ClinicalTrials.gg
RecruitingNCT05734261TPM AOSUpdated Sep 11, 2026

Forced Oscillations Technique During a Metacholine Test in Children

An interventional study of Airway Oscillation System in Asthma in Children, sponsored by University Hospital, Montpellier. Recruiting at 1 site in France. Open to participants aged 6 Years to 16 Years. Per ClinicalTrials.gov, last updated 2026-09-11.

Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Started Sep 2023; still recruiting 3 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
112
Allocation
Not applicable
Ages
6 Years to 16 Years
Sex
All
01

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

02

Conditions studied

  • Asthma in Children

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Keywords

  • Infant
  • Asthma
  • Diagnosis
  • Methacholin
  • Forced oscillation
03

In context

Asthma

4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.

This study's planned enrollment of 112 is above the median of 78 across 3,341 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

University Hospital, Montpellier is the lead sponsor of 1,261 studies on the registry; 224 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age between 6 and 16 years
  • > 60%
  • Child referred to the pulmonary function test laboratory for a non-specific bronchial hyperactivity test with methacholine
  • Child under treatment with inhaled 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

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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
112 participants (estimated)

Study arms

  • Other
    Single Arm

    Procedure: Airway Oscillation System

Interventions

  • ProcedureAirway Oscillation System

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

    Also known as: Tremoflo

06

What researchers measure

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

    Time frame: During the procedure

Secondary outcomes

  1. 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

    Time frame: During the procedure

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

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

    Time frame: During the procedure

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2023 (actual). Primary completion is estimated for Feb 2027, 40 months after the start.

Of 599 non-industry interventional studies with no phase under Asthma, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 50. This study's planned 40 months is above that.

Counting every sponsor, half of 649 studies reached it within 23 months; a quarter within 10 and three quarters within 48.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 2, 2023
First posted
Feb 17, 2023
StartActual
Sep 7, 2023
Primary completionEst.
Feb 6, 2027
CompletionEst.
Feb 6, 2027
Last update
Sep 11, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05734261
Responsible party
Sponsor
First posted
Feb 17, 2023
Start date
Sep 7, 2023
Primary completion
Feb 6, 2027 (estimated)
Completion
Feb 6, 2027 (estimated)
Last update
Sep 11, 2026

Study contacts

Stefan MATECKI, MD
Contact
Stephan.matecki@umontpellier.fr
+33 4 67 33 59 12
Anne REQUIRAND
Contact
a-requirand@chu-montpellier.fr
Stefan MATECKI, MD
principal investigator · Montpellier Univerty Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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