A comparison of cell populations collected in sputum samples to cell populations in bronchoalveolar lavage samples

Date Added
October 27th, 2020
PRO Number
Pro00099320
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer/Lung, Lung, Pulmonary
Summary

The main objective of this study is to analyze sputum collected from the residue remaining from bronchoalveolar lavage (BAL) procedures to compare the cellular characteristics of BAL samples to those of sputum samples collected from the acapella® airway assist device. We intend to enroll volunteers who are being evaluated by an MUSC pulmonologist as part of their standard medical care. The Control Sputum sample will be collected by volunteers at home over a three day period using an acapella® airway assist device. The cellular profiles of the BAL and sputum samples will be analyzed by flow cytometry. Active participation in this study is expected to last less than one month and will be complete once a sample is obtained from the BAL procedure.

Institution
MUSC
Recruitment Contact
Abby Wenzel
843-792-8233
goodsona@musc.edu

COVID-19: Biology and Longitudinal Epidemiology of PETAL COVID-19 Observational Study

Date Added
October 15th, 2020
PRO Number
Pro00103211
Researcher
Andrew Goodwin

List of Studies


Keywords
Coronavirus, Infectious Diseases, Lung, Pulmonary, SARS-CoV-2
Summary

BLUE CORAL is an observational, biorepository study for patients who are hospitalized with COVID-19. The study collects various data and biospecimens, such as blood, urine, and tracheal aspirates, during the patient's hospital stay. The data and biospecimens collected will be used to provide greater knowledge on the biology and epidemiology of COVID-19.

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

A Phase 2, Randomized, Double-blind, Placebo controlled Study of the Efficacy and Safety of VX-864 in PiZZ Subjects

Date Added
September 8th, 2020
PRO Number
Pro00102490
Researcher
Charlie Strange

List of Studies


Keywords
Liver, Lung, Pulmonary
Summary

Alpha-1 Antitrypsin (AAT) is a naturally occurring protein involved in the protection of lungs from inflammation. A mutation in the AAT gene (a change in the body's genetic instructions on how to make AAT) causes it to be made incorrectly and very little of it gets into the bloodstream. Severe AAT deficiency (lack of AAT in the blood) causes emphysema, which causes holes in the lungs. This study is being done to learn more about the safety and effectiveness of VX-864 in patients with Alpha-1 Antitrypsin Deficiency.

The treatment period is 28 days with 3 additional follow-up visits. Participants will be randomized to one of 4 groups. Randomized means there is an equal chance of being placed in any of the 4 groups. The groups are placebo (no active drug) or treatment groups 1-3 with varying doses. All groups will take 5 tablets in the morning and 5 tablets at night. The treatment group will take either 100mg, 300mg, or 500mg tablets twice a day. There is an 80% chance of being assigned to a treatment group and a 20% chance of being assigned to placebo.

Institution
MUSC
Recruitment Contact
Rachel Millan
843-792-0260
millanr@musc.edu

A master protocol to test the impact of discontinuing chronic therapies in people with cystic fibrosis on highly effective CFTR modulator therapy (SIMPLIFY)

Date Added
September 3rd, 2020
PRO Number
Pro00103466
Researcher
Sylvia Szentpetery

List of Studies


Keywords
Cystic Fibrosis, Lung, Pulmonary
Summary

The SIMPLIFY study is being done to test whether or not it is safe to stop taking inhaled hypertonic saline or Pulmozyme® (dornase alfa) in those people that are also taking Trikafta™. The SIMPLIFY studyl consists of two similar studies conducted within the same protocol that are being done to answer the following questions:
• Study A: For people with CF taking Trikafta, does stopping treatment with hypertonic saline (at least 3%) have a similar effect on lung function as continuing treatment with hypertonic saline?
• Study B: For people with CF taking Trikafta, does stopping treatment with Pulmozyme have a similar effect on lung function as continuing treatment with Pulmozyme?
There are a total of 4 study visits (a screening visit and three additional visits during the active part of the study). There is a 2-week screening period and a 6-week active study period.About 920 people with CF who are 12 years of age or older will take part in this study at approximately 80 hospitals and clinics around the country. Of this total, approximately 520 people will participate in the hypertonic saline (Study A) portion and 400 people with participate in the Pulmozyme (Study B) portion of the study.

Institution
MUSC
Recruitment Contact
Angel Darrow
(843) 792-8092
darrowa@musc.edu

A PHASE 1B RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED TRIAL TO EVALUATE THE SAFETY OF CB-280 IN PATIENTS WITH CYSTIC FIBROSIS CX-280-202

Date Added
August 12th, 2020
PRO Number
Pro00102299
Researcher
Patrick Flume

List of Studies


Keywords
Cystic Fibrosis, Lung, Pulmonary
Summary

This clinical study is testing the safety (if there are side effects) and tolerability of CB-280 in approximately 32 subjects with CF. This study is being conducted to indentify which CB-280 doses are safe to take without causing too many side effects. CB-280 is an investigational drug that is taken by mouth that blocks an enzyme called arginase, which is thought to play an important role in promoting lung infection in cystic fibrosis (CF). Participation in the study will be up to 56 days long.

Institution
MUSC
Recruitment Contact
Angel Darrow
(843) 792-8092
darrowa@musc.edu

An Observational Long-Term Safety Surveillance Study Of Participants From Corbus Sponsored Lenabasum Pivotal Clinical Trials

Date Added
July 15th, 2020
PRO Number
Pro00101371
Researcher
Patrick Flume

List of Studies


Keywords
Cystic Fibrosis, Lung, Pulmonary
Summary

This observational research study will collect safety information from subjects who received study treatment (lenabasum or placebo) in a Corbus-sponsored pivotal clinical trial. This is being done to understand how stopping the study treatment affects the subject, and to make sure that the subject is not experiencing any side effects from stopping the study treatment. The subject will not be given any investigational drugs, including lenabasum or a placebo, in this study. The subject will be assessed (by telephone or office visit) approximately every 6 months for up to 2 years from the time of the last safety visit in a pivotal trial, unless Corbus stops studying lenabasum or decides to stop the study itself. The number of potential phone calls will depend on when the subject joins the study, but will not exceed 5 total. Approximately 100 subjects are expected to take part in this study in North America, Europe, and Asia-Pacific (APAC).

Institution
MUSC
Recruitment Contact
Nadine O'Connor
(843) 792-6890
oconnorn@musc.edu

Transbronchial Biopsy Assisted by Robot Guidance in the Evaluation of Tumors of the Lung (TARGET trial)

Date Added
July 6th, 2020
PRO Number
Pro00097400
Researcher
Nicholas Pastis

List of Studies


Keywords
Cancer, Cancer/Lung, Lung, Pulmonary
Summary

Physicians currently have difficulty getting a biopsy of lung spots that are far from the center of the lung. The bronchoscopes that are currently used to reach these spots are sometimes difficult to maneuver and are unable to reach these spots. This study will test the performance of a new robotic bronchoscope that uses navigation software to find the distant spots in the lung so physicians can successfully get a biopsy.

Institution
MUSC
Recruitment Contact
Abby Wenzel
843-792-8233
goodsona@musc.edu

A PHASE III, RANDOMIZED, DOUBLE-BLIND, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF REMDESIVIR PLUS TOCILIZUMAB COMPARED WITH REMDESIVIR PLUS PLACEBO IN HOSPITALIZED PATIENTS WITH SEVERE COVID-19 PNEUMONIA

Date Added
June 29th, 2020
PRO Number
Pro00101225
Researcher
Nandita Nadig

List of Studies


Keywords
Coronavirus, Infectious Diseases, Lung, Pulmonary
Summary

The purpose of this study is to compare the effects, good or bad, of study treatment with remdesivir plus tocilizumab compared with remdesivir by itself on subjects with severe COVID19 pneumonia. In this study, the subject will receive standard supportive care treatment for COVID-19 pneumonia as well as remdesivir, and will additionally receive either tocilizumab, or placebo. About 450 people will take part in this study. Depending on the early results of the study, the total number of people who will take part may be increased to up to 800.

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

Prospective Phase 0 Study to Investigate Pseudomonas aeruginosa and Staphylococcus aureus Bacterial Load, Patient Characteristics and Exploratory Biomarkers in Adult Patients with Cystic Fibrosis or Non-Cystic Fibrosis Bronchiectasis

Date Added
June 25th, 2020
PRO Number
Pro00100720
Researcher
Patrick Flume

List of Studies


Keywords
Cystic Fibrosis, Lung, Pulmonary
Summary

The purpose of this research study is to collect phlegm and blood to learn more about the presence of bacteria in patients with Cystic Fibrosis (CF) or Non-Cystic Fibrosis Bronchiectasis (NCFB). This exploratory research study does not involve the administration of any medication. There are approximately 4 visits (1 visit to see for subject eligibility, and 3 visits during the study) to complete the study participation. The study will take two months. About 100 subjects will take part study-wide.

Institution
MUSC
Recruitment Contact
Angela Millare
(843) 792-3710
millare@musc.edu

Prospective tReatment EffiCacy in IPF uSIng genOtype for Nac Selection (PRECISIONS) trial

Date Added
June 17th, 2020
PRO Number
Pro00097636
Researcher
Timothy Whelan

List of Studies


Keywords
Lung, Pulmonary
Summary

This is a multi-center, randomized, double-blind, placebo-controlled trial of 200 participants to receive N-acetyl cysteine (NAC) or placebo for a 24 month duration. The purpose of this study is to see if n-acetylcysteine (NAC) can help people with idiopathic pulmonary fibrosis (IPF) who have a specific gene type and to see if NAC is safe to take without causing too many side effects.

Institution
MUSC
Recruitment Contact
Nicholas Ciappa
(843) 792-1221
ciappa@musc.edu



-- OR --