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NCT04300920CompletedPhase 3

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

Source: ClinicalTrials.gov · Last updated 20 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
202 (actual)
First submitted
6 Mar 2020
Start date
17 Dec 2020
Primary completion date
2 Mar 2026
Lead sponsor
Fernando J Martinez
NCT number
NCT04300920

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 202
  • From 17 Dec 2020 to the primary completion date, 2 Mar 2026
  • 25 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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

Other illness

  • 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
  • History of lung cancer

Other

  • Pregnancy or planning to become pregnant
  • Inability to perform spirometry
  • Forced vital capacity (FVC) less than 45% predicted, using the global lung function index (GLI) equation at Visit 1

Who the study is looking for

  • ≥ 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

Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (25)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Michigan
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Ann ArborUnited StatesUnknown status
University of Colorado
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AuroraUnited StatesUnknown status
Piedmont Healthcare
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AustellUnited StatesUnknown status
Massachusetts General Hospital
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BostonUnited StatesUnknown status
Medical University of South Carolina
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CharlestonUnited StatesUnknown status
University of Virginia
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CharlottesvilleUnited StatesUnknown status
University of Chicago
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ChicagoUnited StatesUnknown status
Ohio State University
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ColumbusUnited StatesUnknown status
University of Texas, Southwestern
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DallasUnited StatesUnknown status
Indiana University
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IndianapolisUnited StatesUnknown status
University of Kansas Medical Center
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Kansas CityUnited StatesUnknown status
University of Southern California
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Los AngelesUnited StatesUnknown status
Loyola University
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MaywoodUnited StatesUnknown status
University of Minnesota
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MinneapolisUnited StatesUnknown status
Lisa Lancaster
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NashvilleUnited StatesUnknown status
Tulane University
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New OrleansUnited StatesUnknown status
Weill Cornell Medicine
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New YorkUnited StatesUnknown status
Temple University
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PhiladelphiaUnited StatesUnknown status
Mayo Clinic
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RochesterUnited StatesUnknown status
University of Rochester
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RochesterUnited StatesUnknown status
University Of Utah Health
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Salt Lake CityUnited StatesUnknown status
University of Texas Health - San Antonio
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San AntonioUnited StatesUnknown status
University of Washington
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SeattleUnited StatesUnknown status
Stanford University
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StanfordUnited StatesUnknown status
University of Arizona
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TucsonUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.