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NCT Number: NCT05734261

Forced Oscillations Technique During a Metacholine 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

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Key information

Conditions

Asthma in Children Asthma Bronchial Diseases Disease Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

6 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Montpellier

Montpellier, France

Location status: Recruiting

Location contact

Anne Requirand

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Airway Oscillation System

Procedure

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

Other names: Tremoflo

Primary outcomes

  1. Change in lung impedance measurement

    Time frame: 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 outcomes

  1. Average number of trials required for measurement of FEV1 with the spirometry technique

    Time frame: During the procedure

    Average number of trials required for technically satisfactory iterative measurement of FEV1

  2. Average number of trials required for impedance measurement by forced oscillation

    Time frame: During the procedure

    Average number of trials required for technically satisfactory iterative measurement of impedance

Study contacts

Contact information is provided by the study sponsor or research team.

Anne REQUIRAND

CONTACT

[email protected]

Stefan MATECKI, MD

CONTACT

[email protected]

+33 4 67 33 59 12

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Interest of Forced Oscillations During a Methacholine Test in Children

Acronym: TPM AOS

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 17, 2023
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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