Efficacy of MF/IND/GLY on lung function and exacerbations in pts with inadequately controlled asthma on medium-dose ICS/LABA (GINA step 4): Results from IRIDIUM

Clinical Research Results Abstract IntroductionGlobal Initiative for Asthma (GINA) 2020 recommends medium-dose inhaled corticosteroids/long-acting β2-agonist (ICS/LABA) as preferred controller for patients in step 4 therapy. This post hoc analysis from IRIDIUM study evaluated efficacy of once-daily medium- (80/150/50 μg) and high-dose (160/150/50 μg) mometasone/indacaterol/glycopyrronium (MF/IND/GLY) vs twice-daily high-dose fluticasone/salmeterol (FLU/SAL; 500/50 μg) in patients with inadequately controlled asthma (asthma control questionnaire [ACQ]-7 ≥1.5) with medium-dose ICS/LABA therapy prior to enrolment.MethodsIRIDIUM (NCT02571777) was 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 medium-dose ICS/LABA (62.4% at baseline), medium- and high-dose MF/IND/GLY showed greater improvements in trough FEV1 and a greater reduction in exacerbation rate versus high-dose FLU/SAL (Table).ConclusionsIn patients with inadequately controlled asthma with medium-dose ICS/LABA, greater lung function improvement and exacerbation reduction were observed with both doses of MF/IND/GLY versus high-dose FLU/SAL. These results suggest use of MF/IND/GLY as step-up therapy from medium-dose ICS/LABA provides benefit beyond increasing ICS dose. Research Idea Abstract Service Development & Evaluation Abstract Declaration of Interest Huib 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. 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