A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis Save

Date Added
February 27th, 2018
PRO Number
Pro00075593
Researcher
Patrick Flume

Silhouette
Keywords
Cystic Fibrosis, Lung, Pediatrics, Pulmonary
Summary

This is a research study to find out if a drug called lenabasum can help people with Cystic Fibrosis (CF) and if it is safe to take without causing too many side effects. There are 9 planned study visits in the institution during this study.

Institution
MUSC
Recruitment Contact
Abbi Reed
(843) 792-1820
reedab@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

Silhouette
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

Silhouette
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

Silhouette
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

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

Phase 3b, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety, Efficacy, and Tolerability of Tezacaftor/Ivacaftor (TEZ/IVA) in an Orkambi-experienced Population Who Are Homozygous for the F508del-CFTR Mutation Save

Date Added
May 23rd, 2017
PRO Number
Pro00066198
Researcher
Patrick Flume

Silhouette
Keywords
Cystic Fibrosis, Pediatrics, Pulmonary
Summary

The purpose of this study is to learn more about the safety and efficacy of the combination of tezacaftor/ivacaftor (TEZ/IVA) in subjects with CF who have previously discontinued Orkambi. Orkambi® is a combination of ivacaftor with another drug called lumacaftor. This study is being conducted to test whether combining ivacaftor with tezacaftor instead will improve symptoms of cystic fibrosis and cause fewer respiratory side effects.

Institution
MUSC
Recruitment Contact
Abbi Reed
843-792-1820
reedab@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

Silhouette
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

Multiple Patient Program for Lamprene® (clofazimine) for the treatment of Non-Tuberculous Mycobacterial (NTM) Infections Save

Date Added
March 21st, 2017
PRO Number
Pro00065207
Researcher
Patrick Flume

Silhouette
Keywords
Pulmonary
Summary

Lamprene®/Clofazimine, is a product of the pharmaceutical company named Novartis Pharmaceuticals Corporation. Lamprene®/Clofazimine is approved by FDA (the U.S Food and Drug Administration) for the treatment of leprosy. It is being tested in non-Novartis clinical studies for drug resistant tuberculosis and non-tuberculous mycobacteria (NTM).

If you have been diagnosed with NTM, then your doctor may decide that this infection can be treated with Lamprene®/Clofazimine. This medicine is provided to you in an expanded access program. This means that this medicine is not registered for the treatment of NTM, but it can be used in special situations where there are no other possible treatments. For example, this may be because you have a type of Mycobacterial infection that is resistant or failed to respond optimally to other drugs, or because you have had side effects that prevent the use of other drugs.

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

Standardized Treatment of Pulmonary Exacerbations II (STOP2) Save

Date Added
May 17th, 2016
PRO Number
Pro00054432
Researcher
Patrick Flume

Silhouette
Keywords
Cystic Fibrosis, Lung, Pulmonary
Summary

The study is being used to evaluate the efficacy and safety of differing durations of IV antibiotic treatment for CF pulmonary exacerbations. Subject eligibility includes males and females 18 years of age or older. Participation in the study will take 3 visits over a period of 24 to 35 days.

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

A prospective observational study in cystic fibrosis patients with chronic respiratory Pseudomonas aeruginosa infection treated with TOBI® Podhaler™ (tobramycin inhalation powder) or other FDA approved inhaled antipseudomonal antibacterial drugs Save

Date Added
February 23rd, 2016
PRO Number
Pro00044578
Researcher
Patrick Flume

Silhouette
Keywords
Adolescents, Breathing, Cystic Fibrosis, Lung, Pulmonary
Summary

You are invited to volunteer for this non-interventional study if you have been prescribed tobramycin inhalation powder (TOBI® Podhaler™) or another inhaled medication used to treat Cystic Fibrosis (CF) related Pseudomonas aeruginosa (bacteria).

The purpose of this non-interventional study is to assess how well TOBI Podhaler or other approved inhaled antibiotic medications work on treating this bacterium in the lungs, and their safety as used in medical practice. A non-interventional study is a study in which individuals are only observed and certain outcomes are measured. The study will entail around 20 visits over the course of 5 years.

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

Change_preferences

-- OR --

Create_login