NCT05992519Completed
Diagnostic and Translational Values of Point-of-care Blood Eosinophils and Exhaled Nitric Oxide (FeNO) in People Referred by Primary Care for Suspected Asthma
Diagnostic and Translational Values of Point-of-care Blood Eosinophils and Exhaled Nitric Oxide (FeNO) in People Referred by Primary Care for Suspected Asthma (DIVE)
Source: ClinicalTrials.gov · Last updated 19 Nov 2025
Brief summary (registry, in English)
Asthma is characterised by episodic symptoms (attacks) caused by airway inflammation and decreased airflow to the lungs. It affects 10% of the Canadian population and is the most common chronic disease in childhood. Despite its burden and its potential to be life-threatening, establishing the diagnosis takes time due to difficulty in accessing specialised breathing tests. Indeed, the current diagnostic strategy relies on a breathing test (spirometry) and, if non-diagnostic, a subsequent more complicated breathing test conducted in hospitals (a bronchial provocation test). Our dependence on the latter test must be confronted to the bottleneck created by our reliance on it and the difficulty to do these tests in children. Furthermore, within the current framework, people receiving a diagnosis do not know if they have active airway inflammation - a key feature with predicts increased susceptibility to asthma attacks and treatment responsiveness. Our study's goal is to validate clinically accessible and useful diagnostic tests for peoplesuspected to have asthma. Specifically, we are interested in alternative tests that are a) achievable outside the hospital; b) useful markers of airway inflammation/risk c) can identify people at with a higher likelihood of responding to anti-inflammatory therapy. The two tests we are mainly interested in are: * Exhaled nitric oxide (measured with a portable handheld machine) * The blood eosinophil count (obtained on a general blood test) +/- Other tests which we might be able to develop within this cohort (e.g. urine tests)
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 123 (actual)
- First submitted
- 7 Aug 2023
- Start date
- 7 Nov 2022
- Primary completion date
- 30 Oct 2025
- Lead sponsor
- Université de Sherbrooke
- Diseases
- Asthma
- NCT number
- NCT05992519
What you commit to
- Study type: Observational
- Participants enrolled: 123
- From 7 Nov 2022 to the primary completion date, 30 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of an inhaled or systemic corticosteroid in the previous 48 hours;
- Smoking in the previous 6 hours; history of viral and/or bacterial respiratory infection in the past 4 weeks;
Age
- major cardiopulmonary disease, including: a) chronic obstructive pulmonary disease (COPD), defined by all of the following: i) aged ≥ 40 years , ii) permanent obstruction on spirometry (FEV1/FVC \<0.7) and iii) a smoking history of \>10 pack-years or known alpha-1-antitrypsin deficiency, b) lung conditions deemed significant by the investigator, including cystic fibrosis and bronchiectasis, and c) unstable heart disease.
Who the study is looking for
- aged ≥ 12 years who have symptoms suggestive of asthma,
- referred by their primary care provider (defined as a non-respirologist, non-allergist, non-otolaryngologist) using the CHUS suspected asthma decision-making algorithm. Under that algorithm, patients have non-diagnostic pre- and post-bronchodilator spirometry and no contraindications to a methacholine challenge.
- Free and informed consent must be given by the patient (and their legal guardian, if applicable).
Age in the registry: 18 years to - · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre de recherche du CHUS Coordinator of this site? Confirm its status | Sherbrooke | Canada | Unknown status |
Related publications
- Development and validation of a UHPLC-MS/MS method for the quantification of total conjugated 3-bromotyrosine and investigation of its association with asthma severity.Anal Chim Acta · 2026 · PMID 41997677
- 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.BMJ Open Respir Res · 2025 · PMID 41314665
This page is information, not medical advice. Discuss any trial with your doctor.