Status: Ongoing
First registered on:
28/03/2019
Last updated on:
02/09/2019
1. Study identification
EU PAS Register NumberEUPAS29076
Official titleQuality of asthma treatment in children and adolescents
Study title acronymQUAST
Study typeObservational study
Brief description of the studyAsthma is the most common chronic child and adolescent disease with a prevalence that has increased significantly over the past 20 years worldwide as well as the use of antiasthmatic medications. Little is known about the short and long-term therapeutic management of asthmatic children.
Pharmacological treatment aims durable asthma control but despite the existence of international recommendations for the proper use of anti-asthma drugs and inhalation medical devices in this population, asthma control remains unacceptable for at least one-third of asthmatic children and adolescents.
The aim of this study is to assess the prescribing patterns of antiasthma drugs and inhalation medical devices, oral corticosteroids and antibiotics in asthmatic children in primary care in France in order to identify deviations from recommendations.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)?
Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Department/Research groupCentre de pharmaco-épidémiologie
Organisation/affiliationAssistance Publique - Hôpitaux de Paris
Details of (Primary) lead investigator
Title Dr
Last name KAGUELIDOU
First name Florentia
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)
Countries in which this study is being conducted
National study
France
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed02/11/2016
Start date of data collection01/01/201811/05/2018
Start date of data analysis
Date of interim report, if expected
Date of final study report31/12/2020
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government bodyANSM100
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name KAGUELIDOU
First name Florentia
Address line 1Robert Debré Hospital, Clinical Investigations Center, inserm CIC1426, 48 boulevard Sérurier
Address line 2
Address line 3
CityParis
Postcode75019
CountryFrance
Phone number (incl. country code)33140034142
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Dr
Last name KAGUELIDOU
First name Florentia
Address line 1Robert Debré Hospital, Clinical Investigations Center, inserm CIC1426, 48 boulevard Sérurier
Address line 2
Address line 3
CityParis
Postcode75019
CountryFrance
Phone number (incl. country code)33140034142
Alternative phone number
Fax number (incl. country code)
6. Study drug(s) information
Substance class (ATC Code)R03, H02AB, H02BX, J01
7. Medical conditions to be studied
Medical condition(s)Yes
Asthma
8. Population under study
Age
Children (2 - 11 years)
Adolescents (12 - 17 years)
Sex
Male
Female
9. Number of subjects
Estimated total number of subjects140000
10. Source of data
Is this study being carried out with an established data source?Yes
Data sources not registered with ENCePP
EGB, France
Sources of data
Administrative database, e.g. claims database
11. Scope of the study
What is the scope of the study?
Drug utilisation study
Primary scope : Drug utilisation study
12. Main objective(s)
What is the main objective of the study?
The aim of this study is to assess the prescribing patterns of antiasthma drugs (ATC classe R03) and inhalation medical devices, oral corticosteroids and antibiotics in asthmatic children in primary care in France in order to identify deviations from recommendations.
Are there primary outcomes?Yes
- To describe the prescribing patterns of antiasthma drugs and inhalation medical devices, oral corticosteroids, antibiotics and vaccines in asthmatic children in primary care, and their evolution over time.
- To quantify the number of prescriptions that do not comply with international recommendations.
Are there secondary outcomes?Yes
- To compare the use of antibiotics within 2 years of the diagnosis of persistent asthma between matched asthmatic and non-asthmatic children and adolescents.
- To describe the use of influenza vaccination in asthmatic children and adolescents.
13. Study design
What is the design of the study?
Cohort study
Drug utilisation study
14. Follow-up of patients
Will patients be followed up?Yes
Please describe duration of follow up
2 years
15. Data analysis plan
Please provide a brief summary of the analysis method
A retrospective cohort study between January 2011 and December 2017 using the EGB database, a 1/97th sample of the French national healthcare insurance system. Claims data for all individuals aged from 5 to 18 years old will be analysed. Exposure of interest will be identified via ATC codes. Prevalence and incidence rate will be calculated. Volume of use will be assessed as total number of prescriptions dispensed and DU90%. Users will be classified as occasional if they are dispensed antiasthmatic drugs only once during the year, low users if they are dispensed twice and high users if they are dispensed three or more times in a 12-months period. Severity of asthma will be assessed according to the number of antiasthmatic drugs classes prescribed in a 12-months period. All analyses will be stratified by year, age(5-11, 12-18 years) and gender. Adherence to recommendations will be assessed considering specific drugs dispensed and dosage, age, asthma severity, inhaled device prescription.
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
Not submitted
18. Study Results
Not submitted
Please list the 5 most relevant publications using data from your study
ReferenceLink to web-publication
None
19. Other relevant documents
Conflict(s) of interest of
investigator(s)Not submitted
Composition of Steering Group and
ObserversNot submitted
Other documentsNot
submitted
Signed Code of
Conduct Checklist
Not submitted
Signed Code of Conduct Declaration
Not submitted
Signed Checklist for Study
Protocols
Not submitted
