PRISTINE - Personalised Approach to Improve aSThma prescrIbing iN childrEn
Status:
Terminated
Trial end date:
2019-08-30
Target enrollment:
Participant gender:
Summary
Asthma is one of the most common chronic diseases affecting children in the UK. Poorly
controlled asthma manifests with chronic cough, wheeze and shortness of breath which in-turn
has a significant negative impact on a child's quality of life, interfering with sleep,
impairing exercise ability and resulting in frequent school absences and hospital admissions.
Management of paediatric asthma in the UK is directed by the British Thoracic Society (BTS)
Guidelines, which recommend a stepwise (one to five) treatment plan. Step three of the
management guideline for children aged 5-12 years of age recommends the addition of the
preventer inhaled medication, including long-acting β2 agonists such as salmeterol. However,
there is a wide variation in response to this medication with approximately one in seven
people, with a specific genetic change, found to have an increase in asthma symptoms in
association with the use of thisiss medication. A related medicine, formoterol, is used less
commonly in children with asthma.
In this study, the investigators will aim to identify children with asthma whose symptoms are
poorly controlled on inhaled long-acting beta2 agonists. Via a simple saliva test, the
investigators will identify the presence or absence of the specific genetic change potentally
influencing the effectiveness of treatment with salmeterol or related longacting beta2
agonists thus enabling the investigators to recommend either salmeterol or an alternative
medication for the treatment plan such as montelukast. The investigators will randomise the
patients into two groups; to receive "personalised care" where the choice of controller
medication would be based on the child's gene test results and predicted response to
long-acting beta2 agonists, or "standard care" following the BTS guidelines at the
clinician's discretion without knowledge of the gene test results. The investigators aim to
measure whether this individualized approach to asthma prescribing results in improved
control of asthma symptoms and overall quality of life. Targeting treatment to a child's
specific genetic make-up is a concept known as "personalised medicine".
Phase:
Phase 4
Details
Lead Sponsor:
Brighton and Sussex University Hospitals NHS Trust