SCTR / MUSC COVID-19 Biorepository Save

Date Added
April 16th, 2020
PRO Number
Pro00098961
Researcher
Patrick Flume

List of Studies


Profiles_link
Keywords
Coronavirus, COVID-19, Infectious Diseases, Men's Health, Non-interventional, SARS-CoV-2, Women's Health
Summary

The Medical University of South Carolina (MUSC) is developing a COVID-19 biorepository which will contain blood, urine, and other bodily fluids along with relevant medical information from individuals evaluated, exposed to, or treated for COVID-19. To learn from this pandemic ,and to develop treatments and strategies to better prepare and avert future pandemics we must study the disease and its effects. The clinical specimens in the biorepository will be available for investigators to use for future research. Compensation is provided for participation in this project for eligible participants.

Institution
MUSC
Recruitment Contact
Ricardo Cantu
843-792-8894
cantur@musc.edu

A randomised, double-blind, placebo-controlled and parallel group trial to evaluate efficacy and safety of twice daily inhaled doses of BI 1265162 delivered by Respimat® inhaler as add-on therapy to standard of care over 4 weeks in patients with cystic fibrosis. Save

Date Added
November 26th, 2019
PRO Number
Pro00093149
Researcher
Patrick Flume

List of Studies


Profiles_link
Keywords
Cystic Fibrosis, Lung, Pulmonary
Summary

This study is being done to compare the safety, effectiveness, and side effects of different doses of the drug being studied, BI 1265162, with a placebo, in subjects with Cystic Fibrosis (CF). You will be in this study for about 7 weeks. This study will involve study procedures such as, physical and chest exams, blood pressure and pulse, electrocardiograms, blood tests, pregnancy urine tests, breathing tests (pulmonary function tests and multiple breath washout tests), and completing a diary and questionnaires. Each dose of the study drug will consist of 2 puffs which will be taken 2 times per day using the Respimat® inhaler. This is an add-on therapy therefore subjects will continue to take their usual medications (including any therapy), and the treatment period for taking this add-on therapy is 4 weeks.

Institution
MUSC
Recruitment Contact
Caroline Brailsford
(843) 792-1820
brailsfo@musc.edu

A Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in Cystic Fibrosis Subjects Who Are Homozygous for the F508del Mutation Save

Date Added
October 22nd, 2019
PRO Number
Pro00091705
Researcher
Patrick Flume

List of Studies


Profiles_link
Keywords
Cystic Fibrosis, Lung, Pulmonary
Summary

This study is designed to evaluate ABBV-3067 alone and in combination with ABBV-2222 to see how safe they are and how well they work for treating cystic fibrosis. The study will also help select the minimum effective dose of both medicines. Both drugs are investigational and will be taken orally. Both help to restore Cystic Fibrosis transmembrane conductance regulator (CFTR) activity, which is when there isn't enough water on membrane surfaces for those who have cystic fibrosis. You will either receive the drug or a placebo. The study will be done in approximately 3 months. Approximately 189 patients with cystic fibrosis who are older than 18 years of age will be enrolled in this study.

Institution
MUSC
Recruitment Contact
Brooke Alexander
843-792-1221
alexanbr@musc.edu

Multicenter Randomized Pragmatic Clinical Trial Comparing Two-versus-Three Antibiotic Therapy for Pulmonary Mycobacterium Avium Complex Disease Save

Date Added
July 16th, 2019
PRO Number
Pro00089685
Researcher
Patrick Flume

List of Studies


Profiles_link
Keywords
Infectious Diseases, Lung, Pulmonary
Summary

The purpose of this study is to better understand treatment practices for Mycobacterium avium complex (MAC) disease. This study is comparing the effectiveness and tolerability of taking 2 drugs compared to 3 drugs in people with MAC disease.

Institution
MUSC
Recruitment Contact
Abigail Grady
843-792-2072
gradyabi@musc.edu

Prospective study of peripherally inserted venous catheters in CF patients Save

Date Added
November 20th, 2018
PRO Number
Pro00083486
Researcher
Patrick Flume

List of Studies


Profiles_link
Keywords
Cystic Fibrosis, Lung, Pulmonary
Summary

The main purpose of this study is to see if important factors can be identified in each of the three categories (patient, catheter, and catheter management) that are linked to blood clotting complications. This is a multicenter, prospective observational study to evaluate risk factors associated with complications of peripherally inserted central catheter (PICCs) and midline catheters. Both adult and pediatric patients with CF who receive care at participating centers will be eligible for participation. This study can last for 2 weeks.

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

A Proof of Concept Study of Inhaled Nitric Oxide for Adults with Pulmonary Non-Tuberculous Mycobacterial Infection Save

Date Added
September 18th, 2018
PRO Number
Pro00081838
Researcher
Patrick Flume

List of Studies


Profiles_link
Keywords
Lung, Pulmonary
Summary

The purpose of this study is to evaluate the efficacy and safety of open-label exposure of gNO in patients with NTM lung disease. Subjects will receive the study drug by inhaling through a nasal mask. Subjects will be treated for 3 weeks (5 days per week) and followed monthly for 3 months.

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

List of Studies


Profiles_link
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

List of Studies


Profiles_link
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 Phase 2, Randomized, Double-Blind,Placebo-Controlled Study To Evaluate The Safety and Efficacy of SPI-1005 Capsules in Cystic Fibrosis Patients with Acute Pulmonary Exacerbation receiving IV Tobramycin at risk for Ototoxicity Save

Date Added
August 8th, 2017
PRO Number
Pro00067873
Researcher
Patrick Flume

List of Studies


Profiles_link
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

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

List of Studies


Profiles_link
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

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