DROP-FPF is a clinical study that will assess whether an investigational medication called nerandomilast can reduce the risk of interstitial lung abnormalities (ILAs) or interstitial lung disease (ILD) getting worse over time. By learning more about people with early lung abnormalities, it may inform researchers how to reduce the risk of developing progressive pulmonary fibrosis.
The purpose of the Re-Spire Study is to help researchers learn more about the efficacy and long-term safety and tolerability of the research drug L606 in participants with PH-ILD.
There are two phases of the Re-Spire Study participants can potentially join with the second phase starting directly after the first phase ends. The first phase is called the "Blinded Treatment Phase" (BTP). This is the "double-blind," assigned by chance portion of the study and will last approximately 28 weeks (a 30-day Screening period followed by a 24-week study period). The second phase of the Re-Spire Study is called the "Open Label Extension Phase" (OLEP). This phase is optional. It is called "open-label" because there is no placebo and everyone who joins will take the active study drug, L606.
About 350 participants will take part in this research study from around 120 study centers or research sites in various countries or regions.
The overall objective of this proposal is to identify patients with Rheumatoid Arthritis-Interstitial Lung Disease (RA-ILD) that are at the highest risk for progressive disease at the time of diagnosis. Our central hypothesis is that novel quantitative imaging and specific blood markers will be associated with progressive RA-ILD. Approximately 80 subjects will be enrolled from MUSC and participation with last up to 2 years.
The MOMENTOUS study will test the prospective performance of the Tempus Pulmonary Hypertension ECG model within patients with interstitial lung disease (ILD) who do not have a diagnosis of Pulmonary Hypertension. The purpose of the study is to provide information on the clinical utility of this new technology within a multicenter randomized study. The study will target approximately 1000 participants completing the study over a period of 2-3 years. Study participation will consist of 4 visits over a period of 6 months.
This study will see if the experimental medicine MTX-463 can slow or stop idiopathic pulmonary fibrosis (IPF) from worsening in people at least 40 years of age or older. Participants will receive either MTX-463 or a placebo (which contains no active drug) through an intravenous infusion once every 4 weeks, for a total of 6 infusions. Overall, participants will attend a total of 9 visits over the course of approximately 32 weeks, or roughly 8 months.
The goal of this research study is to explore and evaluate the acceptability and feasibility of a 8-week, nurse-led Palliative Care program (SUPPORT-T) delivered over the internet to help educate and support individuals with Progressive Pulmonary Fibrosis (PFF) and their caregivers. In this study, we will enroll 80 PFF patients and 80 careparnters (total N=160 participants) who will then either receive the online SUPPORT-T program or enhanced usual care (educational handouts). At the end of the study, 15 PFF patients and caregivers who received SUPPORT-T and 5 community partners will take part in one-on-one interviews with the researchers to provide their feedback on the program; so as to improve it for a larger study. This study is being conducted by the Medical University of South Carolina in South Carolina and Mount Sinai Hospital in New York.
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.
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.
This study is investigating the drug, called mosliciguat, for the treatment of PH-ILD. Participation in the study may last for about 4 ½ years, although the actual time of participation may be shorter or longer. Part 1 of the study will take about 6 months. Part 2 of the study could last up to about 4 years. During the study, participants will be required to make clinic visits in person and at times will need to meet with study staff over the phone/video. At some of the clinic visits, participants will have blood drawn and have procedures to test their lungs and heart function. Participants will be randomly assigned to get mosliciguat or placebo in Part 1. In Part 2, all participants will get mosliciguat. Approximately 120 people will participate in this study.
This is a randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of 2 doses of AP01 versus placebo on top of standard of care in subjects with Progressive Pulmonary Fibrosis (PPF) over 52 weeks. Subjects will participate in the study for up to 58 weeks, inclusive of a Screening Period of up to 4 weeks, a 52-week Treatment Period, and a 2-week Follow-up Period that includes a Follow-up telephone call (TC) 2 weeks post final dose. Up to 300 eligible subjects will be randomized in a 2:1:2 ratio to 1 of 3 treatment arms: AP01 100 mg twice daily (BID), AP01 50 mg BID, or placebo BID (8 mL; two 4 mL blow-fill-seal [BFS] ampoules BID).