Superiority of Novartis’ Ultibro Breezhaler over Seretide in reducing COPD exacerbations

Ultibro Breezhaler met primary endpoint and demonstrated superiority to Seretide in reducing COPD exacerbations during 52 weeks of treatment. First large-scale study to confirm Ultibro Breezhaler is an effective steroid-free option that both reduces exacerbations and improves lung function in COPD patients with one or more exacerbations in the past year, compared to Seretide -   Full FLAME study results to be shared in 2016 Basel, November 17, 2015 - Novartis today 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.