Prospective Treatment Efficacy in IPF Using Genotype for Nac Selection (PRECISIONS) Trial — PRECISIONS  

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title: Prospective Treatment Efficacy in IPF Using Genotype for Nac Selection (PRECISIONS) Trial

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

This is a multi-center, randomized, double-blind, placebo-controlled trial of NAC or placebo in about 200 participants with IPF with a TOLLIP rs3750920 TT genotype. Eligible participants will be randomized in a 1:1 fashion to NAC or placebo, stratified by stable concomitant IPF therapy use (i.e., pirfenidone or nintedanib administered for at least 6 weeks prior to screening) versus no pirfenidone or nintedanib use. Participants will receive 600 mg NAC orally or matched placebo to take three times daily for 24 months. ;

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

• NCT number: NCT04300920
• Study type: Interventional
• Source: Weill Medical College of Cornell University
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: December 17, 2020
• Completion date: December 31, 2025