Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Study to Test Whether Nerandomilast Can Help Slow Down Changes in the Lung in People With a Family History of Pulmonary Fibrosis
Sponsor: Boehringer Ingelheim
Summary
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.
Official title: 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)
Key Details
Gender
All
Age Range
40 Years - Any
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2026-02-10
Completion Date
2029-05-23
Last Updated
2026-04-01
Healthy Volunteers
No
Interventions
Nerandomilast
Nerandomilast
Placebo
Placebo
Locations (56)
University of California Los Angeles
Los Angeles, California, United States
University of Colorado Denver
Aurora, Colorado, United States
Clinical Research Specialists LLC - Kissimmee
Kissimmee, Florida, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Weill Cornell Medicine-New York-60569
New York, New York, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Baylor College of Medicine
Houston, Texas, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Centro de Investigaciones Metabolicas (CINME)-C.A.B.A-61553
C.a.b.a, Argentina
Hospital Italiano de Buenos Aires
CABA, Argentina
Centro de Investigación Clinica Belgrano
CABA, Argentina
CEDIC - Centro de Investigacion Clinica
CABA, Argentina
Consultorios Médicos del Buen Ayre
Capital Federal, Argentina
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Lung Research Queensland
Chermside, Queensland, Australia
The Prince Charles Hospital
Chermside, Queensland, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Cliniques Universitaires Saint-Luc
Brussels, Belgium
UZ Leuven
Leuven, Belgium
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
McGill University Health Centre (MUHC)
Montreal, Quebec, Canada
Hôpital Louis Pradel
Bron, France
INS Coeur Poumon
Lille, France
HOP Bichat
Paris, France
HOP Pontchaillou
Rennes, France
Hôpital Larrey - CHU de Toulouse
Toulouse, France
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
Essen, Germany
Medizinische Hochschule Hannover
Hanover, Germany
Lungenfachklinik Immenhausen
Immenhausen, Germany
Krankenhaus Bethanien gGmbH
Solingen, Germany
IRCCS MultiMedica
Milan, Italy
Azienda Ospedaliera Universitaria di Padova
Padova, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy
Tosei General Hospital
Aichi, Seto, Japan
Tsuboi Hospital
Fukushima, Koriyama, Japan
Kanagawa Cardiovascular and Respiratory Center
Kanagawa, Yokohama, Japan
National Hospital Organization Kinki-Chuo Chest Medical Center
Osaka, Sakai, Japan
Hamamatsu University Hospital
Shizuoka, Hamamatsu, Japan
National Center for Global Health and Medicine
Tokyo, Shinjuku-ku, Japan
St. Antonius Ziekenhuis
Nieuwegein, Netherlands
Erasmus Medisch Centrum
Rotterdam, Netherlands
Severance Hospital
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Hospital de Galdakao
Galdakao, Spain
Hospital Universitari de Bellvitge
L'Hospitalet Del Llobregat, Spain
Hospital Universitario De La Princesa
Madrid, Spain
Hospital Virgen del Rocío
Seville, Spain
Royal Devon and Exeter Hospital
Exeter, United Kingdom
Royal Brompton Hospital
London, United Kingdom