Efficacy and safety of inhaled once-daily low-dose indacaterol acetate/mometasone furoate in patients with inadequately controlled asthma: Phase III randomised QUARTZ study findings

Abstract Background Global initiative for asthma (GINA) 2019 recommends adding a long-acting β2-agonist (LABA) to an inhaled corticosteroid (ICS) as a maintenance controller therapy in patients with inadequately controlled asthma. Indacaterol acetate (IND, a LABA) in combination with mometasone furoate (MF, an ICS) is under development for the treatment of these patients. Objective This phase III QUARTZ was a multicentre, randomised, double-blind, double-dummy and parallel-group study to assess the efficacy and safety of low-dose IND/MF 150/80 μg once daily (o.d.) versus MF 200 μg o.d. in adult and adolescent patients with inadequately controlled asthma. Methods Eligible patients (n = 802) were randomised (1:1) to receive either low-dose IND/MF 150/80 μg o.d. via Breezhaler® or MF 200 μg o.d. via Twisthaler® for 12 weeks. Primary endpoint was trough forced expiratory volume in one second (FEV1) and key secondary endpoint was Asthma Control Questionnaire (ACQ-7) treatment difference after 12-week treatment. Other secondary endpoints included ACQ-7 responder analysis, morning and evening peak expiratory flow, Asthma Quality of Life Questionnaire total score, rescue medication use, daily symptom score, nighttime awakenings and rate of exacerbations, evaluated over 12-week treatment. Safety was also assessed including serious asthma outcomes. Results Low-dose IND/MF significantly improved trough FEV1 (least squares mean treatment difference [LSMTD]: 0.182 L; p  Conclusion These results support the use of low-dose IND/MF 150/80 μg o.d. as a potential therapy for adult and adolescent patients with inadequately controlled asthma.