Abstract
Aim: This post hoc analysis from the IRIDIUM study (NCT02571777) assessed reduction in exacerbations with indacaterol/glycopyrronium/mometasone (IND/GLY/MF) high-dose MF vs medium-dose MF in patients with inadequately controlled asthma.
Methods: This 52 wk, randomised, double-blind, double-dummy, parallel-group study included patients (≥18–≤75yrs) who were symptomatic (ACQ-7 ≥1.5), had ≥1 severe exacerbations in the previous year, and % predicted FEV1 of <80%. Here, we analysed reductions in moderate or severe, severe, and all exacerbations, and safety with IND/GLY/MF high- (150/50/160µg) vs medium-dose (150/50/80µg), delivered o.d. via Breezhaler®, over 52 wks.
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) vs medium-dose over 52 wks (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- vs medium-dose group.
Conclusion: 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 wks of treatment.
Footnotes
Cite this article as: European Respiratory Journal 2020; 56: Suppl. 64, 2281.
This abstract was presented at the 2020 ERS International Congress, in session “Respiratory viruses in the "pre COVID-19" era”.
This is an ERS International Congress abstract. No full-text version is available. Further material to accompany this abstract may be available at www.ers-education.org (ERS member access only).
- Copyright ©the authors 2020
