RADicA
Research type
Research Study
Full title
To determine the optimum series of investigations to diagnose asthma
IRAS ID
243658
Contact name
Angela Simpson
Contact email
Sponsor organisation
Manchester University NHS Foundation Trust
ISRCTN Number
ISRCTN11676160
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
To determine the optimum series of investigations to diagnose asthma
There is no ‘gold standard’ test to confirm asthma. Asthma has largely been a clinical diagnosis based upon characteristic symptoms and signs. Consequently asthma is both over- and under-diagnosed. The National Institute of Health and Care Excellence (NICE) recently developed guidance on asthma diagnosis incorporating objective tests. Accuracy of these tests, in this specific sequence, remains unknown. There is urgent clinical need for sensitive and specific test(s) to become the ‘gold standard’ for asthma diagnosis. Furthermore, guidelines only recommend tests of large airways. Abnormalities in small airways also contribute to the clinical expression of asthma. Advances in technology now allow small airway function and biomarkers to be measured non-invasively which may provide novel asthma diagnostics. Testing in a symptomatic untreated population is required to measure their accuracy. An early predictor of response to inhaled corticosteroid‘s would be valuable as this would shorten the duration of trials of treatment.
Rapid Access Diagnostics for Asthma (RADicA) is a study involving adults and children with symptoms consistent with asthma, not currently receiving regular treatment. The study will use a prospective observational cohort design. Participants will undergo 4 core visits and up to 2 optional visits. Standard and novel lung function tests will be performed and tissue sample collected, before and following a course of standard asthma treatment. We will recruit age/gender matched healthy controls to attend two visits to collect data on normal ranges and reproducibility of the novel tests.
The study is funded by the National Institute for Health Research(NIHR)Biomedical Research Centre (BRC) and an Asthma UK/Innovate grant. Manchester University NHS Foundation Trust (Wythenshawe site) will house the diagnostic centre. General practitioners, walk-in centres from the local area, secondary care centres (Greater Manchester and Cheshire) will refer patients into the study.
REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
18/NW/0777
Date of REC Opinion
10 Jan 2019
REC opinion
Further Information Favourable Opinion