GSK announce positive results from the COPD Salford Lung Study published in the NEJM and presented at European Respiratory Congress

NWEH are pleased to report that GSK today announced that the results from the pioneering Salford Lung Study (SLS) have been published in the New England Journal of Medicine (NEJM).

This unique study, which reported headline results in May 2016, was designed to evaluate the effectiveness and safety of Relvar® Ellipta® in patients with chronic obstructive pulmonary disease (COPD), compared with their ‘usual care’ administered in an everyday clinical practice setting. Data from the study was presented at the European Respiratory Society (ERS) International Congress on Sunday 4th September in London.

The results show a superior reduction in exacerbations for COPD patients on Relvar / Ellipta (Salford Lung Study results). This is a positive result for the study sponsor, GSK, and for the study partners as a group. For NWEH, this result builds on our proven ability to link consenting patient data from across an entire health economy: primary care; secondary care; national feeds; community pharmacies; out of hours amongst others.

As well as the achievements in terms of the study and its delivery, at the study core is the patient.

“Chronic bronchitis is a dreadful condition where patients are constantly short of breath. The results of the Salford Lung Study show that people receiving Relvar / Ellipta, in a real life setting, are less likely to have exacerbations of their bronchitis compared to people on current treatments. North West EHealth has enabled the Sponsor GSK to deliver this RCT by developing an infrastructure to use the patients existing electronic medical record, this is just the type of evidence that doctors and patients need when deciding what treatment is best".
Dr John New, Clinical Director NWEH 

To deliver this 2802 patient study (and the Asthma study of 4200) NWEH has developed unique capabilities in finding, validating, extracting and secure storage and management of consented healthcare data.  Our teams have an unrivalled experience and understanding of the availability of healthcare data and the processes and systems required to support an Electronic Health Record (EHR) trial.

By collecting healthcare information both quickly and efficiently, in line with best practice guidelines for security of patient data, NWEH can offer improved patient safety, high quality data and shorter timelines for studies. This digitally enhanced design is a new and innovative approach to clinical trials; it is anticipated that the study methodology and underpinning technology could be used in future studies, not just in Greater Manchester but worldwide.

The study was made possible through collaboration between GSK, North West EHealth (NWEH), The University of Manchester, Salford Royal NHS Foundation Trust, University Hospital of South Manchester (UHSM), NHS Salford and GPs and community pharmacists in Salford, Trafford and South Manchester.

“In the SLS study we included a broad spectrum of patients who had minimal interventions to see if this would allow us to observe a difference between treatments. The results from SLS provide robust evidence that will enable the healthcare community to begin to understand how the choice of COPD treatment can significantly influence patient outcomes. We are continuing to analyse the data from the study as we know there is so much more we will learn and we look forward to sharing our findings in future publications. I want to thank all of the patients who participated and the partners who collaborated with GSK to make this unique study possible.”
Neil Barnes, Global Medical Head, Respiratory Franchise at GSK

A second Salford Lung Study is currently being conducted in patients with asthma, with results expected in 2017.

What is COPD?

Chronic obstructive pulmonary disease (COPD) is a disease of the lungs that includes chronic bronchitis, emphysema or both. COPD is characterised by obstruction to airflow that interferes with normal breathing. Cigarette smoke, breathing in second-hand smoke, air pollution including biomass fuels, chemical fumes and dust from the environment or workplace can all contribute to COPD.

People with COPD can experience a sudden worsening in symptoms, known as an exacerbation. Symptoms of an exacerbation can include an increase in breathlessness, coughing and mucus production, as well as fever. In these cases, the patient may need to change their medication or even, in some cases, be admitted to hospital. Exacerbations are common; one in three patients with severe

COPD and almost half of patients with very severe COPD had frequent exacerbations (two or more in the first year following diagnosis). Every exacerbation can cause permanent lung damage and repeated exacerbations can accelerate the progression of the disease. People with frequent exacerbations have a poorer quality of life and may have an increased risk of death.

The study is listed on www.clinicaltrials.gov.