Status: Finalised First registered on: 28/11/2013
Last updated on: 20/06/2017
1. Study identification
EU PAS Register NumberEUPAS5306
Official titleStudy of healthcare consumption of patients over 45 years with chronic Chronic Obstructive Pulmonary Disease
Study title acronym
Study typeObservational study
Brief description of the studyThe Chronic Obstructive Pulmonary Disease (COPD) is defined as a chronic, slowly progressive disease, characterized by incompletely reversible reduction in airflow. It is very closely related to tobacco, responsible for the initiation and the perpetuation of the inflammatory mechanisms that cause bronchial and lung injuries. The symptoms (cough, sputum and dyspnea) induce an early limitation of physical activity, from daily life and work to sports and sleep. This disabling disease costs for society, in part due to the high frequency of comorbidities, including cardiovascular disease, diabetes, cancer, anxiety and psychiatric disorders. In clinical practice, COPD is under-diagnosed and under-treated with an under-use of spirometry to confirm the diagnosis. Based on the French national health insurance database (EGB) which contains healthcare reimbursement data of 1/97 of the French population, the objectives of this study is to define the support in 2006 and in 2011 of patients aged over 45 years with COPD (characteristics of patients, consumption, individual costs, factors associated with high costs and with repeated hospitalizations related to the disease). A longitudinal analysis studies also the support over the period of six years. Finally the healthcare consumption and cost is studied according to comorbidities (cardiovascular, psychiatric, diabetes).
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 signed15/11/2011
Start date of data collection15/11/2011
Start date of data analysis
Date of interim report, if expected
Date of final study report02/08/2013
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesGSK100
Charities
Government body
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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