FIBRONEER-ACT: A Study to Test Whether Nerandomilast Helps People With Fibrosing Interstitial Lung Disease at Risk for Disease Progression (NCT07540988)
A Double-blind, Randomized, Placebo-controlled Trial Investigating the Efficacy and Safety of Nerandomilast Over at Least 52 Weeks in Patients With Fibrosing Interstitial Lung Disease at Risk for Disease Progression (FIBRONEER-ACT)
🩺 Plain-English Summary (8th-Grade Level)
This study is open to adults with fibrosing interstitial lung disease (ILD) other than idiopathic pulmonary fibrosis (IPF). People can join the study if they have been diagnosed with this condition within the last 3 years and are at risk of developing progressive pulmonary fibrosis (PPF). The purpose of this study is to find out whether a medicine called nerandomilast helps people with fibrosing interstitial lung disease who may be at risk for their disease getting worse. Participants are put into 2 groups randomly, which means by chance. One group takes nerandomilast tablets, and the other group takes placebo tablets. Placebo tablets look like nerandomilast tablets but do not contain any medicine. Nerandomilast is a type of medicine that may help reduce lung function decline and slow disease progression. Participants are in the study for up to about 2 years and 4 months. During this time, they visit the study site regularly. Doctors regularly test lung function using methods like spirometry to measure forced vital capacity (FVC, maximum amount of air a participant can blow out after taking a deep breath) and DLCO (diffusing capacity of the lungs for carbon monoxide; it estimates how well oxygen moves from the lungs into the blood). Additionally, high-resolution computed tomography (HRCT) is performed to monitor how the lung condition is changing over time. The results are compared between the groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.
Who can join: Review the eligibility criteria below.
Location: University of Alabama at Birmingham — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (162 Sites)
Showing the first 25 of 162 sites.
- University of Alabama at Birmingham — Birmingham, Alabama
- University of Southern California — Los Angeles, California
- Newport Native MD, Inc — Newport Beach, California
- Yale University School of Medicine — New Haven, Connecticut
- Clinical Research Specialists LLC - Kissimmee — Kissimmee, Florida
- Lakeland Regional Medical Center - Lakeland — Lakeland, Florida
- Advanced Pulmonary Research Institute — Loxahatchee Groves, Florida
- Essence MD Research — Naples, Florida
- Avanza Medical Research Center — Pensacola, Florida
- Coastal Pulmonary & Critical Care — St. Petersburg, Florida
- Indiana University Health Enterprise Clinical Research Operation — Indianapolis, Indiana
- University of Kansas Medical Center — Kansas City, Kansas
- University of Michigan — Ann Arbor, Michigan
- University of Minnesota — Minneapolis, Minnesota
- Mayo Clinic, Rochester — Rochester, Minnesota
- Henderson Clinical Trials — Henderson, Nevada
- Weill Cornell Medicine-New York-60569 — New York, New York
- Columbia University Medical Center-New York Presbyterian Hospital — New York, New York
- Coastal Carolina Health Care, P.A. Pulmonary and Sleep Medicine — New Bern, North Carolina
- Southeastern Research Center-Winston-Salem-61365 — Winston-Salem, North Carolina
- University Hospitals Cleveland Medical Center — Cleveland, Ohio
- University of Pennsylvania — Philadelphia, Pennsylvania
- Temple University — Philadelphia, Pennsylvania
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania
- Lowcountry Lung and Critical Care — Charleston, South Carolina
📞 Contact the Study Coordinator
Phone: (800) 243-0127
Email: clintriage.rdg@boehringer-ingelheim.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Interstitial Lung Diseases
- A Study of the Natural Progression of Interstitial Lung Disease (ILD) — Chicago, Illinois
- A Study to Test Whether Nerandomilast Helps People With Lungfibrosis Related to Rheumatic Diseases — Birmingham, Alabama
Explore by condition: All Interstitial Lung Diseases clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.