Results of phase III IRIDIUM study of Enerzair Breezhaler in asthma published in Lancet Respiratory Medicine.- Novartis

Novartis announced that full results from the Phase III IRIDIUM study were published in The Lancet Respiratory Medicine. The primary endpoint results show that once-daily treatment with high- and medium-dose Enerzair Breezhaler (QVM149; indacaterol acetate, glycopyrronium bromide and mometasone furoate [IND/GLY/MF]) demonstrated statistically significant improvements in lung function compared with once-daily QMF149 (indacaterol acetate and mometasone furoate [IND/MF]). The key secondary endpoint was improvement in Asthma Control Questionnaire (ACQ-7) score for IND/GLY/MF versus IND/MF. Although both treatments delivered clinically meaningful improvements in this measure, the key secondary endpoint was not met. In secondary analyses, improvements in lung function and clinically meaningful reductions in moderate-to-severe and severe asthma exacerbation rates were observed with high-dose IND/GLY/MF compared to high-dose salmeterol xinafoate/fluticasone propionate (Sal/Flu). The overall incidence of adverse events (AEs) and serious adverse events (SAEs) for IND/GLY/MF and IND/MF in the IRIDIUM study were generally low and comparable among treatment groups. See: "Once-daily, single-inhaler indacaterol/glycopyrronium/mometasone versus indacaterol/mometasone or twice-daily salmeterol/fluticasone in patients with inadequately controlled asthma (IRIDIUM): a randomised, double-blind, controlled Phase III study." Kerstjens H et al. Lancet Resp Med; https://doi.org/10.1016/S2213-2600(20)30190-9