Actively Recruiting
Led by Université de Sherbrooke · Updated on 2026-05-06
123
Participants Needed
3
Research Sites
30 weeks
Total Duration
U
Université de Sherbrooke
Lead Sponsor
A
Association Pulmonaire du Quebec
Collaborating Sponsor
Researchers are investigating the use of accessible and non-invasive tests to improve asthma diagnosis in children aged 6 to under 18 years. Asthma is a common inflammatory disease affecting many children, but its diagnosis can be challenging due to limitations in current methods like spirometry and bronchial provocation testing, which is the gold standard but less accessible. This study aims to evaluate the usefulness of type 2 inflammation biomarkers, specifically fractional exhaled nitric oxide (FeNO) and blood eosinophil counts, to help diagnose asthma in children when spirometry results are inconclusive. Participants referred for bronchial provocation testing after inconclusive spirometry will have their FeNO measured using a specialized device and undergo blood tests for eosinophil counts and other markers. Additional tests include allergy testing, inflammatory protein analysis, nasosorption, and urine analysis. These procedures will take place before the methacholine challenge test. The study is observational and will include 123 children to assess the diagnostic accuracy of these biomarkers compared to the standard bronchial provocation test. During the study, participants will undergo medical assessments and complete standardized questionnaires about asthma control and quality of life. Researchers will analyze the diagnostic performance of FeNO and blood eosinophils and study their relationship with inflammatory proteins. Follow-up will include monitoring symptoms, medication use, and asthma exacerbations. The study also considers the impact of diagnostic delays on costs and environmental factors. Participation includes a baseline visit on the day of the methacholine challenge test, with no indication of long-term follow-up visits specified.
CONDITIONS
Diagnosing Asthma With Clinically Accessible, Non-invasive, and Efficient Tests: a Child-inclusive Translational Investigation
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for spirometry and assessment
Duration - 1 day
Participants undergo diagnostic tests including FeNO measurement, blood eosinophil count, nasosorption, and methacholine bronchial provocation testing to evaluate asthma.
1 baseline visit (in-person) including FeNO measurement, blood tests, nasosorption, and bronchial provocation test
Duration - Up to several months to years as per study follow-up
Participants are followed longitudinally to assess medication use, symptoms, quality of life, and asthma exacerbations.
Follow-up visits as scheduled to monitor asthma outcomes and collect data
Total: 3 locations
1
CHU Sainte-Justine
Montreal, Quebec, Canada, H3T 1C5
Not Yet Recruiting
2
Montreal Children's Hospital
Montreal, Quebec, Canada, H4A 3H9
Not Yet Recruiting
3
CIUSSS de l'Estrie - CHUS
Sherbrooke, Quebec, Canada, J1H 5N4
Actively Recruiting
S
Simon Couilard, MD MSc
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Morgane Gronnier, Laurence Désy, Lauranne Pouliot...
https://pubmed.ncbi.nlm.nih.gov/41314665