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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04086628
Other study ID # 2019-A01944-53
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 4, 2019
Est. completion date April 2020

Study information

Verified date December 2019
Source Central Hospital, Nancy, France
Contact Aurore Blondé, Dr
Phone 0383154603
Email a.blonde@chru-nancy.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The occurence of influenza can be a factor of imbalance of asthma. Asthma patients are recommended for annual influenza vaccination . However there is insufficient vaccination coverage of asthmatic patients despite this recommendation. The aim of this study is to evaluate the rate of influenza vaccination coverage of children with asthma aged from 6 month to 17 years of age followed in pediatric pneumology consultation at the university hospital of Nancy.


Description:

Using a questionnaire, the investigator will estimate the percentage of the asthmatic patients vaccinated against influenza. He will then compare the 2 groups of vaccinated and unvaccinated patients : comparison of patients characteristics, comparison of asthma characteristics (severity, asthma control...). He will also analyze the causes of vaccination or non-vaccination.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date April 2020
Est. primary completion date April 2020
Accepts healthy volunteers No
Gender All
Age group 6 Months to 17 Years
Eligibility Inclusion Criteria:

- asthmatic patients followed in pediatric pneumology consultation at university hospital of Nancy aged from 6 months to 17 years

Exclusion Criteria:

- asthmatic children who have been followed for less than 1 year

Study Design


Locations

Country Name City State
France CHRU Nancy Vandoeuvre les Nancy

Sponsors (1)

Lead Sponsor Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of asthmatic patients vaccinated against influenza Percentage of patients vaccinated against influenza will be evaluate among children with asthma followed in pediatric pneumology consultation. through study completion, an average of 6 months
Secondary Socio-demographic characteristics of patients Socio-demographic characteristics will be recorded from the questionnaire and compare between the 2 groups : vaccinated and unvaccinated patients. through study completion, an average of 6 months
Secondary Age of patients (years) Age of patients will be recorded from the questionnaire and compared between the 2 groups : vaccinated and unvaccinated patients. through study completion, an average of 6 months
Secondary Asthma severity (mild, moderate, severe asthma) Asthma severity (mild, moderate, severe asthma) is assessed from the level of treatment required to control symptoms according to Global Initiative for Asthma (GINA) 2018 recommendations. The investigator will compare asthma severity between the 2 groups : vaccinated and unvaccinated patients. through study completion, an average of 6 months
Secondary Asthma symptom control (well controled, partly controlled, uncontrolled) Level of asthma symptoms control (well controled, partly controlled, uncontrolled) is assessed from symptoms control tool, according to GINA 2018 recommendations. The investigator will compare asthma symptom control between the 2 groups : vaccinated and unvaccinated patients. through study completion, an average of 6 months
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