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Mucolytic Agent

N-acetyl Cysteine for Idiopathic Pulmonary Fibrosis (PRECISIONS Trial)

Phase 3

Waitlist Available

Led By Fernando J Martinez, MD

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

≥ 40 years of age

Diagnosed with IPF according to 2018 ATS/ERS/JRS/ALAT, confirmed by enrolling investigator

Must not have

Active respiratory infection requiring treatment with antibiotics within 4 weeks of Visit 1

Listed for lung transplantation at the time of screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Pivotal Trial

Summary

This trial will compare the effect of NAC plus standard care with placebo plus standard of care in patients with idiopathic pulmonary fibrosis who have the TOLLIP rs3750920 TT genotype. The study will compare the time to a composite endpoint of relative decline in lung function, first respiratory hospitalization, lung transplantation, or all-cause mortality.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While the side effects of NAC are not detailed here, common ones may include nausea, vomiting, rash and headache. As it's being tested against a placebo plus standard care in this study; any additional side effects beyond those typically associated with standard IPF treatments would be noted.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 40 years old or older.

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I have been diagnosed with IPF by a doctor.

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My genetic test shows I have the TT TOLLIP variant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am on the lung transplant list.

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I cannot perform a lung function test.

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I have had lung cancer in the past.

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I am a woman able to have children and will use two effective birth control methods during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to one of the following composite endpoint criteria: 10% relative decline in forced vital capacity (FVC), first respiratory hospitalization, lung transplant or death from any cause.

Secondary study objectives

Time to first respiratory hospitalization

Lung