A Study to Test Whether Nerandomilast Can Help Slow Down Changes in the Lung in People With a Family History of Pulmonary Fibrosis (NCT07201922)
A Double Blind, Randomized, Placebo-controlled Exploratory Trial to Investigate the Efficacy and Safety of Nerandomilast Over 24 Months When Administered in Individuals With Interstitial Lung Abnormalities and a Family History of Pulmonary Fibrosis to Reduce the Risk of Worsening (DROP-FPF)
🩺 Plain-English Summary (8th-Grade Level)
This study is open to people aged 40 years or older who have at least 1 family member with pulmonary fibrosis. Pulmonary fibrosis is a condition where lung tissue becomes scarred, making it harder to breathe. People can join if a lung scan shows early changes in the lung, called interstitial lung abnormalities, which may lead to lung scarring. People with family members who have pulmonary fibrosis are more likely to develop it themselves. That is why it is important to check early for lung changes and find ways to prevent the condition from getting worse. The purpose of this study is to find out whether a medicine called nerandomilast can help slow down changes in the lung in people with a family history of pulmonary fibrosis. Participants are put into one of 2 groups randomly, which means the group is chosen 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. Participants take a tablet twice a day for about 2 to 3 years. There is a 3 out of 5 chance that participants will receive nerandomilast instead of the placebo. Participants are in the study for about 2 to 3 years. Participants visit the study site multiple times: more frequently during the first 2 years (about every 3 months), and then every 6 months thereafter. In the 3rd year, participants also have phone calls with the site staff every 3 months. Doctors regularly test lung function and take chest scans to see if the treatment works. The results are compared between the 2 groups to see if nerandomilast helps. The doctors also check participants' health and take note of any unwanted effects.
Who can join: Review the eligibility criteria below.
Location: University of California Los Angeles — Los Angeles, California
Age range: 40 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 (55 Sites)
Showing the first 25 of 55 sites.
- University of California Los Angeles — Los Angeles, California
- University of Colorado Denver — Aurora, Colorado
- Clinical Research Specialists LLC - Kissimmee — Kissimmee, Florida
- University of Kansas Medical Center — Kansas City, Kansas
- Brigham and Women's Hospital — Boston, Massachusetts
- University of Michigan — Ann Arbor, Michigan
- University of Minnesota — Minneapolis, Minnesota
- Weill Cornell Medicine-New York-60569 — New York, New York
- University of Pennsylvania — Philadelphia, Pennsylvania
- Medical University of South Carolina — Charleston, South Carolina
- Vanderbilt University Medical Center — Nashville, Tennessee
- Baylor College of Medicine — Houston, Texas
- Virginia Commonwealth University — Richmond, Virginia
- Centro de Investigaciones Metabolicas (CINME) — Buenos Aires,
- Hospital Italiano de Buenos Aires — CABA,
- Centro de Investigacion Clinica Belgrano — CABA,
- CEDIC - Centro de Investigacion Clinica — CABA,
- Consultorios Médicos del Buen Ayre — Capital Federal,
- Royal Prince Alfred Hospital — Camperdown, New South Wales
- Lung Research Queensland — Chermside, Queensland
- The Prince Charles Hospital — Chermside, Queensland
- The Alfred Hospital — Melbourne, Victoria
- Cliniques Universitaires Saint-Luc — Brussels,
- UZ Leuven — Leuven,
- St. Joseph's Healthcare Hamilton — Hamilton, Ontario
📞 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 Familial Pulmonary Fibrosis
- Mechanisms of Familial Pulmonary Fibrosis — Nashville, Tennessee
Explore by condition: All Familial Pulmonary Fibrosis 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.