NCT07419555

Belgian Lung Function Study

Belgian Lung Function Study: Personalised Longitudinal Lung Function Analysis as a Marker of Disease Progression

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 4,000 (estimated)
• Sponsor: KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Currently, it remains unclear how to manage serial lung function measurements in a clinical setting. The investigators aimed to tackle this problem by developing a machine learning (ML) model that can accurately predict population and individual lung function trajectories. These predictions would enable the investigators to identify positive or negative deviations, thereby revealing unexpected disease patterns. A prospective validation is needed that includes data on mortality, hospitalisations, emergency-room visits and patient-reported outcomes. Within this study, the goal is to validate the ML model with the data collected from this observational study.

Detailed description

The objective of this study is to explore the clinical value of models predicting longitudinal lung function patterns in individuals with chronic respiratory diseases across Belgium. 1. The investigators will assess the accuracy of individualised lung function prediction models in a multicentre lung function dataset with prospective clinical and lung function follow-up. 2. The investigators will evaluate important health outcomes, step-up in care, patient-reported outcomes in individuals identified with an expected and unexpected observed trajectory as compared to the predicted population and individualised trajectory. The hypothesis is that patients with an unexpected decline in lung function will have worse health outcomes, such as a higher mortality rate and more hospitalisations, compared to patients with an expected lung function pattern. The investigators hypothesise to observe better health outcomes and lower mortality rates in patients with an unexpectedly positive lung function evolution compared to patients with an expected negative lung function pattern. Individuals will be recruited from 4 Belgian Hospitals (UZ Leuven, UZ Antwerpen, AZ Delta, ZOL Genk). Based on the annual rate of pulmonary function testing in these hospitals, a sample size of 1.000 participants per centre is anticipated within one year of inclusions, resulting in a total sample size of 4.000 patients. All available historical lung function data of included individuals will be retrieved from the individuals medical file. Additionally, the individual will be prospectively followed for 2 years where all lung function data will be collected.

Conditions

• Chronic Respiratory Diseases

Timeline

• Start date: 2026-03-25
• Primary completion: 2029-03-01
• Completion: 2029-03-01
• First posted: 2026-02-19
• Last updated: 2026-03-30

Locations

4 sites across 1 country: Belgium