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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

RecruitingPhase 3Ages 40 Years - anyAllBoehringer Ingelheim
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In plain words

What the trial is, and whether it could suit you

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 pl

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Individuals โ‰ฅ40 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) โ‰ฅ80% of predicted normal at Visit 1b * Diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for hemoglobin โ‰ฅ70% of predicted normal at Visit 1b Further inclusion criteria apply. Exclusion Criteria: * 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 Further exclusion criteria apply.
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What it tests

  • Nerandomilast
  • Placebo
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Where

55 sites
University of California Los Angeles
Los Angeles, United States
University of Colorado Denver
Aurora, United States
Clinical Research Specialists LLC - Kissimmee
Kissimmee, United States
University of Kansas Medical Center
Kansas City, United States
Brigham and Women's Hospital
Boston, United States
University of Michigan
Ann Arbor, United States
University of Minnesota
Minneapolis, United States
Weill Cornell Medicine-New York-60569
New York, United States

โ€ฆand 47 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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