Asthma in ChildrenTPM AOSNCT05734261
Forced Oscillations Technique During a Metacholine Test in Children
A study testing Airway Oscillation System in people with Asthma in Children, run by University Hospital, Montpellier at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Asthma in Children
- What is being tested?
- Airway Oscillation System
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteFrance
- Study dates
- 7 Sep 2023to 6 Feb 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Anne REQUIRAND contact
France1 site, 1 recruiting
- Recruiting
CHU de Montpellier
Montpellier
Anne Requirand, a-requirand@chu-montpellier.fr
About this study
Official title: Interest of Forced Oscillations During a Methacholine 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
- Conditions
- Asthma in Children
- Being tested
- Airway Oscillation System
- Keywords
- Infant, Asthma, Diagnosis, Methacholin, Forced oscillation
- Medical subject headings
- Asthma, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Airway Oscillation SystemProcedure or surgery
Also called Tremoflo
After each methacholine dose administred, respiratory function will be measured by forced oscillation
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Other | Not described Receives: Procedure: Airway Oscillation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During the procedure
Secondary outcomes (2)
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
Measured: During the procedure
Average number of trials required for impedance measurement by forced oscillation
Average number of trials required for technically satisfactory iterative measurement of impedance
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start7 Sep 2023
- Primary completion6 Feb 2027 (estimated)
- Study completion6 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Each subject is his or her own control
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefan MATECKI, MD, Principal investigator, Montpellier Univerty Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05734261
- Sponsor's protocol ID
- RECHMPL22_0504
- Other IDs
- 2022-A02437-36, RECHMPL22_0504
- Acronym
- TPM AOS
- Status last verified
- Sep 2026
- First submitted
- 2 Feb 2023
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No