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Integrating blood eosinophils and exhaled nitric oxide (FeNO) in asthma diagnostic pathways for adults and children: the PROPULSION SANTÉ observational study with translational sub-studies (DIVE, DIVE2)—protocols

bmjresp · 2025-11-27 · canonical JSON source

12 visible annotations · policy: published · automated confidence ≥ 75.00%

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Introduction Diagnosing asthma requires confirmation by bronchodilator reversibility (BDR) with or without bronchial provocation testing (BPT). Despite being needed in 80% of suspected cases following BDR, BPT access remains limited in Canada. Type-2 (T2) inflammatory biomarkers (fractional exhaled nitric oxide (FeNO) and blood eosinophil count (BEC)) may be underutilised for BPT prioritisation and are insufficiently studied to support asthma diagnosis in real-world primary care, especially in children. We aimed to explore whether T2 biomarker-based prioritisation of BPT reduces diagnostic delays, and improves triage efficiency and guidance based on exacerbation risk.Methods and analysis Three academic centres in Québec will measure inflammatory biomarkers alongside BDR and/or BPT interpretation for patients with suspected asthma referred by primary care providers (PROPULSION SANTÉ, NCT06981169). Consenting patients aged ≥6 years will undergo FeNO, BEC and BDR testing. If BDR is non-diagnostic, subsequent BPT will be prioritised for patients with ≥1 elevated biomarker (BEC ≥300 /µL, (FeNO ≥25 ppb if ≥12 years or FeNO ≥20 ppb if <12 years)); others will follow usual timelines. Reports to the referring healthcare providers will include standard interpretation of BDR/BPT and biomarker results to state exacerbation risk and suggested corticosteroid dosage. Asthma control and quality of life will be assessed at baseline and remotely at 4, 8 and 12 months. The primary outcome will be the delay from the reception of test request for the diagnosis of asthma patients with versus without elevated biomarker(s). Secondary outcomes include biomarkers’ diagnostic performance, asthma control, quality of life, health benefits, cost-effectiveness, environmental impact and patient satisfaction. We aim to recruit 1500 patients to PROPULSION SANTÉ, with optional biobanking for translational sub-studies for 123 adults (DIVE, NCT05992519) and 123 children (DIVE2, NCT07011394).Ethics and dissemination Study protocols were ethically approved CIUSSS de l'Estrie–CHUS #MP-31-2025-5593/MP-31-2024-5346; 2023–4791). Results will be communicated and submitted to peer-reviewed journals.Trial registration number ClinicalTrials.gov ( NCT06981169; NCT05992519; NCT07011394).