A £2.68 million study to investigate the effective use of antibiotics to treat certain types of severe asthma is being spearheaded by researchers in Leicester.
The project, which is funded by the National Institute for Health Research (NIHR) and Medical Research Council (MRC), and part designed by asthma patients through a partnership with Asthma UK, represents one of the largest ever awards by their Efficacy and Mechanism Evaluation programme to a national clinical trials consortium.
It is estimated that around 1 in 20 people with asthma have severe asthma. This typically presents as a high number of symptoms and poor lung function – despite regular medications – and repeated asthma attacks that frequently require time off work and admission to hospital.
Severe asthma is an umbrella term for several different disease types, which can be identified using blood tests (biomarkers). Many patients with severe asthma find that regular oral steroids have multiple intolerable side effects, including difficulty sleeping, weight gain, changes in mood, diabetes, weakening of the bones, high blood pressure and eye conditions such as glaucoma and cataracts, and wish to stop taking oral steroids as early as possible.
Chief Investigator for the study, Professor Salman Siddiqui, is a Professor of Airway Diseases at the University of Leicester and Consultant Respiratory Physician at Leicester’s Hospitals. He said: “In this study we will work with severe asthma specialist centres in the UK to identify patients who experience frequent asthma attacks, which we define as two or more per year.
“We will then take a blood test that measures blood eosinophil level (a type of blood cell associated with inflammation) to identify two important subtypes of severe asthma. The first subtype of interest to us is called “T2-HIGH” severe asthma and might be driven by high numbers of eosinophils in the blood that then move to the airways in the lungs and may cause asthma attacks. The second subtype is called “T2-LOW” severe asthma and might be caused by bacteria living in the lungs and how they work with the immune cells. Depending on which type of severe asthma patients have, they will be split into two arms of the study.”
The national charity, Asthma UK, has led patient involvement in the development and design of the trial and will continue to include patients with severe asthma for the duration of the study, with the support of patient representative, Val Hudson. Two national workshops were held to ensure the patients’ voices were heard in the development of the grant. Asthma UK, which funds research into asthma and provides a nurse helpline to people with asthma, also consulted with the European asthma community, who all agreed this is valuable research.
Mrs Hudson said: “When you are involved as a patient in a clinical trial, both as a member of a patient input platform or as a trial participant, you are aware that you are not likely to personally benefit from the trial results but you hope that you will make a difference to people in the future with severe asthma.
“Asthma UK has over 15 years’ experience in involving people with asthma in research which has helped shape and drive the design and delivery of studies. It is vital that people with asthma are involved at all stages of research as they provide invaluable insight into their experiences and ensure that studies have the biggest possible impact.”
The trial includes industry partners Knopp Biosciences and AstraZeneca. It is hosted by the Leicester Clinical Trials Unit and sponsored by the University of Leicester.
Professor Gavin Murphy, Head of the Leicester Clinical Trials Unit, said: “We at the Leicester CTU are delighted to be working with Salman and his collaborators on this landmark trial that will provide new and important knowledge that should improve the lives of patients with severe asthma.”
The Efficacy and Mechanism Evaluation programme funds ambitious studies evaluating interventions with the potential to make a step-change in the promotion of health, treatment of disease and improvement of rehabilitation or long-term care. It is a partnership between the NIHR and the MRC.
