Forced Oscillations Technique During a Metacholine Test in Children

Last updated: September 12, 2023
Sponsor: University Hospital, Montpellier
Overall Status: Active - Recruiting

Phase

N/A

Condition

Asthma

Treatment

Airway Oscillation System

Clinical Study ID

NCT05734261
RECHMPL22_0504
2022-A02437-36
RECHMPL22_0504
  • Ages 6-16
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age between 6 and 16 years
  • FEV1 > 60%
  • Child referred to the pulmonary function test laboratory for a non-specific bronchialhyperactivity 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

Exclusion Criteria:

  • Use of a short-acting beta-adrenergic bronchodilator within the last 6 hours oranticholinergic bronchodilator within the last 12 hours
  • Use of a long-acting beta-adrenergic bronchodilator (licensed for use in children) inthe 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 respiratoryfunction
  • Patient unable to give consent, vulnerable

Study Design

Total Participants: 112
Treatment Group(s): 1
Primary Treatment: Airway Oscillation System
Phase:
Study Start date:
September 07, 2023
Estimated Completion Date:
December 30, 2026

Connect with a study center

  • CHU de Montpellier

    Montpellier,
    France

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.