GSK's COPD drug Relvar - which was approved in 2013 - is being examined is an ongoing Phase IIIb trial known as the Salford Lung Study (SLS), which is comparing the drug with standard care in chronic obstructive pulmonary disease (COPD) patients at clinics across North West England.
A GSK spokeswoman told us: "The SLS is an open label randomised controlled trial that aims to guide treatment choices by generating unique effectiveness and safety data in a patient population intended to represent that seen in everyday clinical practice."
She added that: "It compares the effectiveness and safety profile of Relvar/Breo Ellipta (FF/VI) with existing maintenance therapy for chronic obstructive pulmonary disease (COPD) and asthma in a patient population intended to represent that seen in everyday clinical practice."
Monitoring drug performance and safety in a real-world trial is a very different from assessing candidates in pre-approval studies according to Martin Gibson, CEO of North West e-Health, who told us SLS included people who would normally be excluded.
“This study was designed to investigate whether safety and effectiveness outcomes could still be tested in an all-inclusive patient population, as there could be considerable patient benefits and cost-savings to be gained from such a study.
“For example, there are some types of patients with other pre-existing conditions – such as lung cancer – who would never be included in a conventional study of COPD medication, even though they might still get real benefits from the medicine being tested, but they would have been eligible to take part in a real-world study such as this.”
Bespoke database linking tech
North West e-Heath was contracted by GSK to both identify and monitor study participants using bespoke software that integrates the medical records of patients across all of their interactions with their GPs, pharmacists and hospitals.
Gibson said: “The real benefits for this study came from our Linked Database System technology to manage the trial, in particular the real-time safety monitoring, reporting and measurement of outcomes, in keeping with late phase study regulatory requirements.”
He explained that the system, which integrates the records of 2,802 consenting patients, is unique and has the potential to change how real-world, post approval research is carried out.
“It’s a game-changing technology because it allows secure collection of information and provision of data that can help get the right drugs to the right people more quickly… We believe this technology has the potential to save several years of development time so accelerating the availability of new therapeutics for patients and reducing development costs.”
Early SLS data published last week show Relvar– a combination of fluticasone furoate and vilanterol delivered using GSK’s Ellipta inhaler - is more effective at reducing COPD exacerbations than standard care. The incidence of serious adverse events and pneumonia is similar between the two treatment groups.
While it continues to work on the SLS, North West e-Health, an organisation formed by the University of Manchester, Salford Royal Foundation Trust and Salford Clinical Commissioning Group, is assessing how its technology can be used outside the UK Gibson said.
“The software we have is currently limited to UK electronic medical records, but we are in discussion with other centres around the globe to see how we can utilise our technology in their healthcare systems.”