Efficacy of MF/IND/GLY on lung function and exacerbations in pts with inadequately controlled asthma on high-dose ICS/LABA (GINA step 5): Results from IRIDIUM

Clinical Research Results Abstract IntroductionGlobal Initiative for Asthma (GINA) 2020 recommends high-dose inhaled corticosteroids/long-acting β2-agonist (ICS/LABA) as preferred controller for patients with asthma in step 5 therapy. This post hoc analysis from IRIDIUM study evaluated efficacy of once-daily high-dose (160/150/50 μg) versus medium-dose (80/150/50 μg) mometasone/indacaterol/glycopyrronium (MF/IND/GLY) in patients with inadequately controlled asthma (asthma control questionnaire [ACQ]-7 ≥1.5) with high-dose ICS/LABA prior to enrolment.MethodsIRIDIUM (NCT02571777) was a 52-week, randomised, double-blind, parallel-group study in patients with symptomatic asthma (ACQ-7 ≥1.5), ≥1 exacerbation in previous year and predicted forced expiratory volume in one second (FEV1) <80%. Trough FEV1 at Week 26 and annualised rate of exacerbations over 52 weeks were assessed.ResultsIn patients with inadequately controlled asthma with high-dose ICS/LABA (37% at baseline), high-dose MF/IND/GLY showed comparable improvements in trough FEV1 at Week 26 and relevant reduction in exacerbation rate (non-significant in this underpowered analysis) versus medium-dose MF/IND/GLY (Table).ConclusionsIn patients with inadequately controlled asthma with high-dose ICS/LABA, comparable FEV1 improvement and a trend toward exacerbation rate reduction were seen with high-dose than medium-dose MF/IND/GLY. These results suggest high-dose MF/IND/GLY as step-up therapy provides better clinical benefit than medium-dose MF/IND/GLY. Research Idea Abstract Service Development & Evaluation Abstract Declaration of Interest Jorge F. Maspero: Reports grants and personal fees from Novartis, during the conduct of the study, grants and personal fees from Sanofi, and personal fees from AstraZeneca and ImmunoTek. Karen Mezzi: Employee of Novartis Pharma.Funding: The study was funded by Novartis Pharmaceuticals Corporation, East Hanover, NJ, United States.Trial registration: This study is registered with ClinicalTrials.gov, NCT02571777. References and Clinical Trial Registry Information