How many trials does it take to change the story for pulmonary fibrosis?
As new clinical data and insights emerge, pulmonary fibrosis needs more global trials
Clinical trials are often measured in the hundreds of thousands. Globally, more than 430,000 interventional clinical studies have been registered to date, covering a wide range of diseases from cancer to heart failure to diabetes. But when we turn to idiopathic pulmonary fibrosis (IPF), the numbers shrink dramatically. Fewer than 500 trials have been conducted worldwide since IPF was first classified as a distinct disease entity.
This gap stands in sharp contrast to the scale of the problem. While IPF remains classified as a rare disease, nearly three million people are living with it worldwide. The patient pool may be smaller than other major chronic diseases, but its impact is devastating. The disease is progressive, irreversible and often fatal. Lung tissue becomes increasingly scarred, breathing becomes difficult, and over time, the simple act of drawing breath requires extraordinary effort.
Transforming lives
The story behind these numbers explains why Boehringer Ingelheim remains deeply invested in pulmonary fibrosis. Across our 140-year history, respiratory care has stood as one of the company’s longest scientific commitments, with more than a century dedicated to studying diseases of the lungs. Each generation of research is built upon the one before it, continuously evolving as science progresses and patient needs grow more urgent. Because everything is for them. The patients. The ones who rely on innovation to fight such debilitating conditions and that became our purpose: transforming lives for generations.
A decade ago, we advanced into global trial programmes designed to address interstitial lung disease (ILD) in its many forms, knowing the road ahead would require patience and scale. Patients who once faced a diagnosis with no clear treatment path were now finding renewed hope, as the trial resulted in therapies that could offer the possibility of slowing the progression of the disease.
A greater response is required
Fast forward to today, it became clear that pulmonary fibrosis would demand an even greater response. The field holds new insights not only clinical data but perspectives from patients, expertise from investigators, and evidence from trials that continue to redefine what is possible in pulmonary fibrosis care.
With the advances, new patient subgroups are being identified. Patterns of progression are revealing complexities that were probably not fully mapped a decade ago. The questions have become sharper, and so must science.
That is why we advanced the Fibroneer programme, one of the most comprehensive global clinical efforts in fibrosing lung disease to date, designed to meet this evolving complexity with scale, precision and speed.
The Fibroneer programme includes two global Phase III trials focused on idiopathic pulmonary fibrosis and progressive pulmonary fibrosis. The FIBRONEER-ILD was conducted across 40 countries, with more than 400 clinical sites and 1,178 patients enrolled, and the FIBRONEER-IPF was conducted across 36 countries with a total of 1,177 patients. These trials represent one of the largest coordinated global efforts in this disease space.
Recently, FIBRONEER-ILD reached its primary endpoint, demonstrating a clinically meaningful reduction in the decline of forced vital capacity (FVC), which measures the maximum volume of air a person can exhale after full inhalation. In diseases marked by scarring of lung tissue, preserving FVC directly translates into preserving patient’s ability to breathe, function, and live with greater stability.
Offering hope to pulmonary fibrosis patients
Why do we continue to invest years, resources, and global networks into studies that require so much?
Because for every person sitting across from a physician hearing the words, “You have pulmonary fibrosis,” this work offers something rare: hope. For families waiting in hospital corridors, for individuals measuring daily life in metres walked or stairs climbed, for every breath that feels increasingly fragile, these advances carry weight that no data table can fully capture.
The science moves forward. So do we. With every trial completed, every patient enrolled, and every question answered, we move closer to changing the story for those who have lived too long in its shadow. We are here now, and we don’t plan to stop.
To learn more about the Fibroneer trial results, visit Fibroneer Global phase III trials Boehringer Ingelheim
The writer is the Head of Human Pharma for India, the Middle East, Turkey and Africa, Boehringer Ingelheim
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