Sensitivity of Forced Oscillation Technique in Children With Asthma &

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03755908
Study type	Observational
Source	Rambam Health Care Campus
Contact	Lea Bentur, MD
Phone	972 4 7774360
Email	l_bentur@rambam.health.gov.il
Status	Not yet recruiting
Phase
Start date	December 2018
Completion date	October 2021

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms