Asthma Clinical Trials in United Kingdom

Benralizumab is a relatively new treatment that is approved by NICE (National Institute for Health and Care Excellence, https://www.nice.org.uk/) for patients with severe asthma who have ongoing eosinophilic inflammation that remains poorly controlled despite high dose inhaled glucocorticosteroid medication. Eosinophils are a type of white blood cell that are linked to allergy and inflammation and are raised in people with severe asthma. Severe asthma is associated with a type-2 (T2) inflammation phenotype characterised by increased T2 cytokines (IL-13, IL-4, IL-5). Increased levels of eosinophils can cause inflammation in the lungs, increasing the risk of asthma attacks. The standard treatment for asthma involves taking inhaled glucocorticosteroid medication which primarily work by suppressing eosinophilic inflammation in the lungs. Benralizumab is a monoclonal antibody that targets a receptor on the surface of eosinophils called interleukin-5 receptor-α (IL-5Rα) leading to the rapid death of these cells and consequently a reduction in airways inflammation. In clinical trials, benralizumab has been shown to reduce both symptoms and the number of asthma attacks suffered by those with severe eosinophilic asthma. However, it remains unclear whether this clinical efficacy relates purely to the removal of the eosinophil, or additionally to the impact of this on other parts of the immune system. The BEUTI study will examine the structure and function of airway cells in patients with severe eosinophilic asthma. Particularly how the immune function of these cells changes with treatment and whether benralizumab leads to a reduction in T2 mediators and/or activation in airway cells. The aim is to take samples of cells from the airways during a bronchoscopy (a camera test looking into the lungs) before starting benralizumab and after 12 weeks of treatment. These investigations will allow us to better understand how benralizumab affects the cells within the airways and the pathways involved. Read Less

A "Clinical Registry" is a database which contains clinical information about people with different medical conditions. They are used in many countries throughout the world to help medical teams to better understand specific diseases and improve the care and treatment of patients. The UK Severe Asthma Registry has been collecting data on patients attending Severe Asthma Clinics in the UK since 2007. After obtaining appropriate consent from patients to use their information, data is entered by the patient's own clinical team and it is kept up-to-date to follow clinical progress and response to treatments. Very strict controls are in place to make sure individuals cannot be identified from the Registry and all information available from the National Registry is anonymous. Apart from the local clinic team, occasionally trusted third parties will also be able to identify you, if required to do so, on a strict need-to-know basis. This is necessary to ensure that the Registry works efficiently, or as a part of a Research Project, previously approved by a Research Ethics Committee. Data from the Registry has a number of uses including judging which severe asthma treatments are of greater benefit, to identify different subgroups of severe asthma and trial new therapies and to provide information for planning future services for people with severe asthma. The use of any information from the UK Severe Asthma Registry requires approval of the Steering Committee which is made up of the refractory asthma specialists from across the UK and who will have access to data protection, legal and ethics expertise where necessary, to safeguard the use of data. If the Registry closes, data will be returned to the local clinic team if requested, otherwise it will be destroyed. Participation is entirely voluntary and patients can withdraw consent form the Registry at any time by informing their local clinical team. The Data Controller from the UK Severe Asthma Registry is Queen's University Belfast and the Data Processor is Dendrite Clinical Services Ltd which is a commercial provider of database and registry systems. Read Less