Patient recruitment is expected to start this month in Salford, Greater Manchester for the first arm of a ‘real-world’ trial assessing the safety and effectiveness of Relovair, GlaxoSmithKline’s late-phase follow-up to its respiratory blockbuster Advair (salmeterol/fluticasone), in chronic obstructive pulmonary disease (COPD) and asthma.

According to GSK, the “multi-million pound” Salford Lung Study marks the first time a large, prospective, real-world trial has been conducted with a pre-licence medicine across a large population within a single geographical setting.

Evidence from the UK study, the company said, will complement GSK’s clinical trial programme for Relovair (fluticasone/vilanterol), which is being developed in partnership with US company Theravance and is scheduled for regulatory filings in the US and Europe later this year.

“What researchers learn from the study is intended to enable healthcare decision-makers to more fully assess the medicine’s potential value at an earlier stage,” GSK stated.

It looks as though Relovair, which combines a once-daily inhaled corticosteroid (fluticasone) with a long-acting beta-agonist (vilanterol), may need the extra help.

The release in January of top-line data from the Phase III clinical trial programme with Relovair, which is seen as one of GSK’s most important pipeline assets, met with a cool reception from analysts.

Study endpoints

Some 4,000 patients with COPD and 5,000 with asthma will be recruited from Salford for the year-long lung study, with around half of the patients receiving Relovair and the other half maintained on existing therapies.

Enrolment for the COPD arm should start during March, with the asthma programme expected to follow in May 2012.

Among a number of study endpoints will be patient symptoms over time, any exacerbation of symptoms, contact with health professionals for respiratory or other reasons, and whether any other medication is required to control symptoms.

GSK and its partners discussed the Salford Lung Study with the Medicines and Healthcare products Regulatory Agency and the National Institute for Clinical Excellence via these bodies’ joint scientific procedure. The project is subject to the usual regulatory and ethical requirements for traditional clinical trials, the company noted.

Unique collaboration

The study is a collaboration between GSK, North West e-Health (NWeH), The University of Manchester, Salford Royal NHS Foundation Trust, NHS Salford, local general practitioners, and local community pharmacists, whose involvement in the project is viewed as another unique feature.

The initiative will draw on Salford’s e-Health records infrastructure, a clinical information system that provides a single, integrated electronic patient record across primary and secondary care. This will ensure patients are closely monitored over the course of the study, yet with minimal intrusion into their everyday lives. 

Professor Martin Gibson, associate director of industry at the National Institute for Health Research Comprehensive Research Network, described the Salford Lung Study as “a major advance in the way we do clinical trials”.

A successful result “will be globally relevant to industry, health services and the general population because this is all about real world outcomes relevant to real people”, he added.