Status: Finalised First registered on: 30/10/2012
Last updated on: 29/07/2016
1. Study identification
EU PAS Register NumberEUPAS3099
Official titleAssessment of the safety of LABAs in asthma in routine care by combining healthcare databases and direct patient follow-up
Study title acronymASTRO-LAB
Study typeObservational study
Brief description of the studyFunded by the European Commission (FP7 Research Program), ASTRO-LAB is a prospective cohort study of persistent asthma patients. ASTRO-LAB aims to provide new information about the safety of inhaled therapy in Asthma, more specifically Long-Acting β2 agonists (LABAs). To reach this objective, 3000 patients aged from 6 to 40 years, will be followed during 2 years in the UK and in France. Three sets of data will be collected : medical data (in the UK: using the THIN data, in France, using data from GPs affiliated to Academia), claims data (for France) and Patient-Reported data. The study will measure the incidence of asthma exacerbations in four different groups: LABAs only, Inhaled Corticosteroids (ICs) only, LABA and ICs in fixed-dose combinations and in distinct inhalers. The study will be also focused on adherence to therapy, to develop new measurement tools and to identify determinants.”
Was this study requested by a regulator?Yes: EMA
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://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
Multiple centres

In total how many centres are involved in this Study?7

IMS Health
Kappa Santé
PELyon
PSMAR, Barcelona, SP
University of Amsterdam, Amsterdam, NL
University of Nottingham, Nottingham, UK
Lyon Ingenierie Projet (LIP), Lyon, FR
Countries in which this study is being conducted
International study

France
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/12/201101/12/2011
Start date of data collection31/05/201329/05/2013
Start date of data analysis02/11/201501/01/2016
Date of interim report, if expected
Date of final study report31/05/201629/07/2016
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 body
Research councils
EU funding schemeFP7 programm65
OtherPrivate partners10
Public and SME partners25
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 Mrs 
Last name Herbage 
First name Sandrine 
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 sandrine.herbage@univ-lyon1.fr 
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