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Breath and blood tests could revolutionize asthma diagnosis in kids

NCT ID NCT07011394

Diagnosis Sponsor: Université de Sherbrooke Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Sep 11, 2026 · Updated 2 times

Summary

This study is testing whether two simple, non-invasive tests—a breath test (FeNO) and a blood test (eosinophil count)—can accurately diagnose asthma in children aged 6 to 17. Currently, diagnosing asthma often requires complex hospital-based breathing tests. The researchers aim to see if these easier tests work well in primary care settings, especially when standard spirometry is unclear. About 123 children with asthma-like symptoms will participate.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
FeNO breath test and blood eosinophil count
What this could lead to
If successful, these simple tests could help doctors diagnose asthma in children more quickly and easily, without needing hospital-based breathing tests.
What could go wrong
This is a small, early-stage study focused on diagnosis, not treatment. The tests may not be accurate enough to replace current methods, and results may not apply to all children.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 123 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2024

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients will be recruited in through two pathways in 3 centers (CHUS, CHUSJ, and Montreal Children's Hospital) 1. In collaboration with the respiratory physiology department of participating centers, patients scheduled for a methacholine challenge test will receive an invitation letter for the study along with their test appointment notice. They will be informed about the study's purpose, procedures, and provided with contact details to reach out to the research team if they wish to decline participation or have any questions. If no refusal is received, the clinical inhalation therapist will contact them to confirm their eligibility. 2. Through the Propulsion Santé study, patients will be scheduled for their respiratory test, which will include eosinophil count and FeNO measurement. If their spirometry results are inconclusive for diagnosis, they will be offered the opportunity to participate in the DIVE2 study.

Ages

6 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

asthma childhood onset asthma disease Inflammation inflammatory disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Asthma Asthma in children Diagnosis Inflammation

Contacts and locations

Locations

  • CHU Sainte-Justine

    Montreal, Quebec, H3T 1C5, Canada

  • CIUSSS de l'Estrie - CHUS

    Sherbrooke, Quebec, J1H 5N4, Canada

  • Montreal Children's Hospital

    Montreal, Quebec, H4A 3H9, Canada

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