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

Completed

• Conditions: Pediatric Asthma

• Registration Number: NCT03814018
• Lead Sponsor: University Hospital, Montpellier

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-01
• Study First Submitted: 2019-01-21
• Study First Submitted QC: 2019-01-21
• Study First Posted: 2019-01-23
• Study Start: 2019-02-01
• Primary Completion: 2019-06-30
• Study Completion: 2019-10-30
• Last Update Submitted: 2019-11-18
• Last Update Posted: 2019-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Uhmontpellier; 🇫🇷 Montpellier, France