Prospective Treatment Efficacy in IPF Using Genotype for Nac Selection (PRECISIONS) Trial
Status:
Recruiting
Trial end date:
2025-07-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to compare the effect of n-acetylcysteine (NAC) plus standard
care with matched placebo plus standard of care in patients diagnosed with idiopathic
pulmonary fibrosis (IPF) who have the TOLLIP rs3750920 TT genotype. The study will compare
the time to a composite endpoint of relative decline in lung function [10% relative decline
in forced vital capacity (FVC), first respiratory hospitalization, lung transplantation, or
all-cause mortality]
The secondary objectives will be to examine the effect of NAC on the components of the
primary composite endpoint, the rates of clinical events, change in physiology, change in
health status, and change in respiratory symptoms.
Phase:
Phase 3
Details
Lead Sponsor:
Weill Medical College of Cornell University
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI) Pulmonary Fibrosis Foundation Three Lakes Foundation University of Michigan University of Virginia University of Washington