Pediatric Asthma Clinical Trial
— VERI-VEMSOfficial title:
A Retrospective Study to Verify FEV1 Reversibility Criteria Proposed by the GINA Guidelines, in Asthmatic Children
Verified date | January 2019 |
Source | University Hospital, Montpellier |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 600 |
Est. completion date | October 30, 2019 |
Est. primary completion date | June 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 5 Years to 18 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | Uhmontpellier | Montpellier |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Montpellier |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | value of FEV1 increase | Positive predictive value of FEV1 increase (%) in asthmatic children after bronchodilation test | 1 day | |
Primary | value of FEF 25-75 | Positive predictive value of FEF 25-75 increase (%) in asthmatic children after bronchodilation test | 1 day |
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