RecruitingNCT07011394

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


Sponsor

Université de Sherbrooke

Enrollment

123 participants

Start Date

Apr 9, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 6 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a set of simple, non-invasive tests to diagnose asthma in children whose breathing tests (spirometry) are unclear — with the goal of developing a faster, child-friendly diagnostic pathway. **You may be eligible if...** - Your child is 6–17 years old - They have symptoms that suggest asthma (such as wheeze, cough, or shortness of breath) - Their spirometry results were inconclusive - They were referred by a general practitioner or primary care doctor (not a lung or allergy specialist) **You may NOT be eligible if...** - Your child used an inhaled or oral corticosteroid in the past 48 hours - Your child smoked in the past 6 hours or has had a respiratory infection in the past 4 weeks - Your child has a significant heart or lung condition unrelated to asthma Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTFeNO

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

DIAGNOSTIC_TESTBlood 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

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NCT07011394


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