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

Overview

Información sobre este estudio

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.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Andrew Limper, M.D.

Cerrado para la inscripción

Contact information:

Shannon Daley C.C.R.C., CCRP

(507) 293-0637

Daley.Shannon@mayo.edu

More information

Publicaciones

Publications are currently not available

Otros temas en investigación

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CLS-20523803

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