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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03814018
Recruitment Status : Active, not recruiting
First Posted : January 23, 2019
Last Update Posted : April 19, 2019
Information provided by (Responsible Party):
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.

Condition or disease
Pediatric Asthma

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Study Type : Observational
Estimated 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 : February 1, 2019
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : October 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Primary Outcome Measures :
  1. value of FEV1 increase [ Time Frame: 1 day ]
    Positive predictive value of FEV1 increase (%) in asthmatic children after bronchodilation test

  2. value of FEF 25-75 [ Time Frame: 1 day ]
    Positive predictive value of FEF 25-75 increase (%) in asthmatic children after bronchodilation test

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Children with a physician-base diagnosis of asthma, undergoing a bronchodilation test

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

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 identifier (NCT number): NCT03814018

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Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
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Principal Investigator: Davide CAIMMI University Hospital, Montpellier

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Responsible Party: University Hospital, Montpellier Identifier: NCT03814018     History of Changes
Other Study ID Numbers: RECHMPL19_0007
First Posted: January 23, 2019    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 University Hospital, Montpellier:
Bronchodilation test
Reversibility criteria