NCT04300920CompletedPhase 3
Prospective Treatment Efficacy in IPF Using Genotype for Nac Selection (PRECISIONS) Trial
Source: ClinicalTrials.gov · Last updated 20 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 202 (actual)
- First submitted
- 6 Mar 2020
- Start date
- 17 Dec 2020
- Primary completion date
- 2 Mar 2026
- Lead sponsor
- Fernando J Martinez
- Diseases
- Idiopathic pulmonary fibrosis
- NCT number
- NCT04300920
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 202
- From 17 Dec 2020 to the primary completion date, 2 Mar 2026
- 25 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Active respiratory infection requiring treatment with antibiotics within 4 weeks of Visit 1
Other illness
- 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
- History of lung cancer
Other
- Pregnancy or planning to become pregnant
- Inability to perform spirometry
- Forced vital capacity (FVC) less than 45% predicted, using the global lung function index (GLI) equation at Visit 1
Who the study is looking for
- ≥ 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
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (25)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Michigan Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| University of Colorado Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Piedmont Healthcare Coordinator of this site? Confirm its status | Austell | United States | Unknown status |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| University of Virginia Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
| University of Chicago Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Ohio State University Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| University of Texas, Southwestern Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Indiana University Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| University of Kansas Medical Center Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| University of Southern California Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Loyola University Coordinator of this site? Confirm its status | Maywood | United States | Unknown status |
| University of Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Lisa Lancaster Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Tulane University Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
| Weill Cornell Medicine Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Temple University Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| University of Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| University Of Utah Health Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| University of Texas Health - San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| University of Washington Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Stanford University Coordinator of this site? Confirm its status | Stanford | United States | Unknown status |
| University of Arizona Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.