Forced Oscillations Technique During a Metacholine Test in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-07

Study Completion Date

2026-12-30

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

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Detailed Description

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Conditions

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Asthma in Children

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Each subject is his or her own control

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Single Arm

Group Type OTHER

Airway Oscillation System

Intervention Type PROCEDURE

After each methacholine dose administred, respiratory function will be measured by forced oscillation

Interventions

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Airway Oscillation System

After each methacholine dose administred, respiratory function will be measured by forced oscillation

Intervention Type PROCEDURE

Other Intervention Names

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Tremoflo

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

Minimum Eligible Age

6 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No