Skip to content

Sensitivity of Forced Oscillation Technique in Children With Asthma and Normal Spirometry

Sensitivity of Forced Oscillation Technique (FOT) in Children With Asthma and Normal Spirometry

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03755908
Enrollment
150
Registered
2018-11-28
Start date
2018-12-31
Completion date
2021-10-31
Last updated
2018-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma in Children

Keywords

Forced oscillation technique, Airway obstruction, Asthma

Brief summary

Exhibiting variable airway obstruction is a key factor in the diagnosis of asthma but too often it is undetected by spirometry. Study hypothesis: The forced oscillation technique (FOT) will show airway obstruction in asthmatic children with normal spirometry pointing out its advantage in measuring AW obstruction in this population. We will conduct a prospective observational study in 6-18 years old children with the diagnosis of asthma and a normal spirometry results. Each subject will undergo evaluation including: asthma control questionnaire, spirometry, FOT and Fractional exhaled nitric oxide (FeNO) to assess the sensitivity of FOT in diagnosing airway obstruction in this circumstances.

Detailed description

Background: Asthma diagnosis and control are based on history of recurrent typical symptoms and variable airflow obstruction by by measuring maximal expiratory flows with spirometry. However, in many children with asthma spirometry can be normal. The forced oscillation technique (FOT) is a simple, noninvasive technique performed during tidal breathing that is relatively easy to apply. The objective of this study is to assess the sensitivity of FOT in children with asthma and normal spirometry. Study design: this will be a prospective observational study. Population: 6-18 years old children visiting the pediatric pulmonary clinic at the investigators institution with the diagnosis of asthma and normal spirometry results (FEV1 & FEV1/FVC \>80% and FEF25-75\>65%) either on treatment or before treatment. Study protocol: After obtaining written informed consent, participants will fill asthma control questionnaires. Family history and risk factors for asthma will be reviewed. Data on blood eosinophils and skin prick test for allergy will be collected from the medical files. Medication (controller and reliever) will be also documented. FOT will be measured using the TremoFlo C-100 Airwave Oscillometry System (Thorasys , Montreal, Quebec, Canada). R5, R20, R5-20 (resistances at the reported frequency), X5 (reactance at 5hz), AX5 (reactance area at 5hz), Fres (resonance frequency) will be reported. Fractional exhaled nitric oxide (FeNO) will be measured using the single breath exhalation technique.

Interventions

FOT will be measured using the TremoFlo C-100 Airwave Oscillometry System (Thorasys , Montreal, Quebec, Canada). R5, R20, R5-20 (resistances in the reported frequency), X5 (reactance in 5hz) and Ax5 (reactance area in 5hz) will be reported.

Sponsors

Rambam Health Care Campus
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

* Diagnosis of asthma * Must be able to perform spirometry and FOT tests * Normal spirometry results (FEV1 & FEV1/FVC \>80% and FEF25-75\>65%)

Exclusion criteria

* Chronic lung disease other than asthma * Severe chronic medical condition such as heart failure, neuromuscular disease etc.

Design outcomes

Primary

MeasureTime frameDescription
R5One yearResistances at the frequency of 5 hertz in kilopascal per liter per second
R20One yearResistances at the frequency of 20 hertz in kilopascal per liter per second
R5-R20One yearThe difference between R5 to R20 in kilopascal per liter per second
Xrs 5One yearReactance at the frequency of 5 hertz in kilopascal per liter

Secondary

MeasureTime frameDescription
FeNOOne yearFractional exhaled Nitric Oxide (parts per billion)

Countries

Israel

Contacts

Primary ContactLea Bentur, MD
l_bentur@rambam.health.gov.il972 4 7774360
Backup ContactGuy Gut, MD
g_gut@rambam.health.gov.il972 4 7774360

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026