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

NCT03814018 | Completed

• 1 other identifier: RECHMPL19_0007
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Asthma

Keywords

Bronchodilation test; GINA; Reversibility criteria

Outcome Measures

Primary Outcomes (2)

• value of FEV1 increase

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

  1 day

• value of FEF 25-75

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

  1 day

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Children with a physician-base diagnosis of asthma, undergoing a bronchodilation test

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

Study Officials

• Davide CAIMMI

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2019
• First Posted: January 23, 2019
• Study Start: February 1, 2019
• Primary Completion: June 30, 2019
• Study Completion: October 30, 2019
• Last Updated: November 19, 2019

Record last verified: 2019-01

Locations

FR (1)