TY - JOUR T1 - Efficacy and safety of once-daily low-dose indacaterol/mometasone via Breezhaler in symptomatic adult and adolescent patients with inadequately controlled asthma: Phase III randomised QUARTZ study findings JF - European Respiratory Journal JO - Eur Respir J DO - 10.1183/13993003.congress-2019.RCT3780 VL - 54 IS - suppl 63 SP - RCT3780 AU - Peter D’Andrea AU - Oliver Kornmann AU - Janos Mucsi AU - Motokazu Kato AU - Lorraine Bandelli AU - Biswajit Sen Y1 - 2019/09/28 UR - http://erj.ersjournals.com/content/54/suppl_63/RCT3780.abstract N2 - Introduction: GINA recommends ICS/LABA as initial controller therapy in inadequately controlled asthma patients (pts) on low-dose ICS. We evaluated efficacy and safety of low-dose indacaterol acetate/mometasone furoate (IND/MF) 150/80 µg once daily (o.d.) via Breezhaler® versus MF 200 µg o.d. via Twisthaler® in symptomatic asthma ptsMethods: This Phase III, 12-week, double-blind study randomised (1:1) asthma pts (≥12yrs) receiving low-dose ICS prior to study, to IND/MF or MF (Figure). Pts were symptomatic (ACQ-7 ≥1.5) prior to randomisation. Primary endpoint: trough FEV1 at Week 12. Key secondary endpoint: change in ACQ-7 score. Other secondary endpoints: ACQ-7 responders, AM and PM peak expiratory flow (PEF), rescue medication use, AQLQ and daily symptom score. We also assessed safetyResults: Of 802 pts randomised, 768 completed study. IND/MF significantly improved trough FEV1 (least squares mean treatment difference [LSMTD]: 0.182L; P < 0.001) and ACQ-7 (LSMTD: −0.218; P < 0.001) versus MF at Week 12. ACQ-7 responder rate, rescue medication use, PEF and AQLQ favoured IND/MF. Safety was comparableConclusion: In symptomatic asthma pts, IND/MF significantly improved lung function and asthma control versus MF. This supports IND/MF as efficacious maintenance therapy for asthmaFootnotesCite this article as: European Respiratory Journal 2019; 54: Suppl. 63, RCT3780.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). ER -