Forced Oscillations Technique During a Metacholine Test in Children

NCT05734261 | Recruiting

• 2 other identifiers: RECHMPL22_05042022-A02437-36
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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

Conditions

Asthma in Children

Keywords

Infant; Asthma; Diagnosis; Methacholin; Forced oscillation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  During the procedure

• Average number of trials required for impedance measurement by forced oscillation

  During the procedure

Study Arms (1)

Single Arm

OTHER

Procedure: Airway Oscillation System

Interventions

Airway Oscillation System PROCEDURE

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

Also known as: Tremoflo

Single Arm

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• Epilepsy under treatment
• Subject's participation in another interventional study that may alter respiratory function
• Patient unable to give consent, vulnerable

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

CHU de Montpellier

Montpellier, France

RECRUITING

MeSH Terms

Conditions

Asthma; Disease

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stefan MATECKI, MD

  Montpellier Univerty Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefan MATECKI, MD

CONTACT

+33 4 67 33 59 12; Stephan.matecki@umontpellier.fr

Anne REQUIRAND

CONTACT

a-requirand@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each subject is his or her own control

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: February 17, 2023
• Study Start: September 7, 2023
• Primary Completion: February 15, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: September 13, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)