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People who experience frequent exacerbations are often prescribed corticosteroid inhalers to reduce inflammation of the airways. Theophylline also helps open up the airways, but the doses needed to be effective can produce unwanted side effects.
The theophylline with inhaled corticosteroids (TWICS) trial, funded by the NIHR Health Technology Assessment (HTA) Programme and supported by the NIHR Clinical Research Network, investigated whether taking a low-dose theophylline tablets in addition to inhaled corticosteroids would reduce chronic obstructive pulmonary disease (COPD) flare-ups.
The trial, which took place from 2014-2017, demonstrated that taking a low-dose theophylline tablets in addition to inhaled corticosteroids did not significantly reduce chronic obstructive pulmonary disease flare-ups. People taking the combination and those taking an inhaled corticosteroid had the same number of exacerbations - just over two per year.
The TWICS trial has been summarised in an NIHR Signal as a result of it’s high quality trial design and relevance to UK decision makers. Professor David Price, Chief Investigator for the TWICS trial says:
“We are delighted that the TWICS trial was chosen as an NIHR Signal. Theophylline tablets can aid breathing but may have unpleasant side effects at the doses usually used in the past. Some small studies have suggested that lower doses of theophylline can increase the anti-inflammatory effect of inhaled corticosteroids and might thereby reduce the risk of flare-ups. This larger scale study helped to address this uncertainty.”
Patients with cancer that has spread (metastasised) often have fluid collecting in the space between the lungs and the chest wall. This is called malignant pleural effusion and affects more than 50,000 people every year in the UK. With as much as three litres of fluid collecting around the lungs, it causes difficult and unpleasant symptoms such as breathlessness, excessive coughing and it can be very painful for patients.
The Second Therapeutic Intervention in Malignant Effusion (TIME2) trial compared whether using an Indwelling Pleural Catheter (IPC) helped people to control their breathlessness more effectively than the usual treatment (talc slurry pleurodesis). People who took part were randomised to either talc slurry pleurodesis or an IPC. It compared the safety of these two treatments, the quality of life, hospital stay and any adverse events of those taking part.
The results of this study has changed the treatment approach for thousands of patients with malignant pleural effusion around the world.
Building on the finding that asthma attacks are caused by viral infections, researchers at the University of Southampton have sought to develop novel therapeutics to prevent or reduce the severity of attacks. This led to the discovery of a new drug, interferon beta (IFNβ), which has been developed by Synairgen, a spin-out company founded in 2003 by Professor Holgate and colleagues.
Clinical trials of the drug were conducted through the NIHR Southampton Biomedical Research Centre and the NIHR Southampton Clinical Research Facility. These trials demonstrated the safety and efficacy of IFNβ in preventing attacks in moderate-severe asthma.
Severe eosinophilic asthma is a distressing and socially isolating condition for patients. It affects up to 100,000 adults and children in the UK and this type cannot be controlled by their regular medicines. The MENSA, DREAM AND SIRIUS studies tested if the drug Mepolizumab could reduce asthma attacks for this group of patients, reduce oral steroid doses and provide cost-effective data for the NHS.
The NIHR Clinical Research Network Respiratory Disorders Specialty has seen an increase of more than 100% in Cystic Fibrosis trials entered onto the NIHR CRN Portfolio in the last five years.
Dr Alexander Horsley, leading expert in Cystic Fibrosis, NIHR Clinician Scientist and Deputy Director of the NIHR Manchester Clinical Research Facility, provides insight about why there has been a huge increase in clinical trials activity in Cystic Fibrosis in the last five years, what this means for patients and what the future looks like for patients with Cystic Fibrosis.
You can find out more about respiratory disorders studies in your area through the Be Part of Research website.
The NIHR Clinical Research Network (CRN) provides researchers with the practical support they need to make clinical studies happen in the NHS. We provide world-class health service infrastructure - research support staff such as clinical research nurses, and research support services such as pharmacy, pathology and radiology - to support organisations seeking to conduct clinical research in the NHS in England. Some of this research is funded by the NIHR, but most of it is funded by NHS non-commercial partners and industry.
We support the set up and delivery of clinical research in the NHS through our Study Support Service and our Research Design Service helps researchers develop proposals to secure funding from our research programmes.
The Respiratory disorders Specialty is one of 30 Specialties which bring together communities of clinical practice to provide national networks of research expertise. Our membership is made up of research-interested clinicians and practitioners at both national and local levels. Our job is to ensure that the Respiratory Disorders studies receive the right support to ensure they are delivered successfully in the NHS - to time and target.
The Clinical Research Network is made up of 15 localities. Each one has at least one nominated local lead for respiratory disorders research. These clinicians lead research groups to promote and support respiratory disorders research within the NHS trusts in their area.
At a national level the local leads come together to manage the national a research portfolio overall. This involves regularly reviewing the progress of studies, identifying barriers to recruitment, and coming up with solutions and strategies to help overcome those barriers.
Key achievements of the CRN Respiratory Disorders Specialty include:
We oversee research that deals with the investigation, diagnosis, monitoring, and treatment of all Respiratory disorders.
We support a wide range of research including:
The Respiratory Disorders specialty group held a meeting in June 2017 to celebrate its successes in delivering industry sponsored studies, and to hear more of the ongoing challenges around the successful delivery of respiratory trials in the UK. Over 50 delegates attended including NIHR Clinical Research Network Research Delivery Managers and front line clinical trials teams, industry partners from both major pharmaceutical companies and from contract research organisations.
Anthony De Soyza, National Specialty Lead for CRN Respiratory Disorders said: “The CRN evidence presented confirms that there is much greater access for our patients to try novel therapies and that sites are providing robust feasibility. This has only been achieved through the enthusiasm of the respiratory community and patients to support the development of new therapies.”
The next Industry meeting is being held on 25 June 2019.
Some of our key stakeholders are listed below. The NIHR Clinical Research Network Respiratory disorders specialty group works closely with organisations including The British Lung Foundation and The British Thoracic Society in integrating clinical research into NHS clinical service provision, and in driving priority setting that encourages research that will have the greatest impact on patients.
The British Lung Foundation is a British charity that promotes lung health and supports those affected by lung disease. The charity campaigns for improvements in all areas of lung health to raise public awareness of lung disease and the impact it has on so many lives. Funding research into understanding, alleviating, treating and preventing lung disease is a vital part of its work. Since the British Lung Foundation was founded, it has invested more than £22 million in supporting research into all lung conditions.
Breathing Matters is part of University College London Hospitals Charity. It has been set up to raise awareness and to work with patients to help find a cure for Interstitial Lung Diseases such as Pulmonary Fibrosis and other Respiratory Infections such as Bronchiectasis and Pneumonia.
The aim of Breathing Matters is to support the Centre for Respiratory Research at University College London Respiratory in their commitment to find better ways to diagnose and treat respiratory diseases, and to also encourage patients, their families and friends to become actively involved as advocates, advisors and fundraisers.
The British Thoracic Society (BTS) exists to improve standards of care for people who have respiratory diseases and to support and develop those who provide that care. It is a registered charity and its activities cover all of the UK. It seeks to work collaboratively with others and maintain a global outlook. Its members include doctors, nurses, respiratory physiotherapists, scientists and other professionals with a respiratory interest.
The Primary Care Respiratory Society (PCRS) UK are a UK wide society for primary care health professionals keen to deliver high value patient-centred respiratory care.
Encouraging research and campaigning for appropriate respiratory targets relevant to primary care is key to achieving their ultimate vision of ‘optimal respiratory health for all’.
The Cystic Fibrosis Trust is working towards a brighter future for everyone with cystic fibrosis by funding cutting-edge research, driving up standards of care and supporting people with the condition and their loved ones every step of the way.
Asthma UK is working to stop asthma attacks and, ultimately, cure asthma by funding world leading research and scientists, campaigning for change and supporting people with asthma to reduce their risk of a potentially life threatening asthma attack.
The NIHR provides the support and facilities the NHS needs for first-class research by funding a range of infrastructure.
NIHR Biomedical Research Centres (BRCs), partnerships between England’s leading NHS organisations and universities, conduct translational research to transform scientific breakthroughs into life-saving treatments. The following BRCs undertake research in respiratory disorders:
NIHR Medtech and In vitro diagnostics Co-operatives (MICs) build expertise and capacity in the NHS to develop new medical technologies and provide evidence on commercially-supplied in vitro diagnostic tests. The following MIC undertakes research in respiratory disorders:
NIHR Collaborations for Leadership in Applied Health Research and Care (CLAHRCs) are collaborations between local providers of NHS services and NHS commissioners, universities, other local organisations and the relevant Academic Health Science Network. The primary focus of CLAHRCs is research targeted at chronic disease and public health interventions. The following CLAHRC undertakes research in respiratory disorders:
NIHR Health Protection Research Units (HPRUs) are research partnerships between universities and Public Health England and act as centres of excellence in multidisciplinary health protection research in England. The following HPRU undertakes research in respiratory disorders:
The NIHR Translational Research Collaboration in Respiratory Disease (TRC) brings together internationally recognised investigators in the UK's leading centres of excellence to carry out early phase research with industry. Together with industry partners, the TRC focuses on early phase clinical research in patients to identify mechanisms of pathophysiology of disease, or to demonstrate proof of concept or evidence of the validity of new discoveries or treatments.
All of the NIHR facilities and centres are opening to working with the public, charities, industry and other partners. If you are interested in collaborating with the NIHR please contact the NIHR Office for Clinical Research infrastructure: nocri@nihr.ac.uk
Our experts in the NIHR Clinical Research Network National Specialty Group can give advice on delivering your study in the NHS.
Tony De Soyza is a Senior Lecturer in Respiratory medicine and Honorary Consultant Respiratory Physician at Newcastle upon Tyne Hospitals Trust. He has a wealth of experience in respiratory.Tony trained in Dundee and Newcastle with a PhD in Respiratory Infections at Newcastle University.
He has held a number of NIHR and MRC grants and has established a biobanked national cohort in bronchiectasis. He has held a number of NIHR roles over 9 years including regional
specialty group lead, cross disciplinary regional industry lead, Respiratory medicine technology lead and Deputy Chair prior becoming National Specialty Lead. He is respiratory lead for a NIHR Diagnostics evidence collaborative and was program lead for an Academic Health Science network.
His research experience includes working on a number of commercial trials ranging from phase II to IV as site PI up to and including leading as a global Chief Investigator. As an expert on respiratory health, his clinical interests link to COPD and bronchiectasis whilst he strives to support innovation and research across the range of respiratory medicine.
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