A44-41 Management of Chronic Obstructive Pulmonary Disease (COPD) Patients With Bora Care® Remote Monitoring Solution Including Bvs³ Early-detection Score for COPD Exacerbations (Austraal Study)

Rationale Chronic Obstructive Pulmonary Disease (COPD) is the fourth leading cause of death worldwide and remains a major public-health and economic burden. Frequent exacerbators account for a disproportionate share of hospital admissions and healthcare costs. Conventional follow-up rarely allows early detection of exacerbations, limiting timely interventions. AUSTRAAL (NCT06523140) is a multicenter, randomized, controlled, open-label clinical investigation, sponsored by Biosency. It aims to evaluate the clinical and organizational impact of remote monitoring using Bora care®, which combines the Bora band® wearable device, the Bora connect® telemonitoring platform, and the BVS³ predictive algorithm designed to detect early signs of exacerbation from trends in SpO2, heart rate, and respiratory rate. Methods The study comprises two sequential phases: 1. Pilot phase (non-randomized): 20 patients / 3 months / < 3 centers; objective: operational optimization 2. Main phase: 1:1 Randomized Controlled Trial comparing standard care versus standard care + Bora care® telemonitoring in 360 adults with confirmed COPD (French-Language Society of Pneumology criteria) and ≥ 1 hospitalization for exacerbation within 12 months. In the intervention arm, trained nurse Case Managers review daily data via Bora connect® and respond to BVS3 alerts through patient contact, symptom assessment and coordination with pulmonologists according to a standardized escalation plan. The primary endpoint is the number of hospital days due to respiratory deterioration per patient over 12 months; a ≥ 15% reduction is considered clinically meaningful. Secondary endpoints include frequency and duration of hospitalizations, quality of life (CAT, SF-36), symptom scores (EXACT E-RS), healthcare use, organizational impact, adherence, user satisfaction, validation of a new predictive questionnaire for exacerbation and the predictive accuracy of BVS³. Statistical analyses will follow an intention-to-treat approach on the randomized population. The overall two-sided alpha is set at 5%, with a predefined interim analysis. Results The pilot phase began in December 2024; the main phase continues until September 2027, with follow-up through October 2028. Recruitment is ongoing. Feasibility data indicate high patient adherence, robust data transmission and no safety signals. Efficacy results will be reported after completion of the interim and final analyses. Conclusions AUSTRAAL is expected to provide robust evidence on the clinical, organizational, and predictive value of digital telemonitoring in high-risk COPD patients. By enabling earlier intervention and closer coordination between patients, nurses, and pulmonologists, Bora care® may reduce hospitalizations and enhance quality of life supporting large-scale implementation and reimbursement of digital respiratory care solutions.