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A Study to Test Whether Nerandomilast Can Help Slow Down Changes in the Lung in People With a Family History of Pulmonary Fibrosis

80 patients around the world

Available in Argentina, United States

Boehringer Ingelheim

5Research sites

80Patients around the world

This study is for people with

Pulmonary fibrosis

Interstitial Lung Disease

From 40 Years

All Gender

: Individuals ≥40 years of age at the time of first signed informed consent at Visit 1a.
Participants must have at least 1 first-degree relative (biological parent, sibling, or child) with confirmed pulmonary fibrosis (idiopathic pulmonary fibrosis [IPF], idiopathic nonspecific interstitial pneumonia [NSIP], and/or pulmonary fibrosis due to known genetic cause [e.g. short telomere syndrome, mucin 5B (MUC5B) mutation, surfactant protein mutations]).
High resolution computed tomography (HRCT) scan with evidence of interstitial lung abnormalities involving at least 5% of a single lung zone or interstitial lung disease (ILD), based on central evaluation.
Forced vital capacity (FVC) ≥80% of predicted normal at Visit 1b.
Diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for hemoglobin ≥70% of predicted normal at Visit 1b.

: Prior known pulmonary fibrosis that, in the opinion of the Investigator, requires treatment with approved therapies.
Prebronchodilator forced expiratory volume in 1 second (FEV1)/FVC <0.7 at Visit 1b.
HRCT findings consistent with probable or definite usual interstitial pneumonia (UIP) pattern.
Any medical condition that is known to predispose to the development of pulmonary fibrosis (e.g. known connective tissue disease).
Prior or current use of nerandomilast, nintedanib, or pirfenidone.

Centro de Investigaciones Metabólicas (CINME) S.A. - CABA, Buenos Aires

Viamonte 2278, C1056ABJ Cdad. Autónoma de Buenos Aires, Argentina

Hospital Italiano de Buenos Aires - CABA, Buenos Aires

Juan Domingo Perón 4190, Piso 1, Ciudad Autónoma de Buenos Aires, C1181ACH

Centro de Investigación Clínica Belgrano S.A.

Juncal 4502, CABA, Buenos Aires

CEDIC Centro de Investigación Clínica - CABA, Buenos Aires

Jerónimo Salguero 2142, CABA, Buenos Aires

Consultorios Médicos del Buen Ayre

Fitz Roy 2468 1er Piso, C1425FVH CABA, Argentina

StudyDROP-FPF

SponsorBoehringer Ingelheim

Study typeInterventional

Conditions

Pulmonary fibrosisInterstitial Lung Disease

Requirements

From 40 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT07201922