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

<b>Introduction:</b> 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 pts <b>Methods:</b> 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 <b>(Figure).</b> 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 safety <b>Results:</b> Of 802 pts randomised, 768 completed study. IND/MF significantly improved trough FEV₁ (least squares mean treatment difference [LSMTD]: 0.182L; P &lt; 0.001) and ACQ-7 (LSMTD: −0.218; P &lt; 0.001) versus MF at Week 12. ACQ-7 responder rate, rescue medication use, PEF and AQLQ favoured IND/MF. Safety was comparable <b>Conclusion:</b> In symptomatic asthma pts, IND/MF significantly improved lung function and asthma control versus MF. This supports IND/MF as efficacious maintenance therapy for asthma