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Completed

NCT Number: NCT04300920

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

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Key information

Conditions

Idiopathic Pulmonary Fibrosis Fibrosis Lung Diseases Lung Diseases, Interstitial Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Fibrosis Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Arizona, Tucson, Arizona, United States

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About this study

This is a multi-center, randomized, double-blind, placebo-controlled trial of NAC or placebo in about 200 participants with IPF with a TOLLIP rs3750920 TT genotype.

Eligible participants will be randomized in a 1:1 fashion to NAC or placebo, stratified by stable concomitant IPF therapy use (i.e., pirfenidone or nintedanib administered for at least 6 weeks prior to screening) versus no pirfenidone or nintedanib use. Participants will receive 600 mg NAC orally or matched placebo to take three times daily for 24 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

N-acetyl cysteine

Drug

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

Other names: NAC

Placebo

Drug

Matching oral placebo tablet three times daily for 24 months.

Primary outcomes

  1. 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.

    Time frame: 24 months

    This is a composite endpoint of time to 10% relative decline in forced vital capacity (FVC), first respiratory hospitalization, lung transplant or death from any cause. Respiratory hospitalizations will be determined by a blinded clinical events classification (adjudication) committee.

Secondary outcomes

  1. Time to one of the following composite criteria: 10% relative decline in FVC % predicted, first respiratory hospitalization, lung transplant or death from any cause.

    Time frame: 24 months

    This is a composite endpoint of time to 10% relative decline in FVC % predicted, based on the global lung initiative (GLI) reference equation, first respiratory hospitalization, lung transplant or death from any cause. Respiratory hospitalizations will be determined by a blinded clinical events classification (adjudication) committee.

  2. Time to death from any cause

    Time frame: 24 months

  3. Time to first respiratory hospitalization, lung transplant, or death from any cause

    Time frame: 24 months

    Respiratory hospitalizations will be determined by a blinded clinical events classification (adjudication) committee.

  4. Time to 10% relative decline in FVC, lung transplant or death from any cause

    Time frame: 24 months

  5. Time to lung transplant, or death from any cause

    Time frame: 24 months

  6. Time to 10% relative decline in FVC %predicted, lung transplant, or death from any cause

    Time frame: 24 months

  7. Time to first all-cause hospitalization, lung transplant, or death from any cause

    Time frame: 24 months

  8. Annualized rate of respiratory hospitalizations

    Time frame: 24 months

  9. Annualized rate of non-elective, all-cause hospitalizations

    Time frame: 24 months

  10. Absolute change in FVC % predicted from randomization at 12 months

    Time frame: 12 months

  11. Absolute change in FVC % predicted from randomization at 24 months

    Time frame: 24 months

  12. Absolute change in FVC from randomization at 12 months

    Time frame: 12 months

  13. Absolute change in FVC from randomization at 24 months

    Time frame: 24 months

  14. Absolute change in diffusing capacity of the lung for carbon monoxide (DLCO) uncorrected for hemoglobin from randomization at 12 months

    Time frame: 12 months

  15. Absolute change in DLCO uncorrected from randomization at 24 months

    Time frame: 24 months

  16. Absolute change in patient reported outcomes scores for the Leicester Cough Questionnaire (LCQ) from randomization at 12 months.

    Time frame: 12 months

  17. Absolute change in patient reported outcomes scores for the EuroQoL EQ-5D Questionnaire from randomization at 12 months.

    Time frame: 12 months

  18. Change in patient reported outcomes scores for the University of California, San Diego Shortness of Breath (UCSD-SOB) Questionnaire from randomization at 12 months.

    Time frame: 12 months

  19. Change in patient reported outcomes scores for the King's Brief Interstitial Lung Disease (K-BILD) Questionnaire from randomization at 12 months.

    Time frame: 12 months

  20. Change in patient reported outcomes scores for the St. George's Respiratory Questionnaire (SGRQ) from randomization at 12 months.

    Time frame: 12 months

  21. Change in patient reported outcomes scores for the Leicester Cough Questionnaire (LCQ) from randomization at 24 months

    Time frame: 24 months

  22. Change in patient reported outcomes scores for the EuroQoL EQ-5D Questionnaire from randomization at 24 months

    Time frame: 24 months

  23. Change in patient reported outcomes scores for the University of California, San Diego Shortness of Breath (UCSD-SOB) Questionnaire from randomization at 24 months

    Time frame: 24 months

  24. Change in patient reported outcomes scores for the King's Brief Interstitial Lung Disease (K-BILD) Questionnaire from randomization at 24 months

    Time frame: 24 months

  25. Change in patient reported outcomes scores for the St. George's Respiratory Questionnaire (SGRQ) from randomization at 24 months

    Time frame: 24 months

  26. Proportion of participants with and number of treatment-emergent adverse events, serious adverse events, adverse events leading to discontinuation, and unanticipated problems

    Time frame: 24 months

  27. Estimated time per six months free of 10% relative decline in FVC, first respiratory hospitalization, lung transplant or death from any cause.

    Time frame: 24 months

  28. Estimated time per six months free of 10% relative decline in FVC % predicted, first respiratory hospitalization, lung transplant or death from any cause.

    Time frame: 24 months

  29. Estimated time lived per six months (based on all-cause mortality).

    Time frame: 24 months

  30. Average time per six months free of first respiratory hospitalization, lung transplantation or death from any cause.

    Time frame: 24 months

  31. Average time per six months free of 10% relative decline in FVC, lung transplant, or death from any cause.

    Time frame: 24 months

  32. Average time per six months free of lung transplant, or death from any cause.

    Time frame: 24 months

  33. Average time per six months free of 10% relative decline in FVC % predicted, lung transplant, or death from any cause.

    Time frame: 24 months

  34. Average time per six months free of all-cause hospitalization, lung transplant, or death from any cause.

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Fernando J Martinez

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • Pulmonary Fibrosis Foundation
  • Three Lakes Foundation
  • University of Michigan
  • University of Virginia
  • University of Washington

Registry information

Acronym: PRECISIONS

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Mar 9, 2020
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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