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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
Sponsor:
Information provided by (Responsible Party):
Rambam Health Care Campus

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.


Condition or disease Intervention/treatment
Asthma in Children 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.


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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Asthma

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.




Primary Outcome Measures :
  1. R5 [ Time Frame: One year ]
    Resistances at the frequency of 5 hertz in kilopascal per liter per second

  2. R20 [ Time Frame: One year ]
    Resistances at the frequency of 20 hertz in kilopascal per liter per second

  3. R5-R20 [ Time Frame: One year ]
    The difference between R5 to R20 in kilopascal per liter per second

  4. Xrs 5 [ Time Frame: One year ]
    Reactance at the frequency of 5 hertz in kilopascal per liter


Secondary Outcome Measures :
  1. FeNO [ Time Frame: One year ]
    Fractional exhaled Nitric Oxide (parts per billion)



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Children with the diagnosis of asthma and a normal spirometry results
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Lea Bentur, MD 972 4 7774360 l_bentur@rambam.health.gov.il
Contact: Guy Gut, MD 972 4 7774360 g_gut@rambam.health.gov.il

Locations
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Israel
Rambam Medical Center
Haifa, Israel, 32000
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
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Principal Investigator: Lea Bentur, MD Rambam Medical Center, Haifa, Israel

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Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT03755908     History of Changes
Other Study ID Numbers: 0384-18-RMB-CTIL
First Posted: November 28, 2018    Key Record Dates
Last Update Posted: November 28, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rambam Health Care Campus:
Forced oscillation technique
Airway obstruction
Asthma

Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases