Forced Oscillations Technique During a Metacholine Test in Children

Study Overview
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Brief Summary
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Asthma is the most common chronic lung disease in children. It affects more than 1 in 10 children in France. The methacholine bronchial challenge test (MBT) is indicated to assess the probability of asthma suggested by clinical symptoms by measuring the forced expiratory volume in one second (FEV1), after inhalation of a cumulative dose of methacholine. In children, the measurement of FEV1 requires a high level of cooperation from the child, which can be the source of false negatives or no result if this is not obtained. The objective of this study is to evaluate if the measurement of the respiratory function by the forced oscillations technique, allows to predict the variation of the FEV1 obtained

Official Title
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Interest of Forced Oscillations During a Methacholine Test in Children

Conditions
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Asthma in Children

Intervention / Treatment
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* Procedure: Airway Oscillation System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Each subject is his or her own control
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single Arm<br> | Procedure: Airway Oscillation System<br>* After each methacholine dose administred, respiratory function will be measured by forced oscillation<br>* Other names: Tremoflo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in lung impedance measurement | Percentage change in lung impedance measurement obtained by the forced oscillation technique in relation to the dose of methacholine required to obtain bronchial hyperresponsiveness | During the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average number of trials required for measurement of FEV1 with the spirometry technique | Average number of trials required for technically satisfactory iterative measurement of FEV1 | During the procedure | 
| Average number of trials required for impedance measurement by forced oscillation | Average number of trials required for technically satisfactory iterative measurement of impedance | During the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Forced oscillation, Infant, Asthma, Diagnosis, Methacholin