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

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.

Study Overview

• Status: Unknown
• Conditions: Asthma in Children
• Intervention / Treatment: Device: Forced oscillation technique (FOT)

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.

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel, 32000
    • Rambam Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Children with the diagnosis of asthma and a normal spirometry results

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
asthmatic children; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
R5	Resistances at the frequency of 5 hertz in kilopascal per liter per second	One year
R20	Resistances at the frequency of 20 hertz in kilopascal per liter per second	One year
R5-R20	The difference between R5 to R20 in kilopascal per liter per second	One year
Xrs 5	Reactance at the frequency of 5 hertz in kilopascal per liter	One year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FeNO	Fractional exhaled Nitric Oxide (parts per billion)	One year

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus
• Investigators: Principal Investigator: Lea Bentur, MD, Rambam Medical Center, Haifa, Israel

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2018
• Primary Completion (Anticipated): October 1, 2020
• Study Completion (Anticipated): October 1, 2021

Study Registration Dates

• First Submitted: October 16, 2018
• First Submitted That Met QC Criteria: November 25, 2018
• First Posted (Actual): November 28, 2018

Study Record Updates

• Last Update Posted (Actual): November 28, 2018
• Last Update Submitted That Met QC Criteria: November 25, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Asthma; Forced oscillation technique; Airway obstruction
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 0384-18-RMB-CTIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No