ASTRO-LAB

ASSESSMENT OF THE SAFETY OF LABAS IN ASTHMA IN ROUTINE CARE BY COMBINING HEALTH-CARE DATABASES AND DIRECT PATIENT FOLLOW-UP

Coordinatore	UNIVERSITE LYON 1 CLAUDE BERNARD    more  Organization address address: BOULEVARD DU 11 NOVEMBRE 1918 NUM43 city: VILLEURBANNE CEDEX postcode: 69622 contact info Titolo: Dr. Nome: Javier Cognome: Olaiz Email: send email Telefono: 33472697600 Fax: 33472697609
Nazionalità Coordinatore	France [FR]
Totale costo	4˙073˙707 €
EC contributo	2˙979˙996 €
Programma	FP7-HEALTH Specific Programme "Cooperation": Health
Code Call	FP7-HEALTH-2011-single-stage
Funding Scheme	CP-FP
Anno di inizio	2011
Periodo (anno-mese-giorno)	2011-12-01   -   2016-05-31

 Partecipanti

#	participant	country	role	EC contrib. [€]
1	UNIVERSITE LYON 1 CLAUDE BERNARD  Organization address address: BOULEVARD DU 11 NOVEMBRE 1918 NUM43 city: VILLEURBANNE CEDEX postcode: 69622 contact info Titolo: Dr. Nome: Javier Cognome: Olaiz Email: send email Telefono: 33472697600 Fax: 33472697609	FR (VILLEURBANNE CEDEX)	coordinator	458˙136.00
2	KAPPA SANTE SAS  Organization address address: RUE DE TURBIGO 21 city: PARIS postcode: 75002 contact info Titolo: Dr. Nome: Stéphane Cognome: Schück Email: send email Telefono: +33 1 44827476 Fax: +33 1 44827475	FR (PARIS)	participant	1˙204˙555.00
3	UNIVERSITEIT VAN AMSTERDAM  Organization address address: SPUI 21 city: AMSTERDAM postcode: 1012WX contact info Titolo: Dr. Nome: Maaike Cognome: Prangsma Email: send email Telefono: 31205253779 Fax: 31205253680	NL (AMSTERDAM)	participant	364˙227.00
4	CONSORCIO MAR PARC DE SALUT DE BARCELONA  Organization address address: PASEO MARITIM 25-29 city: BARCELONA postcode: 8003 contact info Titolo: Mr. Nome: Andreu Cognome: Fort Email: send email Telefono: +34 93 316 0400 Fax: +34 93 316 0410	ES (BARCELONA)	participant	345˙640.00
5	CEGEDIM STRATEGIC DATA MEDICAL RESEARCH LIMITED  Organization address address: POUND ROAD CEGEDIM HOUSE city: CHERTSEY postcode: KT16 8EH contact info Titolo: Ms. Nome: Hassy Cognome: Dattani Email: send email Telefono: +44 207 388 8215 Fax: +44 207 388 8492	UK (CHERTSEY)	participant	320˙050.00
6	LYON INGENIERIE PROJETS  Organization address address: BD DU 11 NOVEMBRE 1918 43 L ATRIUM city: VILLEURBANNE postcode: 69616 contact info Titolo: Dr. Nome: Javier Cognome: Olaiz Email: send email Telefono: 33472697600 Fax: 33472697609	FR (VILLEURBANNE)	participant	217˙000.00
7	WAGENINGEN UNIVERSITY  Organization address address: DROEVENDAALSESTEEG 4 city: WAGENINGEN postcode: 6708 PB contact info Titolo: Ms. Nome: Ingeborg Cognome: Oude Lansink Email: send email Telefono: +31 317 486063 Fax: +31 317 484763	NL (WAGENINGEN)	participant	46˙727.00
8	THE UNIVERSITY OF NOTTINGHAM  Organization address address: University Park city: NOTTINGHAM postcode: NG7 2RD contact info Titolo: Mr. Nome: Paul Cognome: Cartledge Email: send email Telefono: +44 115 9515679	UK (NOTTINGHAM)	participant	23˙661.00

Mappa

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 Obiettivo del progetto (Objective)

'Background: The efficacy of long-acting β-agonists (LABAs) in asthma has been demonstrated but their safety remains an issue, particularly in children. Co-therapy with inhaled corticosteroids (ICs) is recommended in persistent asthma. However, drug-use studies suggest frequently inadequate IC adherence, possibly explaining the occurrence of exacerbations. There is a need for detailed analyses of patterns of use of LABAs and ICs to describe asthma outcomes related to LABAs in monotherapy and at different levels of concomitant ICs, to explore the role of adherence in LABA safety, and to identify populations possibly at risk of adverse LABA-related asthma outcomes. Methods: Summarise available evidence on the risks of LABAs in asthma; develop questionnaires and instruments for the study; identify, in the UK and France, paediatric (6-15) and adult (16-40) patients with persistent asthma treated by LABAs; and link distinct datasets for this group using past and ongoing prescriptions provided by GPs and identified from electronic health records, dispensed therapy identified from claims data, information collected from prescribers, and details on exposures and outcomes collected by computer-assisted telephone interviews with patients over a prospective 24-month period. Analyze the linked datasets to characterise individual asthma care in detail and with high validity, describe patterns of use of LABAs and ICs, and relate these patterns to asthma outcomes. Disseminate results to the scientific community, patients’ associations, physician’s associations, and regulators. Deliverables: Ranking of observed patterns of LABA and IC use according to risk of adverse outcomes due to LABAs. Identification from prescriber and patient data of predictors of patterns of use which put patients at risk. Results for regulators to use regarding recommendations to prescribers and patients on the use of LABAs. Assessment of the potential impact of these recommendations on public health.'