Open Access Study protocol

InternationaL cross-sectIonAl and longItudinal assessment on aSthma cONtrol in European adult patients - the LIAISON study protocol

Fulvio Braido1, Guy Brusselle2, Eleonora Ingrassia3, Gabriele Nicolini3*, David Price4, Nicolas Roche5, Joan B Soriano6, Heinrich Worth7 and on behalf of the LIAISON study group

Author Affiliations

1 Allergy and Respiratory Diseases Clinic, University of Genoa, IRCCS-AOU San Martino, Genoa, Italy

2 Department of Respiratory Medicine, Ghent University Hospital and Ghent University, Ghent, Belgium

3 Chiesi Farmaceutici S.p.A, Via Palermo 26/A, Parma, 43122, Italy

4 Centre of Academic Primary Care, University of Aberdeen, Aberdeen, UK

5 Service de Pneumologie et Réanimation, Hôtel-Dieu, Groupe Hospitalier Cochin-Broca-Hôtel-Dieu, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Paris, France

6 Programme of Epidemiology and Clinical Research, Fundació Caubet-CIMERA Illes Balears, Recinte Hospital Joan March, Mallorca, Illes Balears, Spain

7 Medical Department I, Klinikum Fürth, Fürth, Germany

For all author emails, please log on.

BMC Pulmonary Medicine 2013, 13:18  doi:10.1186/1471-2466-13-18

Published: 25 March 2013

Abstract

Background

According to international guidelines, the goal of asthma management is to achieve and maintain control of the disease, which can be assessed using composite measures. Prospective studies are required to determine how these measures are associated with asthma outcomes and/or future risk. The ‘InternationaL cross-sectIonAl and longItudinal assessment on aSthma cONtrol (LIAISON)’ observational study has been designed to evaluate asthma control and its determinants, including components of asthma management.

Methods/design

The LIAISON study will be conducted in 12 European countries and comprises a cross-sectional phase and a 12-month prospective phase. Both phases will aim at assessing asthma control (six-item Asthma Control Questionnaire, ACQ), asthma-related quality of life (Mini Asthma Quality of Life Questionnaire, Mini-AQLQ), risk of non-adherence to treatment (four-item Morisky Medication Adherence Scale, MMAS-4), potential reasons for poor control, treatment strategies and associated healthcare costs.

The cross-sectional phase will recruit > 8,000 adult patients diagnosed with asthma for at least 6 months and receiving the same asthma treatment in the 4 weeks before enrolment.

The prospective phase will include all patients with uncontrolled/poorly controlled asthma at the initial visit to assess the proportion reaching control during follow-up and to examine predictors of future risk. Visits will take place after 3, 6 and 12 months.

Discussion

The LIAISON study will provide important information on the prevalence of asthma control and on the quality of life in a broad spectrum of real-life patient populations from different European countries and will also contribute to evaluate differences in management strategies and their impact on healthcare costs over 12 months of observation.

Trial registration

ClinicalTrials.gov identifier, NCT01567280.

Keywords:
Asthma control; ACQ; LIAISON; Observational study; Quality of life; Patient reported outcomes