Study identification

PURI

https://redirect.ema.europa.eu/resource/14482

EU PAS number

EUPAS3099

Study ID

14482

Official title and acronym

Assessment of the safety of LABAs in asthma in routine care by combining healthcare databases and direct patient follow-up (ASTRO-LAB)

DARWIN EU® study

No

Study countries

France
United Kingdom

Study description

Funded 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.”

Study status

Finalised
Research institution and networks

Institutions

Kappa Santé
France
First published:
06/03/2024
Institution
Non-Pharmaceutical companyENCePP partner
PSMAR Barcelona, SP, University of Amsterdam Amsterdam, NL, University of Nottingham Nottingham, UK, Lyon Ingenierie Projet (LIP) Lyon, FR

Contact details

Eric VAN GANSE

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
EU institutional research programme
Other

More details on funding

FP7 programm, Private partners, Public and SME partners
Study protocol
Initial protocol

npjpcrm ASTROLAB 2015

English (904.45 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable