A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study

Date Added
May 6th, 2021
PRO Number
Pro00109905
Researcher
Patrick Flume

List of Studies


Keywords
Lung, Pulmonary
Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of the study drug, brensocatib, as treatment for NCFBE. This is a double-blinded study.
The maximum study duration is 62 weeks total for an individual participant, including a Screening Period of up to 6 weeks, a Treatment Period of 52 weeks, and an End-of-Study Visit 4 weeks following the end of treatment. Approximately 1,620 subjects between the ages of 18 and 85 years, with diagnosed NCFBE are expected to participate in this study. The study is being conducted at approximately 480 centers in North America, Europe, Japan, and the rest of the world. All subjects will complete the same study procedures. The study will last approximately 62 weeks from the Screening (Visit 1) to the End of Study (Visit 12). There will be 12 visits including the Screening Visit (1 visit), Study Treatment Visits (10 visits: 6 visits are in the study clinic [Visits 2, 3, 5, 7, 9, and 11], and 4 visits by telephone from your home [Visits 4, 6, 8, and 10]), and an End of Study Visit (1 visit). The End of Study Visit (Visit 12) will occur in the study clinic.

Institution
MUSC
Recruitment Contact
Amy Chamberlain
(843) 792-3162
chambeam@musc.edu

COVID-19: A Mulicenter, Adaptive, Randomized, Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for Hospitalized Patients with Acute Respiratory Distress Syndrome Associated with COVID-19

Date Added
April 8th, 2021
PRO Number
Pro00109695
Researcher
Andrew Goodwin

List of Studies


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

TESICO (Therapeutics for Severely Ill Inpatients with COVID-19) is a master protocol to evaluate the safety and efficacy of investigational agents aimed at improving outcomes for patients with acute respiratory failure related to COVID-19.

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

A PHASE 1B/2A, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, SINGLE AND MULTIPLE ASCENDING DOSE STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF AP-PA02 MULTI-PHAGE THERAPEUTIC CANDIDATE FOR INHALATION IN SUBJECTS WITH CYSTIC FIBROSIS AND CHRONIC PULMONARY PSEUDOMONAS AERUGINOSA (PA) INFECTION

Date Added
February 23rd, 2021
PRO Number
Pro00104908
Researcher
Patrick Flume

List of Studies


Keywords
Cystic Fibrosis, Lung, Pulmonary
Summary

Armata Pharmaceuticals, Inc. (Armata) has begun a study of an investigational drug (also known as the "study drug") called AP-PA02 as a possible treatment for individuals with cystic fibrosis (CF) and chronic pulmonary Pseudomonas aeruginosa (Pa) infection. The main purposes of this study are to learn about how safe and how well tolerated the study drug is compared to the placebo. This study has two parts, Part 1 and Part 2. You may only participate in Part 1 or Part 2, not both. If you participate in Part 1 of the study, the screening period is up to 21 days, and the on-study period is 29 days, for a total of up to 50 days, and you will need to come to the study center 8 times over this study period. If you are in Part 2 of the study, the screening period is up to 21 days, and the on-study period is 31 days, for a total of up to 52 days, and you will need to come to the study center 10 times over this study period. This study will take place in approximately 12 centers in the United States with about 48 people with CF and chronic Pa participating.

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

Randomized, double blind, placebo controlled study to evaluate the effect of dupilumab on airway inflammation through assessments of lung function, mucus plugging and other lung imaging parameters in patients with asthma

Date Added
February 17th, 2021
PRO Number
Pro00105498
Researcher
John Cox

List of Studies


Keywords
Asthma, Lung, Pulmonary
Summary

The purpose of the study is to help doctors learn more about investigational dupilumab (the study drug) and to find out how safe it is and how well it works for patients with asthma. The study will investigate whether the study drug can help to improve the health of your lungs, reduce the inflammation in your airways and also improve your quality of life. If you join the study, your participation will last a minimum of 29 weeks and up to 41 weeks and is planned to include approximately 153 participants. The study will be conducted worldwide. If the study is suited for you, you will be randomized by chance (like drawing straws) to receive either the study drug (300 mg dupilumab) or placebo.

Institution
MUSC
Recruitment Contact
Amy Chamberlain
(843) 792-3162
chambeam@musc.edu

ARISE - A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Multicenter Study to Validate Patient-Reported Outcome Instruments in Adult Subjects with Newly Diagnosed Nontuberculous Mycobacterial (NTM) Lung Infection Caused by Mycobacterium avium Complex (MAC)

Date Added
February 8th, 2021
PRO Number
Pro00107771
Researcher
Patrick Flume

List of Studies


Keywords
Lung, Pulmonary
Summary

This is a randomized, double-blind, placebo-controlled, active comparator study in eligible subjects with a new diagnosis of MAC lung infection. The purpose of this study is to validate a patient-reported outcomes questionnaire in newly diagnosed subjects given amikacin liposome inhalation suspension (ALIS) as part of a study treatment regimen for NTM caused by MAC. This study will also evaluate the safety and efficacy of the study treatments with ALIS inhalation therapy, azithromycin (AZI) and ethambutol (ETH). Around 100 subjects 18 years and above of age with newly diagnosed NTM caused by MAC are expected to participate in this study. The study will last around 9.5 months from the Screening visit to the end of the study.

Institution
MUSC
Recruitment Contact
Grant Allen
(843) 792-3900
allengr@musc.edu

ENCORE - A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Multicenter Study to Evaluate the Efficacy and Safety of an Amikacin Liposome Inhalation Suspension (ALIS)-Based Regimen in Adult Subjects with Newly Diagnosed Nontuberculous Mycobacterial (NTM) Lung Infection Caused by Mycobacterium avium Complex (MAC)

Date Added
February 8th, 2021
PRO Number
Pro00107820
Researcher
Patrick Flume

List of Studies


Keywords
Lung, Pulmonary
Summary

The purpose of this study is to evaluate the effect and safety of amikacin liposome inhalation suspension (ALIS) study treatment on patient-reported symptoms in subjects newly diagnosed with NTM lung infection caused by MAC who have not started standard treatment. Around 250 subjects 18 years and older with newly diagnosed NTM lung infection caused by MAC who have not started standard treatment are expected to participate in this study. The study will last around 17.5 months from the Screening visit to the end of the study.

Institution
MUSC
Recruitment Contact
Grant Allen
(843) 792-3900
allengr@musc.edu

A STUDY OF BREXANOLONE FOR ACUTE RESPIRATORY DISTRESS SYNDROME DUE TO COVID-19

Date Added
February 8th, 2021
PRO Number
Pro00106016
Researcher
Andrew Goodwin

List of Studies


Keywords
Lung, Pulmonary
Summary

This is a randomized, double-blind, placebo-controlled study designed to evaluate treatment with brexanolone in participants with acute respiratory distress syndrome due to COVID-19.Participants will receive continued standard of care in addition to a continuous IV infusion of brexanolone or placebo for 60 hours while hospitalized. Study participation will last approximately 28 days.

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

A Multicenter, Adaptive, Randomized, Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for Hospitalized Patients with COVID-19

Date Added
January 27th, 2021
PRO Number
Pro00102997
Researcher
Andrew Goodwin

List of Studies


Keywords
Coronavirus, Infectious Diseases, Lung, Pulmonary
Summary

This study is testing an experimental drug called "LY3819253" that will provide antibodies that is thought to fight the COVID-19 virus.The subject will receive the study drug (either the experimental study drug or the placebo) only once, on the day he/she joins the study (study "Day 0"). The subject will get it by an intravenous (IV) drip through a tube attached to a needle in the arm. This is called an infusion. As part of the study the subject will also get a study drug called remdesivir once a day intravenously for up to 10 days while in the hospital, as care for COVID-19, unless the study doctor thinks remdesivir would not be safe to be taken. The study will last for 90 days.

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

Pulmonary Vascular Complications of Liver Disease 3 (PVCLD3)

Date Added
January 22nd, 2021
PRO Number
Pro00103260
Researcher
David Koch

List of Studies


Keywords
Hypertension/ High Blood Pressure, Liver, Men's Health, Pulmonary, Transplant, Vascular
Summary

This is a prospective cohort study of subjects with portal hypertension to examine whether increased sphingosine 1 phosphate : ceramide ratio and circulating bile acids are associated with HPS in patients with advanced liver disease. The study will consist of 400 individuals who are evaluated for liver transplantation at the Field Centers. This population has advanced liver disease and will represent the population with cirrhosis at the Centers. As is considered standard of clinical care for these patients and required for liver transplant evaluation, patients will undergo phlebotomy, interviews, pulmonary function testing, echocardiography, and arterial blood gas sampling at their initial evaluation. During the clinical phlebotomy, additional samples will be drawn for research purposes. If any of these procedures does not occur during the clinical visit, it may be conducted for research purposes. Six minute walk testing, frailty scales, SF36, and optional actigraphy, all of which are research-only assessments, will be performed at baseline. Subjects will then be followed via phone for the duration of the study period.

Institution
MUSC
Recruitment Contact
Christian Conley
(843)876-4273
conleyc@musc.edu

A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dose MK-5475 in Participants with Pulmonary Hypertension Associated with COPD

Date Added
November 24th, 2020
PRO Number
Pro00105459
Researcher
Rahul Argula

List of Studies


Keywords
Lung, Pulmonary
Summary

This study is testing MK-5475 in people with pulmonary hypertension (high blood pressure in the blood vessel of the lung) linked to COPD (a chronic lung disease where it is hard to breathe). You may be able to join Part 2 of this study if you have pulmonary hypertension linked to COPD, and you are at least 40 years old but not more than 80 years old. About 24 subjects will be in Part 2 of this research. People from Part 1 of this study may be allowed to enter Part 2.

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



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