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

Conditions

• Idiopathic Pulmonary Fibrosis

Interventions

DRUG

N-acetyl cysteine

600 mg N-acetylcysteine (NAC) oral tablets three times daily for 24 months.

DRUG

Placebo

Matching oral placebo tablet three times daily for 24 months.

Sponsors & Collaborators

• University of Virginia

  collaborator OTHER

• University of Michigan

  collaborator OTHER

• Pulmonary Fibrosis Foundation

  collaborator OTHER

• University of Washington

  collaborator OTHER

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Three Lakes Foundation

  collaborator UNKNOWN

• Fernando J Martinez

  lead OTHER

Principal Investigators

• Fernando J Martinez, MD · University of Massachusetts Chan Medical School

• Imre Noth, MD · University of Virginia

• Kevin Flaherty, MS, MD · University of Michigan

• Cathie Spino, ScD · University of Michigan

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-12-17

Primary Completion

2026-03-02

Completion

2026-03-02

FDA Drug

Yes

Countries

• United States

Study Locations