Biomarkers for Inhaled Corticosteroids in Severe Asthma
Research type
Research Study
Full title
Biomarkers for Predicting Response and Monitoring Adherence to Inhaled Corticosteroids in Severe Asthma\n
IRAS ID
229380
Contact name
Stephen Fowler
Contact email
Sponsor organisation
Manchester University NHS Foundation Trust
Duration of Study in the UK
0 years, 10 months, 0 days
Research summary
The first line therapy for managing asthma is Inhaled CorticoSteroids (ICSs), which help provide long-term disease control by reducing or suppressing airway inflammation. For a number of reason (including forgetfulness, cost, concerns about side effects) adherence to inhaler treatment is very low, with only around 20-30% of people with asthma taking the full prescribed amount. The need for quick and non-invasive procedures that determine adherence and assess the early response to ICS is necessary. The aims of this study are to investigate novel methods: 1. to measure adherence in asthma (by detecting ICS in blood and breath samples); and 2. to identify an early response to ICS using tests of airway inflammation in the breath [Fractional Exhaled Nitric Oxide (FeNO), breath gas Volatile Organic Compounds (VOCs), Particles in of Exhaled Air (PExA), and Breath Exhaled Temperature (EBT)]. Potential participants will be recruited from those due to attend for a clinical test (called a FENO Suppression Test).\n\nAfter the initial assessment, patients will perform baseline measurements which include: FeNO, EBT, VOCs, PExA, Asthma Control Questionnaire (ACQ), spirometry and blood sample. After the initial evaluation, the patients will undergo the FENO suppression test (NB not a research procedure), for which they will initially take 500 µg inhaled fluticasone propionate (Flixotide Accuhaler) attached to an electronic device called Inhaler Compliance Assessment (INCA). Further measurements of FeNO, EBT, PEXA, and VOC will be taken at 30, 60 and 120 minutes post ICS inhaler. Patients will be sent home with Flixotide® 1000 mcg Accuhaler/INCA (to be taken two puffs in the morning) for seven days (again, part of the FENO suppression test). After that, patients will return to the hospital at day seven for clinical assessment (FENO suppression test), and patient will repeat the research measurements (FeNO, EBT, VOCs, PExA, ACQ, blood and spirometry). \n
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
18/SW/0058
Date of REC Opinion
1 Mar 2018
REC opinion
Further Information Favourable Opinion