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

Ziel

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.

Aufforderung zur Vorschlagseinreichung

FP7-HEALTH-2011-single-stage
Andere Projekte für diesen Aufruf anzeigen

Koordinator

UNIVERSITE LYON 1 CLAUDE BERNARD
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Boulevard Du 11 Novembre 1918 Num43
69622 Villeurbanne Cedex
Frankreich

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Higher or Secondary Education Establishments
Kontakt Verwaltung
Javier Olaiz (Dr.)
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€ 458 136

Beteiligte (7)

THE UNIVERSITY OF NOTTINGHAM
United Kingdom
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University Park
NG7 2RD Nottingham

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Paul Cartledge (Mr.)
KAPPA SANTE SAS
Frankreich
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75002 Paris

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Private for-profit entities (excluding Higher or Secondary Education Establishments)
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Stéphane Schück (Dr.)
IMS INFORMATION SOLUTIONS MEDICAL RESEARCH LIMITED
United Kingdom
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€ 320 050
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Pentonville Road 210
NI 9JY London

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Hassy Dattani (Ms.)
WAGENINGEN UNIVERSITY

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Niederlande
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€ 46 727
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Droevendaalsesteeg 4
6708 PB Wageningen
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Ingeborg Oude Lansink (Ms.)
CONSORCIO MAR PARC DE SALUT DE BARCELONA
Spanien
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Paseo Maritim 25-29
08003 Barcelona

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Andreu Fort (Mr.)
LYON INGENIERIE PROJETS
Frankreich
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Bd Du 11 Novembre 1918 43 L Atrium
69616 Villeurbanne

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Javier Olaiz (Dr.)
UNIVERSITEIT VAN AMSTERDAM
Niederlande
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Spui 21
1012WX Amsterdam

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Maaike Prangsma (Dr.)