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Prospective Treatment Efficacy in IPF Using Genotype for Nac Selection (PRECISIONS) Trial
Study Purpose
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.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
No
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
Interventional
Eligible Ages
40 Years and Over
Gender
All
More Inclusion & Exclusion Criteria
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
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Phase 3
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
Weill Medical College of Cornell University
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study.
Weill Medical College of Cornell UniversityUniversity of VirginiaUniversity of MichiganUniversity of Michigan
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
Other, NIH
Overall Status
Recruiting
Countries
United States
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied.
Idiopathic Pulmonary Fibrosis
Additional Details
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.
Arms & Interventions
Arms
Experimental: N-acetylcysteine
600 mg oral N-acetylcysteine (NAC) three times daily for 24 months.
Placebo Comparator: Placebo
Placebo tablet three times daily for 24 months.
Interventions
Drug: - N-acetyl cysteine
600 mg N-acetylcysteine (NAC) oral tablets three times daily for 24 months.
Drug: - Placebo
Matching oral placebo tablet three times daily for 24 months.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
