The New England Journal of Medicine has published a clinical trial showing that Novartis' Ultibro Breezhaler outshone GlaxoSmithKline's Seretide on reducing COPD flare-ups, which could challenge the current reliance on inhaled corticosteroids.
Preventing exacerbations is a key treatment goal because they not only have a detrimental effect on quality of life but also on disease progression, fuelling further lung function decline and, in severe cases, causing hospitalisation and even death.
The FLAME study, which involved 3,362 COPD patients, met its primary endpoint in showing that once-daily treatment with Ultibro Breezhaler (indacaterol/glycopyrronium bromide) was non-inferior to twice daily Seretide (salmeterol/fluticasone) in reducing exacerbations.
But the findings also showed Novartis' drug to be superior to the widely used inhaled corticosteroid (ICS)/LABA combination on this measure, considered the standard of care. Compared to Seretide, Ultibro Breezhaler both reduced the rate of moderate or severe exacerbations with a 17% risk reduction, and prolonged the time to the first of these episodes with a 22% risk reduction, the firm noted.
"The FLAME study has clearly shown that Ultibro Breezhaler is superior to the current standard of care in reducing exacerbations, marking a shift away from therapies containing steroids for the optimal treatment of COPD patients," said Vasant Narasimhan, global head Drug Development and chief medical officer at the the Swiss drugs giant.
Findings from the head-to-head LANTERN study, presented back in September 2014, also demonstrated that once-daily Ultibro Breezhaler was superior in reducing exacerbations and improving lung function compared to twice-daily Seretide, with a risk reduction of 31% in moderate-to-severe COPD patients with a history of one exacerbation or none in the previous year.