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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
Must not have
Active respiratory infection requiring treatment with antibiotics within 4 weeks of Visit 1
Listed for lung transplantation at the time of screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Pivotal 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.
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not had a respiratory infection treated with antibiotics in the last 4 weeks.
Select...
I am on the lung transplant list.
Select...
I cannot perform a lung function test.
Select...
I have had lung cancer in the past.
Select...
I am a woman able to have children and will use two effective birth control methods during the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
Time to first respiratory hospitalization
Lung
Side effects data
From 2024 Phase 2 & 3 trial • 192 Patients • NCT0305537733%
Nausea
26%
Headache
23%
Viral Upper Respiratory Tract Infection
18%
Insomnia
16%
Vomiting
14%
Gastroesophageal Reflux Disease
10%
Dyspepsia
9%
Decreased Appetite
7%
Stomachache
7%
Irritability
7%
Cough
6%
Nightmares
5%
Diarrhea
5%
Gastroenteritis
5%
Sinusitis
5%
Anxiety
4%
Dizziness
4%
Pharyngitis
4%
Nasal Congestion
3%
Abdominal Pain
3%
Heartburn
3%
Fatigue
3%
Poor Quality Sleep
3%
Vivid Dreams
3%
Sore Throat
2%
Tired
2%
Rhinitis Seasonal (Worsening)
2%
Influenza Like Illness
2%
Pharyngitis Streptococcal
2%
Increased Appetite
2%
Migraine
2%
Depressed Mood
2%
Ear Congestion
2%
Concussion
1%
Plantar Fasciitis
1%
Lymphadenopathy
1%
Conjunctivitis
1%
Eyebrow Twitching
1%
Flatulence
1%
Chills
1%
Drug Withdrawal Syndrome
1%
Early Satiety
1%
Hangover
1%
Chest Pain
1%
Coronavirus Infection
1%
Immunization Reaction
1%
Bronchitis
1%
Hordeolum
1%
Influenza
1%
Pyrexia
1%
Tonsillitis
1%
Urinary Tract Infection
1%
Allergy to arthropod bite
1%
Back Pain
1%
Head Injury
1%
Post-traumatic pain
1%
Road Traffic Accident
1%
Sprained Ankle
1%
Sunburn
1%
Abnormal Weight Loss
1%
Limb Injury
1%
Muscle Weakness
1%
Myalgia
1%
Pain in Extremity
1%
Dysgeusia
1%
Dyskinesia
1%
Somnolence
1%
Syncope
1%
Abnormal Dreams
1%
ADHD
1%
Increased Suicidal Thoughts
1%
Mood Swings
1%
Panic Episode
1%
Nocturia
1%
Heavy Menstrual Bleeding
1%
Vulva Cyst
1%
Dysphonia
1%
Epistaxis
1%
Sinus Congestion
1%
Throat Irritation
1%
Wheezing
1%
Dermatitis Contact
1%
Night Sweats
1%
Dental Operation
1%
Intrauterine Contraception
1%
Weight Decrease
1%
Agitation
100%
80%
60%
40%
20%
0%
Study treatment Arm
N-acetylcysteine
Placebo
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
2023
Completed Phase 4
~1280
Find a Location
Who is running the clinical trial?
University of WashingtonOTHER
1,831 Previous Clinical Trials
1,907,367 Total Patients Enrolled
7 Trials studying Idiopathic Pulmonary Fibrosis
940 Patients Enrolled for Idiopathic Pulmonary Fibrosis
Weill Medical College of Cornell UniversityLead Sponsor
1,092 Previous Clinical Trials
1,154,584 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
Three Lakes FoundationUNKNOWN
University of MichiganOTHER
1,863 Previous Clinical Trials
6,441,371 Total Patients Enrolled
10 Trials studying Idiopathic Pulmonary Fibrosis
12,410 Patients Enrolled for Idiopathic Pulmonary Fibrosis
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,943 Previous Clinical Trials
47,797,691 Total Patients Enrolled
22 Trials studying Idiopathic Pulmonary Fibrosis
4,399 Patients Enrolled for Idiopathic Pulmonary Fibrosis
University of VirginiaOTHER
785 Previous Clinical Trials
1,316,244 Total Patients Enrolled
4 Trials studying Idiopathic Pulmonary Fibrosis
2,742 Patients Enrolled for Idiopathic Pulmonary Fibrosis
Fernando J Martinez, MDPrincipal InvestigatorWeill Medical College of Cornell University
3 Previous Clinical Trials
1,131 Total Patients Enrolled
1 Trials studying Idiopathic Pulmonary Fibrosis
50 Patients Enrolled for Idiopathic Pulmonary Fibrosis
Imre Noth, MDPrincipal InvestigatorUniversity of Virginia
4 Previous Clinical Trials
3,089 Total Patients Enrolled
3 Trials studying Idiopathic Pulmonary Fibrosis
2,825 Patients Enrolled for Idiopathic Pulmonary Fibrosis
Cathie Spino, ScDPrincipal InvestigatorUniversity of Michigan
3 Previous Clinical Trials
10,392 Total Patients Enrolled
1 Trials studying Idiopathic Pulmonary Fibrosis
10,000 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