How a digital CompEx endpoint reduced patient numbers by 50% in a Phase II COPD study

A novel digital endpoint enabled live monitoring, reducing the number of patients needed and accelerating the study by six months.

The problem

What makes traditional COPD studies so demanding for patients and sites?

CHALLENGE

Long observation periods and large sample sizes are often needed to gain sufficient power to detect differences between study arms.

Travel and site visits add to the burden on patients’ home life throughout the study.

Poor-quality overreads and delays in results can mean a patient must return to site to retake a test.

SOLUTION

A remote, connected spirometer is combined with AI validation, a telehealth visit, and real-time data transfer.

Remote spirometry is combined with patient-reported outcomes and machine learning algorithms.

The digital endpoint supports event-driven study close-out.

The benefit

Remote connected spirometer

A connected spirometer enables real-time data transfer directly from the patient’s home.

AI-validated overreads

AI-supported quality checks confirm overreads in minutes rather than days, reducing missing data.

Event-driven study close-out

The digital endpoint allows the study to close out based on events, rather than a fixed observation schedule.

In practice

50%

fewer patients needed

288 patients, compared with 604 in a traditional study design.

$8m

reduction in costs

Alongside a 15% total cost reduction from fewer patients required.

6

months faster study completion

Delivered through live, continuous monitoring rather than scheduled visits.

50%

fewer in-person visits

Confirmed by at-home spirometry matching site-based results.

Learn how a digital CompEx endpoint and live monitoring can shorten study timelines and lower costs in Phase II COPD studies.