Novartis announced positive first results from the Phase III FLAME head-to-head trial examining the rate of chronic obstructive pulmonary disease (COPD) exacerbations. Once-daily Ultibro® Breezhaler® (indacaterol/glycopyrronium) 110/50 mcg met its primary endpoint (non-inferiority) and furthermore demonstrated superiority to twice-daily Seretide® (salmeterol/fluticasone) 50/500 mcg in reducing the rate of all COPD exacerbations (mild/moderate/severe) over one year of treatment.
This finding is consistent with the earlier LANTERN trial and is now expanded to patients with at least one exacerbation in the previous year. The safety profiles of the two treatments were consistent with their known profiles, according to the initial FLAME results.
"Today's FLAME study results provide clear further evidence that Ultibro Breezhaler is more effective than Seretide in reducing COPD exacerbations, events linked to significant patient suffering and more rapid progression of the disease," said Vasant Narasimhan, Global Head of Development, Novartis Pharmaceuticals. "We believe FLAME challenges our historical reliance on inhaled corticosteroids and may support expanding the use of dual bronchodilators to both exacerbating and non-exacerbating COPD patients."
In the study, 3362 COPD patients were randomised to 52 weeks of treatment with once-daily Ultibro Breezhaler or twice-daily Seretide, Secondary endpoints included superiority for Ultibro Breezhaler versus Seretide concerning the rate of all COPD exacerbations over the study duration and efficacy in terms of the time to first COPD exacerbation, the rate and time to first moderate-to-severe COPD exacerbation, lung function, health-related quality of life, rescue medication use and safety.
