Digital Endpoint Resource Guide: Respiratory

Establishing clinical benefit is among the most complex and costly stages in developing a new therapy, especially as regulators and payers increasingly demand patient-centered outcomes that reflect meaningful, real-world improvements. With the emergence of sensor-based digital health technologies (DHTs), we now have the ability to objectively and continuously measure how patients function in their daily lives.

Respiratory disease clinical research has led the way in gaining regulatory acceptance of digital endpoints—such as EMA qualification for COPD and FDA support of accelerometer-derived physical activity as a primary endpoint in pivotal trials. Patients with respiratory conditions frequently report symptoms that significantly impair physical function, mobility, daily activities, and sleep. Traditionally, these limitations have been measured through indirect methods like in-clinic performance tests (e.g., the 6-Minute Walk Test), clinician-reported or patient-reported outcomes (e.g., St. George’s Respiratory Questionnaire), and composite scores (e.g., the Asthma Control Questionnaire).

In contrast, wearable DHTs offer a powerful alternative by delivering continuous, remote monitoring of patient-centered outcomes—helping reduce trial burden, increase success rates, and improve condition management. Additionally, wrist-worn wearables enable real-time tracking of vital signs like heart rate, heart rate variability, oxygen saturation, temperature, and sleep apnea, offering even greater insights into patient health.