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

NCT07011394 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 123

Last updated 2026-05-06

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Association Pulmonaire du Quebec

    collaborator OTHER

  • Fonds de la Recherche en Santé du Québec

    collaborator OTHER_GOV

  • Fondation JA DeSève

    collaborator UNKNOWN

  • Opération Enfant Soleil

    collaborator UNKNOWN

  • Université de Sherbrooke

    lead OTHER

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-09
Primary Completion
2026-12-01
Completion
2027-07-01

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07011394 on ClinicalTrials.gov