GlaxoSmithKline has announced that the positive results from the pioneering Salford Lung Study have been published in the New England Journal of Medicine.
This study, which reported headline results in May, 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 are being presented at the European Respiratory Society (ERS) International Congress yesterday in London, (abstract number OA249).
For the primary endpoint in patients, who had exacerbated in the year before the study, treated with Relvar Ellipta 100/25mcg (fluticasone furoate 'FF'/vilanterol 'VI' or 'FF/VI') there was a statistically significant reduction of 8.4% (p=0.025; 95% CI 1.1 to 15.2) in the rate of moderate or severe exacerbations compared with patients receiving 'usual care'.
The majority of these patients in the study on usual care were taking an inhaled corticosteroid (ICS) containing regimen (88%).
A similar reduction in exacerbations with FF/VI was seen in those patients on an ICS/long-acting beta2-agonist (LABA) at baseline (8.0%; 95% CI 0.11 to 15.4, p=0.047).
For the intent to treat (ITT) population there were no differences observed between FF/VI and usual care on secondary outcomes measured including the time to first moderate or severe exacerbation and rate of severe exacerbations, the rate of secondary care healthcare contacts and COPD related primary care contacts.
There were more primary care contacts overall on FF/VI (12.3% increase, 95% CI 5.4 to19.6). The COPD Assessment Test (CAT), which measures the impact of disease on health status, demonstrated 45% of patients receiving FF/VI improved their CAT score by 2 or more, a clinically relevant improvement, compared to 36% in the usual care group (odds ratio 1.51, 95% CI, 1.28 to 1.77).
The incidence of serious adverse events (SAE) was similar between the groups (29% FF/VI, 27% usual care).
For pneumonia, an SAE of special interest, FF/VI demonstrated non-inferiority (7% FF/VI vs 6% usual care). This endpoint was a post-authorisation measure requested by the European Medicines Agency (EMA).
Neil Barnes, Global Medical Head, Respiratory Franchise at GSK said: "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."