In 2017, The Salford Lung Study adopted a new approach to clinical trials, monitoring patients in real-time to find out what happens when a new treatment for Chronic Obstructive Pulmonary Disease (COPD) is used in the ‘real world’. This study aimed to test the effectiveness of a new type of inhaler for treating asthma and COPD symptoms, and involved randomly assigning participants to receive this new treatment or their usual treatment. By linking together electronic healthcare records (EHR) from a number of sources across the NHS, it was possible to track over 2,800 patients over a 12 month period to assess the effectiveness of the treatment in an everyday setting, rather than in a more artificial, clinical trial environment.

In 2023, the study was extended with patients who received the treatment in the original study, to gain a more in-depth and long-term understanding of COPD and asthma by further combining EHR data with self-reported data to assess the impact of respiratory disease on everyday life in the real-world.

Why was this work needed?

In the UK, Chronic Obstructive Pulmonary Disease (COPD) is estimated to affect around 1.2 million people, so improving the available treatments is an important target in healthcare.

Traditionally, clinical trials of new treatments have strict rules that exclude a large number of patients, for example patients with other multiple conditions such as diabetes or heart disease are often excluded from taking part. This study was designed to include those patients who would often be excluded from a traditional clinical trial. This inclusive approach is important because it is more realistic of everyday practice and is therefore representative of a much wider patient population. This study pioneered a new way of conducting clinical trials that could give doctors and researchers a better idea of what happens when a new medicine is used in the ‘real world’.

What happened?

The original Salford Lung Study looked at the safety and effectiveness of a new treatment for COPD. This collaborative study was placed in Salford because of the existing infrastructure of integrated electronic healthcare records. The study relied on a Linked Database System (LDS) securely hosted within the NHS network, which linked together the data of consenting patients across all of their everyday interactions with their GPs, pharmacists and hospitals. This allowed the researchers to get a much more accurate sense of the impact of the treatment, for more typical people with COPD, than they would have had through the traditional clinical trial environment.

In the extended study, participants who had been randomized to receive the treatment in the original study were invited to continue their participation by consenting for their primary and secondary care EHR data to be further obtained.

What were the benefits?

The results showed that patients significantly benefit from the new treatment under investigation compared to current treatments used in everyday practice.

This study also demonstrated the potential for running trials in a new way and so could have implications far beyond COPD. By collecting healthcare information both quickly and efficiently, in line with best practice guidelines for security of patient data, this method of accessing data offered responsiveness to patient safety, high quality data and shorter study timelines.

What type of data was involved?

Patients were monitored through electronic healthcare records, which included interactions with GPs, hospitals and community pharmacies. For example, primary care data included coded information about demographics, prescriptions, symptoms, diagnoses, referrals etc. National datasets were also included to ensure data was captured for patients visiting hospitals outside the Manchester area and to make sure the study team were alerted if a patient on the study changed their address.

All patients who participated in the SLS gave their consent to have their data extracted and linked together from a number of different healthcare locations. For the extended study, participants were asked to consent again for the collection of their EHR data.

Who funded and collaborated on this work?

The study was sponsored by GSK and delivered in partnership with NorthWest EHealth (NWEH), The University of Manchester, Salford Royal NHS Foundation Trust, CK Aspire, Salford CCG, University Hospital of South Manchester, South Manchester CCG and NIHR Clinical Research Network: Greater Manchester.

Where can I go for more information?

The Salford Lung Study published its findings in 2017, and the extended study published its findings in 2023.