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

NCT03755908 | Unknown DMC

• 1 other identifier: 0384-18-RMB-CTIL
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma in Children

Keywords

Forced oscillation technique; Airway obstruction; Asthma

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• FeNO

  One year

Study Arms (1)

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)

Interventions

Forced oscillation technique (FOT) DEVICE

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.

asthmatic children

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Children with the diagnosis of asthma and a normal spirometry results

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam Medical Center

Haifa, 32000, Israel

Location

MeSH Terms

Conditions

Airway Obstruction; Asthma

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Lea Bentur, MD

  Rambam Medical Center, Haifa, Israel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lea Bentur, MD

CONTACT

972 4 7774360; l_bentur@rambam.health.gov.il

Guy Gut, MD

CONTACT

972 4 7774360; g_gut@rambam.health.gov.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2018
• First Posted: November 28, 2018
• Study Start: December 1, 2018
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2021
• Last Updated: November 28, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)