Forced Oscillations Technique During a Metacholine Test in Children
ConditionAsthma in Children
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-16
SponsorUniversity Hospital, Montpellier
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Airway Oscillation System
Procedure/SurgeryAfter each methacholine dose administred, respiratory function will be measured by forced oscillation
Treatment groups
112 Participants
are divided into 1 treatment groupGroup A: Single ArmOther 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
During the procedureSecondary outcomes
1
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
Time frame
During the procedure2
Average number of trials required for impedance measurement by forced oscillation
Average number of trials required for technically satisfactory iterative measurement of impedance
Time frame
During the procedureSponsors and contacts
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Source ClinicalTrials.gov