Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study with Inhaled RVT-1601 for the Treatment of Persistent Cough in Patients with Idiopathic Pulmonary Fibrosis (IPF): SCENIC Trial

Date Added
May 28th, 2019
PRO Number
Pro00087983
Researcher
Timothy Whelan

List of Studies

Keywords
Lung, Pulmonary
Summary

The purpose of this study is to test the effects of the study drug, RVT-1601, in research subjects with persistent cough due to idiopathic pulmonary fibrosis (IPF) in improving cough (frequency and severity) and quality of life. RVT-1601 is delivered as a mist through an eFlow® nebulizer that research subjects will inhale through a mouthpiece attached to the nebulizer. The Screening period will last up to 4 weeks, in order to give the study doctor time to determine if you qualify for the study. After the Screening Period, you will participate in the study for approximately 24 weeks (6 months). Your total study participation is expected to be 28 weeks (7 months).

Institution
MUSC
Recruitment Contact
Abbi Reed
(843) 792-1820
reedab@musc.edu

A Phase 3, randomized, double-blind, parallel-group, placebo-controlled multicenter study to evaluate the efficacy and safety of two doses of GLPG1690 in addition to local standard of care for minimum 52 weeks in subjects with idiopathic pulmonary fibrosis.

Date Added
April 9th, 2019
PRO Number
Pro00075953
Researcher
Timothy Whelan

List of Studies

Keywords
Lung, Pulmonary
Summary

The main purpose of this study is to investigate how well GLPG1690, an experimental drug being investigated for the treatment of Idiopathic Pulmonary Fibrosis (IPF), is tolerated and to see how well GLPG1690 works together with your current treatment of pirfenidone or nintedanib. Approximately 750 participants will take part in the study. It has been described that patients with IPF have increased levels of autotaxin which leads to inflammation of the lungs. It is being investigated whether GLPG1690 can, by decreasing the activity of autotaxin, reduce safely the inflammation in the lungs that occurs in people with IPF, and therefore affect the progression of the disease.

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

A Phase 2, 24-Week, Randomized, Double-blind, Placebo-controlled, Multicenter Study, With an 28-Week Active Treatment Extension, to Evaluate the Efficacy and Safety of CC-90001 in Subjects With Idiopathic Pulmonary Fibrosis

Date Added
November 14th, 2017
PRO Number
Pro00070979
Researcher
Timothy Whelan

List of Studies

Keywords
Lung, Pulmonary
Summary

The purpose of this study is to test an experimental drug called CC-90001. This study will test CC-90001 (at doses of either 200 mg or 400 mg, given by mouth, once daily) compared to placebo, an inactive substance that contains no medicine. This study is being conducted to test the effect of CC-90001 on improving your IPF, and to see how well your body tolerates CC-90001.

Institution
MUSC
Recruitment Contact
Tomika Caldwell
(843) 792-3162
caldwet@musc.edu

Idiopathic Pulmonary Fibrosis Prospective Outcomes Registry (IPF-PRO)

Date Added
May 13th, 2014
PRO Number
Pro00033910
Researcher
Timothy Whelan

List of Studies

Keywords
Lung, Pulmonary
Summary

The purpose of this research registry is to better understand the natural history of Idiopathic Pulmonary Fibrosis and current practice patterns. The IPF-PRO registry will be used to collect data and biological samples that will support future research studies by identifying disease biomarkers for IPF. Through these studies, researchers hope to find new ways to detect, treat, and maybe prevent or cure health problems. Some of these studies may be about how genes affect health and disease, or how a person's genes affect their response to a treatment. Some of these studies may lead to new products, such as drugs or tests for diseases. We are asking you to let us collect and store some of your blood and health information so they might be used in these kinds of future studies.

If you are newly diagnosed with IPF and are eligible for participation in IPF-PRO, you will be asked to sign a consent form to become enrolled if you agree to be in this registry. At enrollment a member of MUSC research staff will collect information from you and about your medical history and medical care, as well as information about the types of health insurance (public or private) that you have. As part of your participation in this registry, you will be required to sign a medical release form giving permission for your medical records to be reviewed for the purposes of data collection for the registry. This is an observational registry which means you will not receive any investigational treatments or investigational drugs, and only minimally invasive procedures will be performed (blood draws) at scheduled clinic visits. In addition to the face to face visits for self-administered participant reported questionnaires and blood collection, at roughly 6-month intervals, sites will review the participant's medical records. Your disease management and treatment decisions will be determined by you and your health care professional. Subjects will be followed until the last enrolled subject has been followed for 3 years up to a maximum of 5 years.

Institution
MUSC
Recruitment Contact
Allison Barger
843-792-3169
Bargera@musc.edu



-- OR --