Reduction in asthma exacerbations with indacaterol/glycopyrronium/mometasone high-dose versus medium-dose: a post hoc analysis from the IRIDIUM study

Aim: This post-hoc analysis from the IRIDIUM study (NCT02571777) assessed reduction in exacerbations with indacaterol acetate/glycopyrronium bromide/mometasone furoate (IND/GLY/MF) high-dose MF versus medium-dose MF in patients with inadequately controlled asthma.Methods: This 52 week, randomised, double blind, double-dummy, parallel-group study included patients (≥18–≤75 years) who were symptomatic (asthma control questionnaire [ACQ]-7 ≥1.5), had ≥1 severe exacerbations in the previous year, and percentage predicted forced expiratory volume in one second (FEV1) of <80%. Here, we analysed reductions in moderate or severe, severe, and all exacerbations, and safety with IND/GLY/MF high- (150/50/160 μg) versus medium-dose (150/50/80 μg), delivered once-daily (o.d.) via Breezhaler®, over 52 weeks.Results: IND/GLY/MF high-dose demonstrated clinically meaningful reductions in moderate or severe (21%; p=0.026) and severe (31%; p=0.003), and a trend towards greater reduction in all exacerbations (14%; p=0.132) versus medium-dose over 52 weeks (Figure). Both doses were well tolerated, with no meaningful increase in frequency of adverse events (AEs) typically associated with inhaled corticosteroids (ICS) use (pneumonia, candidiasis, infection) in IND/GLY/MF high- versus medium-dose group.Conclusions: IND/GLY/MF high-dose o.d. demonstrated clinically relevant reductions in asthma exacerbations compared with the medium-dose o.d., without any meaningful increase in ICS-related AEs after 52 weeks of treatment. Implementation Science/Service Development Research Ideas on Respiratory Conditions and Tobacco Dependency Abstract Declaration of Interest Kenneth R. Chapman reports grants and personal fees from AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Grifols, Novartis, Regeneron, Sanofi, and Takeda, grants from Vertex, and personal fees from CSL Behring, Inhibrx, and Kamada, all outside of the submitted work. Konstantinos Kostikas has received honoraria for presentations and/or consulting services from AstraZeneca, Boehringer Ingelheim, Chiesi, ELPEN, GlaxoSmithKline, Menarini, and Novartis. Huib A.M. Kerstjens reports grants and fees for consultancy or advisory board participation from Novartis, during the conduct of the study; and grants and fees for consultancy or advisory board participation from GlaxoSmithKline and Boehringer Ingelheim, and a grant from Chiesi, outside of the submitted work. All were paid to his institution. Peter D’Andrea and Abhijit Pethe are employees of Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA. Motoi Hosoe, Devendra Jain, and Ana-Maria Tanase are employees of Novartis Pharma, Basel, Switzerland. The study was funded by Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA. References and Clinical Trial Registry Information Clinicaltrials.gov:NCT02571777