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Can a common supplement slow lung scarring? new trial targets gene clue

NCT ID NCT04300920

Disease control Sponsor: Fernando J Martinez Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether the antioxidant N-acetylcysteine (NAC) can slow lung decline in people with idiopathic pulmonary fibrosis (IPF) who have a specific gene variant (TOLLIP TT). Over 200 participants took NAC or a placebo for 24 months. The goal was to see if NAC delays worsening lung function, hospital stays, or death. Results may help tailor IPF treatment based on genetics.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
N-acetylcysteine (NAC) oral tablets
What this could lead to
If successful, this could show that NAC helps slow lung function decline in IPF patients with the TOLLIP TT genotype, offering a personalized treatment option.
What could go wrong
This is a completed phase 3 trial, but the benefit may be limited to a specific genetic subgroup. NAC is generally safe, but it may not work for all IPF patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

202 people

The number who actually took part.

Started

Dec 2020

Finished

Mar 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * ≥ 40 years of age * Diagnosed with IPF according to 2018 ATS/ERS/JRS/ALAT, confirmed by enrolling investigator * Signed informed consent * If taking pirfenidone or nintedanib, must be on stable dose for at least 6 weeks prior to enrollment visit * Confirmed rs3570920 TT TOLLIP genotype Exclusion Criteria: * Pregnancy or planning to become pregnant * Women of childbearing potential not willing to remain abstinent (refrain from heterosexual intercourse) or use two adequate methods of contraception, including at least one method with a failure rate of \<1% per year during study participation * Significant medical, surgical or psychiatric illness that in the opinion of the investigator would affect subject safety, including liver and renal failure * Receipt of an investigational drug or biological agent within the previous 4 weeks of the screening visit or 5 times the half-life, if longer * Supplemental or prescribed NAC therapy within 60 days of enrollment * Listed for lung transplantation at the time of screening * History of lung cancer * Inability to perform spirometry * Forced vital capacity (FVC) less than 45% predicted, using the global lung function index (GLI) equation at Visit 1 * Active respiratory infection requiring treatment with antibiotics within 4 weeks of Visit 1

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Conditions

The condition(s) this trial relates to.

idiopathic pulmonary fibrosis pulmonary fibrosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Idiopathic pulmonary fibrosis

Contacts and locations

Locations

  • Indiana University

    Indianapolis, Indiana, 46202, United States

  • Lisa Lancaster

    Nashville, Tennessee, 37204, United States

  • Loyola University

    Maywood, Illinois, 60153, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Ohio State University

    Columbus, Ohio, 43221, United States

  • Piedmont Healthcare

    Austell, Georgia, 30106, United States

  • Stanford University

    Stanford, California, 94305, United States

  • Temple University

    Philadelphia, Pennsylvania, 19140, United States

  • Tulane University

    New Orleans, Louisiana, 70112, United States

  • University of Arizona

    Tucson, Arizona, 85724, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of Colorado

    Aurora, Colorado, 80045, United States

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of Minnesota

    Minneapolis, Minnesota, 55455, United States

  • University of Rochester

    Rochester, New York, 14642, United States

  • University of Southern California

    Los Angeles, California, 90033, United States

  • University of Texas Health San Antonio

    San Antonio, Texas, 78229, United States

  • University of Texas Southwestern

    Dallas, Texas, 75390, United States

  • University of Utah Health

    Salt Lake City, Utah, 84108, United States

  • University of Virginia

    Charlottesville, Virginia, 22908, United States

  • University of Washington

    Seattle, Washington, 98195, United States

  • Weill Cornell Medicine

    New York, New York, 10016, United States

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