A Phase 3, Placebo Controlled, Double-blind, Randomized, Clinical Study to Determine Efficacy, Safety and Tolerability of Pulsed, Inhaled Nitric Oxide (iNO) versus Placebo in Symptomatic Subjects with Pulmonary Arterial Hypertension (PAH): INOvation-1 Save

Date Added
June 27th, 2017
PRO Number
Pro00067380
Researcher
Rahul Argula
Keywords
Lung, Pulmonary
Summary

The purpose of this study is to determine if inhaled nitric oxide (study drug), when given and breathed through the INOpulse (investigational device), may help treat PAH.The drug being studied is ?inhaled nitric oxide? and the device being studied is called the ?INOpulse.? Inhaled nitric oxide is a drug approved by the FDA and Health Canada for the treatment of infants who have difficulty breathing and have decreased oxygen in their blood associated with pulmonary hypertension. However, inhaled nitric oxide, in combination with the INOpulse delivery device, is an investigational treatment of PAH and is not currently approved by the FDA or Health Canada.

Institution
MUSC
Recruitment Contact
Melissa Spears
843-792-2072
coole@musc.edu

Investigation of the Efficacy of Antimycobacterial Therapy on Pulmonary Sarcoidosis Phase II Randomized, Double-blind, Placebo-controlled Trial Save

Date Added
June 22nd, 2017
PRO Number
Pro00067313
Researcher
Walter James
Keywords
Lung, Pulmonary, Sarcoidosis
Summary

You are being asked to take part in this research study because you have been diagnosed with pulmonary sarcoidosis. Sarcoidosis is a disease that can affect the lungs, skin and other organs of the body. Sarcoidosis also involves immune cells which fight bacteria. The purpose of this study is to see if using specific antibiotics will help these immune fighting cells get rid of bacterial proteins and how the antibiotics affect respiratory (breathing) function. The antibiotics used in this study are Levaquin, Ethambutol, Azithromycin, and either Rifampin or Rifabutin. You will by chance be assigned either these medicines or a placebo (an inactive substance).

Institution
MUSC
Recruitment Contact
Kelly French
843-792-3169
frenchke@musc.edu

A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate Multiple Doses Of Glpg2222 In Subjects With Cystic Fibrosis Who Are Homozygous For The F508del Mutation Save

Date Added
June 13th, 2017
PRO Number
Pro00065901
Researcher
Patrick Flume
Keywords
Cystic Fibrosis, Lung, Pulmonary
Summary

Cystic fibrosis is caused by changes in the genes of your DNA (Deoxyribonucleic Acid) encoding for the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) protein. These changes cause the CFTR to stop working as it should. GLPG2222 is being studied for treatment of cystic fibrosis. The study drug is designed to improve the expression and function of CFTR, which may improve some of the symptoms of cystic fibrosis.

Institution
MUSC
Recruitment Contact
David Longshore
843-792-9697
longshor@musc.edu

A Study to Evaluate a Panel of Blood Biomarkers for Use in Patients Undergoing Evaluation for Lung Cancer, ONC-LN-04 Save

Date Added
June 5th, 2017
PRO Number
Pro00061266
Researcher
Gerard Silvestri
Keywords
Cancer, Cancer/Lung, Lung, Pulmonary
Summary

The primary objective of this study is to develop a blood-based gene expression signature, known as the ONC-LN-04 Lung Test, to be used in the detection of lung cancer in patients who underwent radiologic screening for lung cancer and had lung nodules detected. We intend to enroll volunteers who are being evaluated by a Medical University of South Carolina (MUSC) pulmonologist as part of their standard medical care. Participants will be current or former smokers, who have either (a) radiologic evidence of lung nodules, or (b) a confirmed diagnosis of non-small cell lung cancer (NSCLC) and has not undergone surgical excision, chemotherapy or radiation therapy for this malignancy. A single blood sample will be obtained from willing participants, then stored and analyzed for measurement of gene expression and development of the ONC-LN-04 test. Active participation in this study will be over once a blood sample is obtained; however, we may need access to participants' medical records post-enrollment and sample collection in order to monitor medical outcomes. Review of participants' medical records will occur until up to approximately 2,500 subjects have been enrolled and have provided clinical information and a blood sample.

Institution
MUSC
Recruitment Contact
Katherine Taylor
843-792-2297
taylkat@musc.edu

An Extended Access Program To Assess Long-Term Safety Of Bardoxolone Methyl In Patients With Pulmonary Hypertension Save

Date Added
May 23rd, 2017
PRO Number
Pro00066024
Researcher
Rahul Argula
Keywords
Lung, Pulmonary, Pulmonary Arterial Hypertension (PAH)
Summary

This extended access study will assess the long-term safety and tolerability of bardoxolone methyl in qualified patients with pulmonary hypertension (PH) who previously participated in controlled clinical studies with bardoxolone methyl.
Qualified patients will receive 10 mg of bardoxolone methyl once daily until the drug is available through commercial channels (including reimbursement) or until patient withdrawal, whichever. Dose de-escalation (down to 5 mg) is permitted during the study, if indicated clinically. All patients in the study will follow the same visit and assessment schedule. Patients will be scheduled to be assessed in person during treatment at Day 1, Week 4, Week 24, and every 24 weeks thereafter.
Patients will also be assessed by telephone contact on Day 10. Day 1 for this extended access study should occur on the same day as the last visit in the controlled clinical study. Assessments required for both the last visit in the controlled study and Day 1 for this study should only be completed once.

Institution
MUSC
Recruitment Contact
Courtney Rowley
843-792-8092
rowle@musc.edu

Blood Sample Collection in Subjects Participating in a Lung Cancer Screening Program Save

Date Added
May 1st, 2017
PRO Number
Pro00064511
Researcher
Gerard Silvestri
Keywords
Cancer, Cancer/Lung, Lung, Pulmonary
Summary

The main objective of this study is to better understand the biomarkers of patients who are candidates for lung cancer screening. Biomarkers are biologic substances found in the blood and may be related to lung disease risk and detection. We intend to enroll volunteers who are participating in a lung cancer screening program at the Medical University of South Carolina and are being seen by a pulmonologist as part of their standard medical care. A single blood sample will be obtained, then stored and analyzed to better understand the biomarkers found in blood and to help develop and test blood based screening or diagnostic tests. Active participation in this study will be over once a blood sample is obtained. However, we may conduct medical chart reviews of some participants for up to 27 months in order to look at their medical outcomes.

Institution
MUSC
Recruitment Contact
Lindsey Owens
(843) 792-8233
owensli@musc.edu

Prospective, randomized, placebo controlled trial of the efficacy and safety of inhaled nitric oxide (NO) in cystic fibrosis (CF) patients Save

Date Added
April 11th, 2017
PRO Number
Pro00064789
Researcher
Patrick Flume
Keywords
Cystic Fibrosis, Drug Studies, Lung, Pulmonary
Summary

This study is being done to evaluate an experimental treatment for people with Cystic Fibrosis who have a bacterial infection in their lungs. Subjects will be randomized (selected by chance) to either be treated with an investigational inhaled gaseous drug (in 99.5% nitrogen) that is mixed with room air or breathe 100% nitrogen that is mixed with room air. If you are randomized to the investigational treatment, we are asking you to breathe in a gas called ?nitric oxide?. Participation in the study will take about 43 days

Institution
MUSC
Recruitment Contact
Ashley Warden
843-792-4349
jonesash@musc.edu

A Phase 3, Rollover Study to Evaluate the Safety of Long term Treatment With Lumacaftor/Ivacaftor Combination Therapy in Subjects Aged 2 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Save

Date Added
March 28th, 2017
PRO Number
Pro00064086
Researcher
Patrick Flume
Keywords
Cystic Fibrosis, Drug Studies, Lung, Pulmonary
Summary

This study is being done to learn more about the long-term safety and effects from taking the combination of lumacaftor/ivacaftor in a previous Vertex study (VX15-809-115 Part B).

Institution
MUSC
Recruitment Contact
Ashley Warden
843-792-4349
jonesash@musc.edu

INtervention Study In overweiGHT patients with COPD (INSIGHT COPD) Save

Date Added
March 21st, 2017
PRO Number
Pro00062895
Researcher
Tatsiana Beiko
Keywords
Disease Prevention, Exercise, Lung, Nutrition, Obesity, Pulmonary
Summary

We are conducting the INSIGHT COPD study because symptoms of chronic obstructive pulmonary disease (COPD) and high body mass index (BMI) overlap. There are many medications for patients with COPD, but there is little mention of weight loss as a possible treatment in current research. We are trying to find out if a lifestyle program that promotes modest weight loss and increased physical activity will improve COPD symptoms and lead to better exercise tolerance for those with a high BMI. We are also looking at the effects on shortness of breath, quality-of-life, and cardiovascular disease risk factors. The INSIGHT COPD trial is taking place at many sites across the United States including MUSC, and is planning to enroll approximately 1000 people.

Institution
MUSC
Recruitment Contact
Danielle Woodford
(843) 792-6280
woodfordd@musc.edu

Early Intrapleural TPA Instillation Versus Late (ELEVATE) Save

Date Added
February 17th, 2017
PRO Number
Pro00058518
Researcher
Rohan Arya
Keywords
Cancer/Lung, Drug Studies, Infectious Diseases, Lung, Pulmonary, Shortness of Breath
Summary

When a chest tube is placed, it can be hard for the fluid to drain. Tissue plasminogen activator and DNase are given through the chest tube to help with draining the fluid. We are doing this research to see if early addition of tPA-DNase will help with better fluid draining.

Institution
Palmetto
Recruitment Contact
Rohan Mankikar
803-352-1237
rohan.mankikar@palmettohealth.org

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