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 Save

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

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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

A Multicenter, Randomized, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Benralizumab 100 mg in Patients with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) with a History of Frequent COPD Exacerbations and Elevated Peripheral Blood Eosinophils (RESOLUTE) Save

Date Added
May 12th, 2020
PRO Number
Pro00096200
Researcher
Tatsiana Beiko

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Keywords
Lung, Pulmonary
Summary

Benralizumab is a drug that can potentially reduce the number of exacerbations (attacks of restricted breathing) for people with chronic obstructive pulmonary disease (COPD). Benralizumab is given as an injection under the skin. Eligible participants will have a 50% chance of being placed in the treatment group (Benralizumab 100mg/mL) or a placebo (inactive substance). The study is double blind so neither the treatment team nor the participant will know what treatment they received. The study will take place for a minimum of one year, but can last up to three years. The study will officially end when every participant has completed one year of treatment.

Institution
MUSC
Recruitment Contact
Rachel Millan
8437920260
rmillan@musc.edu

A PHASE II, OPEN-LABEL, RANDOMIZED, MULTICENTER STUDY TO INVESTIGATE THE PHARMACODYNAMICS, PHARMACOKINETICS, SAFETY, AND EFFICACY OF 8 mg/kg OR 4 mg/kg INTRAVENOUS TOCILIZUMAB IN PATIENTS WITH MODERATE TO SEVERE COVID-19 PNEUMONIA Save

Date Added
May 8th, 2020
PRO Number
Pro00099738
Researcher
Nandita Nadig

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Keywords
Coronavirus, Infectious Diseases, Lung, Pulmonary
Summary

The purpose of this study is to compare the effects, good or bad, of two doses of TCZ in combination with standard of care treatment on subjects with moderate to severe COVID-19 pneumonia. This study is testing a drug called tocilizumab (TCZ). During this study, you will be hospitalized and have study procedures daily until discharged (based on your study doctor's decision). After you are discharged from the hospital, you are encouraged to come back for additional assessments; if it is not possible, you may be followed up by telephone by your study doctor or study nurse.
About 100 people will take part in this study in the United States.

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

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects with Idiopathic Pulmonary Fibrosis (IPF) Save

Date Added
April 14th, 2020
PRO Number
Pro00098727
Researcher
John Huggins

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Profiles_link
Keywords
Lung, Pulmonary
Summary

The purpose of this study is to evaluate the potential usefulness of pamrevlumab in IPF, compared to placebo (a substance that looks like the investigational drug, but has no active agent). The total duration of your involvement on the study will be 52 weeks. If you meet the entry criteria (requirements) and decide to participate in this study, you will be randomly assigned to 1 of 2 treatment groups: Arm A: Pamrevlumab or Arm B: Placebo. The study includes clinical visits. Approximately 565 subjects will participate in this study at approximately 200 research sites globally.

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

Outcomes Related to COVID-19 Treated with Hydroxychloroquine among In-patients with Symptomatic Disease Save

Date Added
April 8th, 2020
PRO Number
Pro00099215
Researcher
Andrew Goodwin

List of Studies


Profiles_link
Keywords
Infectious Diseases, Lung, Pulmonary
Summary

This is a blinded, multicenter, placebo-controlled randomized clinical trial. In this trial, the safety and effectiveness of hydroxychloroquine for the treatment of adults hospitalized with COVID-19 will be evaluated. In this study, a medication called hydroxychloroquine is being investigated to see if it improves recovery from COVID-19 in patients admitted to the hospital. Hydroxychloroquine is used to treat malaria and some joint (rheumatologic) diseases, but it is unknown if it helps patients recover from COVID-19. Study medication will be given for 5 days. This medication could be either hydroxychloroquine or placebo. There will be up to 510 patients in the study at about 50 hospitals in the United States.

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

An Open-Label Extension Study of Inhaled Treprostinil in Patients with Pulmonary Hypertension due to Chronic Obstructive Pulmonary Disease (PH-COPD) Save

Date Added
March 24th, 2020
PRO Number
Pro00097579
Researcher
Rahul Argula

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Profiles_link
Keywords
Lung, Pulmonary, Pulmonary Arterial Hypertension (PAH)
Summary

The purpose of this study is to assess safety of the study drug, inhaled treprostinil, and the ability to tolerate long-term treatment with the study drug in patients with PH-COPD. The study will also evaluate the effectiveness of the study drug over long-term treatment. Inhaled treprostinil is a medication that will be given to you by a handheld inhalation device (study nebulizer) called the Tyvaso® Inhalation System. The study is estimated to last 2 to 3 years but could be much shorter or longer. Depending on the final number of subjects who participated in the RIN-PH-304 study, either approximately 136 or approximately 314 subjects may be eligible to participate in this study from the U.S. study centers.

Institution
MUSC
Recruitment Contact
April Rasberry
(843) 792-2375
rasberry@musc.edu

A Phase 2, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of VX-814 in PiZZ Subjects Save

Date Added
February 25th, 2020
PRO Number
Pro00096021
Researcher
Charlie Strange

List of Studies


Profiles_link
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, tolerability and effectiveness of VX-814 in patients with Alpha-1 Antitrypsin Deficiency. There are four groups in the study, one placebo group and three treatment groups with varying doses. This study is double blind with 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 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

APPLAUD: A DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PHASE II STUDY OF THE EFFICACY AND SAFETY OF LAU-7B IN THE TREATMENT OF CYSTIC FIBROSIS IN ADULTS Save

Date Added
November 12th, 2019
PRO Number
Pro00094338
Researcher
Bryan Garcia

List of Studies

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Keywords
Cystic Fibrosis, Lung, Pulmonary
Summary

The purpose of this study is to learn more about the effectiveness and safety of the investigational drug called fenretinide (LAU-7b). The FDA has approved the testing of fenretinide in this study. Researchers hope that treatment with fenretinide will preserve lung function by reducing the persistent inflammation in the lung and to improve its capacity to defend against bacteria such as Pseudomonas aeruginosa. The drug will be administered by capsules. Your participation in this study will last approximately 7 months and includes 8 study visits to the study center (which will last approximately 2-5 hours) and 6 telephone calls. The phone calls are expected to last 10-15 minutes and depend on the amount of information you report.

Institution
MUSC
Recruitment Contact
Max Lento
(843) 792-9697
lento@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

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