TPM AOS: Forced Oscillations Technique During a Metacholine Test in Children

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05734261

Collaborator

(none)

112

Enrollment

Location

Arm

46.5

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Asthma in Children	Procedure: Airway Oscillation System	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

112 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Each subject is his or her own controlEach subject is his or her own control

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Interest of Forced Oscillations During a Methacholine Test in Children

Anticipated Study Start Date :

Feb 15, 2023

Anticipated Primary Completion Date :

Feb 15, 2026

Anticipated Study Completion Date :

Dec 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Other: Single Arm	Procedure: Airway Oscillation System After each methacholine dose administred, respiratory function will be measured by forced oscillation Other Names: Tremoflo

Arm

Intervention/Treatment

Other: Single Arm

Procedure: Airway Oscillation System

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

Other Names:

Tremoflo

Outcome Measures

Primary Outcome Measures

Change in lung impedance measurement [During the procedure]
Percentage change in lung impedance measurement obtained by the forced oscillation technique in relation to the dose of methacholine required to obtain bronchial hyperresponsiveness

Secondary Outcome Measures

Average number of trials required for measurement of FEV1 with the spirometry technique [During the procedure]
Average number of trials required for technically satisfactory iterative measurement of FEV1
Average number of trials required for impedance measurement by forced oscillation [During the procedure]
Average number of trials required for technically satisfactory iterative measurement of impedance

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 16 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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