Southampton part of new multi-million-pound “Innovation Hub” to improve the treatment of cystic fibrosis

The Southampton Clinical Trials Unit (SCTU) is part of a new multi-million-pound research hub that aims to increase understanding and improve treatments for people with cystic fibrosis (CF).

The CF Innovation Hub, led by the University of Manchester, will study the triggers that cause ‘flare-ups’, where the symptoms of the lung condition suddenly get worse, and how best to treat them.

The SCTU will then use the results to develop future trials investigating new treatment approaches for patients with cystic fibrosis.

The hub is part of a nationwide network of four CF Innovation Hubs that are being jointly funded with £15m from the medical research charity LifeArc and leading charity Cystic Fibrosis Trust with the aim to accelerate the discovery of new tests, treatments and medical devices for people with cystic fibrosis.

Addressing an unmet need

Cystic fibrosis is one of the UK's most common life-limiting inherited diseases, affecting over 11,000 people in the UK and nearly 200,000 people worldwide. The condition causes mucus to build up in the internal organs, especially the lungs and digestive system. This can lead to chronic chest infections, lung inflammation and other complications such as digestive problems.

For many people, managing their health involves a rigorous daily treatment regime including physiotherapy and antibiotics. Despite recent advances in research, there is still no known cure, and the average age of death is just 33.

The new CF Innovation Hubs have been guided by insights and experiences of people with cystic fibrosis.

24-year-old Sarah Sharp from London has cystic fibrosis. She experienced her first lung infection when she was a baby and has spent a lot of time in hospital over the years. Sarah explains: “This condition affects everything about my life, every single day. I have to adjust my life around my symptoms, in everything from work to friendships. The dream, for me, is to have less of a treatment burden and more time feeling like a valuable member of society. These new Hubs give me hope because improving research into the cause of exacerbations and the development of potential new treatments takes away a lot of my fears around what my health is going to look like in the future."

Understanding “flare-ups”

The research team within the University of Manchester Innovation Hub including SCTU will study the cause of ‘flare-ups’ (exacerbations) for people with cystic fibrosis by analysing blood, saliva, sputum and sweat samples from patients, gathering lung function test results and recording symptoms via an app and monitoring pollution in homes.

Hub Director, Professor Alex Horsley, a Consultant at the Manchester Adult Cystic Fibrosis Centre at Manchester University NHS Foundation Trust and Professor of Respiratory Medicine at The University of Manchester, said: “This is an amazing opportunity to improve the lung health of people with CF in a way that we’ve never had the opportunity to do before.

“Together with scientists at The University of Manchester and clinicians at Wythenshawe Hospital, we’re building on existing partnerships with doctors and scientists in teams around the country. We hope our research will help us understand why people with CF get flare-ups and how to better prevent and treat these. This will lead to more effective, shorter and tailored or personalised treatment plans that will reduce exacerbations and the disruptions they cause to people’s lives.”

Researchers will also look at why individual people with cystic fibrosis sometimes respond in different ways to IV treatments for exacerbations. The SCTU will use the results of the Hub’s observational trials to develop a future biomarker-guided platform trial to investigate new treatment approaches for patients with cystic fibrosis.

Professor Gareth Griffiths, Director of the Southampton Clinical Trials Unit and co-investigator on the Manchester CF Innovation Hub, said: “Through clinical trials we hope to learn more about who responds to different treatments, and the causes behind that. This could provide the evidence that would allow doctors to prescribe the most effective and personalised course of treatment for individual CF patients, reducing flare-ups and improving patient outcomes and quality of life.

“As part of the Southampton NIHR Biomedical Research Centre respiratory theme and located at Southampton General Hospital, which has a track record of trials in cystic fibrosis, SCTU is well placed to link up with the network of CF Innovations Hubs and sites undertaking respiratory research to conduct these future trials and make the research accessible to people with CF across the UK.”

A nationwide network

The nationwide CF Innovation Hub network will bring together world-leading experts from different fields of knowledge, including scientists, doctors, data scientists, patients, regulators and industry partners, to provide a training ground for the next generation of scientists and clinicians.

The Network will be made up of four Innovation Hubs, led by the universities of Manchester, Liverpool, Cambridge and Imperial College London, as well as partners across the UK and overseas.

Dr Catherine Kettleborough, Head of Chronic Respiratory Infection at LifeArc says: “Even with the development of new treatments like Kaftrio, people with cystic fibrosis still face many challenges which impact their quality of life and life expectancy. The Innovation Hub Network is a unique approach to addressing these problems, using shared knowledge, partnerships and investment to accelerate new tests and treatments for people living with CF.”

Dr Lucy Allen, Director of Research and Healthcare Data at Cystic Fibrosis Trust, said: “We’re thrilled to be partnering with LifeArc and expanding our Innovation Hub programme, combining our expertise and exploring exciting areas of research to maximise the impact for people with CF.

"Those with the condition are particularly susceptible to lung infections, meaning they often have to spend time in hospital having IV antibiotic treatments and this has a huge impact on all areas of their life. These new Innovation Hubs will help transform our understanding and lead the way to new ways to test and treat lung infections.”