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RECRUITING
NCT07011394

Diagnosing Asthma With Clinically Accessible, Non-invasive, and Efficient Tests: a Child-inclusive Translational Investigation

Sponsor: Université de Sherbrooke

View on ClinicalTrials.gov

Summary

Asthma is a common inflammatory respiratory disease affecting 11% of Canadians, but its diagnosis remains challenging, leading to delays in treatment or overtreatment. Spirometry with a reversibility test and bronchial provocation testing (BPT), considered the gold standard, are the reference diagnostic methods. However, access to BPT is limited as it is performed in hospital settings. Type 2 inflammation biomarkers, the fractional exhaled nitric oxide (FeNO) and blood eosinophils (EOS), represent a potential alternative. In addition to their prognostic and theragnostic value, these markers predict a good response to inhaled corticosteroids in individuals aged ≥ 6 years with asthma. However, their use remains restricted to pulmonologists in specialized clinics and is not recommended as a diagnostic tool in Quebec. Despite studies demonstrating their diagnostic value in specialized settings, these tests remain underexplored in primary care and insufficiently studied in children under 12 years. The objective of ou study is to evaluate the relevance and performance of FeNO and blood eosinophils in the diagnosis of asthma in children referred in primary care with non-diagnostic spirometry.

Key Details

Gender

All

Age Range

6 Years - 17 Years

Study Type

OBSERVATIONAL

Enrollment

123

Start Date

2024-04-09

Completion Date

2027-07-01

Last Updated

2025-06-08

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

FeNO

FeNO will be measured before the bronchial provocation test using a FeNO VIOX device

DIAGNOSTIC_TEST

Blood eosinophil count

a blood test will be performed om the day of bronchial provocation test

Locations (3)

CHU Sainte-Justine

Montreal, Quebec, Canada

Montreal Children's Hospital

Montreal, Quebec, Canada

CIUSSS de l'Estrie - CHUS

Sherbrooke, Quebec, Canada