N-acetyl Cysteine for Idiopathic Pulmonary Fibrosis

(PRECISIONS Trial)

Recruiting in Palo Alto (17 mi)

+25 other locations

Overseen by Kevin Flaherty, MS, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Weill Medical College of Cornell University

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Fernando J Martinez, MD

Principal Investigator

Weill Medical College of Cornell University

Imre Noth, MD

Principal Investigator

University of Virginia

Cathie Spino, ScD

Principal Investigator

University of Michigan

Kevin Flaherty, MS, MD

Principal Investigator

University of Michigan

Eligibility Criteria

This trial is for adults over 40 with idiopathic pulmonary fibrosis (IPF) who have a specific genetic marker (TOLLIP rs3750920 TT genotype). They must be on a stable dose of certain IPF medications if used, and able to give informed consent. Pregnant women, those planning pregnancy or not using effective contraception are excluded, as well as individuals with severe illnesses or recent use of investigational drugs.

Inclusion Criteria

I have been on a stable dose of pirfenidone or nintedanib for at least 6 weeks.

Signed informed consent

I am 40 years old or older.

Exclusion Criteria

Your lung function test shows that you have less than 45% of the expected breathing capacity.

I have not had a respiratory infection treated with antibiotics in the last 4 weeks.

I am on the lung transplant list.

Treatment Details

Interventions

• N-acetyl cysteine (Mucolytic Agent)
• Placebo (Other)

Trial Overview The PRECISIONS trial is testing whether N-acetylcysteine (NAC), added to standard care for IPF patients with a particular genotype, can slow down lung function decline compared to placebo. It will also look at hospitalization rates, transplant needs, survival rates, changes in respiratory symptoms and overall health status.

Participant Groups

Group I: N-acetylcysteine Experimental Treatment 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

Placebo tablet three times daily for 24 months.

N-acetyl cysteine is already approved in Canada for the following indications:

Approved in Canada as Acetylcysteine for:

• Acetaminophen overdose
• Chronic bronchitis
• Chronic obstructive pulmonary disease (COPD)
• Cystic fibrosis

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Dr. Robert Min

Weill Medical College of Cornell University

Chief Executive Officer since 2024

MD, MBA

Dr. Adam R. Stracher

Weill Medical College of Cornell University

Chief Medical Officer since 2024

MD

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

Dr. Timothy H. Dellit

University of Washington

Chief Executive Officer since 2023

MD from University of Washington

Dr. Anneliese Schleyer

University of Washington

Chief Medical Officer since 2023

MD, MHA

Pulmonary Fibrosis Foundation

Collaborator

Trials

8

Recruited

12,600+

Three Lakes Foundation

Collaborator

Trials

1

Recruited

200+

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+

Marschall S. Runge

University of Michigan

Chief Executive Officer since 2015

MD, PhD

Karen McConnell

University of Michigan

Chief Medical Officer since 2020

MD

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Dr. Gary H. Gibbons

National Heart, Lung, and Blood Institute (NHLBI)

Chief Executive Officer since 2012

MD from Harvard Medical School

Dr. James P. Kiley

National Heart, Lung, and Blood Institute (NHLBI)

Chief Medical Officer since 2011

MD from University of California, San Francisco

University of Virginia

Collaborator

Trials

802

Recruited

1,342,000+

James E. Ryan

University of Virginia

Chief Executive Officer since 2018

J.D. from Harvard Law School

Nikki Hastings

University of Virginia

Chief Medical Officer since 2018

Ph.D. in Biomedical Engineering from University of Virginia