GlaxoSmithKline (GSK) and Innoviva have reported positive results from a Phase IIIb trial to compare the effectiveness and safety of relvar ellipta (FF / VI) 100mcg / 25mcg with existing usual care to treat chronic obstructive pulmonary disease (COPD).
A total of 2,802 patients with COPD were enrolled in this multi-centre, open label, randomised controlled Phase IIIb trial, called Salford Lung Study (SLS).
COPD is a disease of the lungs that involves chronic bronchitis, emphysema or both.
The SLS trial showed that relvar ellipta 100mcg / 25mcg had achieved a superior reduction in exacerbations, compared to usual care in patients with COPD in an everyday clinical practice setting.
The usual care included long-acting muscarinic antagonists (LAMA), long-acting beta2-agonists (LABA), and inhaled corticosteroids (ICS) given as monotherapy, dual or triple combinations.
It was reported that for the primary effectiveness analysis, in patients treated with FF / VI 100mcg / 25mcg there was a statistically significant reduction of 8.41% in the rate of moderate or severe exacerbations, compared with those receiving usual care.
Within the trial's intent-to-treat (ITT) population, the incidence of serious adverse events (SAE) was similar between the groups.
For pneumonia, an SAE of special interest, FF / VI showed non-inferiority in comparison to usual care.
SLS lead investigator, University Hospital South Manchester NHS Foundation Trust and the University of Manchester Respiratory Medicine professor Jørgen Vestbo said: "The Salford Lung Study is a very important trial to help us understand more about the medicines we prescribe on a day-to-day basis.
"This is an important finding, and what we are seeing today is the tip of the iceberg. Over the coming months we will understand more about the day-to-day effectiveness of FF / VI and how treatment choice, patient behaviour, co-morbidities and other factors combine to influence COPD outcomes.
"This has been a highly collaborative effort to gather data that will help improve understanding about the effectiveness of respiratory medicines when used in usual clinical practice."
During the SLS trial, the enrolled patients were randomised 1:1 to receive FF / VI 100cg / 25mcg, with or without a LAMA, or to continue to receive usual care.
FF / VI was given once daily via the Ellipta inhaler and the patients taking a LAMA, along with ICS / LABA therapy (triple therapy) who were randomised to the FF / VI group were able to continue to use LAMA therapy in addition to FF / VI.
Usual care was taken as advised by the prescribing clinician and had included single or dual long-acting bronchodilator therapy, inhaled corticosteroid either alone or in combination with a long-acting bronchodilator or triple therapy of a LAMA, a LABA and an inhaled corticosteroid.
In order to perform the primary effectiveness analysis the patient population was restricted to patients who had exacerbated in the previous 12 months prior to randomisation, rather than in the previous three years prior to randomisation, as in the intention to treat (ITT) group.
Image: Figure A shows the location of the lungs and airways in the body and figure B shows lungs damaged by COPD. Photo: courtesy of National Heart Lung and Blood Institute.