A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability and Efficacy of Caveolin-1-Scaffolding-Protein-Derived Peptide (LTI-03) in Patients with Idiopathic Pulmonary Fibrosis

Date Added
June 17th, 2025
PRO Number
Pro00145146
Researcher
Timothy Whelan

List of Studies


Keywords
Interstitial Lung Disease (ILD), Lung, Pulmonary
Summary

This study will compare the safety, tolerability, and efficacy of inhaled study drug LTI-03 to placebo in participants diagnosed with IPF within 5 years of Screening who may be receiving standard of care (SoC) antifibrotic therapy. Taking part in this research is expected to last up to 32 weeks, which includes a 4-week screening period, a 24-week treatment period, and 4-week post-treatment follow-up period. The general procedures include review of eligibility; review of medical and medication history and changes in health; completing questionnaires; undergoing physical exams and having vital signs measured; collecting blood samples; examinations such as ECG, spirometry, HRCT, and DLCO and using an inhaler to take the study drug.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

Pivotal Method-Comparison Study for the Cardiac Performance System (CPS) to Measure Hemodynamic Parameters

Date Added
June 19th, 2025
PRO Number
Pro00145464
Researcher
Rahul Argula

List of Studies


Keywords
Pulmonary Hypertension
Summary

Patients suspected of having compromised heart function often require invasive right heart catheterization for diagnosis and management. This study is testing the Cardiac Performance System (CPS), a non-invasive device that uses sensors and electrocardiogram (ECG) electrodes to measure heart function. The purpose of this study is to determine if the CPS provides pulmonary pressure assessment similar to that obtained through right heart catherization.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
(843) 792-0965
recruitment@musc.edu

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamic Effects of REGN7544, an Antagonist Monoclonal Antibody to NPR1, in Patients with Sepsis-Induced Hypotension

Date Added
June 19th, 2025
PRO Number
Pro00145352
Researcher
Andrew Goodwin

List of Studies


Keywords
Critical Care
Summary

The study is researching an experimental drug called REGN7544. The study is focused on adult patients (18 to 85 years old) hospitalized due to a serious infection (called "sepsis" in this form) and receiving standard-of-care medications for low blood pressure (called "vasopressors" in this form) due to sepsis. The aim of the study is to see if REGN7544 is safe, tolerable and effective when compared to placebo, by observing the effects on blood pressure and the total amount of vasopressor dose received. The general procedures include collection of information from medical records, some additional testing, such as electrocardiogram, collection of blood, and having blood pressure and heart rate measured .There will also be a screening visit, two telephone visits, and one additional in-person visit. It is expected that taking part in this research will last about 13 weeks (3 months).

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

A Real-world Patient Registry in Group 3 Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)

Date Added
July 9th, 2025
PRO Number
Pro00144899
Researcher
Denise Gabrielle Sese

List of Studies

Keywords
Interstitial Lung Disease (ILD), Pulmonary Hypertension
Summary

The purpose of this study is to observe and capture demographic characteristics,
treatment patterns, and clinical outcomes of interest for patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD) to further clinical understanding of the epidemiological landscape and outcomes of the disease and treatment. This study will follow patients for up to 5 years after enrollment.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
(843) 792-0965
recruitment@musc.edu

Real Life Evaluation of the LibAirtyTM Airway Clearance System in Adults with Bronchiectasis (RELACS) - A Prospective Study

Date Added
July 15th, 2025
PRO Number
Pro00146145
Researcher
Patrick Flume

List of Studies


Keywords
Bronchiectasis
Summary

Subjects prescribed with the LibAirty system will be instructed to perform daily therapy sessions per standard device use recommendations. During the study period, subjects will be followed according to standard of care procedures and timelines for Bronchiectasis management. Clinical outcomes and healthcare resource utilization during the study period will be collected and compared to the 12-month period prior to study enrollment. Adherence to therapy will be evaluated by device recorded logs. Health related quality of life and subject satisfaction with the system will be evaluated by designated questionnaires, collected during clinic visits. Subjects will be followed for 12 months after starting therapy. Each subject will be required to complete a screening and enrollment visit, and any scheduled follow up visits according to standard of care timelines through 12 months (with data expected to be collected at 6 and 12 (±1m) months at minimum). Up to one hundred (100) subjects older than 21 years of age, with bronchiectasis who meet the entry criteria will be enrolled to the study, in up to ten (10) sites.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437930965
recruitment@musc.edu

A PHASE 1 / 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SINGLE ESCALATING DOSES OF PF-07868489 IN HEALTHY ADULT PARTICIPANTS AND, ADDITIONALLY, CLINICAL ACTIVITY OF REPEAT DOSES IN PARTICIPANTS WITH PULMONARY ARTERIAL HYPERTENSION

Date Added
August 28th, 2025
PRO Number
Pro00144472
Researcher
Rahul Argula

List of Studies


Keywords
Pulmonary Hypertension
Summary

This study is the first time the drug PF-07868489 will be tested in humans. The goal is to see if the drug is safe and how the body reacts to it. In the first part, healthy adults will receive a single dose to check for any side effects and how the drug moves through the body. In the second part, patients with a specific lung condition called Pulmonary Arterial Hypertension (PAH) will receive multiple doses to see if the drug helps their condition and to further check its safety and effects.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

Phase 2 Clinical Platform Trial Investigating Multiple Therapeutic Options for the Treatment of Hospitalized Patients with Acute Respiratory Distress Syndrome (ARDS)

Date Added
September 25th, 2025
PRO Number
Pro00146665
Researcher
Andrew Goodwin

List of Studies


Keywords
Critical Care
Summary

This is a Phase 2 platform research study that is assessing three different investigational medications (versus placebo) for hospitalized adults who have Acute Respiratory Distress Syndrome (ARDS). As a platform study, each of the three treatment groups will receive a different investigational drug (or placebo) depending on the severity of their ARDS. Participants will also receive standard treatment as determined by the treating physician.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
(843) 792-0965
recruitment@musc.edu

A Pilot Study to Assess the Effects of Simeox 200 Airway Clearance Device in Bronchiectasis Patients with Chronic Mucus Hypersecretion

Date Added
October 14th, 2025
PRO Number
Pro00147345
Researcher
Patrick Flume

List of Studies


Keywords
Bronchiectasis, Lung
Summary

This will be a study in the home care setting to further validate the concept of Simeox 200 in a cohort of patients with bronchiectasis and overproduction of mucous as an alternative to other methods of ACT(airway clearance techniques). Bronchiectasis is a chronic lung disease where airways become permanently damaged, widened, and lose their ability to clear mucus, leading to a buildup of bacteria, recurrent infections, and symptoms like a daily cough, thick, discolored phlegm, shortness of breath, and fatigue. The device is a 510(k) FDA cleared device that works using by air and vibration to help clear mucous from the lungs. There are 4 visits and an at home usage period. The study will be running approximately a year or until the cohort is filled. The data from this study will be used to power a future randomized controlled pivotal clinical study comparing Simeox 200 against other ACTs such as High Frequency Chest Wall Oscillation (HFCWO).

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

A Multi-Center, Prospective, Non-Interventional Study of Real-World Effectiveness of Etrasimod in Patients with Ulcerative Colitis

Date Added
October 23rd, 2025
PRO Number
Pro00147432
Researcher
Erin Forster

List of Studies


Keywords
Ulcerative colitis
Summary

The goal is to evaluate how well etrasimod helps reduce symptoms by week 12 of treatment. This involves determining whether patients experience enough improvement to be considered in remission. The focus is on how the medication performs in everyday, real-world conditions.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

A Multinational, Long-Term, Open-Label Extension Study of Subjects Who Have Participated in Avalyn Pharma Studies of Inhaled Antifibrotic Agents (AP-LTE-008 SAIL)

Date Added
November 5th, 2025
PRO Number
Pro00146978
Researcher
Timothy Whelan

List of Studies


Keywords
Lung
Summary

This study gives people who were part of an earlier Avalyn research protocol with inhaled pirfenidone versus placebo an opportunity to convert to open label or active investigational drug treatment. The goal is to continue learning additional safety and efficacy information in patients over a longer period of treatment time. Pulmonary fibrosis is a disorder with a poor prognosis that is often far worse than many cancers with limited treatment options. While this medication has yet to be proven effective, the safety profile currently is acceptable and the risks versus benefits favor offering this opportunity to patients with informed consent.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu



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