NCT07011394Active, not recruiting
Diagnosing Asthma With Clinically Accessible, Non-invasive, and Efficient Tests: a Child-inclusive Translational Investigation
Source: ClinicalTrials.gov · Last updated 11 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 123 (estimated)
- First submitted
- 30 Apr 2025
- Start date
- 9 Apr 2024
- Primary completion date
- 1 Sept 2026
- Lead sponsor
- Université de Sherbrooke
- Diseases
- Asthma
- NCT number
- NCT07011394
What you commit to
- Study type: Observational
- Planned participants: 123
- From 9 Apr 2024 to the primary completion date, 1 Sept 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Age
- 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.
Who the study is looking for
- 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
Age in the registry: 6 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Sainte-Justine Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Montreal Children's Hospital Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| CIUSSS de l'Estrie-CHUS Coordinator of this site? Confirm its status | Sherbrooke | Canada | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.