Status: Finalised First registered on: 06/06/2016
Last updated on: 20/06/2017
1. Study identification
EU PAS Register NumberEUPAS13721
Official titleObservational study to quantify in real life the contribution of SINGULAIR ® 4mg in children aged from 6 to 24 months
Study title acronymNA
Study typeObservational study
Brief description of the studySINGULAIR® 4mg is an additive treatment to inhaled corticosteroids in 6 month to 5 year children with mild to moderate persistent asthma, inadequately controlled by inhaled corticosteroids and in whom immediate and short-term beta 2 agonists, administered at the request, does not provide sufficient clinical asthma control. The French Economic Committee for Health Products (CEPS) asked MSD France laboratory "to establish an epidemiological study of children under 2 years old, with the primary objective to determine whether the introduction of SINGULAIR® in the therapeutic arsenal provides better control of mild to moderate persistent asthma, poorly controlled when real prescribing practice is in relation to existing recommendations". Based on the French national health insurance database (SNII-RAM) which contains healthcare reimbursement data of the French population, the objective of this study is to compare the support, following an exacerbation, of children aged from 6 to 24 months with persistent asthma, between the addition of SINGULAIR® 4mg and a reinforcement of inhaled corticosteroids, according to existing guidelines.
Was this study requested by a regulator?Yes: France
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 groupPharmacoEpidemiology Unit
Organisation/affiliationClaude Bernard Lyon 1 University
Website/Homepagehttp://www.pelyon.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 signed03/10/201103/10/2011
Start date of data collection21/12/201221/12/2012
Start date of data analysis02/05/201302/05/2013
Date of interim report, if expected
Date of final study report30/09/201330/09/2013
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesMSD France100
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, Université Claude Bernard Lyon 1
Address line 211 rue Guillaume Paradin 
Address line 3 
CityLyon 
Postcode69008 
CountryFrance
Phone number (incl. country code)33-478778609 
Alternative phone number 
Fax number (incl. country code) 
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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