Lower ICS dose effect on symptoms and rescue medication use of indacaterol/glycopyrronium/mometasone (IND/GLY/MF) medium-dose vs salmeterol/fluticasone (SAL/FLU) high-dose plus tiotropium (TIO): ARGON study

Aim: Prior studies have confirmed fast and sustained bronchodilation with indacaterol acetate (IND) and glycopyrronium bromide (GLY),1 and improved lung function with mometasone furoate (MF)2. We evaluated effect of IND/GLY/MF fixed-dose combination via Breezhaler® versus salmeterol xinafoate/fluticasone propionate (SAL/FLU) + tiotropium (TIO) on symptoms and rescue medication use in uncontrolled asthma patients.Methods: ARGON was 24-week, Phase-3b, multicentre, randomised, partially-blinded, non-inferiority, active-controlled study in symptomatic (asthma control questionnaires [ACQ]-7 ≥1.5) patients (≥18 years). This exploratory analysis evaluated effect of IND/GLY/MF medium-dose (150/50/80 μg) once-daily (o.d.) versus combination of SAL/FLU high-dose (50/500 μg) twice-daily (b.i.d.) + TIO 5 μg o.d. on symptom scores and rescue medication use at Week 24.Results: Reduction in total daily symptom scores (least mean square treatment difference [Δ]: −0.103, p=0.119), percentage of nights without awakenings (Δ: 0.864, p=0.608) and reduction in rescue medication use (Δ: −0.134, p=0.081) with IND/GLY/MF medium-dose were comparable with SAL/FLU+TIO. Patients receiving IND/GLY/MF medium-dose had higher percentage of days with no day-time symptoms (Δ: 4.453, p=0.016) and mornings with no symptoms (Δ: 4.976, p=0.012) versus SAL/FLU+TIO.Conclusions: IND/GLY/MF medium-dose o.d. via single inhaler was comparable for symptom scores and rescue medication use, resulting in better improvements in day-time symptoms and morning symptoms versus SAL/FLU high-dose b.i.d. + TIO o.d. via two inhalers, at reduced ICS dose. Implementation Science/Service Development Research Ideas on Respiratory Conditions and Tobacco Dependency Abstract Declaration of Interest Outside submitted work- CG: personal fees for advisory board, honoraria for academic talks from GSK, Pfizer, AstraZeneca, Roche, Novartis, BMS, MSD, Berlin-Chemie, Chiesi, Boehringer Ingelheim, Sanofi. OK: fees for conducting study as participating site; personal speaker fees from Sanofi, Boehringer Ingelheim, AstraZeneca, Novartis for advisory boards, consulting fees from Novartis and GlaxoSmithKline. JM: speaker fees, clinical study grants by Novartis, speaker fees from AstraZeneca, speaker fees, research grants by Sanofi; consultancy fees from ImmunoTek. RZ-S: advisory board, honoraria for academic talks from Aspen/GSK, Pfizer, Roche, AstraZeneca, Novartis, MSD, Cipla. MK: advisory board, honoraria for academic talks from ALK, AstraZeneca, Berlin-Chemie, Chiesi, Novartis, Sanofi-Aventis.AS: speaker’s honoraria from AstraZeneca, Bial, Boehringer Ingelhiem, Chiesi, Esteve, Ferrer, GSK, Menarini, Mundipharma, Novartis, Pfizer, Rovi, Teva; honoraria for attending Advisory Boards with AstraZeneca, Bial, Novartis; sponsorship to attend national, international scientific meetings from Boehringer Ingelheim, Menarini, Novartis. LGC: employee of Novartis. AS and PG: employees of Novartis during study. The study was funded by Novartis Pharma AG, Basel. References and Clinical Trial Registry Information Rossi A. et al. Int J Chron Obstruct Pulmon Dis 2015;10:1383-92;Kemp JP. et al. J Allergy Clin Immunol 2000;106:485-92Clinicaltrial.gov: NCT03158311