Sensitivity of Forced Oscillation Technique in Children With Asthma and Normal Spirometry
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|ClinicalTrials.gov Identifier: NCT03755908|
Recruitment Status : Not yet recruiting
First Posted : November 28, 2018
Last Update Posted : November 28, 2018
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.
|Condition or disease||Intervention/treatment|
|Asthma in Children||Device: Forced oscillation technique (FOT)|
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.
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.
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|Official Title:||Sensitivity of Forced Oscillation Technique (FOT) in Children With Asthma and Normal Spirometry|
|Estimated Study Start Date :||December 2018|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||October 2021|
Children with the diagnosis of asthma and normal spirometry results. Each subject will undergo evaluation including: asthma control questionnaire, spirometry, FOT and Fractional exhaled nitric oxide (FeNO).
Device: Forced oscillation technique (FOT)
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.
- R5 [ Time Frame: One year ]Resistances at the frequency of 5 hertz in kilopascal per liter per second
- R20 [ Time Frame: One year ]Resistances at the frequency of 20 hertz in kilopascal per liter per second
- R5-R20 [ Time Frame: One year ]The difference between R5 to R20 in kilopascal per liter per second
- Xrs 5 [ Time Frame: One year ]Reactance at the frequency of 5 hertz in kilopascal per liter
- FeNO [ Time Frame: One year ]Fractional exhaled Nitric Oxide (parts per billion)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03755908
|Contact: Lea Bentur, MD||972 4 firstname.lastname@example.org|
|Contact: Guy Gut, MD||972 4 email@example.com|
|Rambam Medical Center|
|Haifa, Israel, 32000|
|Principal Investigator:||Lea Bentur, MD||Rambam Medical Center, Haifa, Israel|