lung function, 6MWT, biomarkers, and PROs with continued treatment and assessments for up to 18 months.

Study Drug
Experimental; nintedanib or placebo 150mg BID

Status
Pending, not yet recruiting

More information from clinicaltrials.gov

 

  • 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
Pending, not yet recruiting

More information from clinicaltrials.gov

Pulmonary Artery Hypertension Trials

 

  • SYMPHONY: A Multi-center, Open-label, Single-arm, Phase 3b Study of Macitentan in Patients With Pulmonary Arterial Hypertension (PAH) to Psychometrically Validate the PAH-SYMPACT Instrument

Purpose
To validate a new quality of life questionnaire for patients with pulmonary arterial hypertension. The secondary objective is to assess the safety of macitentan in patients with pulmonary arterial hypertension. The exploratory objective is to explore the effects of macitentan on PAH symptoms and their impact (as measured by the PAH-SYMPACT) in patients with pulmonary arterial hypertension.

Study Drug
(FDA Approved 2013) Macitentan - dose of 10 mg, once daily

Status
Active, recruiting

More information from clinicaltrials.gov

 

  • ASPIRE: A Postmarketing Observational Study to Assess Respiratory Tract Adverse Events in Pulmonary Arterial Hypertension Patients Treated With Tyvaso® (Treprostinil) Inhalation Solution

Purpose
A post marketing surveillance to determine the type and incidence of oro/nasopharyngeal or pulmonary adverse events that may occur in patients treated with commercially available Tyvaso® (treprostinil) Inhalation Solution. A comparison will be made to the type and incidence of events in patients receiving other FDA approved therapies for pulmonary arterial hypertension, as a control measure.

Status
Active, recruiting

More information from clinicaltrials.gov

 

  • 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
Not yet recruiting

More information from clinicaltrials.gov