Forced Oscillations Technique During a Metacholine Test in Children (TPM AOS)

Interest of Forced Oscillations During a Methacholine Test in Children

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

Study Overview

• Status: Recruiting
• Conditions: Asthma in Children
• Intervention / Treatment: Procedure: Airway Oscillation System

• Study Type: Interventional
• Enrollment (Estimated): 112
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stefan MATECKI, MD; Phone Number: +33 4 67 33 59 12; Email: Stephan.matecki@umontpellier.fr
• Study Contact Backup: Name: Anne Requirand; Email: a-requirand@chu-montpellier.fr

Study Locations

• France
  • Montpellier, France
    • Recruiting
    • CHU de Montpellier
    • Contact: Anne Requirand; Email: a-requirand@chu-montpellier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 16 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Stefan MATECKI, MD, Montpellier Univerty Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2023
• Primary Completion (Estimated): February 15, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: February 2, 2023
• First Submitted That Met QC Criteria: February 15, 2023
• First Posted (Actual): February 17, 2023

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 12, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Asthma; Infant; Diagnosis; Methacholin; Forced oscillation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: RECHMPL22_0504 (Other Identifier: CHU de Montpellier); 2022-A02437-36 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No