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VERI-VEMS: Bronchoreversibility Test in Asthmatic Children and Correlation With Diagnostic Criteria Proposed by the GINA Guidelines

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Completed
CT.gov ID
NCT03814018
Collaborator
(none)
600
Enrollment
1
Location
8.9
Actual Duration (Months)
67.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    600 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    A Retrospective Study to Verify FEV1 Reversibility Criteria Proposed by the GINA Guidelines, in Asthmatic Children
    Actual Study Start Date :
    Feb 1, 2019
    Actual Primary Completion Date :
    Jun 30, 2019
    Actual Study Completion Date :
    Oct 30, 2019

    Outcome Measures

    Primary Outcome Measures

    1. value of FEV1 increase [1 day]

      Positive predictive value of FEV1 increase (%) in asthmatic children after bronchodilation test

    2. value of FEF 25-75 [1 day]

      Positive predictive value of FEF 25-75 increase (%) in asthmatic children after bronchodilation test

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Uhmontpellier Montpellier France 34295

    Sponsors and Collaborators

    • University Hospital, Montpellier

    Investigators

    • Principal Investigator: Davide CAIMMI, University Hospital, Montpellier

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Montpellier
    ClinicalTrials.gov Identifier:
    NCT03814018
    Other Study ID Numbers:
    • RECHMPL19_0007
    First Posted:
    Jan 23, 2019
    Last Update Posted:
    Nov 19, 2019
    Last Verified:
    Jan 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Montpellier
    Bronchodilation test
    GINA
    Reversibility criteria
    Additional relevant MeSH terms:
    Asthma

    Study Results

    No Results Posted as of Nov 19, 2019