Efficacy and safety of once-daily IND-MF in symptomatic adult and adolescent patients with inadequately controlled asthma: findings from the Phase III randomized QUARTZ study

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 pts.

Methods: This Phase III, 12-week, double-blind study randomized (1 : 1) asthma pts (≥ 12 yrs) receiving lowdose ICS prior to study, to IND/MF or MF. Pts were symptomatic (ACQ-7 ≥ 1.5) prior to randomization. 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.

Results: Of 802 pts randomized, 768 completed study. IND/MF significantly improved trough FEV1 (least squares mean treatment difference [LSMTD]: 0.182 L; 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 favored IND/MF. Safety was comparable.

Conclusion: 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.