Micro endpoints for new antifungal drugs in asthma, version 1
Research type
Research Study
Full title
Prospective cohort study of the stability and efficacy of sputum biomarkers in monitoring response to established oral and inhaled antifungal therapy in patients with allergic bronchopulmonary aspergillosis (ABPA and Aspergillus bronchitis).
IRAS ID
159710
Contact name
David Denning
Contact email
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
At the present time options for the treatment of allergic bronchopulmonary aspergillosis (ABPA) and severe asthma with fungal sensitivity (SAFS) are limited. Furthermore the development of new drugs is hindered by the lack of reliable markers which are easily measurable and can be used to demonstrate a successful response to treatment. Current markers used to assess response to treatment include blood tests, questionnaires and lung function tests which can be slow to respond, subjective and demonstrate a significant degree of natural variability between subjects. Additionally these markers can take a long time to change in response to administered medications.
This single centre study (National Aspergillosis Centre, UHSM) aims to look at specific markers in both sputum and exhaled breath samples to see if they change rapidly and reliably in response to existing antifungal therapies. Sputum samples are routinely collected in patients with ABPA and SAFS to guide and track response to therapy. However, changes seen in response to treatment and the speed of these changes have not yet been fully quantified, nor has the natural variability seen with the ABPA population.
Looking at four markers, (1) aspergillus PCR, (2) galactomannan sampling, (3) fungal culture burden and (4) exhaled breath patterns, we will identify how these markers vary naturally within a group of patients with ABPA. Subsequently, following the introduction of standard anti-fungal treatments (either azole tablets or nebulised amphotericin), we will quantify the change in these markers and establish the rate at which this change occurs.
If any of the markers fall rapidly and reliably within the ABPA group they may be taken forward to be developed for commercial use in the development of new antifungal agents. This is important as it will help us develop better treatment for ABPA and establish whether a patient is responding to therapy much more quickly than we can currently.
REC name
North West - Preston Research Ethics Committee
REC reference
15/NW/0044
Date of REC Opinion
30 Jan 2015
REC opinion
Further Information Favourable Opinion