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Asthma and Chronic Obstructive Pulmonary Disease (COPD): characterising a new clinical syndrome and contributing to a new conceptual framework for developing drugs

Summary of the impact

Asthma and Chronic Obstructive Pulmonary Disease (COPD) are common, global diseases which cause considerable morbidity and mortality. Worldwide, around 235 million people suffer from asthma, while COPD accounts for 3 million, or 5% of all, global deaths, according to the World Health Organization (WHO). The relationship between inflammation and airway dysfunction is central to an understanding of their pathogenesis and treatment. The respiratory medicine group in the Department of Infection, Immunity and Inflammation has shown that optimal management of these conditions requires measurement of airway inflammation to stratify treatment regimes, an approach incorporated into national guidelines in 2012. In the late 1990s the group characterised a new clinical syndrome: `eosinophilic bronchitis', which is one of the commonest causes of chronic cough. The group's work has helped to launch a new class of drugs for asthma and to change the conceptual framework by which anti-inflammatory drugs for asthma are being developed.

Submitting Institution

University of Leicester

Unit of Assessment

Clinical Medicine

Summary Impact Type

Health

Research Subject Area(s)

Medical and Health Sciences: Cardiorespiratory Medicine and Haematology

Breathing New Life into the Treatment of Respiratory Illnesses

Summary of the impact

Ongoing research by the University of Southampton has led to significant advances in the understanding of respiratory diseases, for which the dearth of available treatments had health repercussions on a global scale for many years. The formation of a spin-out company, Synairgen, has enabled the discovery and development of new therapeutics, the filing of several major patents in the UK, the US and Asia and external collaborations with industry and government funders. These continuing developments are key to tackling conditions that affect millions of sufferers in the UK alone and which, according to some estimates, cost the NHS £2.6bn every year. The research has given rise to more than £16m in follow-on funding from the NIHR and the MRC for further studies into the treatment of respiratory illnesses.

Submitting Institution

University of Southampton

Unit of Assessment

Clinical Medicine

Summary Impact Type

Technological

Research Subject Area(s)

Medical and Health Sciences: Cardiorespiratory Medicine and Haematology

Sublingual Allergen Immunotherapy in the Treatment of Hayfever

Summary of the impact

Subcutaneous allergen immunotherapy is highly effective in hayfever sufferers who fail to respond to anti-allergic drugs, but carries the risk of severe allergic side-effects. Professor Durham's group at Imperial College have defined the mechanisms and shown that sublingual tablet immunotherapy is an effective, safer alternative that induces long-term disease remission. The tablet approach is now widespread in Europe and is being successfully extended to other allergies (housedust mite) and internationally (ragweed allergy in USA and Japanese Cedar pollen allergy). The work is quoted in guidelines internationally and regulatory bodies now recognise the disease-modifying potential of immunotherapy and its ability to induce long-term remission.

Submitting Institution

Imperial College London

Unit of Assessment

Clinical Medicine

Summary Impact Type

Health

Research Subject Area(s)

Medical and Health Sciences: Immunology

Exhaled Nitric Oxide as a Non-Invasive Biomarker of Lung Inflammation

Summary of the impact

In 1994, Professor Barnes and colleagues at Imperial College showed that nitric oxide (NO) concentrations were increased in the breath of asthmatic patients compared to non-asthmatic controls and were reduced after treatment with inhaled steroids. They subsequently demonstrated that exhaled NO (FENO) could be reliably measured in the clinic, was correlated with eosinophilic airway inflammation in asthma, was increased with airway inflammation and decreased when asthma was controlled. Exhaled NO has subsequently been shown by many investigators to be a useful non-invasive biomarker of airway inflammation in asthma and to improve clinical management in selected patients. They demonstrated that nasal NO is very low in patients with primary ciliary dyskinesia and is now recommended worldwide as a diagnostic test for this disease as it is a much easier method than previously available tests.

Submitting Institution

Imperial College London

Unit of Assessment

Clinical Medicine

Summary Impact Type

Technological

Research Subject Area(s)

Medical and Health Sciences: Cardiorespiratory Medicine and Haematology

Novel applications of gold nanoparticles to target autoimmune disorders

Summary of the impact

Sumbayev and colleagues have shown that gold nanoparticles represent an excellent platform for the specific delivery of drugs, targeting the HIF-1 biochemical pathway as a novel therapeutic target for diseases such as allergy, leukaemia and other autoimmune disorders. Two international, non-academic institutions have altered the direction of their work as a result of this research and two SMEs have revised their operational procedures and invested in the applied research that derives from this work.

Submitting Institutions

University of Kent,University of Greenwich

Unit of Assessment

Allied Health Professions, Dentistry, Nursing and Pharmacy

Summary Impact Type

Technological

Research Subject Area(s)

Biological Sciences: Biochemistry and Cell Biology
Medical and Health Sciences: Immunology

Development and application of inhaled therapies in airway diseases

Summary of the impact

Research at the University of Manchester (UoM) has led a step-change in respiratory care for airway disease from oral to novel inhaled therapies targeted at asthma and chronic obstructive pulmonary disease (COPD) patients worldwide. UoM researchers carried out >250 studies, partnered industry to deliver >15 new inhaled drug formulations to market and were the first to test novel CFC-free inhalers. UoM led the development of global guidelines that influence better diagnosis and management of airways diseases. Through leadership within the Montreal Protocol since 1995, UoM researchers coordinated the safe global transition to CFC-free inhalers for ~200m patients with asthma and COPD, whilst protecting the ozone layer and climate.

Submitting Institution

University of Manchester

Unit of Assessment

Clinical Medicine

Summary Impact Type

Health

Research Subject Area(s)

Medical and Health Sciences: Cardiorespiratory Medicine and Haematology

Novel class of medicine to treat lung diseases

Summary of the impact

The discovery of a novel, inhaled dual phosphodiesterase 3 and 4 inhibitor, RPL554 — first developed in the Sackler Institute of Pulmonary Pharmacology, King's College London — led to the creation of a SME, Verona Pharma plc, which then successfully demonstrated clinical benefit in Phase II clinical trials. This is a major breakthrough as a "first in class" drug with both bronchodilator and anti-inflammatory activity in a single medicine for the treatment of important respiratory diseases, asthma and chronic obstructive pulmonary disease.

Submitting Institution

King's College London

Unit of Assessment

Allied Health Professions, Dentistry, Nursing and Pharmacy

Summary Impact Type

Technological

Research Subject Area(s)

Medical and Health Sciences: Cardiorespiratory Medicine and Haematology, Clinical Sciences, Pharmacology and Pharmaceutical Sciences

The Evidence-Based Diagnosis and Treatment of Chronic Obstructive Pulmonary Disease (COPD)

Summary of the impact

COPD affects up to 3.5 million people in the UK and costs the NHS £700m pa. Over the last 15 years, research by Professor Calverley and colleagues at the University of Liverpool (UoL) has impacted significantly on the care of COPD patients. Specifically, this group showed that routine testing of COPD patients for the presence of bronchodilator reversibility was unreliable and did not predict clinical outcomes. This changed international guideline recommendations in 2007 and the Quality Outcomes Framework payments to GPs in 2009. They showed that oral corticosteroids accelerated recovery from exacerbations and that anti-inflammatory drugs, whether inhaled corticosteroids or PDEIV inhibitors, reduced exacerbations by 25% with a subsequent fall in the number and length of hospitalisations. This led to changed NICE guidance for corticosteroids in 2010 and drug registration with EMA and FDA for the PDEIV inhibitor treatment in 2011. Treatment in UK and Western Europe has changed as a result of this research.

Submitting Institutions

University of Liverpool,Liverpool School of Tropical Medicine

Unit of Assessment

Clinical Medicine

Summary Impact Type

Health

Research Subject Area(s)

Medical and Health Sciences: Cardiorespiratory Medicine and Haematology, Clinical Sciences

Development of Long-Acting Anticholinergics (e.g. tiotropium bromide) for the Treatment of Chronic Obstructive Pulmonary Disease

Summary of the impact

Imperial College preclinical studies guided the desired selectivity profile for long-acting muscarinic receptor antagonists (LAMA). Binding, functional and clinical studies from Imperial laboratories were the first to demonstrate the long duration of tiotropium bromide (Spiriva®) in human tissue, and confirmed its long duration of action in patients and established it as the first-line treatment for chronic obstructive pulmonary disease (COPD). Tiotropium has had a beneficial impact on the management of COPD and is incorporated into the major international treatment guidelines. It improves symptoms, reduces exacerbations and mortality, and provides a cost-effective therapy. Imperial have also produced the first pre-clinical and clinical data for the next LAMA in development (glycopyrrolate, Seebri®), which has recently been marketed. Our profiling of tiotropium has also led to the development of several novel LAMA.

Submitting Institution

Imperial College London

Unit of Assessment

Clinical Medicine

Summary Impact Type

Health

Research Subject Area(s)

Medical and Health Sciences: Cardiorespiratory Medicine and Haematology, Neurosciences, Pharmacology and Pharmaceutical Sciences

Development of Novel Therapies to Treat Severe Airway Disease

Summary of the impact

Research undertaken within Imperial College showed that corticosteroid resistance in inflammatory diseases, such as chronic obstructive pulmonary disease (COPD) and severe asthma, is explained by reduced histone deacetylase-2 and that reversal of this resistance is possible with theophylline (in low clinical doses) and PI3Kδ inhibitors, which restore HDAC2 function. This led to the founding of a spin-out company RespiVert to develop potent inhaled inhibitors of PI3Kδ. The company has been very successful in finding such new molecules, which have proven to be safe in Phase I studies. RespiVert was acquired by Johnson & Johnson in 2010 and Phase II studies are now in progress in COPD and severe asthma.

Submitting Institution

Imperial College London

Unit of Assessment

Clinical Medicine

Summary Impact Type

Technological

Research Subject Area(s)

Medical and Health Sciences: Cardiorespiratory Medicine and Haematology, Clinical Sciences, Immunology

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