Bronchoreversibility Test in Asthmatic Children and Correlation With Diagnostic Criteria Proposed by the GINA Guidelines

A Retrospective Study to Verify FEV1 Reversibility Criteria Proposed by the GINA Guidelines, in Asthmatic Children

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03814018

Acronym

VERI-VEMS

Enrollment

600

Registered

2019-01-23

Start date

2019-02-01

Completion date

2019-10-30

Last updated

2019-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Asthma

Keywords

Bronchodilation test, GINA, Reversibility criteria

Brief summary

Since 2015, GINA (Global INitiative on Asthma) guidelines were modified and adapted to better fit the pediatric population. Asthma diagnosis is mainly based on the results of PFT (Pulmonary Function Tests) and broncho-reversibility test in adult. GINA guidelines modified the requirements to reach a diagnosis of Asthma in children, based on the reversibility test. GINA guideline propose an increase of 12% of the FEV1 is considered as the diagnostic criterium for asthma in pediatrics. Nevertheless, in clinical practice, most physicians base their diagnosis of asthma in children on the clinical signs presented by the patient and on the efficacy of the prescribed therapy. Also, the spirometric criterium is not sufficiently corroborated by clinical studies. No research has ever looked for the results of bronchoreversibility test in patients receiving a clinical diagnosis of asthma. For this reason, in children with a clinical diagnosis of asthma, the investigators want to look for the results of the bronchoreversibility test and validate that an increase of 12% of the FEV1 correlate with a physician-driven diagnosis of asthma in pediatrics. For further analysis the investigatorswill evaluate also the reversibility of small airways (FEF25-75) and the z-score of the results of the PFT in these children.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

5 Years to 18 Years

Healthy volunteers

Inclusion criteria

* Children aged between 5 and 18 years * Children with a diagnosis of asthma undergoing a PFT and a bronchoreversibility test on the day of the diagnosis * Children evaluated at the University Hospital of Montpellier (France), or at the Pediatric Allergy Unit of the University Hospital of Pavia (Italy)

Exclusion criteria

* Children not able to perform a PFT * Children taking drugs that could affect the results of a PFT * Children included in other trials that don't allow them to be included in the present one

Design outcomes

Primary

Measure	Time frame	Description
value of FEV1 increase	1 day	Positive predictive value of FEV1 increase (%) in asthmatic children after bronchodilation test
value of FEF 25-75	1 day	Positive predictive value of FEF 25-75 increase (%) in asthmatic children after bronchodilation test

Countries

France

Outcome results