A Phase 2, 24-Week Randomized, Double-blind, Placebo-Controlled Multicenter Study, Followed by a 28-Week Treatment Extension, to Evaluate the Efficacy and Safety of CC-90001 in Subjects with Idiopathic Pulmonary Fibrosis Save

Date Added
November 14th, 2017
PRO Number
Pro00070979
Researcher
Timothy Whelan

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Keywords
Lung, Pulmonary
Summary

The purpose of this study is to test an experimental drug called CC-90001. This study will test CC-90001 (at doses of either 200 mg or 400 mg, given by mouth, once daily) compared to placebo, an inactive substance that contains no medicine. This study is being conducted to test the effect of CC-90001 on improving your IPF, and to see how well your body tolerates CC-90001.

Institution
MUSC
Recruitment Contact
Tomika Caldwell
(843) 792-3162
caldwet@musc.edu

Tezacaftor/Ivacaftor Combination Therapy Expanded Access Program for Patients 12 Years of Age and Older With Cystic Fibrosis Save

Date Added
October 24th, 2017
PRO Number
Pro00071782
Researcher
Patrick Flume

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Keywords
Cystic Fibrosis, Lung, Pulmonary
Summary

Vertex is offering the EAP (Expanded Access Program) in order to respond to requests from physicians to make TEZ/IVA available for use by Eligible Patients under the supervision of the requesting physician. This program will be available until TEZ/IVA or a suitable alternative treatment has been approved and is funded or reimbursed by an insurance company or a publicly-funded program or agency or by private supplementary health benefits insurance.

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

A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY OF AEROVANC FOR THE TREATMENT OF PERSISTANT METHICILLIN-RESISTANT Staphylococcus aureus LUNG INFECTION IN CYSTIC FIBROSIS PATIENTS Save

Date Added
October 24th, 2017
PRO Number
Pro00071904
Researcher
Patrick Flume

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Keywords
Cystic Fibrosis, Lung, Pulmonary
Summary

The purpose of this research study is to evaluate the effectiveness and safety of AeroVanc compared to placebo (an inactive substance) in patients (also called subjects) with CF and a chronic MRSA lung infection.

Institution
MUSC
Recruitment Contact
Julia Palmer
(843) 792-3169
palmerju@musc.edu

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

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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

Development of CSD-Based Therapies: Novel Indications and Improved Versions of CSD Save

Date Added
September 26th, 2017
PRO Number
Pro00069613
Researcher
Stanley Hoffman

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Keywords
Heart, Lung, Lupus, Scleroderma
Summary

We have already observed that the blood cells known as monocytes from patients with the fibrotic disease scleroderma behave differently from monocytes from healthy controls. Here we will test whether patients with other fibrotic diseases also have altered monocyte function. Specifically, we will get blood from congestive heart failure and lupus patients and compare their monocytes to scleroderma patient and healthy subject monocytes. Our recent results in a mouse model for congestive heart failure suggest that we will find altered monocyte behavior in human congestive heart failure patients.

Institution
MUSC
Recruitment Contact
Elena Tourkina
843-792-7319
tourkine@musc.edu

A Phase 2b Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Preterm Infants Save

Date Added
September 26th, 2017
PRO Number
Pro00066901
Researcher
Andrew Atz

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Keywords
Children's Health, Drug Studies, Infant, Infectious Diseases, Lung, Pediatrics
Summary

This is a Randomized , Double blinded study to evaluate how effective a single dose of experimental drug called MEDI8897 is at preventing lung disease caused by RSV disease in healthy preterm infants born between 29 weeks 0 days and 34 weeks 6 days.This study also evaluate safety, tolerability and pharmacokinetics (PK) of MEDI8897 in healthy preterm infants compared with placebo.

Institution
MUSC
Recruitment Contact
Kalyan Chundru
834-792-1213
choudhar@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

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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

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

Silhouette
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

Silhouette
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

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

Silhouette
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

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