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Mucolytic Agent
N-acetyl Cysteine for Idiopathic Pulmonary Fibrosis (PRECISIONS Trial)
Phase 3
Waitlist Available
Led By Fernando J Martinez, MD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
≥ 40 years of age
Diagnosed with IPF according to 2018 ATS/ERS/JRS/ALAT, confirmed by enrolling investigator
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
PRECISIONS Trial Summary
This trial will compare the effect of NAC plus standard care with placebo plus standard of care in patients with idiopathic pulmonary fibrosis who have the TOLLIP rs3750920 TT genotype. The study will compare the time to a composite endpoint of relative decline in lung function, first respiratory hospitalization, lung transplantation, or all-cause mortality.
Who is the study for?
This trial is for adults over 40 with idiopathic pulmonary fibrosis (IPF) who have a specific genetic marker (TOLLIP rs3750920 TT genotype). They must be on a stable dose of certain IPF medications if used, and able to give informed consent. Pregnant women, those planning pregnancy or not using effective contraception are excluded, as well as individuals with severe illnesses or recent use of investigational drugs.Check my eligibility
What is being tested?
The PRECISIONS trial is testing whether N-acetylcysteine (NAC), added to standard care for IPF patients with a particular genotype, can slow down lung function decline compared to placebo. It will also look at hospitalization rates, transplant needs, survival rates, changes in respiratory symptoms and overall health status.See study design
What are the potential side effects?
While the side effects of NAC are not detailed here, common ones may include nausea, vomiting, rash and headache. As it's being tested against a placebo plus standard care in this study; any additional side effects beyond those typically associated with standard IPF treatments would be noted.
PRECISIONS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 40 years old or older.
Select...
I have been diagnosed with IPF by a doctor.
Select...
My genetic test shows I have the TT TOLLIP variant.
PRECISIONS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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.
Secondary outcome measures
Annualized rate of non-elective, all-cause hospitalizations
Annualized rate of respiratory hospitalizations
Change in DLCO from randomization at 24 months
+24 moreSide effects data
From 2022 Phase 2 trial • 44 Patients • NCT0400505336%
Psychiatric
36%
Gastrointestinal
100%
80%
60%
40%
20%
0%
Study treatment Arm
Low-Dose NAC
Placebo
High-Dose NAC
PRECISIONS Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: N-acetylcysteineExperimental Treatment1 Intervention
600 mg oral N-acetylcysteine (NAC) three times daily for 24 months.
Group II: PlaceboPlacebo Group1 Intervention
Placebo tablet three times daily for 24 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
N-acetyl cysteine
2016
Completed Phase 4
~990
Find a Location
Who is running the clinical trial?
University of WashingtonOTHER
1,738 Previous Clinical Trials
1,844,149 Total Patients Enrolled
7 Trials studying Idiopathic Pulmonary Fibrosis
940 Patients Enrolled for Idiopathic Pulmonary Fibrosis
Weill Medical College of Cornell UniversityLead Sponsor
1,054 Previous Clinical Trials
1,316,326 Total Patients Enrolled
3 Trials studying Idiopathic Pulmonary Fibrosis
2,638 Patients Enrolled for Idiopathic Pulmonary Fibrosis
Pulmonary Fibrosis FoundationOTHER
7 Previous Clinical Trials
12,415 Total Patients Enrolled
4 Trials studying Idiopathic Pulmonary Fibrosis
12,036 Patients Enrolled for Idiopathic Pulmonary Fibrosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been on a stable dose of pirfenidone or nintedanib for at least 6 weeks.Your lung function test shows that you have less than 45% of the expected breathing capacity.I have not had a respiratory infection treated with antibiotics in the last 4 weeks.I am on the lung transplant list.I cannot perform a lung function test.I have had lung cancer in the past.I have not taken NAC supplements or prescriptions in the last 60 days.I do not have any major health issues that could affect my safety in the trial.I am 40 years old or older.I am a woman able to have children and will use two effective birth control methods during the study.I have been diagnosed with IPF by a doctor.My genetic test shows I have the TT TOLLIP variant.
Research Study Groups:
This trial has the following groups:- Group 1: N-acetylcysteine
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Idiopathic Pulmonary Fibrosis Patient Testimony for trial: Trial Name: NCT04300920 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people are being watched in this experiment?
"This study requires 200 participants that fit the pre-determined inclusion criteria. eligible patients can enroll at sites such as Medical University of South carolina or University of Minnesota."
Answered by AI
Are there any other hospitals in the area participating in this research?
"Presently, there are 26 hospitals enrolling patients for this study. These locations include the Medical University of South carolina in Charleston, the University of Minnesota in Minneapolis, and the University of Colorado in Aurora."
Answered by AI
What are the potential side effects of N-acetyl cysteine?
"N-acetyl cysteine is considered safe because it has gone through multiple rounds of clinical trials, meaning that there is data supporting its efficacy and safety."
Answered by AI
What is the scientific community's current understanding of N-acetyl cysteine?
"N-acetyl cysteine was first explored in 2013 by researchers at Suleyman Demirel University. To date, there have been a total of 18315 completed studies. Currently, 25 studies are ongoing with several taking place in Charleston, South carolina."
Answered by AI
Are there any patients who have yet to enroll in this trial?
"That is correct, the online clinicaltrials.gov database shows that this research is looking for qualified individuals. The study was created on December 17th 2020 and updated as recently as July 25th 2022. They are recruiting 200 total subjects from 26 different locations."
Answered by AI
Who else is applying?
What state do they live in?
Kentucky
Texas
Other
Washington
How old are they?
65+
18 - 65
What site did they apply to?
Indiana University
Weill Cornell Medicine
University of Texas Southwestern
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
3+
Why did patients apply to this trial?
i have tried nintedanid and condition getting worse.
PatientReceived 2+ prior treatments
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