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

Primary Purpose

Asthma in Children

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Airway Oscillation System
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Asthma in Children focused on measuring Infant, Asthma, Diagnosis, Methacholin, Forced oscillation

Eligibility Criteria

6 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de MontpellierRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single Arm

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Average number of trials required for impedance measurement by forced oscillation
Average number of trials required for technically satisfactory iterative measurement of impedance

Full Information

First Posted
February 2, 2023
Last Updated
September 12, 2023
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT05734261
Brief Title
Forced Oscillations Technique During a Metacholine Test in Children
Acronym
TPM AOS
Official Title
Interest of Forced Oscillations During a Methacholine Test in Children
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 7, 2023 (Actual)
Primary Completion Date
February 15, 2026 (Anticipated)
Study Completion Date
December 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma in Children
Keywords
Infant, Asthma, Diagnosis, Methacholin, Forced oscillation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Each subject is his or her own control
Masking
None (Open Label)
Allocation
N/A
Enrollment
112 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single Arm
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Airway Oscillation System
Other Intervention Name(s)
Tremoflo
Intervention Description
After each methacholine dose administred, respiratory function will be measured by forced oscillation
Primary Outcome Measure Information:
Title
Change in lung impedance measurement
Description
Percentage change in lung impedance measurement obtained by the forced oscillation technique in relation to the dose of methacholine required to obtain bronchial hyperresponsiveness
Time Frame
During the procedure
Secondary Outcome Measure Information:
Title
Average number of trials required for measurement of FEV1 with the spirometry technique
Description
Average number of trials required for technically satisfactory iterative measurement of FEV1
Time Frame
During the procedure
Title
Average number of trials required for impedance measurement by forced oscillation
Description
Average number of trials required for technically satisfactory iterative measurement of impedance
Time Frame
During the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stefan MATECKI, MD
Phone
+33 4 67 33 59 12
Email
Stephan.matecki@umontpellier.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Anne REQUIRAND
Email
a-requirand@chu-montpellier.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan MATECKI, MD
Organizational Affiliation
Montpellier Univerty Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Montpellier
City
Montpellier
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Requirand
Email
a-requirand@chu-montpellier.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Forced Oscillations Technique During a Metacholine Test in Children

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