Using a new technique to test asthma in children
Interest of Forced Oscillations During a Methacholine Test in Children
NA · University Hospital, Montpellier · NCT05734261
This study is testing a new way to check asthma in kids aged 6 to 16 to see if it can predict breathing changes without needing them to cooperate as much as with traditional tests.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 112 (estimated) |
| Ages | 6 Years to 16 Years |
| Sex | All |
| Sponsor | University Hospital, Montpellier (other) |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT05734261 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of the Forced Oscillations Technique during a methacholine bronchial challenge test in children aged 6 to 16 years. The aim is to determine if this new method can accurately predict changes in forced expiratory volume (FEV1) without requiring high levels of cooperation from the child. By comparing the results of this technique with traditional methods, the study seeks to improve asthma diagnosis in pediatric patients. Children will be assessed after a period of stopping inhaled corticosteroids to ensure accurate results.
Who should consider this trial
Good fit: Ideal candidates are children aged 6 to 16 years who are referred for a bronchial hyperactivity test and have an FEV1 greater than 60%.
Not a fit: Patients with recent respiratory infections or those currently using certain bronchodilators may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate asthma diagnoses in children, reducing the likelihood of false negatives.
How similar studies have performed: While the Forced Oscillations Technique is a novel approach in this context, similar methodologies have shown promise in other respiratory assessments.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 6 and 16 years * FEV1 \> 60% * Child referred to the pulmonary function test laboratory for a non-specific bronchial hyperactivity test with methacholine * Child under treatment with inhaled corticosteroids stopped for at least 3 weeks * Oral consent from the child and at least one of the legal representatives * Child affiliated or benefiting from a social security plan Exclusion Criteria: * Use of a short-acting beta-adrenergic bronchodilator within the last 6 hours or anticholinergic bronchodilator within the last 12 hours * Use of a long-acting beta-adrenergic bronchodilator (licensed for use in children) in the past 36 hours * Upper or lower respiratory tract infections within 3 weeks prior to inclusion * Epilepsy under treatment * Subject's participation in another interventional study that may alter respiratory function * Patient unable to give consent, vulnerable
Where this trial is running
Montpellier
- CHU de Montpellier — Montpellier, France (RECRUITING)
Study contacts
- Principal investigator: Stefan MATECKI, MD — Montpellier Univerty Hospital
- Study coordinator: Stefan MATECKI, MD
- Email: Stephan.matecki@umontpellier.fr
- Phone: +33 4 67 33 59 12
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Asthma in Children, Infant, Asthma, Diagnosis, Methacholin, Forced oscillation