Periodic Report Summary 2 - ASTRO-LAB (ASSESSMENT OF THE SAFETY OF LABAS IN ASTHMA IN ROUTINE CARE BY COMBINING HEALTH-CARE DATABASES AND DIRECT PATIENT FOLLOW-UP) Project Context and Objectives:Asthma is a common disease in European countries: for example, the prevalence in France in the early 2000s was estimated at 6.7%. Long-acting beta2-agonists (LABAs) are now one of the main treatment options in asthma care, combined with ICs or not. However, more information is needed on their benefits and on their risks in special populations (such as young people) and in different treatment combinations (such as LABAs taken with Inhaled Corticosteroids in separate or single inhalers). Moreover, it is known that patients’ actual use of LABAs and ICs inhalers may be different from the prescribed use. The actual patterns of drug use may be determined by various beliefs and attitudes about asthma and its treatment, and may lead to unpredicted drug utilisation and thus modify the benefits and the risks of LABA. It is also acknowledged that prescription patterns and asthma self-management support activities may vary in different primary care settings depending on the organization of asthma care, and on clinician training, clinical experience, and personal views. These various approaches to asthma care may have an impact on patient behaviours and health outcomes.The ASTRO-LAB project (Assessment of the LABAs benefit/risk ratio in asthma in routine care by combining healthcare databases and direct patient follow-up) aims to provide new information about the benefits and the risks of long-acting bronchodilators (LABAs, also known as long-acting relievers). It addresses several important knowledge gaps by focusing on both adults and young people with asthma, and on the benefits and the risks of LABAs taken with Inhaled Corticosteroids (ICs, also known as controllers). We also examine how people with asthma use LABAs and ICs inhalers, what influences their decisions on how they use inhalers, the care they receive from their clinicians, and what determines how their clinicians help them manage their asthma.The ASTRO-LAB consortium will undertake systematic investigations of the scientific literature in this area, and conduct a prospective observational cohort study which will follow up 2200 people with asthma in France and in the UK during a 2-year period. Among them, 50% will be children. Data will be collected from medical records, insurance claims records, and from patients themselves and their clinicians (via telephone interviews, text messages/emails and online surveys). One of the main assets of the Astro-Lab study design is to combine 3 levels of data: prescribing data, delivery data and treatment consumption reported by patients.The project is funded by the European Commission (EC) through the Seventh Framework Program (FP7) under Grant Agreement n° 282593 and will run for 4 years (2011-2015). Coordinated by the Université Claude Bernard Lyon 1 (UCBL), it includes 6 partners in a Consortium: the University of Nottingham (UON), Kappa Santé SAS (KS), Cegedim Strategic Data Medical Research Limited (CSD), Universiteit van Amsterdam (UvA), Consorcio Mar Parc de Salut de Barcelona (PSMAR) and Lyon Ingénierie Projets (LIP).Project Results:The achievements between December 2011 and November 2014 can be summarized as follows:- Literature reviewSynthesis on current knowledge on asthma adherence and on asthma treatments risk/benefit ratio was performed. Conclusions of these reviews provided recommendations for the ASTRO-LAB cohort study.- Study protocol, documentation and tools developmentAfter 9 months of discussion among partners and experts, a final version of the protocol was validated and reviewed by ASTRO-LAB Ethics and Advisory boards in September 2012. Participants Information Sheets (PISs) and consents as well as Case Report Forms (CRF) were also released. Furthermore, the ASTRO-LAB consortium developed the study website and related tools (General Practitioners and patient online survey, Computer-assisted telephone interviewing and monthly text messages).- Regulatory approvalsIn the UK, The West London Research Ethics Committee (REC) first approval was obtained on the 30th January 2013. Last substantial amendment 3, related to new study design and patient contact procedures in the UK, has been granted 2nd April 2014. Following the UK regulatory process, ASTRO-LAB consortium submitted the protocol to National Institute for Health Research Clinical Research Network (NIHR CRN) for review by PCT (Primary Care Trust) local sites. So far, 164 out of the 175 R&D applications to practices have been approved.In France, the ASTRO-LAB consortium received the protocol approval from the CCTIRS (Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé) on November 21st, 2012.Then ASTRO-LAB partners sent the application form to the CNIL (Commission Nationale d’Informatique et Liberté) for data privacy collection authorization on December 20th, 2013. The authorization was obtained in May 17th, 2013.- Patient pre-selectionIn France, 800 General Practitioners (GPs) have been invited to record their asthma patients in an online register. Since September 2013, access to this register has been extended to pharmacist’s networks in order to increase patient recruitment in treatment group of interest for ASTROLAB (LABA and LABA+IC group).Over 3000 pharmacists have been contacted by telephone. After feasibility steps, in November 2014, 551 health professionals had registered at least one patient in this database.In the UK, THIN database allowed to identify 29.812 eligible patients. Considering only the revised study process in the UK, 2764 invitation packs have been sent out to practices. Among them, 2108 packs had been forwarded to patients in November 2014- Patient recruitmentThe first patient was enrolled in the ASTRO-LAB cohort on the 29th of May 2013 in France, and on 25th of September 2015 in the UK. In November 2014, 1101 patients (910 in France and 191 in the UK) have been enrolled in the cohort. Among the 1101 patients enrolled, 479 are children (6-17 yo) (44%). Recruitment is still open.- Drug exposure validation and adherence measurementSpecific adherence markers have been developed, appropriate for the unique ASTRO-LABA design (adapted to self-report data, medical records data and combined sources). A first pilot linkage between prescription database and French claims database (SNIIRAM) was successfully performed with a matching rate equal to 85%.Potential Impact:Project results should lead to important new knowledge on major and serious adverse drug reactions that constitute public health concerns i.e. those impacting on the balance of benefits and risks of medicinal products. This should be directed towards regulatory decisions on marketing authorisations for medicinal products including the warnings in product information for doctors and patients. A safer and more effective use of medicines should results with positive implications for public health. Moreover adherence measurements and study questionnaires analysis will lead to a better understanding of general practitioners and patient behaviours regarding to the asthma disease management and controller treatments. The findings from this study will be used to formulate recommendations regarding the use of LABAs and ICs in treating asthma, and ways to improve the support offered to adults and young people with asthma in primary care.List of Websites:http://www.astrolab-project.eu Other report summaries Periodic Report Summary - ASTRO-LAB (Assessment of the Safety of Labas in Asthma in Routine Care by Combining Health-care Databases and Direct Patient Follow-up)
