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Table 1 Inclusion and Exclusion Criteria

From: Design and rationale for the prospective treatment efficacy in IPF using genotype for NAC selection (PRECISIONS) clinical trial

Inclusion Criteria

40 years of age or greater

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

Signed informed consent

If taking pirfenidone or nintedanib, must be on stable dose for at least 6 weeks prior to the enrollment visit

Confirmed TOLLIP rs3570920 TT genotype

Exclusion Criteria

Pregnancy or planning to become pregnant

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 < 45% predicted using the global lung function index equation at Visit 1

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