A Multi-Center, Randomized, Placebo-Controlled, Phase 1, Two-Part Study Designed to Assess the Safety, Tolerability, Pharmacokinetics, Food Effect, and Drug-Drug Interactions of PTI-801 in Healthy Volunteers, and Safety, Tolerability, and Pharmacokinetics of PTI-801 in Subjects with Cystic Fibrosis Save

Date Added
September 26th, 2017
PRO Number
Pro00070908
Researcher
Patrick Flume
Keywords
Cystic Fibrosis, Lung, Pulmonary
Summary

This is a research study to test a new investigational drug, PTI-801. An investigational drug is one that is not approved by the US FDA. In this study, PTI-801 will be compared to placebo (a capsule that looks like the investigational drug, but does not contain an active drug substance). Although PTI-801 has been given to normal healthy adults, this is the FIRST time that PTI-801 has been given to people with CF.

Institution
MUSC
Recruitment Contact
Robyn Do
(843) 792-1221
dorobyn@musc.edu

A Double Blind, Randomized, Placebo-Controlled Trial Evaluating The Efficacy And Safety Of Nintedanib Over 52 Weeks In Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD) Save

Date Added
August 22nd, 2017
PRO Number
Pro00068850
Researcher
John Huggins
Keywords
Lung, Pulmonary
Summary

The purpose of this study is to see how well the study drug called nintedanib may help lung disease and to compare its safety and effects with a placebo in subject with PF-ILD.

Institution
MUSC
Recruitment Contact
Daniel Larimore
(843) 792-6890
larimord@musc.edu

HIV-associated Obstructive Pulmonary Disease and Emphysema Save

Date Added
August 15th, 2017
PRO Number
Pro00066169
Researcher
Lynn Schnapp
Keywords
HIV / AIDS, Pulmonary, Smoking
Summary

Emphysema is a type of Chronic Obstructive Pulmonary Disease (COPD) and a major cause of death. Studies suggest that emphysema is more common in HIV positive people (HIV+) compared to HIV negative (HIV-) people. The purpose of this research study is to determine whether emphysema in HIV+ patients is clinically and biologically different compared to emphysema in those without HIV.

Institution
MUSC
Recruitment Contact
Mary Blanton
8437928438
blantonm@musc.edu

Tobacco treatment in the context of lung cancer screening: NRT and text messaging Save

Date Added
August 15th, 2017
PRO Number
Pro00068951
Researcher
Alana Rojewski
Keywords
Cancer/Lung, Lung, Pulmonary, Smoking
Summary

Screening for lung cancer at earlier, more treatable stages has the potential to reduce mortality from the U.S.?s most deadly cancer. Annual lung cancer screening with low-dose computed tomography is now recommended for high risk individuals based on age and smoking history. This study will evaluate a smoking cessation intervention for lung cancer screening patients. We will evaluate quit rates after a standard intervention (brief counseling session at time of LCS) versus a medication and text messaging intervention.

Institution
MUSC
Recruitment Contact
Alana Rojewski
843-876-1593
rojewski@musc.edu

Cystic Fibrosis Patients With Active Pulmonary Exacerbation Receiving IV Tobramycin At Risk For Ototoxicity: Part 1: An Observational Study With Audiologic And Vestibular Assessments: Part 2, A Phase 1b, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Safety, Pharmacokinetics And Pharmacodynamics Of SPI-1005 Capsules Save

Date Added
August 8th, 2017
PRO Number
Pro00067873
Researcher
Patrick Flume
Keywords
Cystic Fibrosis, Lung, Pulmonary
Summary

This study has two parts and will assess your hearing and the potential effects of antibiotic-induced ototoxicity. Ototoxicity is a potential effect of drugs used to treat your lung infections, and its effect on your ears (oto=ears), particularly structures in your inner ear that enable hearing and balance. Part One of the study will assess your inner ear function that may be associated with hearing loss and / or loss of balance in cystic fibrosis patients taking tobramycin. Part Two is looking to determine if SPI-1005, an investigational drug, influences hearing loss, due to mediations (tobramycin).

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

Validation of the Palliative Performance Scale to predict survival of older adults admitted to the hospital from the Emergency Department. Save

Date Added
August 4th, 2017
PRO Number
Pro00063739
Researcher
Leigh Vaughan
Keywords
Cancer, Dementia, Heart, Kidney, Liver, Pulmonary, Stroke
Summary

The Palliative Performance Scale has been shown to predict survival among hospice and palliative medicine patients in the outpatient and inpatient clinical settings, where lower PPS scores are directly related to shorter survival. We seek to evaluate if this relationship persists among a racially diverse, older adult population when assessed at the time of admission from the emergency department.

Institution
MUSC
Recruitment Contact
Jonas Te Paske
8432597649
tepaske@musc.edu

An Open-label Extension Study of Oral Treprostinil in Subjects with Pulmonary Hypertension (PH) Associated with Heart Failure with Preserved Ejection Fraction (HFpEF) - A Long-Term Follow-up to Study TDE-HF-301 Save

Date Added
July 25th, 2017
PRO Number
Pro00068812
Researcher
Rahul Argula
Keywords
Pulmonary, Pulmonary Arterial Hypertension (PAH)
Summary

The purpose of this study is to see how oral treprostinil works to treat PH associated with HFpEF. Oral treprostinil (brand name Orenitram) was approved by the United States Food and Drug Administration (FDA) in December 2013 for the treatment of pulmonary arterial hypertension (PAH). PAH means that the blood vessels going from the right side of the heart to the lungs (pulmonary arteries) have higher than normal pressure. PAH is a specific type of PH.
This study will evaluate the long-term safety of oral treprostinil and the effects of continued therapy on the ability to exercise.

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

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

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