Novartis’ Ultibro Breezhaler Tops GSK’s Seretide in Reducing COPD

Novartis’ Ultibro Breezhaler once-daily inhaler met primary and secondary endpoints in a head-to-head trial with GlaxoSmithKline’s twice-daily Seretide in reducing the rate of chronic obstructive pulmonary disease exacerbations.

In the 52-week, 3,362-patient FLAME study, the Ultibro Breezhaler (indacaterol/glycopyrronium) met its primary endpoint of non-inferiority compared with Seretide (salmeterol/fluticasone) and met the secondary endpoint of superiority, Novartis says. Secondary endpoints included superiority in terms of rate of all COPD exacerbations over the study duration and efficacy in terms of time to first COPD exacerbation rate; lung function; health-related quality of life; and rescue medication use and safety.

FLAME is the final of 11 studies in the IGNITE Phase 3 clinical trial program exploring Ultibro Breezhaler in COPD.