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

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

HIV-associated Obstructive Pulmonary Disease and Emphysema Save

Date Added
August 15th, 2017
PRO Number
Pro00066169
Researcher
Lynn Schnapp

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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

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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

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

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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

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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

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