A trailblazing Salford study is leading the way in its approach to testing the effectiveness of drugs in everyday clinical practice.
Carried out between 2012 and 2016, the Salford Lung Study (SLS) involved an innovative way of testing out a drug treatment for patients with both asthma and chronic obstructive pulmonary disease (COPD).
The study set out to evaluate the effectiveness of a GlaxoSmithKline (GSK) respiratory medicine, Relvar Ellipta, among a large patient population, compared to their existing treatment.
Almost 7,000 patients, 43 GP practices, over 50 nurses working within the practices and all 54 community pharmacies in Salford participated in the study. Some GP practices and pharmacies in Trafford and South Manchester also took part, making it 80 general practices and 130 pharmacies in total.
Over 1,500 healthcare professionals and support staff were trained to carry out the research.
The asthma trial was carried out with 4,233 patients aged 18 and over, and the COPD trial tested 2,800 patients aged 40 and over. Patients were recruited via their own GP practice. A large percentage of eligible patients were keen to volunteer, with some practices reporting up to 70%.
The SLS aimed to ensure that the method of patient care remained as normal as possible, so that the data collected was a close reflection of what really happens in a patient’s everyday life.
Each patient in the study was tracked for 12 months. They had their usual regular check-ups with their GP and collected their medication from their local pharmacy.
Patients described their participation in the study as being quite easy and unobtrusive, enabling them to get on with life as normal.
Christine, an asthma sufferer from Salford, took part in the trial. She said: “Over the year, I had four appointments with a nurse and three asthma control tests to see if my asthma improved or stayed the same. It was quite easy, very friendly, very informal, just like going to the doctor. It didn’t seem like a trial.”
For the asthma patients, results showed that taking the once-daily treatment improved asthma control, without increasing the risk of serious adverse events, when compared with usual care. For the COPD patients, the rate of moderate or severe exacerbations* was significantly lower, by 8.4%, with Relvar Ellipta compared with usual care.
Sheila McCorkindale, Clinical Lead for Diabetes at Salford Clinical Commissioning Group and a Salford GP for over 25 years, was the study lead at Ellenbrook Medical Centre, a member of the clinical governance team and one of the authors of the main papers.
She said: “Prior to the Salford Lung Study, few Salford practices and pharmacies had any experience of research and certainly not on such a scale, so in the beginning, for all of us, it was a steep learning curve.”
Rachel Macdonald, a member of the Pharmacy Steering Group and pharmacist for PCT Healthcare Ltd, said: “Taking part in the study has given community pharmacists and members of the pharmacy team the opportunity to be involved in clinical research, and all have gained valuable training and research experience for the future.
“In particular, it was inspiring to see all community pharmacists, from national chains to local independents, come together to develop practice standards and a pharmacy manual applicable to all.”
Dr. Nawar Bakerly, Consultant Respiratory Physician with interest in Integrated Care and SLS safety lead at Salford Royal Foundation Trust, said: “This is the first time a large ‘real world’ study has been carried out on a pre-licence medication within one geographical setting. This revolutionary trial could significantly increase our understanding of how best to conduct ‘real world’ effectiveness studies in the future.
“All partners in the project would like to thank the many patients who were willing to take part and all the GPs, nurses and pharmaceutical staff who devoted their time and efforts towards making this ground breaking study such a success. Without their willingness and enthusiasm, SLS wouldn't have been possible.”
Professor Martin Gibson, Chief Executive of North West eHealth, said: “Salford was chosen for the study because it has an integrated electronic health record system that connects primary and secondary care. This allowed for the close observation of patients for effectiveness and safety monitoring, across all of their daily interactions with their GPs, pharmacists and hospital, with minimal intrusion.
“Along with partners, we are delighted to have been part of the SLS which has helped us to understand more about the way patients interact with medications in their everyday lives.”
Susan Collier, Head of Medical Operations for the study at GSK, said: “The Salford Lung Study is a first for GSK and the pharmaceutical industry, in that it is the world’s first randomised control trial to explore how medicine works in ordinary COPD and asthma patients, in everyday clinical practice, using the patients’ electronic medical record to collect “real life” data. Salford is one of the few places in the world where a unique study like this could have been possible, and I would like to thank all those involved in making this happen, in particular the patients”.
The results of the COPD study have been published in the New England Journal of Medicine and the asthma study in The Lancet. The innovative study design is of global interest within the research world.
Notes to Editors
* An exacerbation is a sustained worsening of the patient's symptoms from his or her usual stable state, which is beyond normal day-to-day variations and is acute in onset.
Salford Lung Study Partners and their role in the study
The SLS is a unique collaboration between GlaxoSmithKline, North West e-Health (NWeH), the National Institute for Health Research (NIHR) - Greater Manchester, the University of Manchester, Salford Clinical Commissioning Group, Salford Royal NHS Foundation Trust (SRFT), local GPs and local community pharmacists.
- GlaxoSmithKline – Sponsors of study, designed study, provided operational and monitoring support
- North West eHealth – Contributed to study design, designed and built database system, provided technical support.
- Salford Royal NHS Foundation Trust - supported development of ground rules, approved proposals for establishment of teams in hospital. Provided access to electronic health records to allow safety monitoring and collection of study end points.
- University Hospital South Manchester - Provided access to electronic health records and paper medical records to allow safety monitoring and collection of study end points.
- Local Medical Committee leaders, and Salford, South Manchester and Trafford CCGs - gave approval, encouraged and supported GPs to take part in study.
- GP investigators - provided access to electronic health records and investigator services
- Company Chemists Association, Local Pharmacy Committee and Pharmacy Steering Group - provided support to pharmacists, developed pharmacy processes, dispensed medications, allowed collection of dispensing data
- University of Manchester – contributed to design of study
- National Institute for Health Research (NIHR) the Clinical Research Network for Greater Manchester, provided expert staff for study to drive start up.
Patient Results Summary