Status: Finalised First registered on: 28/11/2013
Last updated on: 21/09/2016
1. Study identification
EU PAS Register NumberEUPAS5309
Official titleStudy of the impact of non-compliance with GINA recommendations on the care consumption of adult asthmatic patient
Study title acronym
Study typeObservational study
Brief description of the studyAsthma is a chronic disease that has major implications not only in terms of morbidity and mortality or of deterioration in the quality of life for patients, but also in terms of costs associated with the disease. The management of persistent asthma (GINA 2, 3 and 4) is mainly based on the trigger eviction and on drug therapy. In current medical practice, asthma remains generally under-diagnosed, under-treated and poorly controlled yet. Based on the French national health insurance database (EGB), which contains healthcare reimbursement data of 1/97 of the French population, this study aims to better understand the impact of non-compliance with GINA therapeutic recommendations on healthcare use and on absenteeism of persistent asthmatic patients. It also identifies the characteristics of patients whose care is not in accordance with these recommendations and tests the economic impact of medical nomadism on the management of asthma in 2007 and 2008.
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
Centre to which the investigator belongsPELyon
Department/Research groupUnité de Pharmacoépidémiologie
Organisation/affiliationUniversité Claude Bernard Lyon 1
Website/Homepagehttp://eia.univ-lyon1.fr
Details of (Primary) lead investigator
Title Dr
Last name VAN GANSE
First name Eric
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 signed30/06/2009
Start date of data collection30/10/2009
Start date of data analysis
Date of interim report, if expected
Date of final study report31/03/2011
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 bodyCNAMTS100
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name VAN GANSE
First name Eric
Address line 1Unité de Pharmacoépidémiologie
Address line 2Faculte d'Odontologie Universite Lyon 1 
Address line 311 rue Guillaume Paradin 
CityLyon cedex 08 
PostcodeF-69372 
CountryFrance
Phone number (incl. country code)33-478778610 
Alternative phone number 
Fax number (incl. country code)33-478778660 
Email address eric.van-ganse@univ-lyon1.fr
Public Enquiries
Title Dr 
Last name VAN GANSE 
First name Eric 
Address line 1Unité de Pharmacoépidémiologie 
Address line 2Faculte d'Odontologie Universite Lyon 1 
Address line 311 rue Guillaume Paradin 
CityLyon cedex 08 
PostcodeF-69372 
CountryFrance 
Phone number (incl. country code)33-478778610 
Alternative phone number 
Fax number (incl. country code)33-478778660 
Email address eric.van-ganse@univ-lyon1.fr 
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