Recruiting

FeNO & Eosinophils

Sponsor:

Université de Sherbrooke

Code:

NCT07011394

Conditions

Diagnosis

Inflammation

Asthma in Children

Asthma

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

Interventions

FeNO

Blood eosinophil count

Study Details

Brief 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

Diagnosis

Inflammation

Asthma in Children

Asthma

Study ID

NCT07011394

Start date

Apr 9, 2024

Status verified date

Apr, 2026

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Individuals aged 6 to <18 years, presenting symptoms suggestive of asthma
  • Patients referred for a methacholine bronchial provocation test by primary care (defined as non-pulmonologist, non-ENT specialist, non-allergist)
  • Spirometry inconclusive

Exclusion Criteria:

  • 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;
  • 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.

Study Design

Enrollment

123 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients aged 6-18 with suspected asthma, referred by primary care for methacholine BPT

Patients will be recruited from a larger study, Propulsion Santé, which investigates the usefulness of FeNO and BEC in prioritizing patients whith suspected asthma for bronchial provocation testing in primary care. 1,500 participants will be invited to receive spirometry at 3 centers: CHUS, CHUSJ, and Montreal Children's Hospital. If spirometry is non-diagnostic, patients aged 6 to 18 years who are referred for methacholine challenge testing will be offered the opportunity to participate in the DIVE2 study.In addition to a medical assessment and standardized questionnaires (ACQ5, ACT, and EQ-5D), participants will undergo FeNO and BEC measurements, and additional blood tests (complete blood count with differential, C-reactive protein, total and specific serum immunoglobulin E, and biobank sample collection). a nasosorption and urine analysis will be performed as part of this protocol.

Interventions

FeNO

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

Blood eosinophil count

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

Primary outcome measure

  • Fractional exhaled nitric oxide value: AUC of the ROC analysis to diagnose asthma [ Time Frame: FeNO measured on the day of the methacholine challenge (i.e. Baseline visit) ]
  • Blood eosinophil count value : ROC analysis AUC to diagnose asthma [ Time Frame: Blood eosinophils measured on the day of the methacholine challenge (i.e. Baseline visit) ]
  • Combination of FeNO + Blood eosinophil count: ROC analysis AUC to diagnose asthma [ Time Frame: Time Frame: FeNO and blood eosinophils measured on the day of the methacholine challenge (i.e. Baseline visit) ]

Central Contacts and Locations

Central contacts

Simon Couilard, MD MSc

+1-819-346-1110s.couillard@usherbrooke.ca

Locations

CIUSSS de l'Estrie - CHUS

Recruiting

Sherbrooke, Quebec, Canada, J1H 5N4

Contacts

Morgane Gronnier, MD

+18193461110morgane.gronnier@usherbrooke.ca

Principal Investigator:

Simon Couillard, MD

More Information

Sponsor

Université de Sherbrooke

Last update posted

May 6, 2026

Last verified

Apr, 2026

Keywords

  • observationnal study
  • asthma diagnosis
  • FeNO and eosinophil blood count
  • children

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Université de Sherbrooke on 2026-05-06.