Project

ASTRO-LAB - Assessment of the safety of labas in asthma in routine care by combining health-care databases and direct patient follow-up

The ASTRO-LAB project aims at comparing the rate of serious asthma events in children and adults treated by LABAs alone and with concomitant ICs with the rate amongst those treated by ICs alone under conditions of routine clinical care, after adjusting for baseline differences in severity. Ultimately, it aims at providing new evidence for regulators about the safety of LABAs in children and adults with asthma and should assist agencies’ decisions regarding the safety and so the benefit-risk ratio of LABAs in fixed-dose combinations in these patient populations.

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The ASTRO-LAB project aims to provide new information about the benefit/risk ratio 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 benefit/risk ratio 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.

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, physicians associations, and regulators.

Results

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.

We will undertake systematic investigations of the scientific literature in this area, and conduct a prospective cohort study which will follow up 3000 people with asthma in France and in the UK during a 2-year period and collect information from medical records, insurance claims records, and from patients themselves and their clinicians (via telephone interviews, text messages/emails and online surveys).