Recruiting

Observational Study

Sponsor:

Université de Sherbrooke

Code:

NCT06981169

Conditions

Asthma

Inflammation

Asthma in Children

Eligibility Criteria

Sex: All

Age: 6+

Healthy Volunteers: Not accepted

Interventions

FeNO

blood sample

Study Details

Brief summary:

The objective of this observational study is to assess the relevance of inflammometry (based on the measurement of fractional exhaled nitric oxide (FeNO) and blood eosinophil count (BEC)) as a tool for prioritizing respiratory diagnostic tests.

The study will evaluate the role of inflammometry (FeNO and BEC) in prioritizing diagnostic respiratory tests. It will include patients aged six and older with suspected asthma, referred by non-pulmonologists for diagnostic asthma testing (spirometry or methacholine challenge test) at three hospital centers: Sherbrooke University Hospital Center (CHUS), Sainte-Justine University Hospital Center (CHU Sainte-Justine), and the Montreal Children's Hospital.

The hypothesis is that using inflammometry as a prioritization tool would reduce diagnostic delays for high-risk patients with elevated biomarkers. This study could help shorten wait times, relieve congestion in diagnostic testing queues, and improve the diagnostic pathway. Additionally, it would enhance the interpretation of pulmonary function test results by incorporating inflammometry findings, leading to better patient stratification.

Patients referred from primary care will undergo pulmonary function testing (spirometry ± methacholine challenge) and, as part of the study:

FeNO measurement using a portable device Blood test for eosinophil count Questionnaire on asthma control and quality of life, completed at the visit and at follow-ups at 4, 8, and 12 months

Conditions

Asthma

Inflammation

Asthma in Children

Study ID

NCT06981169

Start date

Mar 24, 2025

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+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • patients age 6 and older
  • referred by primary care ofr an asthma diagnostic test (spirometry or methacholine challenge)

Exclusion Criteria:

  • referred by pulmonologist

Study Design

Enrollment

1500 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients aged ≥6 years awaiting respiratory function tests requested by primary care

People aged ≥6 years waiting for their respiratory test will be invited to a clinical appointment and offered additional evaluation as part of this study, including : 1/ medical history 2/ exhaled fraction of nitric oxide FeNO measurement (using a portable NIOX VERO device) 3/ a blood test to measure blood eosinophil count (BEC) 4/Questionnaires to be completed on quality of life and asthma control, as well as satisfaction forms.

Interventions

FeNO

FeNO measured with a NIOX VERO device before the respiratory test

blood sample

Blood sample for measuring the blood eosinophil count

Primary outcome measure

  • Comparison of the diagnostic delay for asthma in patients with high risk due to elevated inflammatory markers versus those with low risk [ Time Frame: At the time of the methacholine challenge test ]

Central Contacts and Locations

Central contacts

Simon Couillard, 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

Apr 30, 2026

Last verified

Apr, 2026

Keywords

  • Diagnosis
  • Asthma
  • inflammation
  • FeNO
  • Blood eosinophil count

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 2026-04-30.