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Interstitial lung disease (ILD) represents a diverse group of disorders characterized by infiltration of lung parenchyma with extracellular matrix, leading to progressive respiratory impairment and respiratory failure over time.
Patients often experience debilitating symptoms such as breathlessness and chronic cough, significantly affecting their quality of life and limiting daily activities. Treatment options for ILD are limited and vary based on disease etiology and progression. While antifibrotic agents such as nintedanib and pirfenidone have shown efficacy in slowing disease progression, there remains a significant unmet need with novel therapies directed at both underlying pathophysiology and symptomatic relief under active clinical development.
The application of meaningful and measurable endpoints is essential for the success of ILD clinical trials. However, regulatory challenges persist, particularly in validating novel digital biomarkers and patient-reported outcomes (PROs). Regulatory agencies emphasize the need for standardized, reproducible measures that demonstrate clinical relevance, necessitating rigorous validation studies and alignment with evolving guidelines for digital health technologies (DHTs) in clinical trials.
Pulmonary function tests (PFTs) and imaging biomarkers remain standard measures of disease activity; however, given increasing priority to minimize patient burden and optimize the patient voice in clinical development, PROs and DHTs are gaining acceptance.
Endpoint selection in ILD trials must incorporate a multi-faceted approach, combining physiologic, imaging and patient-centric measures. By leveraging respiratory function assessments, medical imaging technologies and digital health solutions, sponsors can enhance data quality, optimize patient-centric evaluations and accelerate therapeutic advancements while improving the trial-participant experience.
Cough is a frequently occurring symptom for patients with ILD; it can present as the earliest and only symptom, and besides dyspnea, is reported to be one of the most distressing. Capture of cough frequency and severity, which is often underrepresented in traditional assessments, has historically relied on patient and/or surrogate recall via patient-reported diaries.
Accuracy of assessment and clinical trial participant burden can be improved with advanced monitoring tools. Application of technologies, like the RESP® Biosensor, offers continuous, accurate and non-invasive assessment. Integrating such technologies enhances endpoint reliability and supports regulatory decision-making.
Advancing clinical development for ILD therapeutics requires thoughtful endpoint selection to ensure meaningful, patient-focused outcomes. The integration of the range of comprehensive endpoint solutions represents a proven approach to refining clinical trial methodologies. By prioritizing objective and patient-relevant measures, researchers can drive more effective and impactful treatment strategies for ILD patients worldwide while aligning with evolving regulatory expectations for digital health endpoints in clinical trials.
Featured Speakers
Dr. Todd Lustine, MD, MS, FCCP, Vice President, Medical Science, Respiratory, Clario
Dr. Todd Lustine has over 25 years of clinical leadership and pharmaceutical industry / medical safety experience. Prior to joining the industry, he spent 17 years in clinical pulmonary / critical care medicine, serving in various leadership roles, including Co-Chair of the Division of Pulmonary/Critical Care Medicine, Medical Director of the Intensive Care Unit/Services and Medical Director of the Pulmonary Diagnostic and Wellness Programs.
Over the last nine years in the pharmaceutical industry, he has held medical safety leadership roles at large and mid-sized companies. In his current role at Clario, he leads Medical Science – Respiratory, emphasizing a “science-first” mentality in all aspects of our customer support. Todd holds BA in Biology and Philosophy from Emory University, a MS in Human Physiology from Georgetown University and a MD from Georgetown University School of Medicine.
He completed his residency, served as Chief Medical Resident (Internal Medicine) and completed fellowship in Pulmonary and Critical Care Medicine at Thomas Jefferson University Hospital.
Kevin McCarthy, RPFT, Director, Scientific Affairs, Clario
Kevin McCarthy has worked in the field of lung function testing for 50+ years with 40 years as the Manager of the Pulmonary Function Laboratories at the Cleveland Clinic Health System. He has always been passionate about the quality of pulmonary function measurements and has moved this passion to the clinical trial world where data quality is critical and where these measurements help accurately answer the questions we are asking.
Kevin’s research experience includes managing the pulmonary function quality control in two NIH-funded registries: patients with severe A1AT deficiency and LAM Registry and the Cleveland Clinic’s NETT study. He has published extensively on pulmonary function testing and is a former member of the ATS PFT Committee and ATS/ERS Task Force to update the standards for Spirometry in 2019 and the standards for Lung Volume testing in 2023.
Amit Vasanji, PhD, Vice President, Medical & Scientific Affairs, Clario
Amit Vasanji has over 20 years of experience in basic and clinical research image acquisition, processing, analysis, visualization and biomedical software engineering across multiple modalities and therapeutic areas. His research has been published in a broad array of peer-reviewed journals and he is frequently invited to speak at international events on effective workflow design and algorithm-based biomarker development for imaging-based clinical trials.
In his current role at Clario, Amit oversees the scientific feasibility and design of Clario’s imaging platform and is responsible for the development and integration of customized image analysis algorithms into clinical trial workflows.
Dr. Peter Cho, PhD, MRCP, FHEA, Adjunct Senior Lecturer, Kings College Hospital NHSFT
Dr. Peter Cho is a consultant respiratory physician with a specialist interest in chronic cough at King’s College Hospital. Peter completed his clinical training in London and South East England in respiratory medicine. Peter also spent 3 years investigating the physiology of cough as part of his PhD, and provided novel insight to the inhibitory mechanisms of cough.
Aside from clinical responsibilities, Peter is an investigator for the main study of the first multi-centre multi- county cough registry by the European Respiratory Society NEuroCOUGH Clinical Research Collaboration. Peter continues to have active research interests in the assessments of cough and the impact of cough.
Peter obtained a PhD from King’s College London, and a postgraduate certificate in Medical Education from University of Dundee following his first medical degree from Imperial College London.