Evaluating contributions of MF, IND and GLY to reduction of exacerbations in patients with inadequately controlled asthma: Results from IRIDIUM study

Clinical Research Results Abstract IntroductionIn the IRIDIUM study, high-dose mometasone/indacaterol/glycopyrronium (MF/IND/GLY) once daily showed substantial reductions in asthma exacerbations versus high-dose fluticasone/salmeterol (FLU/SAL) twice daily. Here we evaluate the contributions of MF, IND and GLY towards exacerbation reduction in patients with inadequately controlled asthma MethodsIRIDIUM (NCT02571777) was a 52-week, randomised, double-blind study in symptomatic patients (Asthma control questionnaire-7, ≥1.5), with ≥1 exacerbation in previous year, % predicted FEV1 <80%. Reductions in annualised rate of moderate or severe, severe, and all (mild, moderate and severe) exacerbations with pooled high- (160/150/50 μg) and medium-dose (80/150/50 μg) MF/IND/GLY vs pooled high- (320/150 μg) and medium-dose (160/150 μg) MF/IND were evaluated for more precise estimation of contribution of GLY. Corresponding comparisons of high-dose MF/IND vs high-dose FLU/SAL (500/50 μg) were evaluated to estimate the contribution of MF and IND. ResultsHigh-dose MF/IND/GLY showed clinically meaningful reductions in moderate or severe (36%), severe (42%) and all exacerbations (40%) versus high-dose FLU/SAL. Pooled MF/IND/GLY showed reduction in moderate or severe (14%), severe (15%) and all exacerbations (17%) versus pooled MF/IND, highlighting potential role of GLY in exacerbation reduction. High-dose MF/IND showed reductions in moderate or severe (24%), severe (26%) and all exacerbations (24%) versus high-dose FLU/SAL, demonstrating benefits of MF and IND. ConclusionsData analysis evaluated in the context of 36 to 42% reduction observed with high-dose MF/IND/GLY versus high-dose FLU/SAL in IRIDIUM study, highlighted the considerable contributions of GLY, IND and MF to exacerbation reduction. Research Idea Abstract Service Development & Evaluation Abstract Declaration of Interest Kenneth R. Chapman reports grants and personal fees from AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Grifols, Sanofi, Regeneron, Novartis and Takeda; personal fees from CSL Behring, Inhibrx, Kamada and Sanofi; grants from Vertex, outside the submitted work.Funding: The study was funded by Novartis Pharmaceuticals. Trial registration: This study is registered with ClinicalTrials.gov, NCT02571777 References and Clinical Trial Registry Information