Forced Oscillations Technique During a Metacholine Test in Children

Asthma in Children Clinical Trial

— TPM AOS  

Official title:

Interest of Forced Oscillations During a Methacholine Test in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05734261
• Other study ID #: RECHMPL22_0504
• Secondary ID: 2022-A02437-36RE
• Status: Recruiting
• Phase: N/A
• Start date: September 7, 2023
• Est. completion date: December 30, 2026

Study information

• Verified date: August 2023
• Source: University Hospital, Montpellier
• Contact: Stefan MATECKI, MD
• Phone: +33 4 67 33 59 12
• Email: Stephan.matecki[@]umontpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: December 30, 2026
• Est. primary completion date: February 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Asthma in Children

Intervention

Procedure:
• Airway Oscillation System
After each methacholine dose administred, respiratory function will be measured by forced oscillation

Locations

Country	Name	City	State
France	CHU de Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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