Abstract
The efficacy and safety of once-daily (o.d.) fixed-dose combination of indacaterol (IND), glycopyrronium (GLY) and mometasone furoate (MF) via Breezhaler® versus concurrent administration of salmeterol/fluticasone (SAL/FLU) twice-daily (b.i.d.) via Accuhaler®+Tiotropium (TIO) o.d. via Respimat® was evaluated in patients with uncontrolled asthma. Patients (aged ≥18 years), symptomatic (Asthma Control Questionnaire [ACQ]-7 ≥1.5) despite treatment with long-acting β2-agonist/inhaled corticosteroid medium- or high-dose, received IND/GLY/MF high- (150/50/160μg) or medium-dose (150/50/80μg) o.d. or SAL/FLU high-dose (50/500μg) b.i.d.+Tio 5μg o.d. for 24 weeks. The primary objective was to confirm the non-inferiority of either dose of IND/GLY/MF to SAL/FLU high dose+TIO in terms of Asthma Quality of Life Questionnaire (AQLQ). Additional endpoints: ACQ-7, lung function, health status (St George's Respiratory Questionnaire [SGRQ]), exacerbations, and safety after 24 weeks. IND/GLY/MF high- and medium-dose met the primary endpoint, confirming non-inferiority to SAL/FLU high dose+TIO for AQLQ (least square mean treatment difference [Δ]: 0.073 and -0.038, respectively; both p<0.001). IND/GLY/MF high-dose improved ACQ-7 (Δ: -0.124; p=0.004), trough FEV1 (Δ: 96mL; p<0.001), peak expiratory flow (morning [Δ: 9.56L/min; p=0.005], evening [Δ: 9.15L/min; p=0.006]) and SGRQ (Δ: -2.00; p=0.04) versus SAL/FLU high dose+TIO. Improvements in these endpoints were comparable for IND/GLY/MF medium-dose and SAL/FLU high dose+TIO. Adverse events were generally comparable across treatments. IND/GLY/MF high- and medium-dose o.d. via a single inhaler were non-inferior to SAL/FLU high-dose b.i.d.+TIO o.d. via two inhalers for AQLQ. IND/GLY/MF high-dose o.d. improved lung function, asthma control and health status versus SAL/FLU high dose+TIO, while IND/GLY/MF medium-dose had comparable efficacy but at a corresponding lower steroid dose.
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