202 Participants Needed

N-acetyl Cysteine for Idiopathic Pulmonary Fibrosis

(PRECISIONS Trial)

Recruiting at 25 trial locations
BP
Overseen ByBetsy Peters
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Fernando J Martinez
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are taking pirfenidone or nintedanib, you must be on a stable dose for at least 6 weeks before joining the study.

Is N-acetylcysteine safe for humans?

N-acetylcysteine (NAC) is generally considered safe for humans, with low toxicity and rare adverse effects, even when used with other treatments. In studies involving patients with idiopathic pulmonary fibrosis and other chronic respiratory diseases, no significant adverse effects were noted.12345

How does the drug N-acetyl cysteine work for idiopathic pulmonary fibrosis?

N-acetyl cysteine (NAC) is unique for idiopathic pulmonary fibrosis (IPF) because it acts as an antioxidant, helping to slow lung function decline by increasing glutathione levels, a key antioxidant in the lungs. It can be administered through inhalation or intravenously, offering flexibility in treatment options.14567

What data supports the effectiveness of the drug N-acetyl cysteine for idiopathic pulmonary fibrosis?

Research shows that N-acetyl cysteine (NAC) can slow the decline of lung function in idiopathic pulmonary fibrosis (IPF) patients when used with other medications. It also helps increase glutathione levels, an important antioxidant, in the lungs of IPF patients, which may enhance lung protection.14578

Who Is on the Research Team?

CS

Cathie Spino, ScD

Principal Investigator

University of Michigan

FJ

Fernando J Martinez, MD

Principal Investigator

University of Massachusetts Chan Medical School

IN

Imre Noth, MD

Principal Investigator

University of Virginia

KF

Kevin Flaherty, MS, MD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have been on a stable dose of pirfenidone or nintedanib for at least 6 weeks.
Signed informed consent
I am 40 years old or older.
See 2 more

Exclusion Criteria

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.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 600 mg oral N-acetylcysteine (NAC) or placebo three times daily for 24 months

24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • N-acetyl cysteine
  • Placebo
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: N-acetylcysteineExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

N-acetyl cysteine is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Acetylcysteine for:
🇪🇺
Approved in European Union as Acetylcysteine for:
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Approved in Canada as Acetylcysteine for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Fernando J Martinez

Lead Sponsor

Weill Medical College of Cornell University

Lead Sponsor

Trials
1,103
Recruited
1,157,000+

University of Washington

Collaborator

Trials
1,858
Recruited
2,023,000+

Pulmonary Fibrosis Foundation

Collaborator

Trials
8
Recruited
12,600+

Three Lakes Foundation

Collaborator

Trials
1
Recruited
200+

University of Michigan

Collaborator

Trials
1,891
Recruited
6,458,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

University of Virginia

Collaborator

Trials
802
Recruited
1,342,000+

Published Research Related to This Trial

N-acetylcysteine (NAC) can significantly reduce the production of inflammatory markers like TNF-alpha and TGF-beta1 in alveolar macrophages from patients with idiopathic pulmonary fibrosis (IPF), suggesting its potential as an anti-inflammatory treatment.
In a study involving 16 IPF patients, NAC demonstrated a dose-dependent effect, with the highest concentration (10 mM) leading to substantial suppression of both spontaneous and LPS-stimulated inflammatory responses, indicating its possible role in slowing disease progression.
N-acetylcysteine inhibits TNF-alpha, sTNFR, and TGF-beta1 release by alveolar macrophages in idiopathic pulmonary fibrosis in vitro.Cu, A., Ye, Q., Sarria, R., et al.[2016]
N-acetylcysteine (NAC) is effective as a mucolytic agent in cystic fibrosis and serves as a safe antidote for acetaminophen overdose, demonstrating its versatility in treating respiratory conditions.
Due to its antioxidative and anti-inflammatory properties, NAC may benefit patients with chronic respiratory diseases like COPD and asthma, with low toxicity and rare side effects, making it a cost-effective treatment option.
Advances in the Use of N-Acetylcysteine in Chronic Respiratory Diseases.Mokra, D., Mokry, J., Barosova, R., et al.[2023]

Citations

N-acetylcysteine inhibits TNF-alpha, sTNFR, and TGF-beta1 release by alveolar macrophages in idiopathic pulmonary fibrosis in vitro. [2016]
Intravenous N-acetylcysteine and lung glutathione of patients with pulmonary fibrosis and normals. [2013]
The effect of oral N-acetylcysteine on lung glutathione levels in idiopathic pulmonary fibrosis. [2022]
Advances in the Use of N-Acetylcysteine in Chronic Respiratory Diseases. [2023]
N-Acetylcysteine attenuated pulmonary fibrosis induced by bleomycin via immunomodulation responses. [2023]
Efficacy of N-Acetylcysteine in Idiopathic Pulmonary Fibrosis: A Systematic Review and Meta-Analysis. [2022]
Multifaceted activity of N-acetyl-l-cysteine in chronic obstructive pulmonary disease. [2019]
Long-term efficacy of inhaled N-acetylcysteine in patients with idiopathic pulmonary fibrosis. [2019]
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